(121 days)
Thommen SPI® VARIO Angled Abutments are intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges.
SPI® VARIO Angled Abutments are titanium dental implant abutments for use with the SP1® Dental Implant system. They connect with the internal hex feature of the implant, have a precision fit interface with the prosthetic attachment, and are intended for screw retained restorations in single unit and small multi-unit solutions. SPI VARIO Angled Abutments are designed for correction of implant divergence and can be used in combination restorations with SPI VARIO abutments.
Here's an analysis of the provided text regarding the acceptance criteria and study for the SPI® VARIO Angled Abutment.
It's important to note that the provided text is a 510(k) Summary, which focuses on demonstrating substantial equivalence to predicate devices, not on proving new clinical effectiveness or performance against specific acceptance criteria in the way an AI/ML device study might. Therefore, many of the typical questions for AI/ML device studies (like sample sizes for test/training sets, expert qualifications, adjudication, MRMC studies, standalone performance, etc.) are not applicable to this type of submission.
The "acceptance criteria" here are implicitly tied to demonstrating substantial equivalence through performance testing, primarily mechanical, rather than predictive accuracy.
Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implicit from Equivalence) | Reported Device Performance and Basis for Acceptance |
|---|---|
| Mechanical Performance: Equivalent to predicate devices | Performance testing was provided to demonstrate substantial equivalence and included methods described in ISO 14801. (ISO 14801 is a standard for fatigue testing of dental implants and abutments, implying the device met mechanical durability requirements comparable to predicates). |
| Biocompatibility: Equivalent to predicate devices | Made of the same materials (titanium) as the predicate devices, which are already deemed safe and effective for biocompatibility. |
| Design Principles: Same as predicate devices | Incorporates the same basic design, internal hex feature, precision fit interface, and is intended for screw-retained restorations. Designed for correction of implant divergence. |
| Intended Use: Same as predicate devices | Intended to be used in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for crowns or bridges, same as predicate devices. |
| Technological Characteristics: No new issues of safety or efficacy | Any differences in technological characteristics (compared to predicates) do not raise new issues of safety or efficacy, implying that minor design variations did not negatively impact performance or safety compared to the established predicate. Uses the same operating principle. |
| Sterilization & Packaging: Same as predicate devices | Similar packaging and sterilized using similar methods and materials. |
Study Details (Based on available 510(k) Summary Information)
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Sample sizes used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The "performance testing" referenced is mechanical testing (ISO 14801), which would involve a certain number of physical units subjected to cyclic loading. This is physical device testing, not a clinical data test set.
- Data Provenance: Not applicable in the sense of clinical data. This refers to laboratory-based mechanical testing of the device itself.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is based on objective measurements against engineering standards (like ISO 14801), not expert interpretation.
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Adjudication method for the test set: Not applicable. This is not a study involving human interpretation or subjective assessment that would require adjudication.
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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. This is not an AI/ML device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an AI/ML device.
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The type of ground truth used: For the mechanical aspects, the ground truth is established by the specified ISO 14801 standard and the physical properties and failure points observed during testing. For biological aspects, it's the known biocompatibility and safety profile of the titanium material used, supported by the predicate devices.
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The sample size for the training set: Not applicable. This is not an AI/ML device with a training set.
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How the ground truth for the training set was established: Not applicable. This is not an AI/ML device with a training set.
Summary of the Study:
The "study" described in this 510(k) summary is not a clinical trial or an AI/ML performance study. Instead, it's a benchtop performance testing study focused on mechanical properties. The central purpose of the submission is to demonstrate substantial equivalence to already legally marketed predicate devices, not to establish novel clinical effectiveness or safety from a blank slate.
The key study mentioned is:
- Method: Performance testing "included methods described in ISO 14801." ISO 14801 is an international standard for dynamic loading of endosseous dental implants. This standard specifies methods for fatigue testing, which is crucial for dental implant components that experience cyclic forces during chewing.
- Purpose: To show that the SPI® VARIO Angled Abutment performs mechanically at a level comparable to the predicate devices and meets established industry standards for durability and strength.
- Conclusion: The results of this testing, combined with the similarity in materials, design principles, and intended use, were deemed sufficient by the FDA to demonstrate substantial equivalence to the predicate devices (K031747, K072856, K090153), leading to the clearance of the device.
§ 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.)