(112 days)
The Double ENDOBUTTON Fixation Device is intended for the treatment of anterior glenoid bone loss using the Latarjet or bone block procedure (allograft or autograft).
The subject of this Traditional 510(k) is the Double ENDOBUTTON Fixation Device. The Smith & Nephew Double ENDOBUTTON Fixation Device is used during the healing period of osteotomies for orthopedic reconstruction and to assist in the management of fracture fixation. The device consists of three components: two stainless steel fixation devices and a UHMW polyethylene suture. This device is provided sterile, for single use only.
The provided document is an FDA 510(k) clearance letter and associated summary for a medical device (Double ENDOBUTTON Fixation Device). It describes the device, its intended use, and its substantial equivalence to predicate devices. However, this document does not contain the information requested in points 1-9 regarding acceptance criteria and a study proving a digital health device or AI/ML device meets those criteria.
Specifically, the document discusses a mechanical fixation device used in orthopedic surgery, not a software device or an AI/ML algorithm. Therefore, the concepts of "acceptance criteria" for an AI/ML model, "sample size for test set," "ground truth establishment," "MRMC study," or "standalone performance" are not applicable to the content of this document.
The performance data mentioned in the document refers to:
- Mechanical testing: Interface pressure, suture construct tests.
- Bacterial endotoxin testing.
- Clinical literature review: Comparing complication rates and clinical outcome scores (ROWE, Walch-Duplay, ASES) between the device's usage and predicate screws.
Since the document provided does not describe an AI/ML device or its validation, I cannot fill in the requested table and information.
To answer your request, I would need a document describing the validation of an AI/ML or digital health device.
§ 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.