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BIOMET 3/ 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.

The 3i T3 Dental Implants are manufactured from Commercially Pure Grade 4 titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. The dental implants will consist of a straight wall or tapered body type with a basic screw-type design in various platform options and feature an internal connection/anti-rotation feature; 3.25 and 4/3mm has a 12pt dual hex; 4, 5, 6, 5/4 & 6/5mm has a six-point hex at the top and lower 12-point dual hex. The 3i T3 Dental Implants are available with either the Prevail platform switching feature or standard collar. In addition, the implants are offered with and without the nano-scale discrete crystalline deposition (DCD) calcium phosphate (CaP) surface treatment.

The provided document is a 510(k) Summary for the BIOMET 3i T3 Dental Implants. This document focuses on demonstrating substantial equivalence to previously cleared devices through non-clinical performance data. It does not describe an AI medical device or a study involving AI with human readers. Therefore, most of the requested information regarding AI device acceptance criteria and study design is not available in this document.

However, I can extract information related to the acceptance criteria and the studies performed for this non-AI medical device.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

This document does not specify exact sample sizes for the non-clinical tests (e.g., how many implants were cycle-tested). The clinical data mentioned refers to postmarket clinical studies of predicate implants, not the new device being tested for equivalence.

• Clinical Data (from predicate implants): Data on over 6,829 implants placed in the posterior from 1996 - 2011.
• Data Provenance: The provenance of the 6,829 implants is "sponsored or supported by Biomet 3i," implying it's from their own studies or collected data. No specific country of origin is mentioned, but Biomet 3i is a US-based company (Palm Beach Gardens, Florida). The studies are explicitly described as "postmarket clinical studies" of predicate implants, indicating retrospective data collection for the clinical portion. The non-clinical tests were performed on the new device, as part of its premarket submission.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. This device is a dental implant, and the testing involves mechanical and material properties, not interpretation of images or data by human experts for establishing ground truth as would be relevant for an AI diagnostic device.

4. Adjudication Method for the Test Set

Not applicable. This is not an AI diagnostic device requiring expert adjudication for ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This is not an AI diagnostic device.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Not applicable. This is not an AI medical device. The "standalone" performance here refers to the device itself meeting mechanical and material standards without human interpretation.

7. Type of Ground Truth Used

For the non-clinical tests, the "ground truth" is based on established engineering standards, test procedures, and design specifications. For example:

• Mechanical Integrity: ISO 14801:2007 for cyclic fatigue testing.
• Design Intent: Biomet 3i internal procedures for print verification, ensuring manufacturing matches design.
• Material Properties: Adhesion strength, tolerance analysis, and torque testing against established parameters for the predicate devices.

For the postmarket clinical data, the ground truth is clinical survival rates of predicate implants, based on actual patient outcomes over several years.

8. Sample Size for the Training Set

Not applicable. There is no training set mentioned, as this is not an AI device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. There is no training set for an AI model.

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