(415 days)
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.
| Acceptance Criteria (Implied from Predicate Equivalence & Standards) | Reported Device Performance (AXIOM® PX) |
|---|---|
| Biomechanical Performance: | Biomechanical Testing: |
| - Conformance to ISO 14801 (2007) and FDA Special Controls Guidance Document for Root-form Endosseous Dental Implants. | - Static and fatigue testing conducted in air in accordance with ISO 14801 (2007) and Special Controls Guidance Document. |
| - Fatigue limit equivalent to predicate Axiom REG implants (K131066). | - The fatigue limit of Axiom PX has been compared to the predicate Axiom REG implants (K131066) fatigue limit. (Implies performance is equivalent). |
| - Equivalent surface area analysis, insertion torque, and pullout strength. | - Surface area analysis, insertion torque testing, and pullout strength testing included in the submission to demonstrate substantial equivalence. |
| Sterilization: | Sterilization Validation: |
| - Sterility of implants maintained through shelf-life, in accordance with ISO 11137 series standards. | - Gamma irradiation sterilization conducted on a representative worst-case implant, in accordance with ISO 11137 series standards. (Note: Sterilization was performed on the predicate device K131066. Both implants and DLC screws are sold sterile). |
| - Validated cleaning and sterilization parameters for end-user sterilized products (specifically DLC screws sold non-sterile) according to ISO 17665-1 and ISO 17665-2. | - Validation of recommended cleaning and sterilization parameters for end-user sterilized products (DLC screws) conducted according to ISO 17665-1 and ISO 17665-2. |
| Shelf-Life & Packaging Integrity: | Shelf-Life Validation: |
| - Product remains sterile throughout its shelf life, demonstrated by accelerated and real-time aging according to ASTM F1980. | - Shelf-life validated in accordance with ASTM F1980 under accelerated and real-time aging, supporting sterility throughout shelf life. |
| - Packaging integrity demonstrated by dye penetration (ASTM F1929-15), peeling, and seal strength (ASTM F88-15) tests. | - Dye penetration test (ASTM F1929-15), peeling testing, seal strength testing (ASTM F88-15) as well as sterility test were performed. |
| Biocompatibility: | Biocompatibility Testing: |
| - Conformance to ISO 10993 series standards. | - Biocompatibility assessment performed according to ISO 10993 series standards for implants and abutment screws. |
| - Implants: Assessment of extractable chemicals (ISO 10993-18:2005) and cytotoxicity (ISO 10993-5:2009). | - Implants: Chemical characterization (ISO 10993-18:2005) and cytotoxicity test (ISO 10993-5:2009) by exposing mouse fibroblast cells after extraction. |
| - Abutment screws: Assessment of extractable chemicals, cytotoxicity, intracutaneous irritation, and sensitization (ISO 10993-18:2005, ISO 10993-5:2009, ISO 10993-10:2010). | - Abutment screws: Chemical characterization (ISO 10993-18:2005), cytotoxicity test (ISO 10993-5:2009), intracutaneous study (ISO 10993-10:2010 - intradermal injection in rabbit), and sensitization study (ISO 10993-10:2010 - contact sensitization in albino guinea pig after polar and non-polar extraction). |
| Surface Analysis: | Surface Analysis: |
| - Microscopic analysis (SEM) of implant surface as required by FDA guidance. | - SEM for the implants as required by FDA guidance (Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments). |
Study Details
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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.
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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.
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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).
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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).
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is not an AI/SaMD submission.
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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.
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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.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set.
§ 872.3640 Endosseous dental implant.
(a)
Identification. An endosseous dental implant is a prescription device made of a material such as titanium or titanium alloy that is intended to be surgically placed in the bone of the upper or lower jaw arches to provide support for prosthetic devices, such as artificial teeth, in order to restore a patient's chewing function.(b)
Classification. (1) Class II (special controls). The device is classified as class II if it is a root-form endosseous dental implant. The root-form endosseous dental implant is characterized by four geometrically distinct types: Basket, screw, solid cylinder, and hollow cylinder. The guidance document entitled “Class II Special Controls Guidance Document: Root-Form Endosseous Dental Implants and Endosseous Dental Implant Abutments” will serve as the special control. (See § 872.1(e) for the availability of this guidance document.)(2)
Classification. Class II (special controls). The device is classified as class II if it is a blade-form endosseous dental implant. The special controls for this device are:(i) The design characteristics of the device must ensure that the geometry and material composition are consistent with the intended use;
(ii) Mechanical performance (fatigue) testing under simulated physiological conditions to demonstrate maximum load (endurance limit) when the device is subjected to compressive and shear loads;
(iii) Corrosion testing under simulated physiological conditions to demonstrate corrosion potential of each metal or alloy, couple potential for an assembled dissimilar metal implant system, and corrosion rate for an assembled dissimilar metal implant system;
(iv) The device must be demonstrated to be biocompatible;
(v) Sterility testing must demonstrate the sterility of the device;
(vi) Performance testing to evaluate the compatibility of the device in a magnetic resonance (MR) environment;
(vii) Labeling must include a clear description of the technological features, how the device should be used in patients, detailed surgical protocol and restoration procedures, relevant precautions and warnings based on the clinical use of the device, and qualifications and training requirements for device users including technicians and clinicians;
(viii) Patient labeling must contain a description of how the device works, how the device is placed, how the patient needs to care for the implant, possible adverse events and how to report any complications; and
(ix) Documented clinical experience must demonstrate safe and effective use and capture any adverse events observed during clinical use.