(26 days)
The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavicle, humerus, radius, ulna, metatarsal, malleolus, tibia, and fibula.
The Acumed Congruent Bone Plate System consists of bone plates and screws for fractures, fusions, and osteotomies. The bone plates are pre-bent to minimize bending which is done intraoperatively. Instruments are supplied with the implants to aid in the insertion of the plates and screws. All plates and screws are manufactured from Titanium in conformance with ASTM F136, Stainless Steel in conformance with ASTM F138 and ASTM F2229, and Cobalt Alloy in conformance with ASTM F90. Plates and screws are provided non-sterile.
The provided text is a 510(k) summary for the Acumed Congruent Bone Plate System. This document is for a medical device (bone plates and screws) and emphasizes its substantial equivalence to previously marketed devices. It does not contain any information about acceptance criteria or a study proving device performance in the way you've described (e.g., diagnostic accuracy metrics, clinical trial results).
Here's why the requested information cannot be extracted from this document:
- Type of Device: The Acumed Congruent Bone Plate System is a hardware device (bone plates and screws) used for fixation. Its safety and effectiveness are established primarily through material conformance, mechanical testing (which is alluded to by "performance data is not applicable" in the context of clinical studies, but certainly performed for mechanical properties), and comparison to predicate devices, not through studies evaluating diagnostic accuracy or algorithmic performance.
- "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable.": This specific statement in the 510(k) summary indicates that the submission relies on substantial equivalence to predicate devices and does not include new clinical or non-clinical performance studies (like a diagnostic accuracy study you're asking about) to demonstrate safety and effectiveness. This is common for many Class II hardware devices.
Therefore, I cannot fill in your requested table and study details. If this were a submission for an AI/ML-driven diagnostic device, that information would be critical and usually included.
Based on the provided document, I must state that the information requested regarding acceptance criteria and a study proving the device meets those criteria (in the context of diagnostic performance) is not available.
§ 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.