(10 days)
Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia restorations after basic dyeing using Heisenberg Dyeing Liquids.
Heisenberg Effect Shade is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Heisenberg Effect Shades are suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth restorations after basic dyeing using Heisenberg Dyeing Liquids. Heisenberg Effect Shades will be available in various colors.
The provided text is a 510(k) summary for "Heisenberg Effect Shades", a device classified as "Porcelain powder for clinical use". This document focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against specific acceptance criteria for a novel device. Therefore, much of the requested information regarding specific acceptance criteria studies for a new device's performance is not available in the provided text.
The overarching acceptance criterion for this 510(k) submission is to demonstrate substantial equivalence to existing legally marketed predicate devices in terms of indications for use, fundamental scientific technology, and performance. The "study" presented here is a comparison report.
Here's a breakdown of the requested information based on the provided text, and where the information is not applicable or not present given the nature of a 510(k) for a substantially equivalent device:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance (Summary of Comparison) |
|---|---|
| Indications for Use Equivalence (Device has the same intended uses as predicate devices) | Heisenberg Effect Shades are "suited for more intensive coloring of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth restorations after basic dyeing using Heisenberg Dyeing Liquids." This is compared to: Lava™ Frame Shades (3M ESPE): "suited to be used for the shading of zirconia frameworks and all-zirconia, monolithic restorations... for anterior and posterior teeth."Zenostar Color Zr (Wieland Dental): "to be used for individual characterization of zirconia restorations."The document states the comparison shows equivalence. |
| Physical and Mechanical Properties Equivalence (Device performs similarly to predicate devices in bench testing) | "The comparison... for performance data... shows that Heisenberg Effect Shades are substantially equivalent to the predicate devices." (Data from bench testing was used in this comparison). |
| Chemical Composition Equivalence (Device has similar chemistry to predicate devices) | "The comparison... for chemistry shows that Heisenberg Effect Shades are substantially equivalent to the predicate devices." |
| Biocompatibility (Device is safe for intended use) | "Biocompatibility testing was carried out. A biocompatibility assessment was developed... using standard risk assessment techniques and consideration of FDA & internationally recognized guidelines. The conclusion of the assessment is that Heisenberg Effect Shades are safe for its intended use." |
2. Sample size used for the test set and the data provenance
The document refers to "bench testing" for physical and mechanical properties and "biocompatibility testing." However, specific sample sizes (e.g., number of restorations tested, number of individual tests) for these comparisons are not provided in this 510(k) summary. Given that the manufacturer is 3M ESPE AG in Germany, it is highly probable the data provenance is from Germany, and it would be retrospective for the purpose of comparison to previously existing predicate devices.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This type of information is not applicable and therefore not provided for a device like "Porcelain powder for clinical use" in a 510(k) submission focused on substantial equivalence. There is no concept of "ground truth" established by experts in the context of comparing the physical, chemical, and biocompatibility properties of a dental coloring agent. The "ground truth" in this context is the established performance and safety profile of the predicate devices.
4. Adjudication method for the test set
This is not applicable and therefore not provided. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies involving interpretation of medical images or patient outcomes, where there might be disagreement in expert opinions. This device's comparison is based on objective physical, chemical, and biocompatibility tests, not subjective expert judgment.
5. If a multi-reader, multi-case (MRMC) comparative effectiveness study was done
No, a MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess the impact of the AI on reader performance. "Heisenberg Effect Shades" is a material for coloring dental restorations, not a diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone "algorithm only" performance study was not done. This concept is specific to AI/software as a medical device (SaMD) where algorithms perform a task without immediate human intervention. This device is a material, not software.
7. The type of ground truth used
For the comparison study:
- The "ground truth" for showing substantial equivalence relies on the established performance, indications for use, chemical composition, and biocompatibility profile of the predicate devices (Lava™ Frame Shades by 3M ESPE and Zenostar Color Zr by Wieland Dental + Technik).
- For the device itself, the ground truth for performance characteristics would be direct measurements from bench testing for physical/mechanical properties and results from biocompatibility testing against established standards.
8. The sample size for the training set
This is not applicable and not provided. The device is a material, not an AI or machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable and not provided, as there is no training set for this type of device.
§ 872.6660 Porcelain powder for clinical use.
(a)
Identification. Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.(b)
Classification. Class II.