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The implant system is intended to be surgically placed in the maxilla or mandible to provide support for prosthetic devices such as artificial teeth in order to restore chewing function. It may be used with single-stage or two-stage procedures, for single or multiple unit restorations, and may be loaded immediately when good primary stability is achieved and with appropriate occlusal loading. Multiple tooth applications may be rigidly splinted.

Anthogyr Multi-Unit prosthetic components directly or indirectly connected to the endosseous dental implants are indicated for use to provide support for multiple-unit prosthetic reconstructions such as bridges and bars. The final devices have the purpose of restoring chewing function. Temporary components can be used prior to the final components to maintain, stabilize and shape the soft tissue during the healing phase. The temporary restoration may not be placed into occlusion.

Temporary components have a maximum duration of usage of 180 days.

The OPMUN0-0 abutments are indicated for maxillary lateral and mandibular central/lateral incisors only.

The Anthogyr AXIOM® BL X3 implants are fully tapered dental bone level implants with external diameters of Ø3.4 mm, Ø4.6 mm, Ø5.2 mm, Ø5.8 mm and Ø6.4 mm and lengths of 6.5 mm, 8 mm, 10 mm, 12 mm, 16 mm, and 18 mm. The implants are manufactured from the Ti 6Al-4V ELI titanium-vanadium alloy material and are finished with BCP (Biphasic Calcium Phosphates) surface treatment. The abutment connection is identified as single conical connection.

The proposed Anthogyr Multi-Unit abutments for AXIOM® BL are dental abutments, which are intended to be screwed onto dental implants to provide support for prosthetic superstructures. Multi-Unit abutments can be used in combination with screw retrained multi-unit dental prosthetics, e.g., bars and bridges. Anthogyr Multi-Unit abutments for AXIOM® BL are very similar to the reference device Medentika Multi-Unit Abutments cleared in K191123.

Anthogyr Multi-Unit abutments for AXIOM® BL include straight and angled (18° and 30°) abutments, prosthetic screw and abutment carrier pin.

Anthoqyr Multi-Unit abutments are available as one-piece straight abutments, which have an integrated thread and can be screwed directly into the AXIOM® Bone Level implants, or as twoparts angled abutments, which can be screwed onto the AXIOM® Bone Level implant with the corresponding M1.6 screw.

Anthogyr Multi-Unit abutments for AXIOM® BL exist in two model types:

• Straight Multi-Unit abutments with various gingival heights and two platform diameters । (Ø 4.0 and Ø 4.8 mm)
• Angulated Multi-Unit abutments with various gingival heights and angulations.

Anthogyr Multi-Unit protective caps are placed to the Multi-Unit abutments and are intended to be used to protect the abutment and maintain, stabilize and form the soft tissue during the healing phase.

Anthogyr Multi-Unit temporary copings are compatible with the Multi-Unit abutments and are used for temporary restorations. The copings are placed on the Multi-Unit abutments to support temporary prosthetic superstructures. Temporary copings can be used prior to the insertion of the final components to maintain, stabilize and shape the soft tissue during the healing phase. They must not be placed into occlusion.

The Multi-Unit temporary copings can be adjusted by the dental technician to fit the oral situation and are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

Anthogyr Flexibase for Multi-Unit abutments are compatible with the Multi-Unit abutments and are used for multiple-unit definitive restorations. The Flexibase are placed on Multi-Unit abutments to support definitive prosthetic superstructures. They are fixed to a compatible Multi-Unit abutment by a M1.4 screw.

The provided text describes a 510(k) summary for Anthogyr AXIOM® BL X3 implants and Anthogyr Multi-Unit components for AXIOM® BL. This document evaluates the substantial equivalence of new devices to existing legally marketed predicate devices, rather than establishing acceptance criteria and providing direct evidence of device performance against those criteria in a typical clinical study format.

Therefore, the requested information elements related to "acceptance criteria and reported device performance tabletop," "sample size for test set," "data provenance," "number of experts and qualifications," "adjudication method," "multi-reader multi-case (MRMC) comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" are not applicable in the context of this 510(k) submission summary.

This document focuses on demonstrating that the new devices are substantially equivalent to predicate devices through comparisons of technological characteristics and performance testing (e.g., dynamic fatigue, biocompatibility, sterilization validation). The "acceptance criteria" here implicitly refer to demonstrating equivalence to the predicate devices and compliance with relevant standards and FDA guidance.

Here's an overview of the performance testing performed, interpreted as demonstrating compliance/equivalence rather than explicitly stated acceptance criteria with numerical performance targets:

1. Acceptance Criteria and Reported Device Performance:

2. Sample Size Used for the Test Set and Data Provenance:

• This information is not provided in the 510(k) summary. The summary refers to "tests were conducted" and "results were substantially equivalent," but actual sample sizes for mechanical, sterilization, or other tests are not detailed. The data provenance (e.g., country of origin, retrospective/prospective) is also not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

• Not applicable. This is a medical device, not an AI/software device requiring ground truth established by experts for a test set. The "ground truth" for non-AI devices is typically established through direct physical measurements, chemical analyses, and standardized test methodologies.

4. Adjudication Method for the Test Set:

• Not applicable.

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/imaging device.

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

• Not applicable. This is not an AI/software device.

7. The Type of Ground Truth Used:

• For a traditional medical device like a dental implant, "ground truth" refers to established physical, chemical, and biological properties measured through standardized testing. Examples include:
  • Mechanical properties: Measured against international standards (e.g., ISO, ASTM) or FDA guidance for dental implants/abutments (e.g., fatigue strength, fracture resistance).
  • Biocompatibility: In vitro (e.g., cytotoxicity tests under ISO 10993-5) and in vivo tests (if new materials are introduced) against established biological safety profiles.
  • Sterilization efficacy: Measured by demonstrating a Sterility Assurance Level (SAL) of 10⁻⁶ via methods compliant with ISO 11137-1 (radiation) or ISO 17665-1 (moist heat).
  • Material composition: Chemical analysis to confirm compliance with medical-grade specifications (e.g., Titanium-6Al-4V ELI conforming to ASTM F136).

8. The Sample Size for the Training Set:

• Not applicable. This is not an AI/software device that uses a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable.

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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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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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