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ONEPLANT is designed for use in dental implant Surgery. These are intended for use in partially or fully edentulous mandibles and maxillae to support for single or multiple-unit restorations such as cemented retained, screw retained, or over denture restorations and terminal or intermediate abutment support for fixed bridgework.

Dental implant systems are devices made of a material such as titanium intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices such as artificial teeth, and to restore the patients chewing function. Dental implant system consists of Fixture, Abutment and Implant surgical instruments.

This 510(k) summary (K081748) for the ONEPLANT Dental Implant System does not contain information about acceptance criteria or a study proving the device meets specific performance criteria in the way typically associated with AI/ML-driven medical devices.

Instead, this submission is for a traditional medical device (dental implants) and focuses on demonstrating substantial equivalence to existing legally marketed predicate devices. This means the manufacturer is showing that their new device is as safe and effective as devices already on the market, by comparing its materials, design, intended use, and functional characteristics.

Therefore, many of the requested categories for AI/ML device studies are not applicable to this document. I will fill in what can be gleaned from the provided text, and explicitly state when information is not available or not relevant for this type of submission.

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the context of an AI/ML device performance study. This submission is for a physical medical device (dental implants). The "acceptance criteria" here are implicitly met by demonstrating substantial equivalence to predicate devices in terms of materials, design, and intended use. The "reported device performance" refers to the characteristics that allow it to be considered equivalent, rather than quantitative performance metrics from a clinical trial.

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

Not applicable. This submission does not involve a "test set" in the context of an AI/ML device or a clinical performance study with patient data. It is a comparison of product specifications and materials.

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)

Not applicable. No ground truth was established by experts from a test set. The comparison is based on the technical specifications of the devices themselves.

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

Not applicable. No adjudication method for a test set was used.

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 not an AI/ML device, 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 not an AI/ML device.

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

Not applicable as there is no "ground truth" derived from patient data or clinical outcomes in this substantial equivalence submission. The "ground truth" for the comparison is the established characteristics and performance of the predicate devices based on their prior clearances and regulatory compliance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device; there is no training set.

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

Not applicable. This is not an AI/ML device; there is no training set or associated ground truth establishment.

Summary regarding K081748:

This 510(k) submission for the ONEPLANT Dental Implant System is a substantial equivalence submission for a traditional medical device (dental implants). It is not for an AI/ML device and therefore does not include or require the types of performance studies and data analyses that would be found in a submission for an AI/ML product. The "study" proving the device meets acceptance criteria is the comparison table demonstrating that the ONEPLANT system has similar design, materials, and intended use as the legally marketed predicate devices (DENTIUM and Osstem Implant systems). The conclusion explicitly states: "In all respects, the Oneplant Dental Implant components are the equivalent of currently marked devices. They are made of the same materials and have similar dimensions and characteristics. This device is substantially equivalent in design, material, intended use and function to the products on the table above."

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