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The PEEK Patient Specific Cranial Craniofacial Implant (PSCI) is intended to replace bony voids in the cranial and/or craniofacial skeleton, excluding maxillofacial and /or oral regions.

The PEEK Patient Specific Cranial/Craniofacial Implants are designed individually for each patient to correct defects in cranial/facial bone, and fabricated using the patient' s CT imaging data. The implants are made of PEEK material which is medical grade material. The PSCI consists of PEEK bone plate, and it is fixated to native bone using previously cleared Bioplate Fixation System manufactured by Bioplate, Inc. The PSCI is provided in non-sterile and must be sterilized before use in Health Care Facility.

I am sorry, but the provided text does not contain the information required to answer your request. The document is an FDA 510(k) premarket notification letter and a 510(k) summary for a medical device (PEEK Patient Specific Cranial/Craniofacial Implant).

It details:

• The device's identification and intended use
• Comparison to a predicate device
• Non-clinical testing for biocompatibility and performance (compression, fitting, fixation)
• A statement that no clinical tests were performed.

Therefore, there is no mention of acceptance criteria based on device performance in a clinical study, sample sizes for test sets, data provenance, expert ground truth establishment, adjudication methods, MRMC studies, standalone algorithm performance, or ground truth for training sets. This information would typically be found in a clinical study report, which is not present here.

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