(113 days)
Used only with FINESSE™ Low-Fusing Porcelain for the fabrication of dental restorations: for inlays, onlays, veneers, complete crowns on anterior teeth, and for single crowns on selected posterior teeth.
The FINESSE™ALL-CERAMIC SYSTEM is a glass-ceramic material designed to be used with Finesse™ Low-Fusing Porcelain. By combining the core material with the Finesse™ Low-Fusing Porcelain, the laboratory can offer the recognized aesthetics wear characteristic and chair-side polishability of Finesse™ Low-Fusing Porcelains combined with the aesthetic benefits of an all-ceramic system.
A dental restoration is prepared by placing a glass material in a heat and pressure deformable crucible. Heat is applied to the crucible to bring the glass to a "working" temperature. The glass is brought into contact with a mold having a preformed dental restorative cavity. The crucible is crushed and the molten glass is then injected into the mold. After cooling, the glass coping is removed from the mold. The glass restoration is heat treated to crystallize into a glass-ceramic. Finesse™ Low-Fusing Porcelain is then applied on the glass-ceramic coping to complete the restoration.
The provided document is a 510(k) summary for the DENTSPLY FINESSE™ ALL-CERAMIC SYSTEM, a dental material. It describes the device, its intended use, and technological characteristics, along with evidence of its safety and substantial equivalence to a predicate device.
However, the document does not contain information about specific "acceptance criteria" in the format of performance metrics (like sensitivity, specificity, accuracy) typically associated with AI/ML-based medical devices or diagnostic tools. It also does not describe a "study that proves the device meets the acceptance criteria" in terms of clinical performance evaluation using ground truth, expert readers, or statistical comparisons of device performance.
Instead, the "acceptance criteria" and "study" described in this document relate to the material's biocompatibility and its comparability to existing devices.
Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is absent:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Non-cytotoxicity | Non-cytotoxic (MEM Elution Test) |
| Non-mutagenicity | Non-mutagenic (Ames Mutagenicity Assay) |
| Non-irritancy | Non-irritant (Hamster Cheek Pouch Irritation Study) |
| Substantial Equivalence to DICOR® Castable Ceramic (K830955A) for intended uses (inlays, onlays, veneers, complete crowns on anterior teeth, and single crowns on selected posterior teeth) | Found substantially equivalent by FDA for stated indications for use. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Test Set): Not applicable in the context of clinical performance evaluation as commonly understood for AI/ML devices. The "test set" here refers to samples used in material safety testing (e.g., biological samples for cytotoxicity, mutagenicity, and irritation). The specific number of samples for these tests is not provided in the document.
- Data Provenance: The studies were conducted on laboratory samples and animal models (hamster). No information on country of origin for these specific tests is provided, nor whether they were retrospective or prospective studies on human subjects.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
- Not applicable. The "ground truth" for the material safety tests (cytotoxicity, mutagenicity, irritation) is determined by established laboratory protocols and biological endpoints, not by human experts interpreting clinical data. For the substantial equivalence, the "ground truth" is regulatory comparison to a predicate device, which is an FDA determination, not an expert consensus on a test set of clinical cases.
4. Adjudication Method for the Test Set
- Not applicable. There was no adjudication method involving multiple experts for interpreting test results in the clinical sense mentioned in the prompt. The material tests follow defined methods with clear endpoints.
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
- No. This document describes a dental material, not an AI/ML-based diagnostic system that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This document describes a dental material, not an algorithm.
7. The type of ground truth used
- For Material Safety: Laboratory test results (e.g., cell viability, mutation rates, irritation scores) using established biological assays.
- For Substantial Equivalence: Comparison to the technological characteristics, intended use, and safety profile of the predicate device (DICOR® Castable Ceramic).
8. The Sample Size for the Training Set
- Not applicable. This document describes a dental material, not an AI/ML system that requires a training set.
9. How the Ground Truth for the Training Set was Established
- Not applicable. This document describes a dental material, not an AI/ML system.
Summary of Device Performance/Studies from the Text:
The document states:
"The FINESSE™ ALL-CERAMIC SYSTEM has been evaluated by the MEM Elution Test and found to be non-cytotoxic, by the Ames Mutagenicity Assay and found to be non-mutagenic, and by the Hamster Cheek Pouch Irritation Study (mucous membrane) and found to be a non-irritant."
These are standard biocompatibility tests for medical devices and materials. The results indicate that the material meets safety standards related to cellular toxicity, genetic mutation, and tissue irritation.
The substantial equivalence claim is based on:
- Prior use of components in predicate medical devices.
- Results of the toxicity and irritation testing.
- Performance data (though specific performance testing beyond biocompatibility is not detailed in the summary, it implies mechanical/physical property data would have been submitted to FDA for comparison).
In conclusion, the provided text pertains to a traditional medical device (dental material) clearance rather than an AI/ML diagnostic or assistive device. Therefore, many of the requested bullet points, which are highly relevant to clinical performance evaluation of AI/ML systems, are not applicable to this document.
§ 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.