(40 days)
Manufacture of all-ceramic inlays, onlays, crowns, and veneers.
GLASS CERAMICS are classified as Porcelain powder for clinical use ( 21 C.F.R. §872.6660). They are glass ceramic blocks intended to manufacture all-ceramic inlays, onlays, crowns, and vencers. GLASS CERAMICS blocks are available in six colors (A1; A2; A3; A3.5; B3; Enamel) and five sizes (I8, 110, 112, I14, V5-12). Like the predicate devices, the glass ccramic blocks "ProCAD® blocks" and "VITABLOCS® Mark II" and the composite block "Paradigm™ MZ 100" blocks, GLASS CERAMICS blocks are grindable blocks for CAD/CAM systems. The allccramic restoration is produced in the dentist's office using the CEREC® system or in a dental laboratory using CEREC® Inlab; both systems are manufactured by the company Sirona, Bensheim, Germany (K012517). The clinical situation is optically scanned and then processed by the CEREC® 3D software. The restoration is fabricated in the CEREC® grinding unit.
This document is a 510(k) summary for "GLASS CERAMICS," a dental product. A 510(k) submission is used to demonstrate that a new device is substantially equivalent to a legally marketed predicate device. This type of submission focuses on comparing the new device to existing ones rather than extensive clinical studies or establishing detailed acceptance criteria with performance metrics in the way a novel therapeutic or diagnostic device might.
Therefore, many of the requested elements for describing "acceptance criteria and the study that proves the device meets the acceptance criteria" are not typically present in a 510(k) submission for a device like this. The primary "study" is a comparison to predicate devices to demonstrate substantial equivalence in terms of composition, performance data, and indications for use.
Here's an attempt to answer the questions based on the provided text, highlighting where information is not available due to the nature of a 510(k) for this type of device:
Acceptance Criteria and Study for GLASS CERAMICS (510(k) Summary)
The provided document is a 510(k) submission summary for a dental product, "GLASS CERAMICS." For such a device, the primary "acceptance criterion" for regulatory clearance is demonstrating substantial equivalence to legally marketed predicate devices. This typically involves showing comparable composition, performance characteristics, and indications for use. Detailed quantitative performance metrics with acceptance limits and formal clinical studies with specific sample sizes, ground truth establishment, and reader adjudications, as might be found for a diagnostic AI device, are not typically reported in this type of submission.
Here's what can be gathered from the provided text:
1. A table of acceptance criteria and the reported device performance
Since this is a 510(k) for a material (glass ceramic blocks for dental restorations), the "acceptance criteria" are not quantitative performance metrics in the way one might expect for a diagnostic or therapeutic AI device. Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices in terms of composition, performance data, and indications for use. The document does not provide a table with specific numerical acceptance criteria and corresponding device performance data for metrics like accuracy, sensitivity, or specificity.
The "reported device performance" is implicitly that it performs comparably to the predicate devices, allowing for the manufacture of all-ceramic inlays, onlays, crowns, and veneers using CAD/CAM systems.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the 510(k) summary. For a material equivalence claim, a "test set" and its provenance in the context of clinical performance data are not typically described. The comparison is primarily based on material properties and intended use.
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 information is not applicable/not provided for this type of 510(k) submission. There is no mention of a "test set" requiring expert-established ground truth for performance evaluation in the context of diagnostic accuracy.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided for this type of 510(k) submission.
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
This information is not applicable/not provided. The device is a material for dental restorations, not an AI-powered diagnostic or assistive tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable/not provided. The device is a material, not an algorithm. Its use involves a human dentist or dental laboratory technician using a CAD/CAM system.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This information is not applicable/not provided. Ground truth in the context of clinical diagnostic accuracy is not typically established for a dental restorative material like this in a 510(k) submission. The "ground truth" for the material's properties would be defined by standard material testing protocols, which are not detailed here.
8. The sample size for the training set
This information is not applicable/not provided. There is no "training set" in the context of an AI algorithm described for this device.
9. How the ground truth for the training set was established
This information is not applicable/not provided.
Summary of the "Study" for this 510(k):
The "study" that proves the device meets the "acceptance criteria" (i.e., substantial equivalence) is a comparison to predicate devices based on:
- Composition: Implied to be comparable to "ProCAD® blocks," "VITABLOCS® Mark II," and "Paradigm™ MZ 100" blocks.
- Performance Data: General statement that "performance data" shows substantial equivalence. Specific data is not detailed in this summary. This would typically involve laboratory testing of material properties (e.g., strength, durability, wear resistance) compared to the predicates.
- Indications for Use: The new device shares the same indications as the predicates: "Manufacture of all-ceramic inlays, onlays, crowns, and veneers."
The conclusion states: "Comparison to the predicate devices for composition, performance data and indications for use shows that GLASS CERAMICS are substantially equivalent to the predicate devices. In summary it can be concluded that safety and effectiveness requirements for GLASS CERAMICS arc fully met." The FDA's letter concurs with this substantial equivalence finding.
§ 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.