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REXLENE is indicated for use in general soft tissue approximation and/or ligation, including use in ophthalmic procedures, but not for use in cardiovascular or neural tissue.

REXLENE is a sterilized nonabsorbable monofilament surgical suture made out of polypropylene used in general soft tissue approximation and/or ligation with or without needle made out of Stainless Steel STS 304.

REXLENE suture is a nonabsorbable, sterile surgical monofilament suture composed of polypropylene. REXLENE sutures are not coated. The sutures are dyed blue to enhance visibility in tissue.

REXLENE suture meets all requirements established by the United States Pharmacopoeia (U.S.P.) for nonabsorbable surgical suture. Available suture size is as below. - Dyed suture blue ([Phthalocyaninato (2-)] Copper): USP 8-0 ~ USP 1

The provided text is a 510(k) Premarket Notification from the FDA for a surgical suture device named REXLENE. It does not contain information about acceptance criteria for a device's performance, nor does it describe a study proving a device meets such criteria in terms of AI or software performance metrics.

Instead, the document focuses on demonstrating that the REXLENE suture is "substantially equivalent" to already legally marketed predicate devices, primarily WG-Surgical Sutures with Needle (K080684) and PROLENE™ Polypropylene Nonabsorbable Suture (K133356). The "acceptance criteria" referred to in this document are compliance with established regulatory standards for surgical sutures.

Here's a breakdown of the information that is available, reframed to address your request as much as possible, and highlighting what is not present:

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

The document outlines compliance with specific USP (United States Pharmacopoeia) and ISO standards for surgical sutures as the "acceptance criteria" for the REXLENE device, and states that the device meets these.

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

This information is not provided in the document. The document mentions "Non clinical tests were conducted," but does not detail the sample sizes for these tests, or the specific provenance of any data beyond the manufacturer being in Korea.

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)

This information is not applicable and not provided. The device is a surgical suture, not a diagnostic imaging device or AI-driven system that would require expert consensus for ground truth establishment. The "ground truth" here is compliance with scientific and regulatory standards as measured through laboratory testing.

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

This information is not applicable and not provided. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or expert reviews to resolve discrepancies in diagnoses or assessments, particularly for AI/CAD devices. This document deals with laboratory testing against physical and biological standards.

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

This information is not applicable and not provided. REXLENE is a surgical suture, not an AI or CAD (Computer-Aided Detection) system. MRMC studies are used to evaluate the performance of diagnostic tools (often involving AI) with human readers.

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

This information is not applicable and not provided. REXLENE is a physical medical device (suture), not an algorithm or software.

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

For the non-clinical tests, the "ground truth" is defined by the specifications and requirements set forth in the US Pharmacopoeia (USP) and ISO 10993 standards. For example, the device must meet specific diameter ranges as defined in USP .

8. The sample size for the training set

This information is not applicable and not provided. Training sets are relevant for AI/machine learning models, which this device is not.

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

This information is not applicable and not provided for the same reason as point 8.

In summary, the provided document is a regulatory submission for a surgical suture and outlines its compliance with established physical and biological standards. It does not describe an AI or software device and therefore lacks the information requested regarding AI acceptance criteria, study design, expert involvement, or data sets for AI development.

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