(53 days)
Rainbow Block is used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering.
Rainbow Block is a dental ceramic made out of zirconia. Rainbow Block is milled into cores for teeth and then is fired in the furnace to harden of ZrO2. Then the core is layered with porcelain to make a finished tooth.
The provided text is a 510(k) summary for the "Rainbow Block" dental ceramic material. This summary focuses on demonstrating substantial equivalence to predicate devices, rather than detailing a study that proves a device meets specific acceptance criteria in the way a diagnostic AI or medical imaging device might be evaluated for performance.
Therefore, the requested information cannot be fully provided as the "Rainbow Block" is a dental material, and its evaluation process (as described in the 510(k) summary) does not involve the types of studies typically associated with AI-driven diagnostic tools or medical devices that have performance metrics like sensitivity, specificity, or reader agreement.
However, based on the principle of substantial equivalence, we can infer some "acceptance criteria" and the "study" that implicitly proves them.
Inferred Acceptance Criteria and Device Performance (based on Substantial Equivalence):
| Acceptance Criteria (Inferred) | Reported Device Performance |
|---|---|
| Material Composition | Zirconia-based ceramic, similar to predicate devices. |
| Indication for Use | "Used in the manufacture of a dental core through milling by machine (MAD/MAM or CAD/CAM) followed by sintering." This matches the intended use of predicate devices. |
| Technological Characteristics | Similar to predicate devices in "Main material, Indication for use and design." |
| Biocompatibility | Performed safety tests including biocompatibility to ensure compliance with applicable International and US regulations. |
| Safety and Effectiveness | Concluded "safe and effective and substantially equivalent to predicate devices." |
Study and Data Information (based on Substantial Equivalence):
- Sample size used for the test set and the data provenance: Not applicable in the context of a dental material substantial equivalence claim. There isn't a "test set" in the sense of patient data. The evaluation relies on material science testing and comparison to predicate devices.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Material evaluations typically involve laboratory testing and comparison to established standards, not expert consensus on ground truth in a diagnostic sense.
- Adjudication method for the test set: Not applicable.
- 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, not an AI-assisted diagnostic tool requiring human reader studies.
- 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 algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's acceptance is based on its material properties and performance characteristics being comparable to legally marketed predicate devices, along with demonstrating biocompatibility. This involves laboratory testing following recognized standards for dental materials.
- The sample size for the training set: Not applicable. There is no training set as this is not an AI/ML device.
- How the ground truth for the training set was established: Not applicable.
Summary of the "Study" for Substantial Equivalence:
The "study" for the Rainbow Block device, as described in the 510(k) summary, is a comparison to legally marketed predicate devices (K061851 Zirkonzahn Ice and K063511 Ceramill Zi Blank). This comparison focused on:
- Technological Characteristics: Main material (zirconia), indication for use, and design. The submission asserts these are "similar."
- Safety Tests: Including biocompatibility, conducted to comply with applicable International and US regulations. While the specific tests or their results are not detailed in this summary, the conclusion states they were performed.
The conclusion drawn from this comparative "study" is that the Rainbow Block is "safe and effective and substantially equivalent to predicate devices." This substantial equivalence is the basis for its market clearance by the FDA without requiring a full Premarket Approval (PMA) application, which would necessitate more extensive clinical trial data.
§ 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.