(52 days)
Thommen SPI® VARIOmulti 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 splinted crowns, bridges or overdentures.
SPI® VARIOmulti Angled Abutments are dental implant abutments for use with the SPI® Dental Implant System. They have an internal connection to the implant and are used for multi-unit, screw-retained, prefabricated restorations. VARIOmulti Angled Abutments are made of titanium and are available in diameters from 3.5 to 4.5 mm with an angle of 30° to the implant. The system includes dedicated prosthetic components including protective and temporary caps. SPI® VARIOmulti Angled Abutments are compatible with the Nobel Biocare Multi-unit Abutment System.
The provided text is for a 510(k) premarket notification 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 proving the device meets specific acceptance criteria through a clinical study with detailed performance metrics.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not applicable to this document. The focus here is on performance testing to show equivalence to a predicate device, not on a clinical trial with a defined acceptance threshold for performance metrics like sensitivity, specificity, etc.
Here's a breakdown of what can be extracted and what information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Fatigue Resistance (ISO 14801): The device must have sufficient resistance to fatigue and perform comparably to the predicate device. | The subject device (SPI® VARIOmulti Angled Abutment) was determined to have sufficient resistance to fatigue and performed comparably to the predicate device (cleared under K090153). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size: Not specified. The document only states "Fatigue testing was performed." It doesn't mention the number of units tested.
- Data Provenance: Not specified. The testing was performed according to an international standard (ISO 14801), but the location of the testing facility or the origin of any "data" beyond the test results is not mentioned. It is not a clinical study, so concepts like "prospective" or "retrospective" are not relevant here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This was a physical performance test for fatigue, not a study requiring expert clinical assessment or ground truth establishment in a diagnostic context.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This was a physical performance test for fatigue, not a study requiring adjudication of expert opinions.
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
Not applicable. This document describes a dental implant abutment, not an AI-powered diagnostic device. An MRMC study is not relevant here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a medical device (dental abutment), not an algorithm or AI system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. For the fatigue testing, the "ground truth" would be the engineering standard (ISO 14801) and the performance of the predicate device. There is no biological or outcome-based ground truth in this context.
8. The sample size for the training set
Not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
Not applicable. This device does not involve a "training set" or "ground truth" in the context of machine learning or AI.
Summary specific to this document:
The provided 510(k) summary focuses on demonstrating substantial equivalence of the new SPI® VARIOmulti Angled Abutment to previously cleared predicate devices (K090153 and K072856). The primary method used to support this claim, beyond shared materials and design, was fatigue testing according to ISO 14801. The acceptance criterion for this testing was that the device should have "sufficient resistance to fatigue and performed comparably to the predicate device." The study stated that this criterion was met. No other formal studies with clinical acceptance criteria, sample sizes, or ground truth establishment (as would be seen in diagnostic device submissions) are presented in this document.
§ 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.)