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CeraRoot TL dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The CeraRoot TL dental implants can be used for single or multiple unit restorations in splinted or non-splinted applications. CeraRoot TL implants can be placed in immediate or delayed tooth extractions. CeraRoot TL implants are intended for delayed loading. The CeraRoot TL dental implants are specially indicated in patients with metal allergies and chronic illness due to metal allergies.

The CeraRoot TL Implant System is the two-piece tissue level variant of the original ceramic dental implant one-piece CeraRoot Implant System (K093595) available since 2011 in the USA and 2006 in Europe. CeraRoot® dental implants are made of Y-TZP zirconium dioxide ceramics in accordance with ISO 13356. CeraRoot® dental implants are especially designed for the surgical implantation in the maxilla and mandible for the retention of fixed prosthetic devices, such as an artificial tooth, in order to restore patient aesthetics and chewing function. The outer surface is acid etched for good osseointegration. The new TL (two-piece) variants are available in different lengths (8,10, 12 and 14mm) and only for the models CeraRoot 34TL (⌀ 5mm), CeraRoot 21TL (⌀ 5.6mm) and CeraRoot 16TL (⌀ 7mm).

The implants are provided sterile in sterile packaging and are intended for single use. CeraRoot implants must not be re-sterilized or disinfected either.

The CeraRoot TL abutments are made of the same Y-TZP ceramic material as the implants, and are attached to the CeraRoot TL implants by cementation. After the cementation of the abutments into the implant then the restorative prosthesis can be custom-made, produced and cemented on top to finish the treatment.

The CeraRoot TL abutments are available with the lengths 4.3 and 5.8 mm.

The CeraRoot TL abutments are provided non-sterile. They are intended for single use and must not be reused. Before use they must be cleaned, disinfected and sterilized according to the instructions given in the "instructions for use of CeraRoot TL abutments" document.

The provided document is an FDA 510(k) clearance letter for the CeraRoot TL Implant System. This type of document is generally a summary for a medical device, specifically a dental implant, and not an AI/ML-enabled device used for diagnostic or screening purposes that would involve image analysis or similar data interpretation.

Therefore, the typical acceptance criteria and study designs described in your request (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, type of ground truth, adjudication methods) are not applicable to this specific device. These criteria are usually for devices that perform a measurement, classification, or diagnostic function, often involving AI/ML.

The "study that proves the device meets the acceptance criteria" in the context of this dental implant is primarily the non-clinical testing (bench testing) and biocompatibility evaluations to demonstrate that the device is substantially equivalent to existing, legally marketed predicate devices.

Here's how to interpret the provided information in the context of the CeraRoot TL Implant System:

1. Table of acceptance criteria and reported device performance:

The acceptance criteria for a dental implant focus on its physical properties, biocompatibility, and mechanical performance rather than diagnostic accuracy.

Regarding the other points of your request:

• 2. Sample sized used for the test set and the data provenance:

  • For biocompatibility and mechanical testing (e.g., fatigue), specific sample sizes are used as defined by the relevant ISO standards (e.g., ISO 14801). The document does not specify these exact numbers, but indicates that the testing was performed "like the predicate devices" and "according to ISO 14801."
  • Data Provenance: The studies are bench tests (laboratory performance testing) rather than clinical studies with human patient data. Therefore, concepts like "country of origin of the data" or "retrospective/prospective" patient data are not applicable. The data provenance is the testing facility/laboratory where the bench tests were conducted.

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

  • Not applicable. This is a physical device being tested against engineering and biological performance standards, not a diagnostic or AI device requiring expert interpretation of data to establish ground truth.

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

  • Not applicable. Adjudication relates to resolving discrepancies in human expert interpretations, which is not part of dental implant performance 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 not an AI/ML-enabled diagnostic or assistance device.

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

  • Not applicable. There is no algorithm or human-in-the-loop component for this physical medical device.

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

  • The "ground truth" for this device is compliance with established international engineering and biocompatibility standards (e.g., ISO 14801 for fatigue, ISO 10993 for biocompatibility) and demonstrated substantial equivalence to predicate devices. There is no "pathology" or "outcomes data" ground truth directly from this 510(k) summary, as human clinical testing was explicitly stated as "Not applicable."

• 8. The sample size for the training set:

  • Not applicable. There is no "training set" for a physical dental implant. This term applies to machine learning models.

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

  • Not applicable. No training set for this device.

In summary, this 510(k) clearance is for a conventional dental implant, and the requested details about AI/ML device validation are not relevant to the information provided in this document. The "proof" of meeting acceptance criteria for this device rests on rigorous bench testing against established performance standards and a thorough comparison to legally marketed predicate devices to demonstrate substantial equivalence.

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