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The implant is indicated for use in restoring masticatory function in the edentulous and/or partially edentulous patient.

The Steri-Oss implant is designed to serve as support for prosthetic devices to restore patient chewing function. Natural dentition is composed of a root (subgingival) and a crown (supragingival). Designs in existence are intended to mimic this structure to aid the patient in restoring natural masticatory function. The implant is designed to serve as the root of the artificial tooth and the abutment/prosthetic is designed to serve as the crown. The implants are 3.8, 5.0 or 6.0 mm in diameter, from 8 - 18 mm in length and are composed of a titanium body and titanium coating. They are tapered, have a hexed superior surface, and are threaded.

The provided text describes a 510(k) summary for Steri-Oss's "Replace TPS Coated Implants." It primarily focuses on demonstrating substantial equivalence to a predicate device and does not involve a study with acceptance criteria in the typical sense of AI/algorithm performance. The "Performance Data" section explicitly states: "A mathematical justification demonstrates the substantial equivalence of the predicate to the Steri-Oss products." This indicates that the regulatory approval is based on a comparison of device characteristics and design rationale, rather than a clinical study evaluating diagnostic accuracy or a specific performance metric against a defined threshold.

Therefore, many of the requested elements for describing acceptance criteria and a study proving device performance (especially those related to AI or diagnostic accuracy) are not applicable or cannot be extracted from this document.

Here's an attempt to address the request based on the available information:

1. Table of acceptance criteria and the reported device performance

The concept of "acceptance criteria" here is framed around demonstrating substantial equivalence to a predicate device, rather than achieving specific performance metrics in a clinical study. The "performance" is implicitly about matching or being comparable to the predicate's established characteristics and function.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not applicable/not provided. The document describes a comparison against a predicate device's specifications, not a clinical trial with a "test set" in the context of diagnostic performance or AI evaluation.

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)

This information is not applicable/not provided. Ground truth in the context of a 510(k) for a medical implant typically refers to established safety and effectiveness of the predicate, or to the inherent design and material properties. There is no mention of an expert panel or ground truth establishment for a test set.

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

This information is not applicable/not provided. There was no "test set" in the sense of a set of cases requiring 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

This information is not applicable/not provided. This document pertains to a dental implant, not an AI-assisted diagnostic tool.

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

This information is not applicable/not provided. This document describes a physical medical device, not an algorithm.

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

The "ground truth" for regulatory approval in this context is the established safety and effectiveness of the existing predicate device (Nobelpharma's 3.75 mm implant) against which the new device claims substantial equivalence. The characteristics and intended use of the Steri-Oss implant are compared directly to those of the predicate.

8. The sample size for the training set

This information is not applicable/not provided. There is no "training set" in the context of this regulatory submission for a physical medical implant.

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

This information is not applicable/not provided. There is no "training set." The relevant "ground truth" is the established data and regulatory history of the predicate device.

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