(38 days)
The device is indicated for use by dental technicians in the construction of custom porcelain (ceramic) and porcelain (fused to metal) dental restorations for anterior and posterior locations.
For use in prosthetic dentistry to create porcelain (ceramic) and porcelain (fused-to-metal) prostheses.
The device is comprised of dental porcelain powder that is used in the form of powder or blanks as a part of dental laboratory processes that are used to fabricate porcelain (ceramic) and porcelain (fused-to-metal) dental devices that are custom fitted to conform precisely to patients' models.
The provided text is a 510(k) summary for a dental porcelain powder, not a medical device that would typically have acceptance criteria based on performance metrics like sensitivity, specificity, or accuracy, especially as demonstrated through a study with a test set, ground truth from experts, or MRMC studies.
The document discusses substantial equivalence based on the device's function and intended use being similar to predicate devices already on the market. It doesn't present a study designed to prove specific performance metrics against acceptance criteria that involve diagnostic accuracy or similar outcomes.
Therefore, most of the requested information (points 1-9) cannot be extracted from this document because it describes a different type of regulatory submission and device.
Here's an analysis of what can be inferred or stated based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated in terms of performance metrics like sensitivity, specificity, or accuracy. The "acceptance criteria" for a 510(k) submission for this type of device are primarily related to demonstrating substantial equivalence to predicate devices, meaning it functions similarly and has the same intended use without raising new safety concerns.
- Reported Device Performance: The document states, "The device functions in a similar manner to other comparative devices and the intended use is the same. The differences between comparative devices are minor and do not raise new safety concerns. 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." This is a qualitative statement of performance similarity rather than quantitative data.
2. Sample Size Used for the Test Set and Data Provenance:
- Not applicable. There is no mention of a test set, clinical data, or data provenance in the context of a performance study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. No ground truth establishment for a test set is discussed.
4. Adjudication Method for the Test Set:
- Not applicable. No adjudication method is mentioned as there is no test set for performance evaluation.
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 is not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a material (porcelain powder), not an algorithm or software.
7. The Type of Ground Truth Used:
- Not applicable in the context of a diagnostic performance study. The "ground truth" for this submission is implicitly established by the long-standing safe and effective use of similar predicate devices in the dental field.
8. The Sample Size for the Training Set:
- Not applicable. There is no mention of a training set for an algorithm or model.
9. How the Ground Truth for the Training Set was Established:
- Not applicable.
In summary: The provided 510(k) summary for "Prismatik™ Ceramic" focuses on demonstrating substantial equivalence to legally marketed predicate devices rather than presenting a performance study against specific, quantifiable acceptance criteria typical for diagnostic or AI-powered devices. The "study" mentioned is the general understanding and use of similar materials in the dental field, which is deemed sufficient to assure its safety and effectiveness.
§ 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.