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31 T3 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.

31 T3® 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.

The 31 T3® External Hex Dental Implants are manufactured from commercially pure titanium and feature a roughened apex and traditional OSSEOTITE® coronal surface. In addition, the implans are offered with or without a nano-scale discrete crystalline deposition (DCD®) of calcium phosphate (CaP) surface treatment. The dental implants are basic screw-type designs available in either parallel walled or tapered body geometries. The implants are available in various platform options and feature an external hex connection for mating with associated Biomet 3i™ external connection restorative components. The implants are offered in a variety of diameters (3.25mm -6.0mm) and lengths (Parallel walled: 6.5mm - 18.0mm, Tapered: 8.5mm - 15.0mm) to accommodate varying patient anatomy.

The provided text describes a 510(k) premarket notification for the 3i T3® External Hex Dental Implants. Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria, based on the input provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Note: The document states that the devices met the acceptance criteria, but it does not specify what those criteria were (e.g., minimum cycles to failure, maximum displacement) or the exact performance values achieved by the device. It only refers to "predetermined acceptance criteria" from ISO 14807:2007.

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

• Sample Size for Test Set: The document does not explicitly state the sample size used for the mechanical testing. It refers to "worst case subject devices" but provides no count.
• Data Provenance: The data is described as "Non-clinical testing" in the form of "mechanical testing." It is implied to be laboratory testing conducted by the manufacturer (BIOMET 3i™) to support the 510(k) submission. No information on country of origin of the data is provided, nor is it described as retrospective or prospective human data.

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

• Not Applicable. The "ground truth" for this type of non-clinical mechanical testing is the established standard (ISO 14807:2007) and the physical measurements/observations during the test. There were no human experts involved in establishing a "ground truth" for this mechanical performance study in the way one would for clinical imaging or diagnostic studies.

4. Adjudication Method for the Test Set:

• Not Applicable. As this was a mechanical test against an ISO standard, there would not be an adjudication method in the context of human expert review or consensus. The results would be objectively measured and compared to the standard's requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

• No, an MRMC comparative effectiveness study was not done. The study described is a non-clinical mechanical fatigue test, not a clinical study involving human readers or patient cases.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not Applicable. This device is a dental implant, not a software algorithm or AI system. The concept of "standalone performance" for an algorithm is not relevant here. The testing described is for the physical device itself.

7. The Type of Ground Truth Used:

• Standard-based performance specifications. The "ground truth" for this non-clinical testing is the performance requirements and methodologies outlined in ISO 14807:2007 (Dentistry - Implants - Dynamic fatigue test for endosseous dental implants). The device's performance was compared against these established mechanical engineering standards.

8. The Sample Size for the Training Set:

• Not Applicable. There is no "training set" referenced in this context. The study is a mechanical performance test, not a machine learning or AI model development project.

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

• Not Applicable. As there is no training set, this question is not relevant.

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