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510(k) Data Aggregation
(201 days)
The Straumann® CARES® Screw-retained Bridge and Straumann® CARES® Dolder® Bar are indicated for use as bars and bridges that attach to dental implants (Straumann RN (Reqular Neck) Ø4.8mm and WN (Wide Neck) Ø6.5mm) in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Straumann® CARES® Screw-retained Bridge is available in different sizes and spans and can be fitted on 2 to 16 implants.
The Straumann® CARES® Dolder® Bar is available in different sizes and spans and can be fitted on 2 to 10 implant.
Straumann® CARES® Screw-Retained Bridges and Straumann® CARES® Dolder® Bars are dental restorative devices intended to be attached directly to dental implants by basel screws. The Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are designed with implant interfaces comparable to a single tooth abutment which are attached to a Straumann implant RN (Regular Neck) Ø 4.8 mm and WN (Wide Neck) Ø 6.5 mm.
The implant positions and oral situation are recognized by a scan of a dental master model with implant analogs and scanbodies. Based on the scan data, the dental technician selects the proper implant interfaces and designs the bar or bridge according to a dentist's prescription.
Once the Straumann CARES Screw-Retained Bridge or Straumann CARES Dolder Bar is designed, the digital dataset is sent to Straumann CADCAM by an internet connection where the bridge or bar is milled from a cobaltchromium-based blank.
Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars allow for individual customization regarding function and esthetics. They attach directly to Straumann dental implants. The device is intended to be finished into a bridge or overdenture using standard dental laboratory techniques and materials. The devices are CAD-derived, CAMproduced and have a scanner as its data source.
The milling blanks used for the manufacture of Straumann CARES Screw-Retained Bridge and Straumann CARES Dolder Bar are manufactured from a cobalt chromium base metal alloy, which has been tested and found biocompatible for its intended use. The cobalt chromium alloy meets the physical and mechanical requirements of ISO 22674, Dentistry - Metallic materials for fixed and removable restorations and appliances and ISO 9693, Metal-ceramic dental restorative systems.
The provided 510(k) summary for the Straumann® CARES® Screw-Retained Bridge and Straumann® CARES® Dolder® Bar describes non-clinical testing to demonstrate substantial equivalence to predicate devices. This submission focuses on material properties, biocompatibility, and mechanical performance rather than AI-driven insights or diagnostic accuracy. Therefore, many standard AI/ML study components, such as sample size for test/training sets, expert qualifications for ground truth, adjudication methods, and MRMC studies, are not applicable here.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria and performance are presented in several tables within the document for different aspects of the device.
Table 1: Metallic Material Properties (Derived from Table 2 in document)
| Property | Unit | Acceptance Criteria with and without Thermal Treatment | Conclusion |
|---|---|---|---|
| Color | na | Silver gray | Passed |
| Density | g/cm³ | 8.3 | Passed |
| Solubility in water | mg/l | insoluble | Passed |
| Proof strength Rp0.2 | MPa | > 360 | Passed |
| Vickers hardness | HV10 | 260 | na |
| Elongation after fracture | % | > 2.0 | Passed |
| CTE (25-500°C) | 10-6 K-1 | 14.4 | na |
| Solidus | °C | 1320 | na |
| Liquidus | °C | 1420 | na |
Table 2: Ceramic Bonding Properties (Derived from Table 3 in document)
| Veneering Porcelain | Debonding/Crack-Initiation Strength $\tau_b$ [MPa] | Acceptance Criterion | Conclusion |
|---|---|---|---|
| Initial MC (GC) | > 25 MPa | N/A (implied from results) | Passed |
| IPS InLine (Ivoclar Vivadent) | > 25 MPa | N/A (implied from results) | Passed |
| HeraCeram (Heraeus Kulzer) | > 25 MPa | N/A (implied from results) | Passed |
| VM13 (Vita Zahnfabrik) | > 25 MPa | N/A (implied from results) | Passed |
Table 3: Biocompatibility Testing (Derived from Table 4 in document)
| Test Method | Biocompatibility Acceptance Criteria | Results |
|---|---|---|
| Cytotoxicity of extract | < 30 % | Passed |
| Organic leachables qualitative | na | na |
| Leachables quantitative | na | na |
Table 4: Static Corrosion Testing (Derived from Table 5 in document)
| Composite Material | Units | Acceptance Criterion | Results |
|---|---|---|---|
| Cobalt (Co) | µg/cm² | ≤ 100 | Passed |
| Chromium (Cr) | µg/cm² | ≤ 100 | Passed |
| Aluminum (Al) | µg/cm² | ≤ 100 | Passed |
| Titanium (Ti) | µg/cm² | ≤ 100 | Passed |
| Niobium (Nb) | µg/cm² | ≤ 100 | Passed |
| Tungsten (W) | µg/cm² | ≤ 100 | Passed |
| Silicon (Si) | µg/cm² | ≤ 100 | Passed |
| Manganese (Mn) | µg/cm² | ≤ 100 | Passed |
| Iron (Fe) | µg/cm² | ≤ 100 | Passed |
| Beryllium (Be) | µg/cm² | ≤ 100 | Passed |
| Cadmium (Cd) | µg/cm² | ≤ 100 | Passed |
Table 5: Dynamic Fatigue Testing (Derived from Table 6 in document)
| Composite Material | Results |
|---|---|
| Minimal body testing (Connection testing) | Passed |
| Free hanging bridge (Connector testing) | Passed |
| Free end pontic bridge (Connector testing) | Passed |
2. Sample size used for the test set and the data provenance
The document specifies "Non-Clinical Testing" was performed. However, it does not specify the sample size for individual tests (e.g., number of samples for proof strength, number of samples for cytotoxicity). It also does not mention data provenance (e.g., country of origin, retrospective or prospective) as the testing is related to manufacturing material properties, not patient data.
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 to this submission. The "ground truth" here is based on internationally recognized standards (ISO 22674, ISO 9693) and established material science and biocompatibility testing methodologies, not expert interpretation of medical images or patient records. The results are quantitative measurements against predefined criteria.
4. Adjudication method for the test set
This is not applicable as the tests involve objective, quantitative measurements against predefined criteria, not subjective interpretations 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 is not applicable. This submission is for a medical device (dental bridge/bar) and its material properties and manufacturing process, not an AI/ML diagnostic or assistive device. There are no "human readers" or AI assistance involved in the described testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is not applicable. The device is an implantable dental restoration, not an algorithm. While CADCAM software is used in its design, the testing performed is for the physical product, not the standalone performance of the software as a diagnostic or AI tool. The document states: "Validation of the CARES Visual CAD software provides evidence that design parameters for the Straumann CARES Screw-Retained Bridges and Straumann CARES Dolder Bars have met their pre-determined acceptance criteria and that dental restorations meeting their design specifications can be manufactured by Straumann CAM milling devices." This refers to the software's ability to produce designs that meet specifications for manufacturing, not its "standalone performance" in an AI/ML context.
7. The type of ground truth used
The ground truth used for this submission is based on:
- International Standards: ISO 22674 (Dentistry - Metallic materials for fixed and removable restorations and appliances) and ISO 9693 (Metal-ceramic dental restorative systems) for physical and mechanical requirements.
- Biocompatibility Standards: Implicitly, standards related to biocompatibility testing for medical devices.
- Established Material Science Metrics: Specific quantifiable parameters like density, proof strength, elongation, corrosion rates, and cytotoxicity.
8. The sample size for the training set
This is not applicable. There is no "training set" in the context of material and device performance testing for a traditional medical device like this, which is not an AI/ML product.
9. How the ground truth for the training set was established
This is not applicable for the same reasons as point 8.
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