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Rondek PGA suture is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular and neurological procedures.

RK's Rondek PGA suture is a sterile, absorbable, braided suture composed of a homopolymer of glycolic acid and coated with a copolymer of Polycaprolactone and Polyglycolic acid.

This document is a 510(k) summary for the Rondek PGA Suture and as such, it focuses on demonstrating substantial equivalence to a predicate device rather than detailing specific acceptance criteria and an independent study proving the device meets those criteria.

Therefore, the requested information elements related to acceptance criteria, specific study design, sample sizes, expert involvement, and ground truth establishment cannot be fully provided from this document alone, as it describes a different type of regulatory submission process.

Here's what can be extracted based on the provided text:

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

The document states that the device meets "relevant USP specifications" and lists several types of performance tests. However, it does not provide a table specifying the exact acceptance criteria for each test or the exact performance results achieved by the Rondek PGA Suture. It only generally states that the tests "support that the Rondek PGA suture meets relevant USP specifications and is equivalent to its predicate."

2. Sample size used for the test set and the data provenance:

• Sample size: Not specified.
• Data provenance: Not specified (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This is not applicable as the submission focuses on laboratory and performance testing for a suture, not on diagnostic output requiring expert interpretation.

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

Not applicable for this type of device and submission. The performance data listed (e.g., USP testing, Eto Residuals, Biocompatibility) are typically objective laboratory measurements, not subjective evaluations requiring adjudication.

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. This is a surgical suture, not a diagnostic AI device.

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

Not applicable. This is a surgical suture, not an algorithm.

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

The "ground truth" for the performance data would be the established scientific and regulatory standards (e.g., USP monographs for suture properties, recognized standards for biocompatibility, pyrogenicity, and sterilization residuals). These are objective measurements rather than interpretations requiring expert consensus or pathology.

8. The sample size for the training set:

Not applicable. This is a physical medical device, not an AI model requiring a training set.

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

Not applicable. This is a physical medical device.

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