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The Emerge Medical Locking One-third Tubular Plate System is intended for fixation of fractures, osteotomies, and non-unions of the clavicle, scapula, olecranon, humerus, radius, ulna, pelvis, distal tibia, and fibula, including osteopenic bone.

The System consists of stainless steel components including locking plates and standard cortex screws, locking cortex screws and standard cancellous screws and washers. The plates are available in a variety of lengths with the number of holes varying depending on plate length. The screws and plates are provided non-sterile.

The provided text describes a medical device, the "Emerge Medical Locking One-third Tubular Plate System," and its 510(k) summary, which outlines its substantial equivalence to a predicate device. However, it does not contain information related to an AI/ML powered device, acceptance criteria related to such a device, nor any study proving an AI/ML device meets certain acceptance criteria.

Therefore, I cannot fulfill the request to describe acceptance criteria and the study that proves the device meets them, as the provided input pertains to a traditional medical device (bone plates and screws) and its mechanical performance, not an AI/ML-powered device.

The document explicitly states under "PERFORMANCE DATA": "Mechanical testing performed according to ASTM F543 and ASTM F382 demonstrated that the device performs as well as or better than the predicate device. Clinical data were not needed to demonstrate substantial equivalence." This indicates that the regulatory clearance was based on mechanical testing, a common approach for such devices, rather than a study involving human readers, AI assistance, or complex ground truth establishment as would be relevant for an AI/ML product.

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