(64 days)
Thommen SPI® VARIOmulti Angled Abutments are intended to be used in conjunction with SP1® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures.
SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SP10 Dental Implant System. They have an internal connection to the implant and an external hex prosthetic attachment, and are used for multi-unit, screw-retained, prefabricated restorations. The system includes dedicated prosthetic components.
The provided text is a 510(k) summary for a dental implant abutment (SPI® VARIOmulti Angled Abutment). This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting entirely new clinical data or performance studies against specific acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, specific device performance, sample sizes, expert involvement, and ground truth establishment will not be present in this document.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of quantitative performance metrics for the device itself. The primary "acceptance criterion" for a 510(k) is demonstrating substantial equivalence to a predicate device.
- Reported Device Performance: No specific quantitative performance data is provided. The document states that the device is "substantially equivalent in indications and design principles to predicate devices."
| Acceptance Criteria (Implicit for 510(k)) | Reported Device Performance |
|---|---|
| Substantial Equivalence to Predicate Device | Device is "substantially equivalent in indications and design principles to predicate devices." |
| Intended Use Conformance | Intended for use in conjunction with SPI® System dental implants in the maxillary and/or mandibular arch to provide support for splinted crowns, bridges or overdentures. |
| Design Principles Consistency | Internal connection to implant, external hex prosthetic attachment, for multi-unit, screw-retained, prefabricated restorations. |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable/not provided. This document doesn't describe a performance test set in the traditional sense with a specific sample size of units tested against acceptance criteria. The equivalence demonstration is likely based on design comparisons, materials testing, and adherence to relevant standards, not a clinical performance study with a "test set" of patients or devices.
- Data Provenance: Not applicable. No specific experimental data from a "test set" of patients or devices is referenced.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable/not provided. Ground truth establishment is not relevant in this 510(k) summary as it does not rely on a clinical "test set" requiring expert evaluation.
4. Adjudication method for the test set:
- Adjudication Method: Not applicable/not provided. This is not a clinical study requiring adjudication of results.
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:
- MRMC Study: No. This device is a dental implant abutment, not an AI-assisted diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Standalone Study: No. This device is a physical medical device, not an algorithm.
7. The type of ground truth used:
- Type of Ground Truth: Not applicable. There is no specific "ground truth" referenced for performance testing in this document. Substantial equivalence in a 510(k) relies on comparison to a legally marketed predicate device's established safety and effectiveness.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable/not provided. This is not an AI/machine learning device, so there is no concept of a "training set."
9. How the ground truth for the training set was established:
- Ground Truth Establishment for Training Set: Not applicable.
Summary of the Study (Equivalence Demonstration):
The "study" described in this 510(k) summary is not a traditional clinical trial or performance study with acceptance criteria and specific performance metrics. Instead, it is a demonstration of substantial equivalence conducted as part of the FDA 510(k) premarket notification process.
- Methodology: Thommen Medical AG "demonstrated that... the SPI® VARIOmulti Angled Abutments are substantially equivalent in indications and design principles to predicate devices that have been determined by FDA to be substantially equivalent to preamendment devices." This involves comparing the new device's indications for use, technological characteristics (design, materials, intended function, attachment mechanism), and performance (often non-clinical testing like mechanical strength, fatigue, biocompatibility, but no specific data is included in this summary) to those of a legally marketed predicate device.
- Proof of Meeting Acceptance Criteria (Substantial Equivalence): The FDA's letter (K090153) explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially-equivalent... You may, therefore, market the device..." This letter serves as the FDA's "acceptance" that the device meets the regulatory requirements for market clearance based on substantial equivalence.
In essence, for a 510(k) submission, the "acceptance criteria" relate to regulatory compliance and the ability to demonstrate that the new device is as safe and effective as a legally marketed predicate device, rather than achieving specific quantitative performance thresholds from a de novo study.
§ 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.)