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NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste used as a cavity liner and as a temporary root canal dressing.

NuCal is a non-setting, pre-mixed, radiopaque calcium hydroxide paste that has a pH > 12, is easily removed from the root canal with water, has been designed for ease of handling and will flow through a 27 gauge applicator tip.

The provided text describes a 510(k) premarket notification for a dental device called NuCal. This submission focuses on establishing substantial equivalence to predicate devices based on design, composition, performance, and intended use, rather than presenting a study of a novel AI/ML device. Therefore, much of the requested information about AI model performance is not applicable.

Here's an analysis of the available information:

Acceptance Criteria and Reported Device Performance for NuCal

The acceptance criteria are established through bench testing to demonstrate that NuCal performs as intended and is substantially equivalent to predicate devices.

Regarding the other requested information, it is not applicable or not provided in the document for the following reasons:

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 relevant as no AI/ML model was being tested. The "test set" here refers to the samples of NuCal undergoing bench testing. The document does not specify the number of samples used for each bench test, nor their provenance beyond being manufactured by Pulpdent Corporation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for a physical product's bench tests is typically established through standardized laboratory procedures and measurements, not expert consensus in the way it's used for AI diagnostic tasks.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable. Adjudication methods are typically used in clinical studies or for establishing ground truth for AI models, not for bench testing of a physical substance.

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 document is for a dental material (calcium hydroxide paste), not an AI-powered diagnostic or assistive tool.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable. NuCal is a physical product, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance characteristics in the table, the ground truth is based on physical and chemical measurements performed in a laboratory setting (e.g., pH meter for pH, specific gravity meter, visual inspection for appearance/consistency, radiographic assessment for radiopacity, accelerated aging for shelf life).

8. The sample size for the training set: Not applicable. There is no AI model or "training set" in this context.

9. How the ground truth for the training set was established: Not applicable, as there is no AI model or training set.

In summary: The provided document is a 510(k) summary for a conventional medical device (a dental material), not an AI/ML powered device. The "study" described is a series of bench tests to demonstrate the physical and chemical properties of the NuCal product, and its substantial equivalence to previously cleared predicate devices.

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