(58 days)
The Acumed Small Fragment Base Set contains orthopedic plates and screws with the following indications: Acumed Hook Plates and Locking Peg Hook Plates are intended for fixation of fractures, osteotomies, and non-unions of small bones including the ulna, radius, tibia, and fibula, Acumed Fragment Plates and 4.0mm Cancellous Screws are intended for fixation of fractures, osteotomies, non-unions, replantations, and fusions of small bones and small bone fragments. Acumed One-Third Tubular Plates are intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula.
The Acumed Small Fragment Base Set contains orthopedic plates and screws indicated for general fragment fixation as described below. Plates and screws are manufactured from titanium alloy Ti-6Al-4V ELI per ASTM F136, or from commercially pure titanium per ASTM F67. All implants are provided both sterile and non-sterile. The set also contains typical instrumentation for general orthopedic fracture fixation cases.
This document is a 510(k) Pre-Market Notification from the FDA regarding the Acumed Small Fragment Base Set. It declares the device substantially equivalent to legally marketed predicate devices.
The document does not describe acceptance criteria for an AI/CADe device, nor does it detail a study proving such a device meets acceptance criteria. Instead, it describes a traditional medical device (orthopedic bone plates and screws) and the non-clinical testing performed to demonstrate its substantial equivalence to predicate devices.
Therefore, I cannot extract the requested information regarding acceptance criteria and performance of a device that uses AI, as this information is not present in the provided text.
The information provided is about traditional mechanical testing for orthopedic implants.
Here's what kind of information is provided:
- Device: Acumed Small Fragment Base Set (orthopedic plates and screws)
- Predicate Devices: Synthes (USA) Modular Mini Fragment LCP System, Synthes (USA) 3.5mm LCP Hook Plate, Synthes One-Third Tubular DCL Plate, and Synthes Sterile 3.5mm and 4.0mm Cannulated Screws.
- Non-clinical Testing:
- Fragment Plate static bending strength and cyclic fatigue testing (per ASTM F382)
- One-Third Tubular Plate static bending strength and cyclic fatigue testing (per ASTM F382)
- Hook Plate static bending strength and cyclic fatigue testing (per ASTM F384)
- Locking Peg Hook Plate static bending strength and cyclic fatigue testing (per ASTM F384)
- 4.0 Cancellous Screw pullout and torque testing (per ASTM F543)
- Conclusion of Testing: "The results provided in Section 20 demonstrate the substantial equivalence of the Acumed Small Fragment Base Set."
This data does not pertain to acceptance criteria or studies for an AI-powered 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.