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The FRIALIT-2 ® Bone Profiler in intended to be used for the removal of bone that has grown over the top of the implant during the integration period.

The FRIALIT-2 Bone Profiler is part of the FRIALIT-2 Dental Implant System. The Bone Profiler consists of a stainless steel drill guide. The drill is available in the same diameters as the FRIALIT-2 implant bodies. The Bone Profiler is designed to remove bone that has grown over the top of an implant during the integration period. The FRIALIT-2 Bone Profiler can be used in a standard latch handpiece or by hand in a lab handle.

This document is a 510(k) summary for the FRIALIT-2 Bone Profiler, an accessory to a dental implant system. The document focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study with specific acceptance criteria and performance metrics for a novel AI or diagnostic device.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert adjudication, and MRMC studies is not available in the provided text. The document describes a medical device (a bone profiler used in dental implant procedures) and its substantial equivalence to an existing device, which is a different type of regulatory submission than one requiring a detailed performance study like those for AI or diagnostic tools.

The document primarily provides:

• Device Description: The FRIALIT-2 Bone Profiler is a stainless steel drill guide designed to remove bone overgrowth from dental implants.
• Intended Use: Used in the FRIALIT-2 Dental Implant System for single tooth restorations, edentulous spans, free-standing bridges, and retaining overdentures, for immediate, delayed immediate, or late implant placement.
• Predicate Device: Implant Innovations Inc., Bone Profiler (K960417).
• Substantial Equivalence Claim: The FRIALIT-2 Bone Profiler is similar to the predicate device in design, material, function, and intended use.
• Regulatory Classification: Class III, product code DZE.
• FDA Clearance: Cleared by the FDA on January 10, 22000, based on substantial equivalence.

In summary, none of the requested information about acceptance criteria or a performance study is present because this document is a 510(k) summary for a medical device claiming substantial equivalence, not a performance study for an AI or diagnostic device.

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