Transfer Alert

This paper was transferred from another journal. As a result, its full editorial history (including decision letters, peer reviews and author responses) may not be present.

PONE-D-21-19490

Mapping the genealogy of medical device predicates in the United States

PLOS ONE

Dear Dr. Pai,

Thank you for submitting your manuscript to PLOS ONE. After careful consideration, we feel that it has merit but does not fully meet PLOS ONE’s publication criteria as it currently stands. Therefore, we invite you to submit a revised version of the manuscript that addresses the points raised during the review process.

Please submit your revised manuscript by Aug 20 2021 11:59PM. If you will need more time than this to complete your revisions, please reply to this message or contact the journal office at plosone@plos.org. When you're ready to submit your revision, log on to https://www.editorialmanager.com/pone/ and select the 'Submissions Needing Revision' folder to locate your manuscript file.

Please include the following items when submitting your revised manuscript:

• A rebuttal letter that responds to each point raised by the academic editor and reviewer(s). You should upload this letter as a separate file labeled 'Response to Reviewers'.
• A marked-up copy of your manuscript that highlights changes made to the original version. You should upload this as a separate file labeled 'Revised Manuscript with Track Changes'.
• An unmarked version of your revised paper without tracked changes. You should upload this as a separate file labeled 'Manuscript'.

If you would like to make changes to your financial disclosure, please include your updated statement in your cover letter. Guidelines for resubmitting your figure files are available below the reviewer comments at the end of this letter.

If applicable, we recommend that you deposit your laboratory protocols in protocols.io to enhance the reproducibility of your results. Protocols.io assigns your protocol its own identifier (DOI) so that it can be cited independently in the future. For instructions see: http://journals.plos.org/plosone/s/submission-guidelines#loc-laboratory-protocols. Additionally, PLOS ONE offers an option for publishing peer-reviewed Lab Protocol articles, which describe protocols hosted on protocols.io. Read more information on sharing protocols at https://plos.org/protocols?utm_medium=editorial-email&utm_source=authorletters&utm_campaign=protocols.

We look forward to receiving your revised manuscript.

Kind regards,

Dylan A Mordaunt

Academic Editor

PLOS ONE

Additional Editor Comments:

I think there is value in this paper. It needs some refinement both to increase the appeal and relevance to a broader audience, but also to increase the potential impact. Our reviewers have provided some good suggestions that the authors should consider and address. In taking on a complex cross-disciplinary area, they have done well but created a considerable challenge in terms of creating a meaningful output so far for anyone other than a highly technical (and therefore highly limited) range of readers. Please reconsider your paper with regards to the range of authors to whom this is both of potential interest and potential application. Thanks again, Dylan.

Journal Requirements:

When submitting your revision, we need you to address these additional requirements.

1. Please ensure that your manuscript meets PLOS ONE's style requirements, including those for file naming. The PLOS ONE style templates can be found at

https://journals.plos.org/plosone/s/file?id=wjVg/PLOSOne_formatting_sample_main_body.pdf and

https://journals.plos.org/plosone/s/file?id=ba62/PLOSOne_formatting_sample_title_authors_affiliations.pdf

[Note: HTML markup is below. Please do not edit.]

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Partly

Reviewer #2: Yes

**********

2. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: N/A

**********

3. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: No

Reviewer #2: Yes

**********

5. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: the use of predicate / child and predicate / children terms is confusing. suggest chage to antecedent / sucessor or similar. The discussion section includes statements that are not supported with data that is obvious eg "prodiuct codes with more class 2 recalls tended to have more devices and more complaints" is not supported by data and analysiss within the body of the paper. similarly the conlcusions are unsupported by data or anlsyis from the body of the paper - for example the statement that ".. the technological characteristics of the predicate and its child can fluctuate wiedly, suggetsing a wide vaiation in the accpeted characteristics of the substantial equivalence test."

both the absence of supprting data and the volubl language will need to be adressed.

Reviewer #2: Dhruv High Pai summarizes in this article that if the medical devices can be shown to be substantially equivalent in safety and effectiveness to a pre-existing FDA via the 510(k) pathway, they can be cleared to market. Author claims that mapping of connectivity of various predicates could help increase consumer confidence in the medical devices that are currently in the marketplace. Devices approved first in the EU are associated with an increased risk of post-marketing safety alerts and recalls, therefore the paper addresses an essential public health concern and this is a strength to acknowledge. The study appears to be sound, however some details should be expanded and clarified to ensure that readers understand what the researcher studied.

