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Apacal ART and is suitable for several indications including:

• · Liner to be applied to the interior of a prepared cavity prior to the insertion of restorative materials.
• · Indirect pulp capping or management of deep caries lesions, or
• · Direct pulp capping

CAL-LC is indicated for use as a cavity liner and pulp capping material. It is self-adhering and highly filled.

Calcigel is a calcium hydroxide paste that has a creamy consistency and is suitable for several indications including;

• · Indirect pulp capping or management of deep caries lesions, or
  · Direct pulp capping

CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

Apacal ART is a light cured single-component paste reinforced with tricalcium phosphate and hydroxyapatite. It is sold in a syringe with accompanying applicator tips.

CAL-LC is a highly filled cavity liner and pulp capping material. It is sold in a syringe with accompanying applicator tips.

Calcigel is a creamy, ready -to -use calcium hydroxide paste with a pH above 11. It is syringe with accompanying applicator tips.

CalUltra is a hard-setting calcium hydroxide cavity liner and pulp capping agent. CalUltra is a two-part base/catalyst paste/paste system. It is sold in a tubes with accompanying spatula and mixing pad.

The provided text describes the substantial equivalence of Prevest Denpro Cavity Liners to predicate devices, focusing on physical parameters and material composition rather than AI performance. Therefore, many of the requested categories related to AI studies and expert review are not applicable to this document.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The document states that "All tests results met the criteria in standards." The acceptance criteria are implicit in the ISO and USP standards referenced for each test. The performance is reported as meeting these standards.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes used for the testing of these physical and chemical properties. The data provenance is presumed to be from the manufacturer's testing conducted in India (Prevest Denpro Limited, Jammu, India). The testing is described as being performed "according to protocols based on" relevant ISO and USP standards, indicating manufacturer-conducted in vitro/bench testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This is a medical device clearance based on material properties and performance against established international standards, not an AI or diagnostic device requiring expert ground truth for image interpretation or similar tasks.

4. Adjudication method for the test set

Not applicable. This type of adjudication is typically used in clinical or image-based studies. The "adjudication" here is the assessment against specified ISO/USP standard requirements.

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. The device is a dental material, not an AI-assisted diagnostic tool.

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

Not applicable. The device is a dental material, not an algorithm.

7. The type of ground truth used

The "ground truth" for the device's performance is based on the objective measurements against established international and national standards (ISO and USP) for material properties (e.g., flexural strength, depth of cure, water sorption/solubility, pH, setting time, radio-opacity).

8. The sample size for the training set

Not applicable. There is no training set mentioned, as this is not an AI or machine learning device.

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

Not applicable, as there is no training set.

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