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510(k) Data Aggregation
(265 days)
Anthogyr FlexiBase**®** titanium bases for Axiom**®** BL
Anthogyr FlexiBase® titanium bases for Axiom® BL are indicated for use as a support for singleunit customized prosthetic restorations. All digitally designed copings and / or crowns for use with the Anthogyr Flexibase® titanium bases for Axiom® BL are intended to be sent to Straumann for manufacturing by a validated milling center (Straumann CARES System).
Anthogyr FlexiBase® titanium bases for Axiom® BL are intended to be placed into Anthogyr dental implants to provide support for single-unit restorations. The second component of the two-piece abutment (coping or crown) must be cemented onto the titanium component of the FlexiBase® abutment to constitute the final two-piece abutment design, which is then screwed onto the implant.
The bottom portion of the FlexiBase® are made from Titanium alloy. They are provided in several dimensions, there is one chimney height, and two platform diameters of 4.0 mm and 5.0 mm, and for each of the platform diameters there are three gingival heights of 1.5 mm, 2.5 mm and 3.5 mm.
Anthogyr FlexiBase® titanium bases for Axiom® BL are very similar to the primary predicate device Medentika TiBase CAD/CAM Abutments cleared in K150203.
The FlexiBase® are fixed in the implant by means of a prosthetic screw which is manufactured in titanium alloy and DLC coated identical to K161177.
The FlexiBase® abutments are two-piece abutments used as a base when fabricating a CAD/CAM customized restoration. The design and milling of the customized restoration must be made using the Straumann CARES® Visual software.
The FlexiBase® is a two-piece abutment ultimately composed by three components:
- . FlexiBase® abutment titanium component
- Top-half component (coping and/or crown) .
- . Prosthetic screw
The FlexiBase® abutments will be marketed:
- through a validated Straumann Centralized milling center, in this case all digitally . designed copings and/or crowns are intended to be manufactured at a validated Straumann milling center (Straumann CARES® System).
The provided text describes a 510(k) premarket notification for "Anthogyr FlexiBase® titanium bases for Axiom® BL". This document focuses on demonstrating substantial equivalence to predicate devices, and therefore, the acceptance criteria and study detailed below relate to the performance of the device in comparison to these predicates, rather than proving a specific diagnostic accuracy or clinical outcome for a novel AI algorithm.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria Category | Specific Test/Standard | Acceptance Criteria | Reported Device Performance (Anthogyr FlexiBase®) |
|---|---|---|---|
| Sterilization | ISO 17665-1, ISO 17665-2, FDA Guidance "Reprocessing Medical Devices..." | Validation of recommended sterilization method for end-user moist heat (steam) sterilization. | Sterilization method validated according to ISO 17665-1 and ISO 17665-2 and applicable FDA guidance. Parameters equivalent to predicate devices. |
| Biocompatibility | ISO 10993-1, ISO 10993-5, FDA Guidance "Use of International Standard ISO 10993-1..." | Biological assessment performed, cytotoxicity testing conducted. Equivalent materials to predicate devices. | Biological assessment performed. Cytotoxicity testing performed as per ISO 10993-5. No new issues raised due to material equivalence to predicate devices. |
| Electromagnetic Compatibility (EMC) | Not explicitly stated, referenced from prior testing/clearance (K180564) | MR Conditional status due to no significant material/dimension changes from marketed predicate devices. | Considered MR Conditional. No new issues of electromagnetic compatibility raised due to physical equivalence to predicate devices. |
| Dynamic Fatigue | FDA Guidance "Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments", ISO 14801 | Covered permanent restoration without failure for 2 million cycles (in saline, 2 Hz, 37°C); Covered temporary restoration without failure for 200,000 cycles (in saline, 2 Hz, 37°C). | Demonstrated equivalence to primary predicate and reference devices. Tested without failure for 2 million cycles (permanent restoration) and 200,000 cycles (temporary restoration) under specified conditions. |
2. Sample size used for the test set and the data provenance
The document does not detail specific "sample sizes" in the context of a statistical test set using patient data. The performance testing described relates to in-vitro bench testing of the devices themselves.
- Dynamic Fatigue Testing: The document states the test was conducted on the devices, but the specific number of units tested is not provided ("the subject devices").
- Data Provenance: Not applicable in the context of clinical patient data. The testing described is laboratory-based bench testing.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable. The device is a physical dental implant component, and the testing described is engineering performance testing (sterilization, biocompatibility, fatigue). There is no "ground truth" to be established by clinical experts in the context of this 510(k) submission.
4. Adjudication method for the test set
Not applicable, as this is laboratory bench testing, not a clinical study involving human judgment on a test set.
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. The device is a dental implant base, not an AI, imaging, or diagnostic device that would involve human readers or AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The performance criteria are based on engineering standards and regulatory guidance for device performance and safety (e.g., ability to withstand dynamic loading, biocompatibility, sterility) rather than clinical "ground truth" derived from patient data or expert consensus on clinical findings.
8. The sample size for the training set
Not applicable. This is not an AI algorithm or a device requiring a training set in that sense.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is detailed under "Performance Testing - Bench" and "Performance Testing 1.1 - Sterilization Validation and Shelf-life", as well as "Biocompatibility Testing" and "Electromagnetic Compatibility".
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Study Design: The studies essentially comprised benchtop engineering tests performed according to recognized international standards and FDA guidance documents. This included:
- Sterilization Validation: Demonstrated the effectiveness of the recommended moist heat (steam) sterilization method for end-users, aligning with ISO 17665-1, ISO 17665-2, and FDA guidance.
- Biocompatibility Testing: Conducted biological assessment according to ISO 10993-1 and ISO 10993-5, including cytotoxicity testing. The materials were deemed equivalent to those in predicate devices, implying comparable biocompatibility.
- Electromagnetic Compatibility (EMC): Assessed by confirming no significant changes in materials and dimensions compared to previously cleared predicate devices, thus inferring MR Conditional status based on prior clearances (e.g., K180564).
- Dynamic Fatigue Testing: Conducted in accordance with FDA guidance for endosseous dental implants and ISO 14801. This involved cyclic loading tests in saline (2 Hz, 37°C) for:
- 2 million cycles for permanent restorations (without failure).
- 200,000 cycles for temporary restorations (without failure).
-
Proof of Meeting Acceptance Criteria: The outcome of these tests indicated that the "Anthogyr FlexiBase® titanium bases for Axiom® BL" devices successfully met the performance requirements outlined by the respective standards and guidance documents. The key finding was that the subject devices demonstrated equivalence to the primary predicate and reference devices in all these aspects of performance and safety. This equivalence is the primary basis for the 510(k) clearance.
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