(135 days)
The Elos Accurate® Customized Abutments are intended for attaching to dental implants in order to provide basis for single or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to a dental implant using the included Elos Prosthetic screw.
The Elos Accurate® Customized Abutments are compatible with the implant systems listed in table 1:
Table 1.
| Elos Accurate Customized
Abutment - Model Type | Platform compatibility | Platform diameter
[mm] | Implant Body diameter
[mm] |
|---------------------------------------------------|-------------------------|---------------------------|-------------------------------|
| AB-NBR35 | Nobel Replace NP | 3.5 | 3.5 |
| AB-NBA30 | Nobel CC 3.0 | 3 | 3 |
| AB-NBA43 | Nobel CC RP | 3.9 | 4.3 & 5 |
| AB-NBA60 | Nobel CC WP | 5.1 | 5.5 |
| AB-SBO33 | Straumann Bone Level NC | 3.3 | 3.3 |
| AB-SBO41 | Straumann Bone Level RC | 4.1 & 4.8 | 4.1 & 4.8 |
All digitally designed CAD/CAM customizations for the Elos Accurate® Customized Abutments are only intended to be sent and manufactured at a FDA registered Elos Medtech approved milling facility.
The Elos Accurate® Customized Abutment is a patient specific abutment intended for attaching to dental implants in order to provide basis for single- or multiple tooth prosthetic restorations. The Elos Accurate® Customized Abutment will be attached to the implant using the included Elos Prosthetic Screw and attached to the crown/coping manually by cementation. The Elos Accurate® Customized Abutment consists of an Abutment Blank used in fabricating of a full patient-specific abutment in Titanium alloy per ASTM F136. The Abutment Blank used in creation of the Elos Accurate® Customized Abutment has a pre-manufactured connection interface that fits directly to a pre-specified dental implant. The customized shape of the abutment is intended to be manufactured by an Elos Medtech approved milling facility. The Elos Accurate® Customized Abutment is delivered nonsterile and the final restoration including corresponding Elos Prosthetic Screw is intended to be sterilized at the dental clinic before it is placed in the patient. The Elos Accurate® Customized Abutment provides clinicians and laboratories with a prosthetic device that can be used in definitive (permanent) single- or multi restorations.
The provided text describes the Elos Accurate® Customized Abutment, a dental device, and its FDA 510(k) clearance. This document is a regulatory submission, not a study report detailing AI/ML model performance. Therefore, many of the requested criteria related to AI/ML model evaluation are not applicable or cannot be extracted directly from this type of regulatory submission.
However, I can provide information based on the device's performance against engineering and material acceptance criteria, as well as the non-clinical testing performed to demonstrate substantial equivalence to its predicate device. This is primarily focused on mechanical and biological compatibility, not AI/driven diagnostic accuracy.
Here's the information derived from the provided text, adapted to the closest relevant categories:
1. A table of acceptance criteria and the reported device performance
For a device like the Elos Accurate® Customized Abutment, acceptance criteria primarily relate to mechanical properties, biocompatibility, and compatibility with implant systems. The "reported device performance" here refers to the aspects that were tested and deemed acceptable through non-clinical testing to establish substantial equivalence.
| Acceptance Criteria Category | Specific Criteria/Test | Reported Device Performance (as demonstrated by testing) |
|---|---|---|
| Mechanical Performance | Fatigue Strength & Durability (per ISO 14801 guidance) | Demonstrated acceptable fatigue performance, supporting the extended angulation (up to 30°) and reduced minimum wall thickness (0.4mm) compared to the predicate (20° and 0.5mm respectively). The specific numerical fatigue values are not provided, but the conclusion states "fatigue testing" was performed and supported substantial equivalence. |
| Implant System Compatibility (for new compatible platforms) | Demonstrated compatibility with new implant systems: Nobel Replace NP, Nobel CC (3.0, RP, WP), and Straumann Bone Level (NC, RC) through engineering and dimensional analysis. | |
| Biocompatibility | Cytotoxicity (per ISO 10993-5) | Tests showed acceptable cytotoxicity for the non-coated prosthetic screw (subject device), the MediCarb coated screw (predicate device), and the Elos Accurate® Customized Abutment (representative of subject device as per predicate testing). |
| Sterilization Efficacy | Sterility Assurance Level (SAL) of 10^-6 (per ISO 17665-1 & 17665-2 for steam sterilization) | No additional testing was necessary for the subject device as the primary predicate device (K171799) had already demonstrated an SAL of 10^-6 for steam sterilization, and the subject device will use the same sterilization process. |
| Manufacturing Consistency | Digital CAD/CAM Customization | All digitally designed customizations must be sent to and manufactured at an FDA-registered Elos Medtech approved milling facility. This is a process control, not a performance metric per se, but ensures the final product meets design specifications. |
| Design Specifications | Minimum Wall Thickness | 0.4 mm (demonstrated to be acceptable through fatigue testing, despite being thinner than the predicate). |
| Maximum Angulation | Up to 30° (demonstrated to be acceptable through fatigue testing, an increase from the predicate's 20°). |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" in the context of an AI/ML model. The evaluation here is based on non-clinical testing (mechanical, dimensional, and biocompatibility).
- Sample Size: The document does not provide specific numerical sample sizes for the engineering tests (e.g., how many abutments were subjected to fatigue testing). This level of detail is typically found in the full test reports, not the 510(k) summary.
- Data Provenance: The data comes from non-clinical laboratory testing and engineering analyses performed by or for Elos Medtech Pinol A/S. The country of origin of the data is not explicitly stated, but the company is located in Denmark. The data is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence.
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. The device is a physical dental abutment, not an AI/ML diagnostic tool requiring expert interpretation for "ground truth." Ground truth, in this context, would be established by validated measurement techniques, material science principles, and biological testing standards (e.g., ISO standards for mechanical testing and biocompatibility).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. "Adjudication method" refers to the process of resolving disagreements among human readers or experts for establishing ground truth in a diagnostic study. For this device, acceptance is based on meeting predefined engineering and biological performance standards through validated testing.
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 is not applicable. No MRMC study was performed as this is not an AI-assisted diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This is not an AI algorithm. Its design uses CAD/CAM technology, but the clearance is for the physical abutment itself, not a diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" or basis for acceptance relies on:
- Established engineering standards: e.g., ISO 14801 for fatigue testing of dental implants.
- Biocompatibility standards: e.g., ISO 10993-5 for cytotoxicity.
- Dimensional analysis: Verifying compatibility with specified implant systems.
- Material specifications: Conformance to Titanium Alloy 6Al-4V ELI (medical grade 5).
There is no "expert consensus" in the diagnostic sense or pathology/outcomes data used for device clearance as described in the summary.
8. The sample size for the training set
This is not applicable because there is no AI/ML model for which a "training set" would be used.
9. How the ground truth for the training set was established
This is not applicable because there is no AI/ML model for which training set ground truth would be established.
§ 872.3630 Endosseous dental implant abutment.
(a)
Identification. An endosseous dental implant abutment is a premanufactured prosthetic component directly connected to the endosseous dental implant and is intended for use as an aid in prosthetic rehabilitation.(b)
Classification. Class II (special controls). 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.)