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The Bioplate Resorbable Bone Fixation Tack will be used to support non-load bearing tissues of the craniomaxillofacial anatomy, including but not limited to brow fixation.

The Bioplate Resorbable Bone Tack consists of a bone fixation device manufactured from a Poly (L-lactide-co-DL-lactide) co-polvmer that has been implanted safely for a number of years. The bone fixation devices will be provided sterile to the end-user, using gamma radiation as the method of sterilization and are not intended for re-sterilized by the enduser.

The provided text is a 510(k) premarket notification for a medical device (Bioplate Resorbable Tack for craniomaxillofacial surgery) and not a study report demonstrating the device meets acceptance criteria.

Therefore, none of the requested information (acceptance criteria, reported device performance, sample sizes, expert details, adjudication methods, MRMC study, standalone performance, ground truth types, or training set details) can be extracted from this document, because such information is not typically part of a 510(k) summary for this type of device.

510(k) submissions primarily focus on demonstrating substantial equivalence to a predicate device rather than providing detailed performance studies with acceptance criteria in the manner described in the prompt. The text confirms substantial equivalence to predicate devices (K996040 and K012908) based on similar technological characteristics and restrictive indications for use.

In summary, there is no information in the provided text to fulfill the request.

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