(267 days)
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
The device is a feldspathic porcelain supplied for fusing to a metal sub-structure to form an aesthetic restoration which is then fitted as a crown or bridge.
The provided text is a 510(k) Notification for a dental product (porcelain) and does not describe a software-based medical device or AI system. Therefore, most of the requested information (acceptance criteria, study details, sample sizes, ground truth establishment, expert involvement, MRMC studies, standalone performance) is not applicable to this document.
The document discusses the substantial equivalence of the "Matchmaker/Propaque porcelain" to a predicate device named "Creation". The equivalence is based on chemical similarities, application similarities, and performance similarities.
Here's a breakdown of what can be extracted from the provided text, aligning with the spirit of your request where possible, but acknowledging it's not an AI/software device:
1. Table of Acceptance Criteria and Reported Device Performance
This product is demonstrated to meet acceptance criteria by conforming to an established international standard for dental materials.
| Acceptance Criterion (Specified in ISO 9693:1991) | Reported Device Performance (Matchmaker/Propaque porcelain) |
|---|---|
| Flexural Strength | Conforms to ISO 9693:1991 |
| Chemical Solubility | Conforms to ISO 9693:1991 |
| Fired Porosity | Conforms to ISO 9693:1991 |
| Coefficient of Expansion | Conforms to ISO 9693:1991 |
| Glass Transition Temperature | Conforms to ISO 9693:1991 |
| Metallo-ceramic Bond Characterization | Conforms to ISO 9693:1991 |
The document states, "Both products are manufactured to conform to ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material." This implies that the Matchmaker/Propaque porcelain, to achieve substantial equivalence, meets the performance criteria specified in this standard.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a material science claim, not a data-driven AI device. The "test set" would be physical samples of the porcelain material tested according to ISO 9693 methods. The sample sizes for these material tests are not specified in the provided text.
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)
Not applicable. Ground truth for material properties is established by standardized physical and chemical testing methods, not by expert consensus on interpretations as in medical imaging.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are relevant for subjective interpretations or diagnostic decisions, not for objective material property measurements.
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 device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is objective measurements of physical and chemical properties as defined and standardized by ISO 9693:1991 Dental Ceramic Fused to Metal Restorative Material. This standard specifies how to measure properties like flexural strength, chemical solubility, etc.
8. The sample size for the training set
Not applicable. This is not an AI/machine learning device that uses training sets.
9. How the ground truth for the training set was established
Not applicable. This is not an AI/machine learning device.
§ 872.3920 Porcelain tooth.
(a)
Identification. A porcelain tooth is a prefabricated device made of porcelain powder for clinical use (§ 872.6660) intended for use in construction of fixed or removable prostheses, such as crowns and partial dentures.(b)
Classification. Class II.