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APTUS® Canulated Compression Screws are indicated for the treatment of fractures, osteotomies and arthrodeses of bones e.g. in the hand, wrist, elbow, foot with the appropriate screw size.

APTUS Cannulated Compression Screws are headless screws provided in diameters of 2.2 and 3.0 mm, overall lengths from 10 to 40 mm, and threaded lengths from 3.5 to 18 mm. APTUS Cannulated Compression Screws have head and shaft threads with different pitch thus creating compression of the bone segments upon insertion of the screw. APTUS Cannulated Compression Screws are made of titanium alloy conforming to ASTM F136.

The provided document is a 510(k) summary for a medical device called "APTUS® Cannulated Compression Screws." This type of document is for pre-market notification where a manufacturer seeks to demonstrate that their new device is substantially equivalent to a legally marketed predicate device.

This document describes a physical medical device (screws for bone fixation) and not a software or AI-based diagnostic device.

Therefore, the requested information about acceptance criteria for device performance, types of studies (MRMC, standalone), ground truth establishment, expert involvement, and sample sizes for test and training sets are not applicable to this submission. The 510(k) process for such a device focuses on demonstrating equivalence through:

• Dimensional analysis: Comparing physical characteristics of the new device to predicate devices.
• Material equivalence: Confirming the new device uses the same or similar materials as predicate devices.
• Performance testing: Conducting mechanical and functional tests to ensure the device performs as intended and similarly to predicate devices.

The document states: "Performance data are provided to demonstrate substantial equivalence. This includes detailed dimensional analysis of the subject and predicate screw designs, and testing of the subject and predicate screw designs." However, the specific acceptance criteria and the results of those performance tests are not detailed in this 510(k) summary. Such details would typically be found in the full 510(k) submission, which is not publicly available in its entirety.

In summary, the information requested in your prompt (especially concerning AI/software performance) cannot be extracted from this document because it pertains to a physical medical device and its 510(k) submission for substantial equivalence, not an AI or diagnostic software device.

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