(61 days)
The device is indicated for use by dental technicians in the construction of custom made all ceramic restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) prostheses.
For use only by or on the order of a dental professional such as a DDS or DMD. Not for use by the general public or OTC.
The device is comprised primarily of of dental porcelain zirconium oxide powder that is used in the form of blanks as a part of dental laboratory processes that are used to fabricate all ceramic dental restorations, reinforced with a hard ceramic core, that are custom fitted to conform precisely to patients' models.
This 510(k) submission for the Prismatik™ Clinical Zirconia (Prismatik™ CZ) porcelain powder does not include a specific study that outlines acceptance criteria and device performance in the same way a diagnostic AI device would. This device is a material used in the fabrication of dental restorations, not a diagnostic tool requiring performance metrics like sensitivity or specificity.
Instead, the submission relies on the concept of substantial equivalence to existing legally marketed predicate devices. This means that the manufacturer argues the new device is as safe and effective as similar devices already on the market without needing extensive clinical trials to prove efficacy.
Here's an breakdown based on the provided document, addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Similar Functionality to Predicate Devices | "The device functions in a similar manner to other comparative devices." |
| Same Intended Use as Predicate Devices | "the intended use is the same." |
| No New Safety Concerns Compared to Predicate Devices | "The differences between comparative devices are minor and do not raise new safety concerns." |
| Effectiveness and Suitability to Intended Purpose (Demonstrated by Predicates) | "The effectiveness and suitability to the intended purpose of the device is assured through wide, general use of similar other predicate devices, and demonstrates the safe use of the device to construct dental restorations." |
2. Sample Size Used for the Test Set and Data Provenance
Not applicable. This is a material device, not a diagnostic device tested on a "test set" of patient data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. Ground truth as typically defined for AI/diagnostic devices (e.g., patient diagnoses) is not relevant for this material device. The "ground truth" here is the long-standing safe and effective use of similar dental materials.
4. Adjudication Method for the Test Set
Not applicable.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance in diagnostic tasks, which is not applicable to a dental material.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm or AI device.
7. The Type of Ground Truth Used
The ground truth is based on the established safety and efficacy of predicate dental materials (Cercon® base, Lava™ Frame, and IPS e.max ZirCAD) through their "wide, general use." The FDA's substantial equivalence determination implies that if the existing devices are safe and effective, and this new device is similar enough, then it is also considered safe and effective.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable.
§ 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.