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The Arthrex K-Wire is indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system. Examples include:

• Fixation of small bone fragments, in long bone or small bone fractures .
• Arthrodesis in hand and foot surgery .
• Distal or proximal metatarsal or metacarpal osteotomies .
• Mono or Bi-Cortical osteotomies in the foot or hand .
• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, . Chevron, etc)
• . Guide Wire in hip pinning procedures
• Align and reduce long bone fractures .
• For use with cerclage wire/cable in treating greater trochanter fractures ●

The Arthrex K-Wire devices are made of stainless steel per ASTM F138. They are offered in several sizes and tip styles, sterile or non-sterile.

This document is a 510(k) summary for the Arthrex K-Wire, which focuses on establishing substantial equivalence to previously marketed devices. It does not contain information about a study proving the device meets specific acceptance criteria in the way a clinical trial or algorithm performance study would.

Therefore, most of the requested information cannot be extracted from this document, as it pertains to performance studies for software, AI, or diagnostic devices, not a physical medical implant for which equivalence is being sought based on material and intended use.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot be provided. This document does not describe specific numerical acceptance criteria or performance metrics for the Arthrex K-Wire in the context of a study. The primary acceptance criterion for this 510(k) submission is "substantial equivalence" to a predicate device, meaning it has the same intended use and similar technical characteristics, or can be demonstrated to be as safe and effective.

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 / Cannot be provided. There is no "test set" in the context of a performance study described in this document. The submission relies on demonstrating substantial equivalence, not on a new performance study with human subjects or data.

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 / Cannot be provided. There is no "ground truth" or expert review in the context described because no performance study for diagnosis or classification is presented. The "ground truth" for substantial equivalence would be regulatory and scientific consensus on the safety and effectiveness of the predicate device, not expert labeling of data.

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

• Not applicable / Cannot be provided. No adjudication method is relevant as there is no test set or expert disagreement to resolve.

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 / Cannot be provided. This is a physical medical device (K-Wire), not an AI or diagnostic software. Therefore, an MRMC study is not relevant to its clearance process as described here.

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

• Not applicable / Cannot be provided. This is not an algorithm or software device.

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

• Not applicable / Cannot be provided (in the context of a performance study). The "truth" in this submission relies on the established safety and effectiveness of the predicate device and the materials used, as well as the device's conformance to recognized standards (e.g., ASTM F138 for stainless steel).

8. The sample size for the training set

• Not applicable / Cannot be provided. There is no "training set" as this is not a machine learning or AI device.

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

• Not applicable / Cannot be provided. There is no "training set" or corresponding ground truth.

Summary of Information from the Document:

While the document doesn't fit the requested format for AI/diagnostic studies, it does provide the following key information about the device and its clearance:

• Device Name: Arthrex K-Wire
• Intended Use: Fixation of bone fractures, bone reconstructions, guide pins for other implants, and traction application.
• Material: Stainless steel per ASTM F138.
• Clearance Method: 510(k) substantial equivalence to a predicate device.
• Basis for Equivalence: Same intended use, technical characteristics, or demonstrated to be as safe and effective as the predicate. Materials are well-characterized and used in predicate devices.
• FDA Determination: The FDA found the device substantially equivalent to legally marketed predicate devices.

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