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510(k) Data Aggregation
(189 days)
Prismatik's Universal Paste Stains and Glaze are intended to be used in dental applications for coloration and finishing of glass ceramic and zirconia-based restorations.
Prismatik's Universal Paste Stains and Glaze are based on Silicate Sintered Glass Ceramic that is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660) and are available in a variety of colors. They include stain pastes, a glazing paste, and a liquid which can be used to thin the pastes. The pastes serve solely for the color staining and glazing of the surfaces of restorations.
The Universal Paste Stains and Glaze contains 17 stain shades, Fluorescent Paste Glaze, and Stain and Glaze Liquid, which are all silicate glass based.
The Stains are available in colors A, B, C, D and A Light, C Light, C Light, D Light, as well as White, Yellow, Orange, Brown, Dark Brown, Blue, Purple, Dark Pink, and Grey. The Fluorescent Paste Glaze is used to achieve an esthetic finishing coat. It also provides fluorescent properties under ultra-violet lighting. The Stain and Glaze Liquid can be mixed with the pastes in order to modify the consistency, and can also be used to clean the brush.
The provided document is a 510(k) summary for the "Universal Paste Stains and Glaze" device. This is a premarket notification for a medical device that aims to demonstrate substantial equivalence to an already legally marketed device (predicate device). Such submissions typically do not involve the kind of elaborate clinical studies with acceptance criteria, sample sizes, ground truth establishment, and expert involvement that would be typical for a novel high-risk device or an AI/software as a medical device (SaMD).
Instead, this submission relies on demonstrating technological characteristics equivalency and non-clinical testing (biocompatibility and chemical similarity) to assert that the new device is as safe and effective as the predicate device.
Therefore, many of the requested categories are not applicable or not explicitly detailed in this type of regulatory submission.
Here's an analysis based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criterion | Reported Device Performance | Notes |
|---|---|---|---|
| Biocompatibility | Negative result for cytotoxicity (per DEN EN ISO 10993-5) | Raw materials tested for cytotoxicity with negative result. | This demonstrates that the device's components are not toxic to cells, meeting a fundamental safety requirement. The acceptance criterion is a "negative result," meaning no cytotoxic effect was observed. |
| Solubility | Similar to predicate device (per DIN EN ISO 6872) | Porcelains investigated were similar in composition and show similar solubility acc DIN EN ISO 6872. | This indicates that the device's material properties, specifically its behavior in a physiological environment, are comparable to the already approved predicate device, ensuring similar safety and performance in terms of material degradation or leaching. The acceptance criterion is "similar solubility" to the predicate. |
| Technological Characteristics (General Material, Indications, Sterility, Machining/Sintering, Performance) | Substantially equivalent to predicate device | Demonstrated in comparison table: "Same" or equivalent statements for most characteristics like "Powder, porcelain" for General Material, "Non-sterile" for Sterility, "Yes" for Machining and Sintering, and "Simulating the natural tooth dentine" for Performance. Indications for Use are similar in scope, though phrasing differs: "coloration and finishing of glass ceramic and zirconia-based restorations" (new device) vs. "Color staining and glazing of glass ceramic restorations made from 3M ESPE's Glass Ceramics 'Jolly'" (predicate). | This is the core of a 510(k) submission. The acceptance criterion is "substantial equivalence" in these aspects. The reported performance is that these characteristics are functionally identical or very similar to the predicate device, supporting the claim of equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not explicitly stated as a separate "test set" in the context of clinical performance data. The non-clinical tests (biocompatibility, solubility) would have involved specific test samples (e.g., raw materials, porcelain batches), but specific numbers are not given.
- Data Provenance: The studies were non-clinical, laboratory-based tests ("biocompatibility testing was carried out," "raw materials were tested," "porcelains investigated"). Not applicable to country of origin or retrospective/prospective in a clinical sense.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. This submission focuses on non-clinical, laboratory-based testing (biocompatibility, chemical properties) and comparison of technological characteristics, not on clinical performance evaluated by experts making diagnoses or assessments. Ground truth in this context would be objective laboratory measurements against established standards (e.g., ISO for cytotoxicity, DIN EN ISO for solubility).
4. Adjudication Method for the Test Set
- Not applicable. There were no human expert adjudications for the non-clinical tests. The tests would likely follow standardized protocols, and results would be interpreted by laboratory personnel based on the criteria defined in those standards (e.g., cell viability percentages for cytotoxicity).
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 device is a dental material (paste stains and glaze), not an AI/SaMD or an imaging device requiring human reader interpretation, nor does it involve human-plus-AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
- Not applicable. This device is a physical material, not an algorithm or software.
7. The Type of Ground Truth Used
- Objective Laboratory Standards and Measurements: For biocompatibility, the ground truth was defined by the criteria of the DEN EN ISO 10993-5 standard for cytotoxicity. For solubility, it was the measurements taken according to DIN EN ISO 6872, compared against the predicate device. For technological characteristics, the ground truth was the objective composition and physical properties of the materials themselves, alongside their intended use and manufacturing processes.
8. The Sample Size for the Training Set
- Not applicable. There is no "training set" as this is not a machine learning or AI device.
9. How the Ground Truth for the Training Set was Established
- Not applicable. As there is no training set.
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