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510(k) Data Aggregation
(228 days)
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using a prosthetic screw and attached to the zirconia superstructure by cementing.
The Elos Accurate® Hybrid Base™ is compatible with the implant systems listed in table 1:
| Implant Platform compatibility | Platform diameter [mm] | Implant Body diameter [mm] |
|---|---|---|
| Nobel Replace NP | 3.5 | 3.5 |
| Nobel Replace RP | 4.3 | 4.3 |
| Nobel Replace WP | 5 | 5 |
| Nobel Replace 6.0 | 6 | 6 |
| Nobel OC 3.0 | 3 | 3 |
| Nobel CC NP | 3.5 | 3.5 & 3.75 |
| Nobel OC RP | 3.9 | 4.3 & 5 |
| Nobel CC WP | 5.1 | 5.5 |
| Straumann Bone Level NC | 3.3 | 3.3 |
| Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
| Astra Tech 3.0 | 3 | 3 |
| Astra Tech 3.5/4.0 | 3.5 & 4 | 3.5 & 4 |
| Astra Tech 4.5/5.0 | 4.5 & 5 | 4.5 & 5 |
| Astra Tech EV 3.0 | 3 | 3 |
| Astra Tech EV 3.6 | 3.6 | 3.6 |
| Astra Tech EV 4.2 | 4.2 | 3.6 & 4.2 |
| Astra Tech EV 4.8 | 4.8 | 4.2 & 4.8 |
| Astra Tech EV 5.4 | 5.4 | 5.4 |
| Brånemark NP | 3.5 | 3.3 |
| Brånemark RP | 4.1 | 3.75, 4 & 5 |
| Brånemark WP | 5.1 | 5 & 6 |
The zirconia superstructures for use with the Elos Accurate® Hybrid Base™ are only intended to be designed and manufactured according to digital dentistry workflow system integrates multiple components of the digital dentistry workflow: scan files from Intra-Oral Scanners, CAD software, CAM software, ceramic material, milling machine and associated tooling and accessories.
The Elos Accurate® Hybrid Base™ is intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Hybrid Base™ is used as an interface between a dental implant and a zirconia superstructure and will be attached to the implant using the included prosthetic screw and attached to the zirconia superstructure by cementing. The Elos Accurate® Hybrid Base™ is a two-piece abutment composed of the Hybrid Base as the bottom-half and the zirconia superstructure as the top-half.
The Elos Accurate® Hybrid Base™ consists of a pre-manufactured prosthetic component in Titanium alloy per ASTM F136, as well as supporting digital library file for 510(k) cleared design software (i.e. 3Shape Abutment Designer Software, K151455) which facilitates the design of a patient specific zirconia superstructure by the laboratory/clinician. The Elos Accurate® Hybrid Base™ fits directly to an endosseous dental implant. The laboratory designed superstructure is manufactured from 510(k) cleared Zirconia (Lava Plus, K011394) according to digital dentistry workflow. For all Elos Accurate® Hybrid Base™ models the zirconia superstructure must be designed according to following limits:
- Minimum wall thickness 0.5 mm
- Minimum post height 4.0 mm (for single unit restorations)
- Maximum gingival height 5.0 mm
- Maximum angulation 20°
The laboratory designed superstructure is attached to the Elos Accurate® Hybrid Base by use of 510(k) cleared cement (Multilink Hybrid Abutment, K130436) and the final prosthetic restoration is attached to the implant using a Prosthetic screw. The Elos Accurate® Hybrid Base™ is delivered non-sterile and the final restoration and corresponding screw is intended to be sterilized at the dental clinic before it is placed in the patient.
The provided text describes the regulatory clearance of a dental device, the "Elos Accurate® Hybrid Base™", through a 510(k) premarket notification. This process is based on demonstrating substantial equivalence to previously marketed predicate devices, rather than proving safety and effectiveness through clinical trials with acceptance criteria traditionally associated with new drug or high-risk device approvals.
Therefore, the document does not contain information on acceptance criteria for device performance in the classical sense (e.g., sensitivity, specificity, accuracy for an AI/diagnostic device), nor does it describe a study to prove the device meets these types of acceptance criteria.