Some points to consider in subsequent versions:

Major – The study lacks general statement about its limitations. However, the use of bag-of-words model as one of the most popular representation methods for object categorization is associated with a number of uncertainties. The key idea is to quantize each extracted key point into one of visual words, and then represent each image by a histogram of the visual words. For this purpose, a clustering algorithm (e.g., K-means), is generally used for generating the visual words. As K-means tends to ‘starve’ medium density regions in feature space, measures to minimize the loss of information should be implemented and justified. It has been previously demonstrated that the pairwise similarity cannot be computed directly and to show the statistical consistency, Kernel Density Function Estimation / also referred as “Quantization via Kernel Estimation”, or QKE for short/ is encouraged in previous similar researches as an alternative to empirical distribution as “Quantization via Empirical Estimation”, or QEE. Therefore, additional justification is needed how author avoids in the model the problem of ‘code word uncertainty’ and ‘code word plausibility’.

Major – the references are very limited and only 8 /15 in total/ are research articles. The 510(k) ancestry as well as the related safety and effectiveness concerns have been elaborated in a number of rigorously peer- review publications, to note a few:

Ardaugh BM, Graves SE, Redberg RF (2013) The 510(k) ancestry of a metal-on-metal hip implant. N Engl J Med 368: 97–100.

Kramer DB, Xu S, Kesselheim AS (2012) Regulation of medical devices in the United States and European Union. N Engl J Med 366: 848–855

Zuckerman D, Brown P, Das A (2014) Lack of publicly available scientific evidence on the safety and effectiveness of implanted medical devices. JAMA Intern Med 174: 1781–1787.

Zuckerman DM, Brown P, Nissen SE (2011) Medical device recalls and the FDA approval process. Arch Intern Med 171: 1006–1011

Kessler DA, Pape SM, Sundwall DN (1987) The Federal regulation of medical devices. N Engl J Med 317: 357–366.

Day CS, Park DJ, Rozenshteyn FS, Owusu-Sarpong N, Gonzalez A (2016) Analysis of FDA-Approved Orthopaedic Devices and Their Recalls. J Bone Joint Surg Am 98: 517–524.

Fargen KM, Frei D, Fiorella D, McDougall CG, Myers PM, Hirsch JA, et al. (2013) The FDA approval process for medical devices: an inherently flawed system or a valuable pathway for innovation? J Neurointerv Sur 5: 269–275.

Haylen BT, Sand PK, Swift SE, Maher C, Moran PA, Freeman RM. (2012) Transvaginal placement of surgical mesh for pelvic organ prolapse: more FDA concerns—positive reactions are possible. Int Urogynecol J 23: 11–13.

Sedrakyan A, Campbell B, Merino JG, Kuntz R, Hirst A, McCulloch P. (2016) IDEAL-D: a rational framework for evaluating and regulating the use of medical devices. BMJ 353: i2372.

Sorenson C, Drummond M (2014) Improving medical device regulation: The United States and Europe in perspective. Milbank Q 92: 114–150.

I hereby encourage the author to enrich his references as it is hard to explain why such landmark sources were omitted.

Minor – more robust explanations are needed to explain the impact of poor quality of PDF files /line 167 onwards/ and the limitations of the OCR /lines 168-171/ to verify the efficacy of the proposed framework by applying it to object recognition.

Minor- In testing recalls and complaints for predicate device /lines 176- 199/ - may author elaborate on how many complaints have been found causal.

In summary, the paper raises interesting points that seem worth discussing, but requires

revisions.

**********

6. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: Borislav Borissov

[NOTE: If reviewer comments were submitted as an attachment file, they will be attached to this email and accessible via the submission site. Please log into your account, locate the manuscript record, and check for the action link "View Attachments". If this link does not appear, there are no attachment files.]

While revising your submission, please upload your figure files to the Preflight Analysis and Conversion Engine (PACE) digital diagnostic tool, https://pacev2.apexcovantage.com/. PACE helps ensure that figures meet PLOS requirements. To use PACE, you must first register as a user. Registration is free. Then, login and navigate to the UPLOAD tab, where you will find detailed instructions on how to use the tool. If you encounter any issues or have any questions when using PACE, please email PLOS at figures@plos.org. Please note that Supporting Information files do not need this step.

