(254 days)
The Wafer System, in conjunction with commercially available supplemental fixation, is intended for use in proximal tibial opening wedge osteotomies as a means to restore anatomical alignment and relative position.
The Wafer System consists of a delivery gun, a delivery track and a wafer cartridge assembly. The Wafers are used to open the osteotomy and act as a spacer until bone graft and supplemental fixation can be placed. The Wafer System Implants are manufactured from Polyetheretherketone (PEEK) with 6% Barium Sulfate.
The provided text describes the "Wafer System," an orthopedic device, and details its 510(k) submission. However, it does not contain information about acceptance criteria, device performance studies to meet those criteria, sample sizes, ground truth establishment, expert qualifications, or comparative effectiveness studies (MRMC or standalone AI performance) as requested.
The document primarily focuses on:
- Submitter and Device Information: Company name, contact, product name, common name, classification.
- Device Description: Components (delivery gun, delivery track, wafer cartridge assembly, PEEK wafers with Barium Sulfate).
- Intended Use: Proximal tibial opening wedge osteotomies, in conjunction with supplemental fixation, to restore anatomical alignment and relative position.
- Substantial Equivalence: To Arthrex Opening Wedge Osteotomy System (K973812) and Synthes Spiked Washer (K011583).
- Mechanical Testing: A brief mention that "mechanical testing demonstrated that The Wafer System met the performance requirements for its intended use." No details of these tests, specific criteria, or results are provided.
- FDA Approval Letter: A standard FDA 510(k) clearance letter.
Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and performance study details from the provided text. The document only confirms the device's clearance based on substantial equivalence and a general statement about mechanical testing.
§ 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.