(41 days)
The PTA (Progressive Tibial Alignment) external fixation system is a modular system with the components of: joints, bars, clamps or screws. Such components form a device indicated for reconstruction and corrections of bone segments of the human body.
The PTA is for progressive realignment of the knee.
The PTA has multiple components of metallic bone fixation appliances and accessories. It is designed for a progressive correction of the lower limb using tibial osteotomy. This device is composed of a main section of a bar and proximal distraction unit upon which are connected the clamps and grasping components. All components are made of either Aluminum alloy 7012 or Stainless steel, AISI 316 LVM, ISO 5832-1.
The provided text is a 510(k) Summary for the PTA (Progressive Tibial Alignment) external fixation system. This document is for a medical device that realigns bone segments, primarily for progressive realignment of the knee, and it's seeking clearance based on substantial equivalence to a predicate device (FEP, K032427).
Crucially, the provided text DOES NOT contain the type of information requested about acceptance criteria, study details, performance metrics, ground truth establishment, or sample sizes related to an AI/algorithm-based device.
The document describes a physical medical device (an external fixation system) and its components, materials, and intended use. It focuses on demonstrating substantial equivalence to a previously cleared device, not on evaluating the performance of a software algorithm.
Therefore, I cannot extract the requested information. The prompt specifically asks for details related to acceptance criteria and a study proving device meets these criteria, typically found in submissions for AI/ML-driven devices or diagnostic tools. This document is for a mechanical orthopedic 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.