(90 days)
The Spectrum Designs Bilateral Groove Chin Implant is intended to augment or reconstruct congenital or traumatic chin deficiencies.
The Spectrum Designs Bilateral Chin Implant is manufactured from medical grade solid silicone elastomer which is implanted in a pocket created by the surgeon, either intraorally or extraorally, in the mandibular region of the facial skeleton. It is provided non-sterile and available in six sizes.
This document is a 510(k) Pre-Market Notification summary for a medical device, specifically the Spectrum Designs Bilateral Groove Chin Implant. It is not an AI/ML device, and therefore the majority of the requested information (acceptance criteria, study details, sample sizes, expert ground truth, MRMC study, standalone performance) is not applicable or cannot be extracted from the provided text.
The document discusses the device's description, indications for use, contraindications, and potential warnings/precautions. It then details the FDA's decision regarding substantial equivalence to predicate devices. There is no mention of an algorithm, AI, or any performance study based on quantitative metrics typically associated with AI/ML device submissions.
Therefore, I cannot fulfill the request as it pertains to AI/ML device performance and acceptance criteria. The provided text does not contain that type of information.
§ 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.