(87 days)
Fractures of the long bones and pelvis, joint fusion, limb lengthening, osteotomies, and peri-articular fracture
TransFx External Fixation System
It appears the provided document is an FDA 510(k) clearance letter for the "TransFx External Fixation System." This document primarily grants clearance for a medical device based on substantial equivalence to a predicate device, rather than detailing a specific study proving the device meets acceptance criteria derived from a performance study.
FDA 510(k) clearances typically do not contain the type of detailed performance study information requested (e.g., specific acceptance criteria for AI algorithms, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment) because the basis of clearance is substantial equivalence. The device's performance is assumed to be similar to legally marketed predicate devices, and often bench testing or limited clinical data is used to demonstrate this equivalence, not a rigorously designed performance study as would be required for a novel AI-powered diagnostic device.
Therefore, the provided document does not contain the information necessary to answer the questions about acceptance criteria and the study that proves the device meets those criteria.
The document states: "We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976..." This is the core of a 510(k) clearance.
To answer your questions for an AI/ML medical device, one would typically need a much more detailed clinical study report or a 510(k) summary that specifically addresses the performance of such an algorithm.
§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.
(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.