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The Arthrex Fiberwire™ and FiberTape™ Families are intended for use in soft tissue approximation and or ligation. These sutures may be incorporated, as components, into surgeries where constructs including those with allograft or autograft tissues are used for repair.

Arthrex, Inc. suture grafting kits contain Fiberwire™ and FiberTape™ sutures of varying lengths and needle types, as components. The sutures are made of long chain polyesters and braided with a variety of cleared fiber material 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 (Arthrex Suture Grafting Kit), indicating substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study that proves the device meets those criteria, nor does it provide details about any clinical performance studies.

Therefore, I cannot fulfill your request for the specific details you asked for. The document focuses on regulatory approval based on equivalence to existing, cleared devices, rather than on the results of a new performance study with acceptance criteria.

Here's why the information you requested is not present in the provided text:

• Acceptance Criteria and Reported Device Performance: This document states the device's "Intended Use" and "Description," and argues "Substantial Equivalence" to predicate devices. It does not define specific performance metrics or acceptance criteria, nor does it report performance against such criteria.
• Sample Size, Data Provenance, Expertise, Adjudication, MRMC Study, Standalone Study, Ground Truth: These are all elements typically found in detailed study reports. This 510(k) summary is a high-level regulatory document that does not include such granular study details.
• Training Set Sample Size and Ground Truth Establishment: Similar to the above, these are specific to the development and validation of an algorithm, which is not the focus of this document.

The core of this 510(k) summary is to demonstrate that the "Arthrex Suture Grafting Kit" has the "same basic features and intended uses" as previously cleared predicate devices, and that "minor differences... do not raise any questions concerning safety and effectiveness and have no apparent effect on the performance, function, or intended use of this device." This is a regulatory pathway that relies on similarity to already approved devices, rather than a new clinical trial proving performance against defined criteria.

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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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