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PDS* Plus Antibacterial monofilament synthetic absorbable sutures are indicated for use in soft tissue approximation, including use in pediatric cardiovascular tissue where growth is expected to occur and ophthalmic surgery (other than contact with cornea and sclera). PDS Plus is not indicated in adult cardiovascular tissue, microsurgery, and neural tissue. These sutures are particularly useful where the combination of an absorbable suture and extended wound support (up to six weeks) is desirable.

PDS* Plus (Polydioxanone) Antibacterial monofilament synthetic absorbable suture is prepared from a polyester, poly (p-dioxanone). The suture is available dyed (D&C Violet No. 2) or undyed (natural). The suture contains Irgacare MP** (triclosan), a broad-spectrum antibacterial agent, at no more than 2360 ug/m.

This document describes the marketing authorization for the PDS* Plus (Polydioxanone) Antibacterial Suture (K061037) by Ethicon, Inc. However, the provided text does not contain acceptance criteria or a study proving the device meets acceptance criteria in the way typically expected for an AI/ML device submission.

Instead, this document is a 510(k) summary for a medical suture, which focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical performance data.

Therefore, the requested information elements related to acceptance criteria, device performance tables, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, and ground truth establishment cannot be extracted from the provided text.

Here's what can be extracted based on the nature of the submission:

1. A table of acceptance criteria and the reported device performance

• Not applicable / Not provided. The document states "Non-clinical laboratory testing was performed demonstrating that the device conformed to the USP Monograph for absorbable surgical sutures" and "in-vivo/in-vitro testing was provided showing that the device performed as intended and as claimed." However, specific acceptance criteria values and corresponding performance results are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not applicable / Not provided. This information is for clinical studies or performance studies involving a "test set" for an AI/ML device. For a suture, "non-clinical laboratory testing" and "in-vivo/in-vitro testing" are mentioned, but sample sizes, provenance, or retrospective/prospective nature of these tests are not disclosed.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not applicable / Not provided. This pertains to expert-annotated ground truth for AI/ML performance evaluation, which is not relevant to a suture submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable / Not provided. This pertains to ground truth establishment for AI/ML performance evaluation, which is not relevant here.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not applicable / Not provided. An MRMC study is for evaluating the impact of an AI device on human readers' performance. This is not relevant for a surgical suture.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable / Not provided. This is for evaluating AI algorithm performance, not relevant for a surgical suture.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not applicable / Not provided. The "performance data" mentioned refers to conformity with USP Monograph and "in-vivo/in-vitro testing" which likely involves physical and biological property measurements, not a "ground truth" as understood in AI/ML evaluation.

8. The sample size for the training set

• Not applicable / Not provided. This is relevant for AI/ML model training, not for a medical suture.

9. How the ground truth for the training set was established

• Not applicable / Not provided. This is relevant for AI/ML model training, not for a medical suture.

Summary of what is available:

• Device: PDS* Plus (Polydioxanone) Antibacterial Suture
• Purpose of Submission: Demonstrate substantial equivalence to predicate devices (PDS II* (Polydioxanone) Suture, VICRYL* Plus Antibacterial Suture, MONOCRYL* Plus Antibacterial Suture).
• Performance Data Mentioned:
  • Non-clinical laboratory testing demonstrating conformity to the USP Monograph for absorbable surgical sutures (except for diameter - this deviation is likely assessed as acceptable given the claim of substantial equivalence).
  • In-vivo/in-vitro testing showing the device performed as intended and claimed.
• Conclusion: Based on the provided information, the FDA found the device substantially equivalent to its predicate devices.

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