(139 days)
The JAWS Nitinol Staple System implants are indicated for use in osteotomy, arthrodesis and fragment fixation of the bones and joints of the foot including fixation of small bone fragments (i.e. small fragments of bone which are not comminuted to the extent to preclude staple placement) located in the long bones of the lower extremities such as the fibula and tibia.
The JAWS Nitinol Staple System includes three styles of bone staples having various sizes to accommodate a variety of small bone applications. The implants and instruments are sold sterile.
The provided text describes a 510(k) premarket notification for the JAWS Nitinol Staple System, focusing on substantial equivalence to a predicate device and MRI safety and compatibility testing. It does not describe an AI/ML powered device, and therefore does not contain information on acceptance criteria for an AI model, a study proving an AI model meets acceptance criteria, sample sizes for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, or standalone algorithm performance.
The "Performance Testing" section states that "MR Safety and Compatibility Testing has been completed and presented in the submission as recommended in the FDA Guidance 'Testing and Labeling Medical Devices for Safety in the Magnetic Resonance (MR) Environment' issued May 20, 2021, including FDA-recognized standards tests for the following potential hazards."
Therefore, I cannot fulfill your request for an AI/ML-specific acceptance criteria and study description based on the provided document. The document describes a physical medical device (bone staples) and its testing for safety and compatibility in an MRI environment.
§ 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.