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Fiberwire™ USP sizes are intended for use in approximation or ligation of soft tissues, including use of allograft tissue for orthopedic surgeries.

Arthrex, Inc. Fiberwire™ suture consists of a family of varying length, needle type, and standard USP diameter sutures. They are made of long chain polyesters which are braided and sterilized for surgical use. They are available in dyed and non-dyed varieties, with or without needles.

The provided text is a 510(k) summary for a medical device called "Arthrex Fiberwire™ USP suture family." This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a study with acceptance criteria and device performance as typically understood for AI/algorithm-based devices.

Therefore, the requested information elements related to AI algorithm performance (acceptance criteria table, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable to this type of submission.

Here's why and what information is available:

This 510(k) submission is for a physical medical device (sutures), not an AI/software as a medical device (SaMD). The regulatory pathway for this device, at the time of submission (2002), primarily involved demonstrating that the new device is as safe and effective as a legally marketed predicate device. This is done by comparing device characteristics, materials, intended use, and performance claims to those already approved.

Summary of available information based on the prompt's request:

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

   • Not Applicable. The document does not describe a study with specific acceptance criteria and a reported performance for an AI/algorithm. Instead, it asserts "substantial equivalence" based on similar features and intended use to predicate devices. The "performance" for a suture would typically relate to mechanical properties, biocompatibility, and sterility, which are not detailed in this summary but would have been part of the full 510(k) submission.

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. No test set or data provenance related to an AI/algorithm's performance is mentioned.

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. No ground truth establishment for an algorithm is described.

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

   • Not Applicable. No adjudication method for an algorithm's test set is described.

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 type of study is relevant to AI/diagnostic imaging devices, not physical sutures.

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

   • Not Applicable. This device is not an algorithm.

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

   • Not Applicable. Ground truth in the context of AI is not relevant here. The "truth" for this device's safety and effectiveness is established by its similarity to already approved devices and its compliance with relevant standards (though not explicitly stated in this summary).

8. The sample size for the training set:

   • Not Applicable. No training set for an algorithm is mentioned.

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

   • Not Applicable. No ground truth establishment method for a training set is described.

Key takeaway for this document:
The purpose of this 510(k) summary is to assert substantial equivalence of the "Arthrex Fiberwire™ USP suture family" to predicate devices based on common features and intended use in soft tissue approximation and ligation for orthopedic surgeries. It does not contain information about studies for an AI/algorithm-based device as requested.

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