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BIOMET 3i dental implants are intended for surgical placement in the upper or lower jaw to provide a means for prosthetic attachment in single tooth restorations and in partially or fully edentulous spans with multiple single teeth utilizing delayed or immediate loading, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures.

BIOMET 3i Osseotite and NanoTite dental implants are intended for immediate function on single tooth and/or multiple tooth applications when good primary stability is achieved, with appropriate occlusal loading, in order to restore chewing function.

BIOMET 3i Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface, both with and without the additional proprietary NanoTite treatment. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections. Implants are also offered in various diameters and length.

This looks like a 510(k) premarket notification for a dental implant. 510(k)s generally demonstrate substantial equivalence to a predicate device, rather than proving performance against specific acceptance criteria with detailed studies like those of an AI/ML device.

Therefore, the requested information regarding acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, ground truth, and training data is not applicable to this type of submission.

Instead, the submission focuses on demonstrating that the BIOMET 3i Dental Implants have technological characteristics and intended uses that are substantially equivalent to already legally marketed predicate devices. The "Performance Testing" section mentions:

• Laboratory testing: Conducted to determine device functionality and conformance to design input requirements and FDA's Class II special controls guidance document.
• Risk analysis: Conducted in accordance with ISO 14971.
• Results: Included in the premarket notification submissions for the predicate device.

The FDA's decision letter also confirms that they have determined the device is "substantially equivalent" to legally marketed predicate devices.

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