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Anthogyr dental implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for stabilization of removable prostheses or fixation of single tooth restorations or partial dentures. Anthogyr dental systems are indicated for one-stage or two-stage surgery. It is up to the practitioner to decide whether immediate or delayed loading is most appropriate, based on clinical factors like good primary stability and appropriate occlusal loading.

The AXIOM® PX implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The file concerns the implants and abutment screws. The prosthetic components and surgical instrumentation are the same as for the AXIOM® REG (see 510(k) K101913 and K131066) and are compatible with Axiom® PX implants. Implants: Replacement of a missing root for placement of a dental restoration. The implant is screwed in the upper or lower jaw. Material: Ti6AI4V-ELI Surface treatment: BCP® Dimensions, Ø3.4, length 8, 10, 12, 14, 16, 18 mm Ø 4.0, length 8, 10, 12, 14, 16, 18 mm Ø4.6, length 6.5, 8, 10, 12, 14 mm Ø5.2, length 6.5, 8, 10, 12 mm Screws: Screwing the abutment into the implant and the secondary parts into the abutment. Material: Ti6AI4V-ELI Surface treatment: DLC Dimensions: M1.4, length 5, 7.9 mm

Here's a breakdown of the acceptance criteria and the study information based on the provided document.

It's important to note that this document is a 510(k) summary, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting a standalone study proving a new device meets predefined acceptance criteria in the way a clinical trial for a novel AI device might. The "acceptance criteria" here are largely implied by the need to show equivalence to existing, legally marketed devices and adherence to relevant standards.

Acceptance Criteria and Reported Device Performance

Given that this is a 510(k) submission for a dental implant system (AXIOM® PX), the "acceptance criteria" are primarily established by the performance characteristics of its predicate devices and compliance with relevant industry standards and FDA guidance. The study presented is a non-clinical performance testing suite designed to demonstrate substantial equivalence to these predicates.

Study Details

1. Sample sizes used for the test set and the data provenance:

   • Sample Size: The document does not specify the exact numerical sample sizes for each test (e.g., number of implants tested for fatigue, number of animals for biocompatibility). It generally refers to "representative worst case" scenarios for mechanical testing and indicates tests were performed.
   • Data Provenance: The studies are non-clinical (laboratory/bench testing, and in-vitro/animal biocompatibility). Provenance is likely the testing labs approved by Anthogyr SAS, based in Sallanches, France. It is retrospective, meaning the tests were conducted prior to this submission.

2. 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 is not applicable as the studies described are non-clinical performance and biocompatibility tests for a physical medical device (dental implant). The "ground truth" is established by adhering to widely accepted international standards (ISO, ASTM) and FDA guidance, with results interpreted by qualified laboratory personnel, rather than clinical experts establishing a diagnostic ground truth.

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

   • Not applicable for non-clinical bench and biocompatibility testing. The methods are standardized and results are objectively measured per the specified test protocols (e.g., force to failure, chemical composition analysis, cell viability).

4. 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:

   • No. This is not an AI/Software as a Medical Device (SaMD) submission. It's a traditional physical medical device (dental implant) 510(k).

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

   • No. This is not an AI/SaMD submission.

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

   • The "ground truth" for the non-clinical tests is adherence to established, validated test methodologies and performance criteria outlined in international standards (ISO, ASTM) and FDA guidance documents. For example, for biocompatibility, the ground truth is whether the device elicits a toxic or inflammatory response as defined by the ISO 10993 series. For mechanical testing, it's whether the device meets or exceeds the strength and fatigue limits specified by ISO 14801 or exhibits equivalence to the predicate device.

7. The sample size for the training set:

   • Not applicable. There is no "training set" in the context of this traditional medical device submission, as it does not involve machine learning or AI.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set.

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