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The Implant-One™ system is indicated for surgical placement in partially or completely edentulous upper or lower jaws to provide a means for prosthetic attachment to restore a patient's chewing function. The Implant-One™ system is indicated for immediate loading only when primary stability is achieved and with the appropriate occlusal loading.

The Implant-One™ Dental Implants include endosseous dental implants, cover screws, healing caps, dental implant abutments and abutment screws in a variety of sizes to accommodate differing patient anatomy. Endosseous implants are self-tapping, root-form and threaded. They range from 3.25mm to 5.5mm in diameter with lengths ranging from 8mm to 14mm and have an internal, threaded abutment connection having a Morse style taper. Cover screws and healing caps provide protection to the threads of the abutment connection during endosseous and gingival healing. Cover screws are pre-packaged with each implant. Healing caps are provided as an alternative to the cover screw and are packaged separately. Abutment options include Standard and Restorative in various heights. These are fastened to the implant using an abutment screw.

The provided text describes the 510(k) summary for Custom Dental Implants Inc.'s Implant-One™ Dental Implants. This document focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing rather than through clinical studies involving human patients or complex AI algorithms. Therefore, many of the requested elements for describing a study proving device acceptance (like sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or specific ground truth types for AI models) are not applicable to this submission.

The acceptance criteria are implicitly defined by the demonstration of equivalent performance to predicate devices through mechanical testing.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The acceptance criteria for this device are not explicitly stated as quantitative thresholds in the document. Instead, the acceptance is based on demonstrating that the "worst case Implant-One™ system construct performed as well as or better than the predicate devices" in non-clinical dynamic testing according to ISO 14801.

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

• Sample Size: Not specified for non-clinical testing, however it refers to "worst case Implant-One™ system construct" which usually implies a limited number of samples designed to represent the most challenging scenario.
• Data Provenance: Not applicable as it's a non-clinical mechanical test. The test was performed by Custom Dental Implants Inc.

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

• Not applicable as no human experts were involved in establishing ground truth for mechanical testing. The "ground truth" here is the objective measurement of mechanical properties.

4. Adjudication method for the test set

• Not applicable as no adjudication was needed for objective mechanical testing.

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 medical device (dental implant) 510(k) submission, not an AI/software as a medical device (SaMD) submission, and no MRMC study was performed.

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

• Not applicable. This is a medical device (dental implant) 510(k) submission, not an AI/SaMD submission.

7. The type of ground truth used

• Ground Truth Type: Objective mechanical measurements (e.g., fatigue life, fracture strength) as defined by the ISO 14801 standard for dynamic testing of endosseous dental implants. This is a physical, measurable "ground truth" for the device's performance under simulated physiological loading conditions.

8. The sample size for the training set

• Not applicable. There was no training set as no machine learning or AI algorithm was developed or evaluated.

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

• Not applicable. There was no training set.

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