(47 days)
Full veneering of crowns and bridges
Complete crowns
Inlays/onlays
Fiber reinforced crowns and bridges
Direct bonded bridges
Telescopic and conical crowns
Attachments and implant works
Veneers
Long term temporary restorations and their characterization
Customization of acrylic and ceramic artificial teeth
Extraoral repairs
SINFONY is classified as a tooth shade resin material (21 C.F.R. § 872.3690) because it is a device composed of methacrylates intended to be used for full and partial coverage of crowns and bridges and as a material for the fabrication of inlays and onlays to restore carious lesions or structural defects in teeth.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define "acceptance criteria" with specific thresholds (e.g., "flexural strength must be > X MPa"). Instead, it outlines a strategy to demonstrate substantial equivalence by comparing SINFONY®'s performance to predicate devices. The "reported device performance" is implicitly that SINFONY® performed "as effectively" as the predicate devices.
| Performance Metric/Aspect Examined | Acceptance Criteria (Implicit) | Reported Device Performance (Implicit) |
|---|---|---|
| Performance for New Indications | SINFONY® must perform commensurate with predicate devices for new indications (crowns, inlays, onlays, fiber-reinforced crowns/bridges). | "The comparison shows that SINFONY® is as effective as the predicate devices which are all well established on the world market." (Based on provided performance test data.) |
| Toxicological Assessment | No new toxicological assessment required if changes are minor and components are well-known and previously cleared. | "This photo stabilizer is a well-known compound and also contained in some other already 510(k)-cleared ESPE products... Therefore a new toxicological assessment is not required in our point of view." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not specified in the provided text. The document only states "performance test data are provided."
- Data Provenance: Not explicitly stated. However, given that ESPE Dental AG is based in Germany, it's highly probable the testing was conducted in Germany or Europe. The study is retrospective in the sense that it evaluates the device's performance against established predicate devices.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. The study focuses on material performance testing, not diagnostic accuracy based on expert interpretation.
4. Adjudication Method for the Test Set
This information is not applicable and not provided. Adjudication is typically relevant for studies involving human interpretation or subjective assessments.
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
This information is not applicable and not provided. The device described, SINFONY®, is a dental material, not an AI-assisted diagnostic tool.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable and not provided. The device described is a dental material, not an algorithm.
7. The Type of Ground Truth Used
The "ground truth" for this type of device (dental material) would be derived from physical, mechanical, and chemical property testing according to established standards, as well as clinical performance data from the predicate devices. The document implies a comparison of SINFONY's performance test data against the known performance of predicate devices. Specific types of data would likely include:
- Mechanical properties (e.g., flexural strength, wear resistance)
- Physical properties (e.g., water absorption, solubility)
- Biocompatibility data (although the document states a new toxicological assessment wasn't required due to similarity to existing materials)
8. The Sample Size for the Training Set
This information is not applicable and not provided. There is no mention of a "training set" as this is a material science study, not a machine learning model.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided since there is no "training set." The performance of the SINFONY® material was likely measured via lab-based testing and compared to the established performance characteristics and clinical history of the predicate devices.
§ 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.