(15 days)
The Titanium Hip Tool™ Locking Plate is intended to stabilize a bone graft within the femoral head and neck to assist healing of an intraosseous fracture.
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The provided text is a 510(k) summary for a medical device (Titanium Hip Tool™ Locking Plate), indicating its administrative information, intended use, and substantial equivalence to a predicate device. It is a regulatory document and does not contain details about acceptance criteria, device performance studies, or clinical trial methodologies as typically found in a scientific study or clinical report.
Therefore, I cannot extract the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample sizes and data provenance for test sets
- Number and qualifications of experts for ground truth establishment
- Adjudication method
- MRMC comparative effectiveness study details (effect size)
- Standalone algorithm performance
- Type of ground truth used
- Sample size for the training set
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This document is focused on demonstrating regulatory compliance based on substantial equivalence rather than presenting detailed performance study data.
§ 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.