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Touareg CloseFit™ Dental Implants are intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

Touareg CloseFit™ Dental Implants may be immediately loaded when good primary stability is achieved and with appropriate occlusal loading

Touareg CloseFit™ Dental Implants are threaded, root-form dental implants intended for surgical placement in the maxillary and/or mandibular arch to support crowns, bridges, or overdentures in edentulous or partially edentulous patients.

The Touareg CloseFit™ Dental Implants are similar in design to the Touareg Dental Implant cleared under Adin Dental Implant System. K081751. The predicate internal connection was changed to internal hex (hexagonal) Morse tapered connection. In addition, dental implant name was changed from Touareg Dental Implants to the Touareg CloseFit™ Dental Implants to extend Touareg Implants family's product line, and surface treatment name was changed to OsseoFix™ due to marketing reasons only. Also, lengths and diameters were added - implants are now provided in diameter of 4.3mm, and lengths of 15.0 mm and 18.0 mm.

The provided text describes the Touareg CloseFit™ Dental Implant System and its premarket notification (510(k)) for FDA clearance. The document focuses on establishing substantial equivalence to a predicate device, primarily through non-clinical testing.

Here's an analysis of the acceptance criteria and study information based on the provided text, focusing on the requested categories:

1. A table of acceptance criteria and the reported device performance

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

• Sample Size: The document does not explicitly state the specific number of implants or test specimens used in the fatigue testing. It only mentions "bench performance test was performed on Subject Devices and Predicate Devices."
• Data Provenance: The study described is a non-clinical, bench performance test. The manufacturer, Adin Dental Implants Systems Ltd., is located in Afula, Israel. Therefore, the data likely originated from their testing facilities in Israel. It is retrospective in the sense that the testing was performed to demonstrate compliance for clearance.

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 section is not applicable as the clearance is based on non-clinical, mechanical fatigue testing, not on human expert review or diagnostic accuracy.

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

This section is not applicable as the clearance is based on non-clinical, mechanical fatigue testing, not on human expert review or diagnostic accuracy.

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 section is not applicable. The submission is for a dental implant system (a physical device), not an AI/software product that would involve human readers or diagnostic interpretation.

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

This section is not applicable. The submission is for a dental implant system (a physical device), not an algorithm or software. The "standalone" performance refers to the device's mechanical integrity as tested in the lab.

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

For the fatigue testing, the "ground truth" is defined by the ISO 14801:2007 standard ("Dentistry-Implants-Dynamic fatigue test for endosseous dental implants") which specifies the methodology and acceptance criteria for dynamic fatigue testing of dental implants. The performance is measured against the requirements of this standard.

8. The sample size for the training set

This section is not applicable. The submission describes a physical medical device (dental implant). There is no "training set" in the context of an AI/machine learning model. The testing was done to confirm the physical properties of the device.

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

This section is not applicable for the same reasons as #8.

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