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"O" Company's Titanium CP Endosseous Implant is intended to be surgically placed in the bone of the upper of lower jaw arches providing support for prosthetic devices resulting in the restoration of the patient's chewing function.

A cylinder shaped commercially pure titanium dental implant with external threads and a Hydroxylapatite Coating.

The provided text is a 510(k) premarket notification for a medical device called the "O" Butment HS Implant, a type of dental implant. It focuses on demonstrating substantial equivalence to previously marketed devices rather than presenting a study for meeting specific acceptance criteria for performance.

Therefore, most of the requested information regarding acceptance criteria, performance studies, sample sizes, expert ground truth, adjudication methods, and MRMC studies is not available in the provided document. The document describes a regulatory process for market clearance, not an evaluation of device performance against pre-defined acceptance criteria through a clinical or non-clinical study designed for that purpose.

Here's a breakdown based on the information that is available:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Not applicable / Not provided. No test set in the sense of patient data or clinical images was used for performance evaluation against acceptance criteria. The "test" mentioned relates to non-clinical stress analysis.

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

• Not applicable / Not provided. No ground truth established by experts is mentioned, as there was no test set of clinical cases.

4. Adjudication Method for the Test Set:

• Not applicable / Not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

• No. An MRMC study was not done. The submission focuses on substantial equivalence based on design, materials, and non-clinical testing.

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

• Not applicable. This device is a physical dental implant, not an algorithm.

7. The Type of Ground Truth Used:

• Not applicable / Not provided. The evaluation was based on design comparison and non-clinical engineering stress analysis, not clinical ground truth.

8. The Sample Size for the Training Set:

• Not applicable / Not provided. This is not a machine learning device; therefore, no training set is relevant.

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

• Not applicable / Not provided.

Summary of Relevant Information from the Document:

• Non-clinical tests: Lateral and vertical stress analysis performed by Rocky Mountain Testing.
• Finding: "It has been determined that the physical integrity of the implant has not been compromised by the modifications."
• Basis for Substantial Equivalence: Design, function, labeling, material composition, and intended use compared to predicate devices ("O" Butment ES Implant and Screw-Vent Implant).

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