(85 days)
The pressable ceramic pellets are pressed onto zirconia frames by dental technicians to fabricate full ceramic crowns and the ceramic layering porcelain and liquids are used to build up the pressed ceramic to final tooth morphology and shade. The ceramic layering porcelain and liquids are also used in building ceramic crowns and bridges on titanium and titanium alloy substructures. Both applications are to provise protheses for missing / damaged teeth.
The InSync Ceramic System consists of pressable silica based ceramic pellets and silica based ceramic layering porcelain and liquids.
The provided text is a 510(k) summary for "The InSync Ceramic System" by Jensen Industries. It is a premarket notification to the FDA for a dental porcelain product.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. A table of acceptance criteria and the reported device performance
The document states: "Independently, the InSync Ceramic System meets the applicable sections of concensus standards ISO 9693 and ISO 6872."
The text does not provide a table of specific numerical acceptance criteria from ISO 9693 and ISO 6872, nor does it report specific numerical device performance against those criteria. It only makes a general statement of compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size used for any testing or the data provenance. It refers to "Data has been presented to demonstrate that the respective composition, mechanical properties, chemical qualities, and the indications for use make the InSync Ceramic System substantially equivalent to the predicate devices," but no details of this data or its origin are provided.
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 provided in the document. The study described is a comparison of material properties, not an evaluation requiring expert interpretation of diagnostic images or clinical outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable/not provided in the document as it describes a study of material properties, not a study requiring adjudication of expert interpretations.
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
An MRMC comparative effectiveness study was not done. This document describes a dental porcelain system, and the study focuses on its material properties and chemical qualities, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study as typically understood for AI algorithms was not conducted. The device itself is the material (dental porcelain), not an algorithm. The "study" described is the testing of the material's properties against established consensus standards (ISO 9693 and ISO 6872) and comparison to predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the material property comparison would be defined by the consensus standards (ISO 9693 and ISO 6872) for mechanical and chemical properties of dental ceramics. The performance of the device (its material properties) is compared against the specifications within these standards and against the properties of the predicate devices.
8. The sample size for the training set
The document does not mention a training set, as this is not an AI/machine learning device. The "training" in this context would be the development and formulation of the ceramic system itself, not a data-driven training process.
9. How the ground truth for the training set was established
The concept of a "training set" and "ground truth for the training set" as it relates to AI/machine learning is not applicable to this device or its reported data. The "ground truth" for the material's development would be established through established scientific principles of material science, chemistry, and engineering validated by industry standards (like ISO).
§ 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.