Instead, the "acceptance criteria" here refer to the regulatory requirements for demonstrating substantial equivalence. The "study that proves the device meets the acceptance criteria" refers to the non-clinical testing and analyses performed to support this substantial equivalence claim.
Here's a breakdown of the requested information based on the provided text, highlighting where information is absent or different from a typical AI/diagnostic device performance study:
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't define quantitative performance acceptance criteria like sensitivity/specificity for a diagnostic. The "acceptance criteria" for this 510(k) submission are met by demonstrating:
| Acceptance Criterion (Regulatory) | Reported "Performance" / Evidence Presented |
|---|---|
| Intended Use Equivalence | Subject device has the same intended use as predicate: "attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations." |
| Operating Principle Equivalence | Uses the same operating principle as predicate. |
| Basic Design Equivalence | Incorporates the same basic design (two-piece abutment, titanium alloy base, zirconia superstructure). |
| Material Equivalence | Incorporates same or very similar materials (Ti-6Al-4V alloy for Hybrid Base and screw, 3M Lava Plus Zirconia for superstructure, specific cement). |
| Sterilization Process Equivalence | To be sterilized using the same processes (non-sterile delivery, final restoration sterilized at dental clinic). |
| Dimensional and Compatibility Equivalence | Engineering and dimensional analyses of original manufacturers' components (abutments, implants & abutment screws) were made to determine nominal dimensions and tolerances and ensure compatibility with listed implant systems. |
| Fatigue Resistance (Mechanical Performance) | Fatigue testing per ISO 14801 was performed according to FDA guidance. |
| Biocompatibility | Biocompatibility testing for cytotoxicity according to ISO 10993-5 was performed. Previous 510(k) cleared products sharing identical manufacturing processes and materials also showed non-cytotoxicity. |
| Digital Workflow Validation | Validation of the digital dentistry workflow (scanner, design software, milling unit) with the subject product line, ensuring design limits are enforced by the software. |
2. Sample Sized Used for the Test Set and the Data Provenance
- Test Set Sample Size: The document does not specify a "test set" in the context of clinical data for performance evaluation (e.g., a set of medical images). The "testing" refers to mechanical and biocompatibility tests of the device components.
- For fatigue testing (ISO 14801): The sample size for this mechanical test is not explicitly stated in the provided text.
- For biocompatibility (cytotoxicity ISO 10993-5): "a complete restoration produced via the described validated workflow was performed." The exact number of samples tested is not specified.
- For engineering and dimensional analysis: The number of components analyzed is not specified.
- Data Provenance: The document does not mention human subject data or data provenance like country of origin or retrospective/prospective studies. The testing is described as non-clinical (mechanical, material, software validation).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
- This question is not applicable as the document describes non-clinical testing of a dental implant component, not a diagnostic or AI device requiring expert-established ground truth from patient data.
4. Adjudication Method for the Test Set
- This question is not applicable for the same reasons as point 3.
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 question is not applicable as the device is not an AI software intended to assist human readers. It is a physical dental implant component.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This question is not applicable as the device is a physical component, not an algorithm.
7. The Type of Ground Truth Used
- For the non-clinical tests:
- Mechanical Integrity (Fatigue): Ground truth is defined by the performance standards of ISO 14801, which sets limits for mechanical failure under specific loading conditions.
- Biocompatibility (Cytotoxicity): Ground truth is defined by the standards of ISO 10993-5, determining if the material elicits a cytotoxic response.
- Dimensional Accuracy/Compatibility: Ground truth is defined by engineering specifications and measurements of existing implant systems and the device itself.
8. The Sample Size for the Training Set
- This question is not applicable as there is no "training set" of data in the context of machine learning for this physical device.
9. How the Ground Truth for the Training Set was Established
- This question is not applicable for the same reasons as point 8.
In summary, the provided text details a regulatory submission for a physical dental device, focusing on demonstrating substantial equivalence through non-clinical testing (mechanical, material, digital workflow validation) rather than complex diagnostic performance studies common for AI or imaging devices.
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