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The Stryker® Patient Specific Polymer Implant is designed individually for each patient to correct trauma and/or defects in mandibular, maxillofacial, or craniofacial bone.

The Stryker Patient Specific Polymer Implant is a pre-formed plate made of cured Simplex P bone cement that is shaped to match a specific patient's bony defect based on CT scans provided by the surgeon. The plate is fixed into place using compatible Stryker plate and screw systems.

Response:
The provided documentation does not contain information regarding detailed acceptance criteria, device performance metrics, or specific studies that would typically be conducted for performance evaluation of a device. The 510(k) summary focuses on demonstrating substantial equivalence to predicate devices, particularly highlighting an online ordering system modification, rather than presenting a clinical or performance study with acceptance criteria.

Therefore, the requested information elements (1 through 9) cannot be extracted from the provided text. The document refers to the device being "verified and validated according [to] Stryker procedures for product design and development" and that "The validation proves the safety and effectiveness of the system," but it does not detail these procedures, validation studies, or their results, nor does it provide the specific data requested in your prompt.

It's important to note that this 510(k) submission primarily addresses the addition of an online ordering system and its impact on substantial equivalence, rather than a new design requiring extensive performance studies with specific statistical measures.

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