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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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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 31 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 NanoTite Dental Implants cleared by K051461, K063341 & K063286 have both the proprietary OSSEOTITE acid-etched surface and NanoTite CaP Discrete Crystalline Deposition (DCD) surface treatment.

The devices themselves have not been modified since their original clearance. Specific performance claims for NanoTite Dental Implants are being modified. Two independent prospective randomized controlled studies provide clinical data to support the requested claims.

The provided text describes a 510(k) premarket notification for BIOMET 3i NanoTite™ Dental Implants. This is a medical device submission, and the content focuses on establishing substantial equivalence to a predicate device and supporting claims for use. It is not a study about an AI-powered device, and therefore, most of the requested information (acceptance criteria, device performance, sample sizes, ground truth, MRMC studies, standalone performance, training set details) is not applicable.

However, I can extract the relevant information regarding the device itself and the type of evidence provided:

Device: BIOMET 3i NanoTite™ Dental Implants
Classification Name: Endosseous dental implant
Product Code: DZE
Predicate Device: K051461 - 3i Osseotite (Nano CaP) Dental Implant

Study Information (as pertains to this 510(k) submission):

The submission refers to changes in "specific performance claims for NanoTite Dental Implants," which are supported by clinical data.

Description of Study:

"Two independent prospective randomized controlled studies provide clinical data to support the requested claims."

Type of Ground Truth Used: Clinical data (implied patient outcomes and immediate function assessment).

Conclusion of the Submission:

"The clinical data submitted for the NanoTite dental implant compared to the control implant supports the modifications to specific performance claims requested within this premarket notification."

Regarding your specific questions, this document does not contain the following information as it pertains to an AI/Software as a Medical Device (SaMD):

1. A table of acceptance criteria and the reported device performance: This document reports modifications to performance claims, not specific quantitative acceptance criteria or performance metrics for an AI device.
2. Sample sizes used for the test set and the data provenance: The document states "Two independent prospective randomized controlled studies" were conducted but does not provide sample sizes, country of origin, or specific details of the test sets.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience): Not applicable for a dental implant study. The ground truth refers to clinical outcomes.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable, as this is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is not an AI device.
7. The type of ground truth used: As mentioned, it's "clinical data" from patient studies, which would involve assessing implant success, immediate function, etc. This is not an expert consensus on interpreting images for an AI device.
8. The sample size for the training set: Not applicable, as this is not an AI device.
9. How the ground truth for the training set was established: Not applicable, as this is not an AI device.

In summary, this 510(k) document pertains to a physical dental implant device and its clinical performance, not an AI software device. Therefore, the requested information about AI model acceptance criteria, ground truth establishment by experts, and MRMC studies is not present.

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