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The In2Bones® Kirschner wires are indicated for fixation of bone fractures, bone reconstruction, and as guide pins for insertion of other implants. The size of the In2Bones® Kirschner wire chosen should be adapted to the specific indication.

The In2Bones® Kirschner wire is a metallic wire available in four point styles: sharp, partially threaded, lanceolate, both ends sharp. One part is fixed on standard surgical power tool equipment for insertion. Sizes: The In2Bones® Kirschner wire is available in various diameters (0.8mm to 2.5mm) and length (70mm to 300mm). Material: The In2Bones® Kirschner wire is manufactured from stainless steel 316LVM, according to ISO 5832-1 and ASTM F138-13. It does not have any coating. Single use: The In2Bones® Kirschner wire is designed for single use only. Sterilization: The In2Bones® Kirschner wire is supplied sterile and non-sterile. The sterile In2Bones® Kirschner wire is sterilized using gamma radiation. The non-sterile In2Bones® Kirschner wire must be steam sterilized before use. Place of use: The In2Bones® Kirschner wire is indicated for use in a hospital, or outpatient surgery center, where sterile field may be created and maintained.

The document provided is a 510(k) summary for a medical device called the "In2Bones® Kirschner wire." It does not present a study with acceptance criteria and device performance results in the context of an AI/algorithm-driven device.

Instead, this document focuses on demonstrating substantial equivalence to existing predicate devices based on design, materials, indications for use, and a statement about conformity to an international standard. There is no mention of an AI/algorithm component in this device.

Therefore, the following information cannot be extracted from the provided text:

1. A table of acceptance criteria and the reported device performance: Not applicable for this type of device and submission.
2. Sample size used for the test set and the data provenance: No test set in the context of an AI/algorithm study is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

Summary of what the document does provide regarding "performance":

The document states:

• "The In2Bones® Kirschner wires are stainless steel wires with diameters and lengths comparable to those featured in the predicate device systems. The design and indications of the In2Bones® Kirschner wires are substantially equivalent to the predicate devices identified in the 510(k) submission. No new materials or processes are used in the development of this implant. Moreover, the In2Bones® Kirschner wires conform to the international standard ISO 5838-1 (2013). Testing, therefore, is not needed to demonstrate that the subject devices are substantially equivalent to other legally marketed Kirschner wires."

This indicates that the "performance" verification relies on:

• Substantial equivalence: The device is similar in design, materials, and intended use to already legally marketed devices (NEWDEAL K WIRE (K022599) and Syntec-Taichung Non-sterile Kirschner Wires and Steinmann Pins (K983121)).
• Conformity to international standards: The device conforms to ISO 5838-1 (2013), which is a standard for implantable devices for surgery - metallic materials.

In essence, for this specific K-wire device, the "acceptance criteria" and "proof" presented are based on its similarity to existing devices and adherence to relevant material standards, not on a study with performance metrics in the way one would describe for an AI or diagnostic device.

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