(27 days)
The OrthoNovis bones plates and screws system are intended to be used for internal fixation of bone fractures, fusions or osteotomies in the ankle, foot, hand, wrist, clavicle, scapula, pelvis, long bone (such as humerus, ulna, radius, femur, tibia, and fibula, and small bones (such as metacarpals, metatarsals, phalanges). The washers are intended to prevent a screw head from breaking through the cortex of the bone by distributing the forces/load over a large area when used for fracture fixation of large bone and bone fragments.
The bone fragment fixation plates and washers of various sizes, consists of various shapes as well as screws are intended to treat fractures and osteotomies of various bones, including the clavicle, acetabulum, pelvis, scapula, humerus, radius, ulna, femur, tibia,phalanges, carpals, metacarpals, tarsals, metatarsals and fibula. The washers are to function with screw head from breaking through the cortex of the bone by providing additional surface area during screw placement. The plates s are a one-piece device made of commercially pure titanium alloy or stainless steel.
I am sorry, but the provided text does not contain information about an AI/ML-based device or a study proving its performance against acceptance criteria. The document is a 510(k) premarket notification for a traditional medical device: "BPS - Bone Fragment Fixation Plates, Screws and Washers."
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them for an AI/ML device, as this information is not present in the given text.
The document primarily discusses:
- The FDA's review and determination of substantial equivalence for the BPS device.
- Regulatory requirements for medical devices.
- The identity of the applicant and correspondent.
- The device name, common name, classification, and product codes.
- Legally marketed predicate devices.
- A summary description of the BPS device.
- Indications for Use for the BPS device.
- A comparison of intended use and technological characteristics to predicate devices, noting the introduction of additional material options and minor modifications to screw geometry.
- A statement that engineering justifications were provided to demonstrate adequate mechanical properties, and that the device is substantially equivalent to the primary predicate.
There is no mention of acceptance criteria, test sets, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training sets, or how ground truth was established, as these are typically relevant for AI/ML device evaluations, not for the type of traditional bone fixation device described.
§ 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.