(21 days)
The TS-Bone Hip Tool™ is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
Not Found
This document is a 510(k) summary for the TS-Bone Hip Tool™. It describes an orthopedic device intended to stabilize a bone graft, not an AI/ML powered device. As such, the requested information regarding acceptance criteria and studies for device performance as it relates to AI/ML devices, such as sample size, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details, is not applicable to this submission.
The 510(k) process for this type of device typically focuses on substantial equivalence to a predicate device based on manufacturing materials, design, intended use, and mechanical testing, rather than algorithmic performance.
Therefore, I cannot provide the requested table and details because the provided document does not contain information about an AI/ML powered device or a study comparing its performance to acceptance criteria in the manner described by your prompt.
§ 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.