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The Luminesse Porcelain System is dental porcelain material to be used in conjunction with metal, zirconia, or pressable ceramic framework in the construction of crowns and/or bridgework and veneers.

The Luminesse Porcelain is dental porcelain used by dental technicians to create biocompatible crowns, bridges, and veneers. It consists of three categories: low fusing, high fusing, and zirconia porcelain. The application, indication, and performance is the same for all three categories; therefore, it is a porcelain system. It includes Pressable Ingots, Opaque Powders, Opaque Powders, Opacious Dentins, Dentins, Incisal Powders, Stains, Incisal Transluscents, Dentin Modifiers, Correction Powder, Glaze Powder, Glaze Liquid, Modeling Liquid, and Opaque Liquid. The dental technician will use various components of the system to create the specific, desired dental prosthetic, for the sole use of individual dental patients. It is for prescription use only.

The provided text describes the Luminesse Porcelain System, a dental porcelain material, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving that the device meets specific performance acceptance criteria.

The document is a 510(k) premarket notification letter and a 510(k) summary. These types of documents focus on demonstrating that a new device is "substantially equivalent" to a legally marketed predicate device, rather than providing detailed acceptance criteria and performance study data in the way you've requested for an AI/CADe device.

Here's a breakdown of what is available based on your request, and what is missing:

1. A table of acceptance criteria and the reported device performance

• Missing. The document does not specify quantitative acceptance criteria (e.g., minimum flexural strength, maximum solubility) that the Luminesse Porcelain System needed to meet.
• Reported performance: The document states that "Bench testing to determine flexural strength, solubility, and glass transition temperature was conducted in accordance with ISO 6872." However, the results of these tests (the actual reported device performance values) are not provided in the summary. It only indicates that "All components found in Luminesse Porcelain have been used in legally marketed devices and were found safe for dental use. It has the same technological characteristics, chemical composition, manufacturing process, and same intended use as the predicate devices." This implies that the performance was deemed comparable to the predicates, but specific numbers are absent.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Missing. The document does not describe a "test set" in the context of clinical or AI performance evaluation. The "bench testing" mentioned for flexural strength, solubility, and glass transition temperature would have involved material samples, but the specific sample sizes, provenance, or whether it was retrospective/prospective are not mentioned.

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)

• Missing. This information is completely irrelevant to this type of device (dental porcelain) and submission (510(k) for substantial equivalence). Ground truth and expert adjudication are concepts typically associated with medical diagnostic devices, especially those involving image analysis or expert interpretation.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Missing. See point 3.

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

• Missing. See point 3. This device is a material, not a diagnostic tool or an AI/CADe system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Missing. See point 3.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Missing. See point 3. The "ground truth" for a material device like this would typically be its physical and chemical properties as measured by standardized tests (like ISO 6872), compared against established standards or predicate device properties.

8. The sample size for the training set

• Missing. This concept of a "training set" is for AI/machine learning devices, which this medical device is not.

9. How the ground truth for the training set was established

• Missing. See point 8.

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