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The StarFuse Interphalangeal Pin is indicated for use with osteotomies, arthrodeses, and reconstruction procedures involving the correction of the lesser digits of the toes.

The StarFuse Interphalangeal Pin is a fusion device available in a range of profile diameters and lengths as well as straight or pre-bent options. Implants are made from 316LVM Stainless Steel per ASTM F138 and range in size from 3 to 4 mm in diameter and 16 to 30 mm in length.

The provided text is a 510(k) premarket notification for a medical device called the StarFuse Interphalangeal Pin. This document outlines the regulatory approval process for a physical medical device (a bone fixation fastener), not a software-based AI/ML device.

Therefore, the information required to answer your query about acceptance criteria and studies for an AI/ML device (such as sample size for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, etc.) is not present in the provided document.

The "Performance Data" section specifically mentions: "Static and dynamic 3-point bending testing (per ASTM 1264-14) confirmed that the Subject device performed as intended." This refers to biomechanical testing of the physical pin, not the performance of an algorithm.

In summary, this document does not contain the information needed to describe the acceptance criteria and study proving an AI/ML device meets those criteria.

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