(94 days)
The AFT™ Greater Tuberosity Cannulated Screws are intended for fracture fixation of long bones and long bone fragments.
The AFT™ Greater Tuberosity Fracture Plate is intended for fractures and fracture dislocations, osteotomies, and non-unions of the proximal humerus, particularly in osteopenic bone.
The AFT™ Greater Tuberosity Fracture System (AFT-GTF) consists of anatomically shaped plates which are fixated with 3.5mm or 4.5mm locking screws and 4.5mm diameter non-locking screws. 4.5mm Cannulated screws are provided to be used with or without 10mm washers. The anatomic plate contains multiple holes to allow for suturing. It is available in left and right configurations. The fasteners are available in various lengths. All components are manufactured from Ti-6Al-4V (ASTM F136). The components are provided non-sterile for singleuse.
The provided text is a 510(k) summary for the "AFT™ Greater Tuberosity Fracture System," which is a cannulated bone screw and plate system. This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a study on device performance against specific acceptance criteria.
Therefore, the requested information regarding acceptance criteria, device performance, study details (sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance), and training set information is not present in the provided 510(k) summary.
Instead, the document states:
- Acceptance Criteria/Performance: Not explicitly defined or measured with a study detailed in the way requested. The core of the submission is demonstrating "geometric equivalence and engineering rationale" and "substantial equivalence" to predicate devices.
- Study Data Summary: "Geometric equivalence and engineering rationale is provided to demonstrate substantial equivalence." This refers to comparative analysis of design, materials, and intended use against existing, approved devices, not a clinical performance study with defined acceptance criteria and statistical outcomes.
In summary, the provided document does not contain the information required to populate the requested table and answer the specific study-related questions. It's a regulatory submission demonstrating equivalence, not a clinical trial report.
§ 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.