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APTUS Hand Scaphoid Plates are indicated for fractures and non-unions of the scaphoid.

The purpose of this submission is to obtain marketing clearance for an additional device design to expand the range of the Medartis APTUS® Hand Plates, previously cleared under K102537.
The subject device APTUS Hand Scaphoid Plates is available in three designs - small, standard, large - all with 6 screw holes. All plates have anatomical designs that are appropriate for the scaphoid. The subject device plates are compatible with screws and k-wires previously cleared in K102537, K051567, K232144 (for srews), K092038, K202589 and K232144 (for k-wires).
The subject device plates are manufactured from unalloyed titanium conforming to ASTM F67, and are provided non-sterile and sterile.

This document is a 510(k) Premarket Notification from the FDA regarding the "APTUS Hand Scaphoid Plates." It outlines the regulatory review and states that the device is substantially equivalent to legally marketed predicate devices.

However, the provided text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI/Software as a Medical Device (SaMD) product.

Instead, this document pertains to a physical medical device (bone fixation plates) and references mechanical testing to demonstrate performance and substantial equivalence to predicate devices, not AI performance.

Therefore, I cannot fulfill your request as the required information (acceptance criteria for an AI/SaMD product, details of an AI performance study, number of experts, ground truth establishment, etc.) is absent from the provided text.

The document explicitly states: "Clinical data were not provided in this submission." and refers to "Mechanical fatigue and static testing" as the non-clinical testing performed.

To complete your request, I would need a regulatory submission document for an AI/SaMD product that discusses its performance characteristics, acceptance criteria, and the study conducted to demonstrate its capabilities.

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