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The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

The MTA2 ROOT AND PULP MATERIALS are designed and developed for dentists to use in dental procedures that contact with vital pulp tissue and periradicular tissue, as well as obturation and sealing of root canals. The MTA2 ROOT AND PULP MATERIALS can be used for dental procedures such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and sealing/obturation. The dentist mixes the powder with the provided gel and places the mixed MTA2 material into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. The MTA2 ROOT AND PULP MATERIALS are available in white or gray.

The provided text describes the 510(k) summary for a dental device, the MTA2 ROOT AND PULP MATERIALS. This device is a cement primarily used for root canal procedures and interaction with pulp and periradicular tissues.

Here's an analysis of the acceptance criteria and supporting study details based on the provided input:

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

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 primarily describes non-clinical performance (bench testing). There is no information provided about a "test set" in the context of human subjects or a clinical study. The data provenance is laboratory testing.

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)

Not applicable. This device's evaluation was based on non-clinical, bench testing against recognized standards (ADA 57, ISO 9917). There was no "test set" requiring expert ground truth in the traditional sense of diagnostic accuracy studies. The standards themselves serve as the 'ground truth' for performance.

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

Not applicable. Without a clinical test set or expert evaluation component, there is no adjudication method described.

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 is not an AI/CAD device. It is a dental material.

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

Not applicable. This is not an AI/CAD device.

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

The "ground truth" for this device's performance was established by adherence to recognized international and national standards for dental materials: ADA 57, ISO 6876, and ISO 9917. These standards define the acceptable physical, chemical, and biological properties for such materials.

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

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MTA MATERIAL is indicated for use as a root end filling material.
MTA MATERIAL II is indicated for use as a root end filling material.

MTA MATERIAL is a powder consisting of fine hydrophilic particles. Hydration of the powder results in a colloidal gel, which solidifies to a hard structure.

The provided text is related to a 510(k) premarket notification for a dental material called "MTA MATERIAL." The notification states that MTA MATERIAL is identical to previously cleared predicate devices (K964174 and K980332) but is seeking clearance for a new intended use: as a root end filling material.

The crucial information needed to answer your request (acceptance criteria, study details, sample sizes, expert qualifications, etc.) is not present in the provided 510(k) summary and FDA clearance letter. These documents primarily focus on demonstrating substantial equivalence to a predicate device based on identical composition and previous biocompatibility studies, rather than providing detailed clinical study results for the new intended use.

Here's why the information is missing and an explanation of what is available:

• Identical Device, New Intended Use: The core of this submission is that "MTA MATERIAL is identical to K964174 and K980332." Because the composition is the same, the manufacturer argues that prior biocompatibility and performance data for the material itself from the predicate devices supports the safety and effectiveness for the new intended use.
• No New Clinical Study for Substantial Equivalence: For a 510(k) submission, especially when a device is identical to a predicate for a new, but related, intended use, a full-blown clinical trial with detailed acceptance criteria might not have been required by the FDA. The submission states, "The fact that the formula is identical to K964174 and K980332 leads to the conclusion that biocompatibility studies with the formulation are not necessary." It also mentions "in-vitro and animal study performance data provided, and the results of previous testing in K964174." This implies reliance on non-clinical data and existing data for the predicate, not a new human clinical study specifically designed for the "root end filling" indication with defined acceptance criteria.

Therefore, I cannot provide the requested table or study details because the provided documents do not contain them.

Here is what can be extracted and inferred based on the documents:

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

   • Acceptance Criteria: Not explicitly stated for the "root end filling" intended use in this document. The implicit acceptance criteria would have been "substantial equivalence" to the predicate devices for safety and effectiveness, based on identical material composition and existing data.
   • Reported Device Performance: The document only states that "the prior use of the formula in K964174 and K980332, the in-vitro and animal study performance data provided, and the results of previous testing in K964174 support the safety and effectiveness of MTA MATERIAL for the new intended use." No specific performance metrics (e.g., success rates, leakage rates, healing times) are reported here.

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

   • Sample Size: Not specified. The reference is to "in-vitro and animal study performance data" and "results of previous testing in K964174." These would be non-human studies.
   • Data Provenance: Not specified, but likely from laboratory (in-vitro) and animal studies. Type: Retrospective (referring to existing data from K964174 and K980332).

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):

   • Not applicable. No human clinical "test set" with ground truth established by experts is described in this submission.

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

   • Not applicable. No such human test set described.

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 is a material for a dental procedure, not an AI diagnostic device.

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

   • Not applicable. This is a material for a dental procedure, not an algorithm.

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

   • For the "in-vitro and animal study performance data," the ground truth would typically be measured physical, chemical, or biological parameters relevant to material performance (e.g., pH, setting time, radiopacity, cell viability in vitro, tissue response in animal models), rather than clinical outcomes on human patients.

8. The sample size for the training set:

   • Not applicable. No "training set" in the machine learning sense is described. The "training" here refers to the extensive prior testing and use of the identical material under previous clearances.

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

   • Not applicable.

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