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The 4.5mm diameter implants are designed for use in edentulous sites in the mandible or maxilla for support of a complete denture prosthesis, a terminal or intermediate abutment for fixed bridge work , partial dentures, and / or a single tooth replacement.

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It appears the provided text is a 510(k) clearance letter from the FDA for a dental implant system. This type of document does not typically contain the detailed technical study information required to answer your specific questions about acceptance criteria, device performance, and study methodologies for an AI/algorithm-based device.

The document grants clearance for a physical medical device (Bicon Dental Implants), not a software or AI-driven diagnostic tool. Therefore, information such as sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types for training/test sets, and training set information are not relevant to this specific FDA letter.

To answer your questions accurately, I would need a different type of document, such as a clinical study report, a technical performance report for a software device, or an FDA submission (PMA, De Novo, or 510(k)) specifically for a device involving AI or complex algorithms.

Based on the provided text, I cannot extract the information you've requested.

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