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510(k) Data Aggregation
(260 days)
IMPLANT BAR
The Inclusive® Implant Bridge Framework is indicated for use as a bridge framework in the treatment of partially or totally edentulous jaws for the purpose of restoring chewing function.
The Inclusive® Implant Bridge Framework is compatible with the following implant system: Nobel Biocare's Replace 3.5mm, 4.3mm, 5.0mm, and 6.0mm; Nobel Biocare's Branemark System 4.1mm; Nobel Biocare's Active 3.5mm and 4.3mm, Zimmer Dental Screw-Vent 3.5mm, 4.5mm, and 5.7mm; Biomet 3i Certain 3.4mm, 4.1mm, 5.0mm, and 6.0mm; Straumann Bone Level 4.1mm; Astra Tech OsseoSpeed 3.5mm and 4.5mm.
Inclusive® Implant Bridge Framework attaches to implants. The Implant Bridge Framework is intended to be finished into a dental prosthesis using standard laboratory materials. The Inclusive® Implant Bridge Framework is customized by following instructions and models specific to each patient.
The Inclusive® Implant Bridge Framework is made of titanium and shipped non-sterile. The Inclusive® Implant Bridge Framework will be attached with titanium screws.
Here's a breakdown of the acceptance criteria and the study information for the Inclusive® Implant Bridge Framework, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implicitly based on predicate device and guidance) | Reported Device Performance |
|---|---|---|
| Material | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. | Ti-6Al-4V ELI Alloy conforming to ASTM F 136. |
| Indications for Use | For use as a bridge framework in the treatment of partially or totally edentulous jaws for restoring chewing function. | The device meets this indication as stated. |
| Design | Precision-milled bars made of titanium; comparable to predicate devices. | Precision-milled bars made of titanium. |
| Mechanical Performance | Sufficient mechanical strength for intended use (comparable to predicate devices and ISO 14801:2007). | Titanium materials have sufficient mechanical strength for their indicated use. All testing conducted met the acceptance criteria and evaluated the worst-case scenario. Performance testing data indicated the compatibility, and the safety and the effectiveness of the proposed device which meets the mechanical properties. |
| Sterilization | Sterilization validation according to ANSI-AAMI ST79-2006. | Sterilization tests were validated by following the ANSI-AAMI ST79-2006. |
| Implant Compatibility | Compatibility with specified implant systems (Nobel Biocare, Zimmer Dental, Biomet 3i, Straumann, Astra Tech). | Performance testing data indicated compatibility with listed implant systems. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not explicitly state a sample size in terms of number of manufactured devices or clinical cases used for the performance testing. It refers to "various static and fatigue tests."
- Data Provenance: The document does not specify the country of origin for the data or whether the tests were retrospective or prospective. The tests were laboratory-based (material and mechanical testing).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- This information is not applicable as the study described is a laboratory-based mechanical and material performance study, not a clinical study involving expert interpretation of data or images. Ground truth for material and mechanical properties is established through adherence to international standards (e.g., ASTM F136, ISO 14801:2007).
4. Adjudication Method for the Test Set
- This information is not applicable as the study described is a laboratory-based mechanical and material performance study. Adjudication methods are typically used in clinical studies or studies involving human assessment.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The document describes laboratory performance testing only. Therefore, there is no effect size of human readers improving with or without AI assistance.
6. Standalone (Algorithm Only) Performance Study
- Not applicable. The device is a physical dental implant bridge framework, not an algorithm or AI software. Therefore, there is no "standalone algorithm" performance to report.
7. Type of Ground Truth Used
- The ground truth used for this device's performance assessment is based on:
- International Standards: Adherence to material specifications (ASTM F 136 for Ti-6Al-4V ELI Alloy) and mechanical testing standards (ISO 14801:2007 for dynamic fatigue testing).
- Guidance Documents: Following the FDA's "Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Root-form Endosseous Dental Implants and Endosseous Dental Abutments" for implant to abutment compatibility.
- Validated Sterilization Protocols: Adherence to ANSI-AAMI ST79-2006 for sterilization.
8. Sample Size for the Training Set
- This information is not applicable. As the device is a physical medical device and the study is for performance testing, there is no "training set" in the context of machine learning or AI models. The "training" for the manufacturing process would be established through quality control and process validation, which is not detailed in terms of sample size in this summary.
9. How the Ground Truth for the Training Set Was Established
- This information is not applicable for the same reasons as #8. Ground truth for manufacturing processes is established through engineering specifications, validated manufacturing procedures, and quality control checks, not through a "training set" in the AI sense.
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