(76 days)
The Extremity Staple System is indicated for use in fracture, osteotomy fixation and joint arthrodesis as well as fixation of bone fragments (i.e., small fragments of bone which are not comminuted to the extent that preclude staple placement). The device is intended for use in short, long, or flat bones. The Extremity Staple System is intended for single use only.
The Extremity Staple System, which consists of the Extremity Staple and associated instruments, is intended for use for fixation and compression and supports several surgical techniques (e.g., fracture, osteotomy, joint arthrodesis, and fixation of bone fragments). The staples are made of implant-grade Nitinol and are designed to exhibit superelastic properties at room temperature. This allows for continued compression to be applied across bone segments, thus enhancing long-term stability and promoting fusion. Each staple is pre-loaded on an inserter for implantation and sterile packed. The staples are available in multiple sizes, varying by bridge length and leg length, to accommodate individual patient anatomy. Disposable Instrumentation is provided to assist in the surgical placement of the Extremity Staple.
The provided text describes a medical device, the "Extremity Staple," and its regulatory review for substantial equivalence to existing predicate devices. However, this document does not contain any information regarding acceptance criteria, device performance metrics, or details of a study involving AI or human reader performance.
The document solely focuses on:
- Regulatory Clearance: A letter from the FDA confirming substantial equivalence (K231458).
- Device Description: What the Extremity Staple is, its material (Nitinol), and its intended use (fracture, osteotomy fixation, joint arthrodesis, fixation of bone fragments).
- Predicate Devices: Identification of similar devices already on the market (BME Speed™ Implant and BioPro Memory Staple).
- Comparison to Predicates: Discussion of similarities and differences in material, design, technological characteristics, and intended use.
- Performance Testing (Mechanical): A list of mechanical tests conducted (ASTM F564-17 for static/dynamic bend and pull-out, ASTM F2129-19a for cyclic corrosion) to demonstrate mechanical performance for its intended use and support substantial equivalence.
Therefore, I cannot provide the requested information about acceptance criteria, reported device performance, sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance, as these details are not present in the provided text.
The document explicitly states: "The results of this non-clinical testing demonstrate that the mechanical performance of the Extremity Staple is sufficient for its intended use and no new questions of safety or effectiveness were identified during device testing; therefore, the Extremity Staple is considered substantially equivalent to the BME Speed™ predicate device." This indicates that the mechanical tests were used to support substantial equivalence, but it does not provide specific performance metrics or acceptance criteria in the format requested.
§ 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.