(9 days)
Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth.
Heisenberg Dyeing Liquid is classified as Porcelain powder for clinical use (21 C.F.R. § 872.6660). Heisenberg Dyeing Liquid is intended to be used for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth. Heisenberg Dyeing Liquids will be available in various shades which are corresponding to every tooth color.
This is a difficult request since the provided text describes a dental dyeing liquid and not a medical device that would typically involve acceptance criteria and a study with performance metrics in the way you've outlined. The submission is for a 510(k) premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than proving novel performance.
However, based on the information provided, I can construct an answer by reinterpreting "acceptance criteria" and "device performance" in the context of a 510(k) for a dyeing liquid. The "study" here refers to the testing done to demonstrate substantial equivalence, which primarily involves comparing the new device to the predicate device.
Here's how I'll address each of your points, making assumptions where necessary to fit the framework you've provided:
1. A table of acceptance criteria and the reported device performance
For a dyeing liquid, the "performance" isn't in terms of diagnostic accuracy, but rather in meeting the functional and safety requirements to be equivalent to its predicate. The acceptance criteria would be that its properties are comparable or equivalent to the predicate device.
| Acceptance Criteria (Implied for Substantial Equivalence to Predicate) | Reported Device Performance (Summary from text) |
|---|---|
| Chemical Composition: Equivalent or acceptable differences | Differs primarily in coloring ions and secondary chemistry; deemed acceptable. |
| Indications for Use: | "Heisenberg Dyeing Liquids are suited for the shading of Heisenberg zirconia frameworks and Heisenberg all-zirconia, monolithic restorations for anterior and posterior teeth." (Identical to predicate's type of use, though specific zirconia framework name has changed from Lava Mill Blanks to Heisenberg zirconia). |
| Physical and Mechanical Properties: Equivalent (e.g., chemical solubility, strength, remission) | The comparison for performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device. |
| Biocompatibility: Safe for intended use | Biocompatibility testing was carried out, finding the device safe. |
| Overall Safety and Effectiveness: | Concluded to be as safe and effective as the predicate device (Lava Frame Shade). |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The text does not specify sample sizes or detailed data provenance for the tests conducted to compare the Heisenberg Dyeing Liquids to the Lava Frame Shade. It broadly states "The comparison for chemistry, indications for use, and performance data shows that Heisenberg Dyeing Liquids are substantially equivalent to the predicate device." It also mentions "Biocompatibility testing was carried out."
- Sample Size: Not specified.
- Data Provenance: Not specified, but the applicant company is 3M ESPE AG from Germany. The testing would have been conducted by or for them. The nature of the tests (chemical, physical, mechanical, biocompatibility) usually implies laboratory-based, prospective testing for the specific purpose of the 510(k).
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)
This type of information is not relevant to a 510(k) for a dyeing liquid, as "ground truth" in the clinical imaging sense is not established. The evaluation relies on laboratory tests and comparative analysis by chemists and materials scientists to demonstrate equivalence to a known predicate device. No details are provided about the experts involved in conducting or evaluating these specific tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Adjudication methods like 2+1 or 3+1 are used in clinical studies involving interpretation of medical images or diagnostic outcomes. This is not applicable to the type of comparative testing done for a dental dyeing liquid. The "adjudication" in this context would be the internal scientific review and regulatory assessment of the test results by the manufacturer and subsequently by the FDA.
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
An MRMC study is completely irrelevant for this device. This is a dyeing liquid, not a diagnostic AI system. There are no "human readers" interpreting images or clinical data, and no AI involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept is not applicable. The device is a material (dyeing liquid), not an algorithm or software. Its performance is intrinsic to its chemical and physical properties when applied as intended.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this device, the "ground truth" for the comparison is the established properties and safety profile of the predicate device, Lava Frame Shade (K011394). The new device is compared against the known characteristics and performance of this predicate using laboratory-based chemical, physical, mechanical, and biocompatibility tests.
8. The sample size for the training set
This concept is not applicable. There is no "training set" for a dyeing liquid. Data is collected through laboratory testing of the material itself.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device. The relevant "ground truth" is the performance of the legally marketed predicate device, established through its own prior regulatory clearance (K011394), which would have involved similar types of laboratory evaluations at the time.
§ 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.