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For use as an endosseous dental implant in the upper or lower jaw arches to provide support for a dental prosthesis.

The device consists of the implant (root component), collar, collar retaining screw, coping, coping retaining screw, healing cap, and healing cap retaining screw. Alternatively, the overdenture abutment (with an overdenture abutment retaining screw) is available; this assembly incorporates the coping retaining screw, collar, and collar retaining screw into a combined component for attachment to the root component. All of the component parts of the Endopore Implant are fabricated from a surgical grade (ASTM F 136-9) titanium-aluminum-vanadium (TicAl;V) alloy. The bone-contacting portion of the implant component has a powder-sintered porous coating of a surgical grade titanium-aluminum-vanadium alloy. The bonccontacting portion of the implant component is a truncated conical design with tapered sides.

The provided text describes a 510(k) summary for the Innova LifeSciences Corporation Endopore® Endosseous Dental Implant System. This document focuses on demonstrating substantial equivalence to predicate devices, rather than establishing specific acceptance criteria or detailing a clinical study with performance metrics in the way a diagnostic algorithm or AI device submission would.

Therefore, many of the requested categories (e.g., sample size for test set, number of experts, adjudication method, MRMC study, standalone performance, training set details, ground truth for training set) are not applicable to this type of device submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample size used for the test set and the data provenance

• Not Applicable. This submission is for a medical device (dental implant), not a diagnostic algorithm or AI device that would typically involve a "test set" in the computational sense. The "performance data" mentioned likely refers to mechanical testing or a summary of existing clinical data related to the predicate devices or the modified device. The document does not specify human subject data for this particular submission's performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. See explanation above.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

• Not Applicable. See explanation above.

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. This is a hardware medical device; it does not involve AI or human readers in an MRMC study context.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This is a hardware medical device; it does not involve algorithms.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• The "ground truth" in this context is implicitly the established safety and effectiveness of the predicate dental implants through their long-standing use and prior FDA clearances, supported by material characterization and mechanical testing to demonstrate that the new, shorter length of the implant does not compromise these established performance parameters. The "performance data" mentioned would likely consist of engineering and bench test results.

8. The sample size for the training set

• Not Applicable. This is a hardware medical device and does not use a "training set" in the machine learning sense.

9. How the ground truth for the training set was established

• Not Applicable. See explanation above.

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