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The intended use for this device is to serve as support for prosthetic devices to restore patient chewing function.

This device is designed to serve as support for prosthetic devices to restore patient chewing function. This implant is 3.25 mm in diameter, 10 to 16 mm in length, and is fabricated from titanium alloy. They are threaded and have a superior external hex. The threaded portion of the implant body has a 50 micron thick plasma sprayed hydroxyapatite coating, and the surface of the external hex is anodized magenta in color.

The provided text is a 510(k) summary for a dental implant device and does not contain information about acceptance criteria, performance studies, or clinical trial results that would typically be found for a medical diagnostic device. It focuses on demonstrating substantial equivalence to a predicate device.

Therefore, the requested information cannot be extracted from the provided text.

Here is why each point cannot be addressed:

1. A table of acceptance criteria and the reported device performance: The document does not define any acceptance criteria (e.g., sensitivity, specificity, accuracy targets) or report performance metrics from a study.
2. Sample size used for the test set and the data provenance: There is no mention of a "test set" or any data used for evaluating the device's performance.
3. Number of experts used to establish the ground truth... and qualifications: Not applicable as no ground truth was established for a performance study.
4. Adjudication method: Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done: The document explicitly states "Performance Data: Not applicable," which means no such study was conducted or provided.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable for this type of device.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable as this is a physical medical device, not a diagnostic algorithm that requires a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily focuses on:

• Device description (material, dimensions, coating).
• Intended use (support for prosthetic devices to restore patient chewing function).
• Comparison to predicate devices to establish substantial equivalence based on technological characteristics (material, surface characteristics, sterility).
• The FDA letter confirms substantial equivalence without requiring performance data for this specific type of submission.

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