(60 days)
The Stryker CMF MEDPOR Customized Implant is indicated for the augmentation of bony and/or soft tissue deformities in post-traumatic, post-surgical, or congenital craniofacial defects; including but not limited to, the correction and prevention of persistent temporal hollowing (PTH).
The Stryker CMF MEDPOR Customized Implant (CI) product offerings provide customized craniofacial patient specific implants designed at the request of a surgeon. The customized craniofacial implants are molded from porous high density polyethylene (HDPE) and the MEDPOR material provides a porous structure which allows for tissue ingrowth. The MEDPOR CI is manufactured to the specific reconstruction boundaries indicated by the surgeon via submission of CT scans and a customized implant request.
This document is a 510(k) premarket notification for a medical device called the "Stryker CMF MEDPOR Customized Implant." The purpose of this notification is to demonstrate that the device is substantially equivalent to a previously cleared predicate device.
The provided text does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria. It is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, primarily through comparison of technological characteristics and indications for use, rather than presenting de novo performance data against specific acceptance criteria.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study proving the device meets them because this information is not present in the provided document. The document explicitly states:
- "Biocompatibility and sterility testing of the device is not required as a basis for substantial equivalence." (Page 5)
- "Performance Bench testing was not required as a basis for substantial equivalence." (Page 5)
- "Animal testing was not required as a basis for substantial equivalence." (Page 5)
- "Clinical Testing: To support the inclusion of the PLUS design option, and the corresponding indication for use, Stryker has leveraged clinical literature and case history." (Page 6) - This indicates a literature review, not a new clinical study with acceptance criteria.
The document is a declaration of substantial equivalence, which often relies on demonstrating that a new device is "as safe and effective" as a legally marketed predicate device without requiring new performance data against specific acceptance criteria, especially if the changes are minor or relate to a new indication for a similar device.
§ 878.3550 Chin prosthesis.
(a)
Identification. A chin prosthesis is a silicone rubber solid device intended to be implanted to augment or reconstruct the chin.(b)
Classification. Class II.