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ANTHOGYR implants are intended for use as artificial root structures for replacement of missing teeth. They can be used for fixation of single tooth restorations.
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.
Axiom® 2.8 implants are indicated for single replacement of mandibular incisors and lateral maxillary incisors in cases presenting a restricted mesiodistal space.
The prosthetic components of the Axiom 2.8 product line are intended to ensure support for single crowns only.

The AXIOM® 2.8 implant system has been designed in order to enhance the functional and aesthetic integration of implant supported restorations. The implant-abutment combination can support occlusal charge without risk of damaging the restoration and will not generate hazardous peek of stress at the prosthetic interface level.
The file concerns the implants and abutments.
Implants:
Replacement of a missing root for placement of a dental restoration.
Material: Ti6Al4V
Surface treatment: BCP®
Dimensions: Ø2.8, length: 10-14 mm
Abutments:
Provide support for a single permanent restoration.
Material: Ti6Al4V
Dimensions: Ø2.8
Angle: 0-23°
Gingival height: 1-5.5 mm
Temporary abutments:
Provide support for a temporary restoration.
Material: PEEK
Dimensions:Ø2.8
Gingival height: 1-5.5 mm

The provided text is a 510(k) Summary for the ANTHOGYR AXIOM® 2.8 endosseous dental implant system. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:

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 for Test Set: Not explicitly stated. The document mentions "a fatigue testing," but doesn't specify the number of samples tested.
• Data Provenance: The study was conducted by ANTHOGYR SAS, located in Sallanches, France. It is a non-clinical in vitro test (fatigue testing), not involving human or animal subjects, so terms like "retrospective" or "prospective" are not applicable.

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. The "ground truth" here refers to the performance of the device against a defined standard (ISO 14801 for mechanical properties). This is an objective measurement based on a standardized test, not a subjective interpretation by experts.

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

This section is not applicable. As stated above, the performance assessment is based on objective, standardized mechanical testing, not a subjective interpretation requiring adjudication.

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. This device is an endosseous dental implant, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study involving human readers and AI assistance is irrelevant to its evaluation.

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

This section is not applicable. This device is a physical medical device (dental implant), not an algorithm or software. Its performance is assessed through physical, mechanical testing.

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

The "ground truth" for the device's performance is established by the ISO 14801 (2007) standard for fatigue testing and the mechanical properties of the legally marketed predicate device. The goal of the study was to demonstrate comparable mechanical properties to the predicate, ensuring the new device performs at least as safely and effectively.

8. The sample size for the training set

This section is not applicable. This is not an AI/ML device, so there is no "training set."

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

This section is not applicable. There is no training set for this type of device.

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