Mapping the genealogy of medical device predicates in the United States

PONE-D-21-19490R1

Dear Dr. Pai,

We’re pleased to inform you that your manuscript has been judged scientifically suitable for publication and will be formally accepted for publication once it meets all outstanding technical requirements.

Within one week, you’ll receive an e-mail detailing the required amendments. When these have been addressed, you’ll receive a formal acceptance letter and your manuscript will be scheduled for publication.

An invoice for payment will follow shortly after the formal acceptance. To ensure an efficient process, please log into Editorial Manager at http://www.editorialmanager.com/pone/, click the 'Update My Information' link at the top of the page, and double check that your user information is up-to-date. If you have any billing related questions, please contact our Author Billing department directly at authorbilling@plos.org.

If your institution or institutions have a press office, please notify them about your upcoming paper to help maximize its impact. If they’ll be preparing press materials, please inform our press team as soon as possible -- no later than 48 hours after receiving the formal acceptance. Your manuscript will remain under strict press embargo until 2 pm Eastern Time on the date of publication. For more information, please contact onepress@plos.org.

Kind regards,

Dylan A Mordaunt

Academic Editor

PLOS ONE

Additional Editor Comments (optional):

Thank you for your resubmission. The revised manuscript has been assessed by the reviewers and there is agreement to accept without any further revisions.

Reviewers' comments:

Reviewer's Responses to Questions

Comments to the Author

1. If the authors have adequately addressed your comments raised in a previous round of review and you feel that this manuscript is now acceptable for publication, you may indicate that here to bypass the “Comments to the Author” section, enter your conflict of interest statement in the “Confidential to Editor” section, and submit your "Accept" recommendation.

Reviewer #1: All comments have been addressed

Reviewer #2: All comments have been addressed

**********

2. Is the manuscript technically sound, and do the data support the conclusions?

The manuscript must describe a technically sound piece of scientific research with data that supports the conclusions. Experiments must have been conducted rigorously, with appropriate controls, replication, and sample sizes. The conclusions must be drawn appropriately based on the data presented.

Reviewer #1: Yes

Reviewer #2: Yes

**********

3. Has the statistical analysis been performed appropriately and rigorously?

Reviewer #1: Yes

Reviewer #2: Yes

**********

4. Have the authors made all data underlying the findings in their manuscript fully available?

The PLOS Data policy requires authors to make all data underlying the findings described in their manuscript fully available without restriction, with rare exception (please refer to the Data Availability Statement in the manuscript PDF file). The data should be provided as part of the manuscript or its supporting information, or deposited to a public repository. For example, in addition to summary statistics, the data points behind means, medians and variance measures should be available. If there are restrictions on publicly sharing data—e.g. participant privacy or use of data from a third party—those must be specified.

Reviewer #1: Yes

Reviewer #2: Yes

**********

5. Is the manuscript presented in an intelligible fashion and written in standard English?

PLOS ONE does not copyedit accepted manuscripts, so the language in submitted articles must be clear, correct, and unambiguous. Any typographical or grammatical errors should be corrected at revision, so please note any specific errors here.

Reviewer #1: Yes

Reviewer #2: Yes

**********

6. Review Comments to the Author

Please use the space provided to explain your answers to the questions above. You may also include additional comments for the author, including concerns about dual publication, research ethics, or publication ethics. (Please upload your review as an attachment if it exceeds 20,000 characters)

Reviewer #1: thank you for addressing my comments. the changes meet the issues raised in my first comments., including conclauions based on data and information provided in the body.

Reviewer #2: The author has embedded in the appropriate sections of the background content of the manuscript the reviewers comments and have strengthened the quality of the manuscript appropriately.

**********

7. PLOS authors have the option to publish the peer review history of their article (what does this mean?). If published, this will include your full peer review and any attached files.

If you choose “no”, your identity will remain anonymous but your review may still be made public.

Do you want your identity to be public for this peer review? For information about this choice, including consent withdrawal, please see our Privacy Policy.

Reviewer #1: No

Reviewer #2: Yes: Borislav Borissov