(49 days)
The Alphatec External Fixation System is indicated for limb salvage from traumatic injury; fracture treatment (i.e., long bone fracture, including the tibia, femur, humerus, radius, and ulnar bones); reconstruction of extremities with deformity and dysfunction; limb lengthening; arthrodesis; and pelvic fractures.
The Alphatec External Fixation System Compression/Distraction (CD) Rod consists of a CD rod that is available in two lengths and a CD rod to rod connector. These components are designed to be used in conjunction with the Alphatec External Fixation System and the Alphatec Wire External Fixation System which were the subject of prior premarket notifications. The additional use of the CD rod with the systems listed adds the capabilities of limb lengthening during fracture fixation. The CD rod and CD rod to rod connector are manufactured from titanium alloy (Ti-6Al-4V).
The provided document is a 510(k) Pre-Market Notification for the Alphatec External Fixation System Compression/Distraction Rod. This document is a regulatory submission to the FDA demonstrating that a new device is substantially equivalent to a legally marketed predicate device.
It does NOT contain information about acceptance criteria or a study proving the device meets acceptance criteria in the context of an AI/ML medical device.
Instead, it focuses on:
- Device Description: What the device is made of and how it works.
- Intended Use: The medical conditions the device is designed to treat.
- Substantial Equivalence: A comparison of the device to existing, legally marketed devices to show it is as safe and effective.
- FDA Clearance: The official letter from the FDA stating that the device is substantially equivalent.
Therefore, I cannot extract the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance, as these concepts are not addressed in this type of regulatory document for a mechanical medical 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.