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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.

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The Acumed Congruent Bone Plate System provides fixation for fractures, fusions, or osteotomies for the clavilce, humerus, radius, ulna, metacarpal, metatarsal, malleolus, tibia. and fibula.

The Acumed Scapula 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 F67 and ASTM F136 and stainless steel in conformance with ASTM F138 and ASTM F2229. Plates and screws are provided non-sterile.

The Acumed Congruent Bone Plate System is a medical device and the provided 510(k) summary explicitly states: "An assessment of performance data is not applicable. A discussion of clinical and non-clinical tests is not applicable."

Therefore, based on the provided document, there is no information available regarding acceptance criteria or a study that proves the device meets acceptance criteria.

The device obtained substantial equivalence based on its technological characteristics and intended use being similar to legally marketed predicate devices, not on specific performance data or a study demonstrating meeting acceptance criteria.

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