(246 days)
The Arthrex Opening Wedge Osteotomy System is intended to be used in conjunction with bone screws to provide fixation following Proximal Tibial or Distal Femoral opening wedge osteotomies.
The Arthrex Opening Wedge Osteotomy System includes the following basic components: a guide system, osteotomes, a forked-wedge tool for opening the wedge, and a set of bone plates for maintaining the wedge opening. The osteotomy plates are made of surgical grade stainless steel.
This document is a 510(k) premarket notification for the Arthrex Opening Wedge Osteotomy System. It does not contain information about acceptance criteria or a study proving device performance against such criteria. Instead, it focuses on demonstrating substantial equivalence to a predicate device.
Therefore, I cannot provide the requested information. The document does not describe:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for a test set or data provenance.
- The number or qualifications of experts for ground truth.
- Adjudication methods.
- A multi-reader multi-case (MRMC) comparative effectiveness study.
- A standalone algorithm performance study.
- The type of ground truth used.
- The sample size for a training set.
- How ground truth for a training set was established.
This is a regulatory submission for a surgical instrument system, relying on the substantial equivalence pathway, which typically involves comparing the device's technical characteristics and intended use to an already legally marketed predicate device rather than conducting new performance studies against specific acceptance criteria like those found in AI/ML device submissions.
§ 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.