(36 days)
- Restorations in deciduous teeth
- Class V restorations (cervical caries, root erosion, wedge-shaped defects)
- Class III restorations
- Intermediate Class I and II restorations
Not Found
The provided text describes a 510(k) premarket notification for a device named "Compoglass F," indicating that the FDA has determined it to be substantially equivalent to a legally marketed predicate device. This type of regulatory document typically focuses on demonstrating equivalence rather than presenting extensive clinical study data with detailed acceptance criteria and performance metrics as might be found in a De Novo or PMA submission.
Therefore, many of the requested details about acceptance criteria, specific study design elements (like sample size for test/training sets, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment), and reported device performance are not available in the provided text. The document is primarily a regulatory approval letter based on demonstrating substantial equivalence, not a summary of a clinical trial proving specific performance against predefined acceptance criteria.
However, based on the context, we can infer some limited information:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly stated in the provided document. The letter indicates that the device "Compoglass F" is substantially equivalent to predicate devices for specific "Indications For Use." Substantial equivalence typically means the device has the same intended use and technological characteristics as a predicate device, or if there are differences, those differences do not raise new questions of safety or effectiveness. The "reported device performance" is essentially that it is deemed safe and effective enough to be on the market, as demonstrated by its equivalence to existing marketed devices.
Indications For Use (which implicitly define the scope of acceptable performance):
| Acceptance Criteria (Implicit by Indication) | Reported Device Performance |
|---|---|
| Effective for restorations in deciduous teeth | Deemed substantially equivalent to predicate devices for this use. |
| Effective for Class V restorations (cervical caries, root erosion, wedge-shaped defects) | Deemed substantially equivalent to predicate devices for this use. |
| Effective for Class III restorations | Deemed substantially equivalent to predicate devices for this use. |
| Effective for intermediate Class I and II restorations | Deemed substantially equivalent to predicate devices for this use. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not available in the provided text. A 510(k) submission might include bench testing, and potentially some limited clinical data, but the letter itself does not specify these details.
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/Not available. The concept of "ground truth" established by experts for a test set is typically associated with performance studies, often for diagnostic AI devices. This document is for a dental restorative material, likely relying on established material properties, biocompatibility, and clinical performance data that existed for the predicate device(s) or standard dental practices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable/Not available. See point 3.
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. MRMC studies are specific to diagnostic devices, particularly those involving human interpretation of imaging. This device is a dental restorative material.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a dental material, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
For a material like "Compoglass F," the "ground truth" equivalent would likely be:
- Biocompatibility: Established through standard ISO or ASTM tests.
- Physical and Mechanical Properties: Measured against established dental material standards (e.g., strength, wear resistance, fluoride release).
- Clinical Performance (historically): The performance of the predicate devices would serve as the benchmark for safety and effectiveness in the stated indications. This would likely be supported by clinical data or long-standing clinical practice.
This information is not provided in the document, but these are typical "ground truths" for such devices.
8. The sample size for the training set:
Not applicable/Not available. The concept of a "training set" in the context of machine learning is not relevant for this type of device and regulatory submission.
9. How the ground truth for the training set was established:
Not applicable/Not available. See point 8.
§ 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.