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The Arthrex BioSuture is intended for soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs, including those with allograft tissues, are used for repair.

The proposed Arthrex BioSuture is a braided construct made of Ultra High Molecular Weight Polyethylene (UHMWPE) and polyester and coated with collagen coating. The proposed suture is braided flat with round ends and may be available in precut lengths in straight and loop configurations. The Arthrex BioSuture is packaged sterile for single use. The Arthrex BioSuture is a line extension to the Arthrex Bio-Suture consisting of a new size.

The provided document is a 510(k) summary for the Arthrex BioSuture, a surgical suture. It details the device's indications for use, technological characteristics, and conformity to established standards through performance testing. However, the document does not describe a study involving an AI/ML device, human readers, or any of the specific criteria typically associated with such studies (e.g., sample size for test sets, data provenance, expert ground truth adjudication, MRMC studies, standalone performance, or training set details).

This document focuses on demonstrating substantial equivalence to predicate devices for a physical medical device (suture) through mechanical testing and comparison of attributes.

Therefore, most of the requested information regarding AI/ML device acceptance criteria and studies cannot be extracted from this document.

Here's an attempt to answer the questions based only on the provided text, highlighting what is present and what is absent:

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

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

• Sample Size: Not specified. The document only states "representative samples" for the Bacterial Endotoxins Test and generally mentions "mechanical testing."
• Data Provenance: Not specified.

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. This is not an AI/ML study involving human expert ground truth. The "ground truth" here is based on physical material properties and established industry standards for sutures.

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

• Not applicable. This is not an AI/ML study involving human expert ground truth 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

• No, an MRMC comparative effectiveness study was not done. This document describes a submission for a surgical suture, not an AI/ML device that assists human readers.

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

• Not applicable. This document is for a physical medical device (suture), not an algorithm.

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

• The "ground truth" or reference for comparison described in this document is based on:
  • Established physical and mechanical properties of surgical sutures: Primarily tensile strength (straight pull, knot pull) as defined by internal acceptance criteria and implicitly compared to predicate devices.
  • Regulatory standards: Specifically pyrogen limits as outlined in ANSI/AAMI ST72:2011/(R)2016, USP , USP , EP 2.6.14.
  • Characteristics of legally marketed predicate devices: For demonstrating substantial equivalence in design, materials, manufacturing, and performance.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device that requires a training set.

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

• Not applicable. This is not an AI/ML device that requires a training set.

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