(70 days)
Synthes TomoFixTM Osteotomy System is intended for open and closed wedge osteotomies of the medial proximal tibia, lateral proximal tibia, medial and lateral distal femur, treatment of bone and joint deformities, fractures, and malalignment caused by injury or disease such as osteoarthritis.
The Synthes TomoFix TM Medial Distal Femur Plates are part of the Synthes TomoFix TM Osteotomy System which is a system consisting of titanium plates with locking and combination holes designed to provide stable fixation of osteotomies close to the knee. The TomoFix TM Medial Distal Femur Plates consist of titanium plates anatomically contoured to fit the medial distal femur. The plates are available in right and left versions and feature locking holes in the head and combination locking/dynamic compression holes in the shaft.
The provided text is a 510(k) summary for the Synthes (USA) TomoFix™ Medial Distal Femur Plates. This document is related to a medical device's regulatory clearance and does not contain information about acceptance criteria or a study proving device performance using AI or human readers with AI assistance. It focuses on demonstrating "substantial equivalence" to predicate devices, which is a regulatory pathway for certain medical devices.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results or effect sizes of human readers with/without AI assistance.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
These elements are typically found in a clinical study report or a detailed technical report for an AI/CADe device, not in a 510(k) summary for a bone fixation plate. The 510(k) summary only describes the device, its intended use, classification, and predicate devices to demonstrate substantial equivalence to a legally marketed product.
§ 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.