(80 days)
The DePuy Motech PEAK Fixation System is intended for use in treating fractures of small bones such as the metacarpals, ulna, radius, humerus and metatarsals and in treating fractures of the lateral malleolus, olecranon, and intra-articular distal tibia.
The system consists of 5 sizes of channeled reconstruction plates ranging from 26mm to 104mm in length, 13 sizes of 3.5mm cortical screws ranging from 16 to 30mm in length and a steplock washer. The reconstruction plates are 3mm thick and 9mm wide. All plates incorporate a tooth pattern, on one outer surface. The teeth are designed to interlock with the "tabs" on the steplock washer.
This 510(k) summary describes a medical device, the DePuy Motech PEAK Fixation System, and its substantial equivalence to predicate devices, but does not contain any information regarding acceptance criteria or a study proving the device meets specific acceptance criteria in the manner requested.
The provided text focuses on:
- Device Description and Intended Use: Explaining what the device is, what it's used for, and its components.
- Basis of Substantial Equivalence: Comparing its materials, design, and intended use to existing devices.
- Mechanical Testing: A statement that its mechanical properties (rigidity, strength, stiffness in 4-point bending) exceed those of predicate devices.
However, it lacks the specific details required to answer your questions about acceptance criteria, clinical study methodology, expert involvement, and ground truth establishment. This type of information is typically found in detailed study reports, clinical trial summaries, or more extensive sections of a 510(k) submission, which are not present in the provided excerpt.
Therefore, I cannot populate the table or answer the subsequent questions based solely on the input provided. The summary only mentions "mechanical testing shows that..." without describing the acceptance criteria for that testing or the full study details.
§ 888.3040 Smooth or threaded metallic bone fixation fastener.
(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.