(90 days)
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.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.