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The newly improved AIDI Dental Implant System (AIDI Fixtures and AIDI Abutments with Screws) is made up of endosseous implants intended to be surgically placed in the bone of the upper or lower jaws to provide support for prosthetic devices, such as an artificial tooth, in order to restore patient esthetics and chewing function. Straight abutments indicated for both screw retained and cemented restorations are included. The implants are indicated for single or multiple unit restorations and can be used in splinted and non-splinted applications. The device is intended for immediate loading when good primary stability has been achieved with the appropriate occlusal loading.

The improved AIDI Dental Implant System is a threaded root-form dental implant intended for use in the upper and lower jaw arches to support prosthetic devices, such as an artificial tooth, in order to restore esthetics and chewing function to partially or fully edentulous patients. Also included are straight abutments (which provide cemented and screw retained restorative options), cover screws, abutment screws, and healing abutments.

The provided text is a 510(k) summary for the AIDI Dental Implant System. It describes the device, its indications for use, technical characteristics, and a nonclinical test summary, concluding with a statement of substantial equivalence. However, it does not contain information about acceptance criteria, specific device performance metrics (beyond generalized statements of "high torque strength"), or detailed study methodologies that would allow for a comprehensive answer to the requested questions.

Here's an analysis based on the provided text, highlighting what is present and what is missing:

1. A table of acceptance criteria and the reported device performance

Missing Information: The document does not explicitly define acceptance criteria in terms of quantitative thresholds or specific metrics. It focuses on demonstrating equivalence to predicate devices, particularly regarding "torque strength." The exact measurement or quantitative comparison of "high torque strength" is not provided.

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

Missing Information: The document states, "The nonclinical test data of the currently submitted AIDI Dental Implant System Torque Test Report revealed high torque strength for AIDI Dental Implants." However, it does not specify:

• The sample size used for the torque test set.
• The data provenance (e.g., country of origin, retrospective or prospective nature).

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

Missing Information: This section is not applicable to the provided document. The submission pertains to a medical device (dental implant system) for which performance is assessed through nonclinical engineering tests (like torque strength), not by expert interpretation of images or other data that would require "ground truth" established by experts in a clinical context.

4. Adjudication method for the test set

Missing Information: Not applicable. As mentioned above, this is an engineering performance test, not a clinical study involving human interpretation with adjudication.

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

Missing Information: Not applicable. This document describes a dental implant system, not an AI-powered diagnostic or assistive tool that would necessitate an MRMC study or assessment of human reader improvement with AI. No clinical studies were submitted.

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

Missing Information: Not applicable. The device is a physical medical implant, not an algorithm.

7. The type of ground truth used

Missing Information: For the "Torque Test," the "ground truth" would be the measured torque strength itself, comparing the subject device to predicate devices. However, the exact methodology and quantitative results are not detailed in this summary.

8. The sample size for the training set

Missing Information: Not applicable. There is no mention of a "training set" as this is not an AI/ML device.

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

Missing Information: Not applicable.

Study Summary (Based on Section 4 & 6):

The device's performance was evaluated through a nonclinical Torque Test.

• Objective: To demonstrate that the AIDI Dental Implant System (current submission) possesses comparable or superior torque strength to its predicate devices.
• Methodology (limited detail): The "Torque Test Report" was submitted, which presumably details the experimental setup and measurements.
• Findings: The test "revealed high torque strength for AIDI Dental Implants (current submission)." Furthermore, the study concluded that "The predicates IDI (K081806) implants and previous AIDI implants (K101755) resembled the same torque strength."
• Conclusion: Based on this nonclinical testing, among other comparisons of materials, design, and technical characteristics, the manufacturer concluded that the "AIDI Dental Implant System (current submission) is substantially equivalent for its intended use and performs as well as the predicates."

In essence, the entire submission hinges on demonstrating "substantial equivalence" through nonclinical testing (specifically, a torque test) and comparison of technical characteristics, rather than establishing performance against defined acceptance criteria via comprehensive clinical studies or expert-driven evaluations.

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