(85 days)
The Arthrex Small Fragment Plates and Screws are intended to be used for internal bone fixation for bone fractures, fusions, or osteotomies in the ankle, foot, hand, and wrist, such as opening wedge osteotomies for Hallux Valgus.
The Arthrex Small Fragment Plate is an L-shaped opening wedge plate with four holes for insertion of screws for fixation. The plate is available in opening and closing wedge design, in various lengths, in both left and right configurations. The Arthrex screw is a cortical, headed, self-tapping screw available in one diameter, in numerous length options.
The provided document is a 510(k) summary for the Arthrex Small Fragment Plates and Screws, which are medical devices (implants). The information requested pertains to the evaluation of a software algorithm's performance, which is not relevant to this type of medical device submission.
Here's why the requested information cannot be provided from this document:
- Device Type: The Arthrex Small Fragment Plates and Screws are physical implants used for internal bone fixation. They are not a software algorithm, an AI model, or an diagnostic imaging device.
- Approval Process: A 510(k) for a device like this focuses on demonstrating substantial equivalence to pre-existing, legally marketed devices (predicates) based on material properties, design, manufacturing, and intended use. It does not involve studies to establish performance criteria like sensitivity, specificity, or reader studies in the way an AI/software device would.
- Missing Information: The concepts of "acceptance criteria for an algorithm," "test set," "ground truth," "expert adjudication," "MRMC study," "standalone performance," or "training set" simply do not apply to the regulatory evaluation of a bone plate and screw system.
Therefore, I cannot extract the requested information from this document because it is not applicable to the 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.