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Aqueous ointment material that temporarily fills the root canal for the following indications: Apexification Temporary root filling Root canal filling for primary teeth Vital pulpotomy Temporary pulp capping

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

The provided document is a 510(k) summary for a medical device called DiaPaste, a root canal filling resin. It focuses on demonstrating substantial equivalence to a predicate device rather than detailing extensive clinical studies with acceptance criteria for device performance in diagnosing or predicting conditions.

Therefore, I cannot extract the information required for a table of acceptance criteria and reported device performance related to diagnostic or predictive capabilities, nor can I provide information on sample sizes for test sets, data provenance, number of experts, adjudication methods, MRMC studies, standalone performance, training set details, or how ground truth was established for a diagnostic AI.

However, I can provide the non-clinical performance data and acceptance criteria as presented in the document for the physical properties of the device:

1. Table of Acceptance Criteria and Reported Device Performance (Non-Clinical Physical Properties)

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

This information is not provided in the document. The performance data listed (Table 1) pertains to non-clinical physical and material property tests of the device itself, not to a test set of patient data.

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 applicable and not provided. The ground truth for physical properties (flowability, film thickness, radiopacity) is established by standardized laboratory measurements rather than expert human interpretation.

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

This information is not applicable and not provided. Adjudication methods are typically relevant for human interpretation of medical images or clinical data, not for material property testing.

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

This information is not applicable and not provided. This document describes a paste used for root canal filling, not an AI-powered diagnostic device.

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

This information is not applicable and not provided. This document describes a physical medical device, not an algorithm.

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

For the physical property tests, the "ground truth" is derived from established laboratory measurement standards and protocols (e.g., ISO 6876). For biocompatibility, the ground truth is established through standardized biological evaluation tests (e.g., ISO 10993 series), confirming that the material does not cause adverse biological responses.

8. The sample size for the training set

This information is not applicable and not provided. This document describes a physical medical device, not an algorithm that requires a training set.

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

This information is not applicable and not provided. As noted above, this is a physical device, not an algorithm with a training set.

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Aqueous ointment material that temporarily fills the root canal for the following indications:

• Apexification
• Temporary root filling
• Root canal filling for primary teeth
• Vital pulpotomy
• Temporary pulp capping

Diapaste is a calcium hydroxide paste with barium sulfate, used as a temporary root canal filling material.

The provided text is an FDA 510(k) summary for a dental device called "Diapaste." It describes the device, its intended use, and compares it to predicate devices to establish substantial equivalence.

However, the information provided does not contain any data or discussion regarding the acceptance criteria and study proving a device meets performance criteria related to AI/ML or human-in-the-loop performance, as implied by the original question's structure. The document is a regulatory submission for a dental material (root canal filling resin), not an AI/ML powered medical device.

Therefore, I cannot extract the requested information (table of acceptance criteria with reported performance, sample sizes for test/training sets, expert details, adjudication methods, MRMC studies, standalone performance, ground truth types, etc.) because it is not present in the provided text.

The closest relevant sections in the document are about non-clinical performance data for the dental material itself, which are physical properties and biocompatibility tests, not AI/ML performance.

Here's an analysis of what is present in the document regarding performance:

1. A table of acceptance criteria and the reported device performance (for physical properties, not AI/ML):

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

• The document does not specify sample sizes for these performance tests.
• Data provenance is not mentioned (e.g., country of origin, retrospective/prospective). These are typical lab tests for material properties.

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

• Not applicable. These are physical property measurements, not data requiring expert interpretation or ground truth establishment in the context of diagnostic AI.

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

• Not applicable for physical property measurements.

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

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

• Not applicable. This is not an algorithm.

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

• For physical properties, the "ground truth" is established by direct measurement against a standard (ISO 6876).
• For biocompatibility, the "ground truth" is established by laboratory tests against ISO standards (ISO 7405, ISO 10993 series).

8. The sample size for the training set:

• Not applicable. This is not an AI/ML device requiring a training set.

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

• Not applicable.

In summary, the provided document does not contain the information requested about AI/ML device performance. It is a regulatory clearance for a traditional medical device (a dental filling material), primarily demonstrating substantial equivalence through comparison of indications for use, composition, and conformance to relevant material-specific performance and biocompatibility standards.

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