(96 days)
The Sinfony® system is indicated for use as a light-curing composite veneer material for:
- full and partial coverage of:
- fixed crown and bridgework .
- telescopic and conical crowns .
- precision attachments
- implant superstructures .
- adhesive bridgework .
- laminate veneers .
- o individualizing denture teeth
- individualizing long-term temporary restorations .
light-curing composite veneer material
The provided text describes a 510(k) premarket notification for a dental material (Sinfony®), focusing on its substantial equivalence to previously cleared devices. It outlines the intended use and states that physical and technical characteristics were compared using specific ISO and DIN standards. However, it does not contain the detailed information necessary to complete all sections of your request regarding acceptance criteria and a study proving device performance as typically understood for AI/ML device evaluations.
Specifically, the document discusses a dental material and its mechanical properties, not an AI/ML device, and thus the concepts of "device performance," "sample size for test set," "experts to establish ground truth," "adjudication method," "MRMC study," "standalone performance," "type of ground truth," "training set," and "ground truth for training set" are not applicable in the context of this traditional medical device submission.
Therefore, I will only be able to provide information relevant to the material described in the input text.
Here's what can be extracted and inferred from the text provided:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Measured Characteristics) | Reported Device Performance (Reference Standard) |
|---|---|
| Surface finish | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Flexural strength | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Water absorption | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Solubility | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Color and translucency | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Color stability | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Surface hardness | Compared to Visio-Gem® (K833757) and Visio-Gem® Art-System (K905604) |
| Improved mechanical properties | Allows for full (not just partial) coverage of crown and bridgework veneers, including occlusal areas (compared to Visio-Gem®) |
Note: The document states "To support substantial equivalence... characteristics of Sinfony® have been compared to those of Visio-Gem® using tests undertaken pursuant to ISO 10477 and DIN 53456." It does not provide the specific numerical acceptance thresholds or the detailed quantitative results for each characteristic, only that they were compared to establish substantial equivalence.
Regarding the other points, the provided text does not contain the information requested, as it pertains to a different type of medical device (a dental material) than what your questions imply (an AI/ML device). Therefore, the following points cannot be answered from the provided input:
- 2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): Not applicable for a material test.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): Not applicable for a material test.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for a material test.
- 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 as this is not an AI device.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable as this is not an AI device.
- 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): For material testing, "ground truth" is typically established by standardized physical/chemical measurements rather than expert consensus on diagnostic images or pathology. The "ground truth" here is the performance of the predicate device and the standards ISO 10477 and DIN 53456.
- 8. The sample size for the training set: Not applicable as this is not an AI device.
- 9. How the ground truth for the training set was established: Not applicable as this is not an AI device.
§ 872.3690 Tooth shade resin material.
(a)
Identification. Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.(b)
Classification. Class II.