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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, or as a terminal or intermediary abutment for fixed or removable bridgework, and to retain overdentures. In addition, when a minimum of 4 implants, ≥ 10mm in length, are placed in the maxilla and/or mandible and splinted in the anterior region, immediate loading is indicated.

The NanoTite Dental Implants, hereinafter referred to as NanoTite Dental Implants, are the same dental implants referred to as "3i Nano CaP OSSEOTITE" Dental Implants, subject of the predict device submission K051461. The NanoTite Dental Implants are provided with the proprietary OSSEOTITE acid-etched surface further treated with a deposition of nanometer scale crystals of calcium phosphate. Implants are offered in both tapered and parallel-walled/straight designs, and each design provides offerings for either external hex or internal connections.

This document is a 510(k) Premarket Notification for the NanoTite™ Dental Implants. It seeks to demonstrate substantial equivalence to previously cleared predicate devices (K051461). The nature of this submission is not for an AI/ML device, therefore the requested information regarding acceptance criteria, study data, and ground truth for an AI/ML device is not applicable.

The document describes a medical device (dental implants) and its intended use, and it relies on established engineering and materials performance testing rather than clinical study of an AI algorithm.

Here's an explanation of why the requested AI/ML specific information cannot be extracted from this document:

• No AI/ML Component: The submission describes a physical medical device (dental implants) that is treated with a specific surface technology (nanometer scale crystals of calcium phosphate). There is no mention of any artificial intelligence, machine learning, or software algorithm that provides diagnostics, prognostics, or treatment recommendations.
• Performance Testing for Physical Device: The "Performance Testing" section states: "Laboratory testing was conducted to determine device functionality and conformance to design input requirements, as well as FDA's Class II special controls guidance document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments. Risk analysis was conducted in accordance with ISO 14971. Results from all of these tests were included in the premarket notification submission for the predicate devices, K051461." This indicates that the performance data refers to physical and biological compatibility testing of the implant itself, not the performance of an AI algorithm.
• Substantial Equivalence: The primary goal of this 510(k) is to demonstrate substantial equivalence to the predicate device (3i OSSEOTITE Dental Implants, K051461). This involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety or effectiveness. This is a common regulatory pathway for non-AI/ML devices.

Therefore, the questions regarding acceptance criteria, study details, sample sizes, experts, adjudication, MRMC studies, standalone performance, and ground truth for an AI/ML device are not applicable to this 510(k) submission.

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