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The MTA2.2 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

The MTA2.2 MATERIAL is designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. This material can be used for dental procedures contacting pulpal or periradicular tissue such as: Pulp capping, Cavity lining, Base material in a cavity, Pulpotomies, Root-end filling, Apexification, Perforation repair, Root resorption, and Obturation (pulpectomy) in primary or secondary teeth.

The dentist will mix the powder and water-based gel of MTA2.2 and place the mixed MTA2.2 MATERIAL into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. These procedures are performed on primary and secondary dentition and are color stable over time. MTA2.2 MATERIAL is tinted yellow, pink and gray.

This document describes the premarket notification (510(k) submission) for the MTA2.2 MATERIAL, a root canal filling resin. However, it does not present a study with acceptance criteria and reported device performance in the way typically expected for a medical imaging or diagnostic device involving statistical metrics like sensitivity, specificity, or reader studies.

Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MTA2.1 MATERIAL, K140955) based on material properties, design, indications for use, and conformance to established dental standards.

Therefore, many of the requested sections about acceptance criteria, study design, sample sizes for test/training sets, expert ground truth, adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as they pertain to clinical performance evaluations not present here.

Here's a breakdown of what can be extracted based on the provided text:

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

The "acceptance criteria" here are conformance to recognized consensus standards for dental materials. The "reported device performance" refers to the MTA2.2 MATERIAL meeting these standards.

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

• Not applicable for a "test set" in the context of diagnostic performance. The document describes bench testing of material properties. The specific sample sizes for each bench test (e.g., number of specimens for compressive strength) are not provided.
• Data Provenance: Not specified, but likely from laboratory bench testing conducted by the manufacturer, Avalon Biomed Inc.

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. Ground truth in this context refers to established material properties measured according to standardized laboratory protocols, not expert consensus on clinical findings.

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

• Not applicable. No expert adjudication process is described for batch testing of material properties.

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

• No. This is a material safety and effectiveness submission, not an AI or diagnostic imaging device. No MRMC study was conducted or is relevant.

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

• No. This is not an algorithmic device.

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

• The "ground truth" for the performance data in this document is derived from measurements of physical and chemical properties according to established and recognized consensus standards (ISO 6876, ADA 57, ISO 9917).

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. See point 8.

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The MTA2.1 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.

The MTA2.1 MATERIAL is designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. This material can be used for dental procedures contacting pulpal or periradicular tissue such as: Pulp capping, Cavity lining, Base material in a cavity, Pulpotomies, Root-end filling, Apexification, Perforation repair, Root resorption, and Obturation (pulpectomy) in primary or secondary teeth. The dentist will mix the powder and water-based gel and place the mixed MTA2.1 MATERIAL into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. These procedures are performed on primary and secondary dentition and are color stable over time. MTA2.1 MATERIAL is tinted yellow, pink and gray.

The provided document describes the Avalon Biomed Inc.'s MTA2.1 MATERIAL and its substantial equivalence determination to a predicate device (MTA2 ROOT AND PULP MATERIAL, K122892). This submission is for a material, not an AI/ML powered medical device, therefore, many aspects of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.

However, I can extract the acceptance criteria and the studies performed to demonstrate the device meets those criteria, focusing on the available non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the MTA2.1 MATERIAL are based on established dental material standards, specifically ADA 57 and ISO 9917. The document states that the MTA2.1 MATERIAL meets these standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: Not specified. The document refers to "bench testing" and "design validation" for these non-clinical tests, implying laboratory experiments. The specific number of samples for each test (e.g., radiopacity, solubility) is not detailed.
• Data Provenance: The tests were conducted as part of the device's "design validation." This implies laboratory testing performed by or for the manufacturer (Avalon Biomed Inc.). The country of origin of the data is not explicitly stated beyond the company being in Bradenton, FL, USA, and the submission being to the US FDA. The studies are prospective in the sense that they were conducted specifically for this regulatory submission to evaluate the material's properties against predefined standards.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Not applicable. The "ground truth" for material properties like radiopacity, solubility, or compressive strength is established through standardized laboratory measurement methods as defined by ADA 57 and ISO 9917, rather than expert consensus.

4. Adjudication Method for the Test Set

Not applicable for material property testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human readers evaluate cases with and without AI assistance. This submission is for a dental material, not an AI system.

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

No, this is not applicable as the device is a dental material, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for the material's performance relies on standardized measurement methods specified by ADA 57 and ISO 9917. These standards define the procedures and expected ranges for various physical and chemical properties of dental root canal filling and pulp materials. For example:

• Radiopacity: Measured according to the method described in ADA 57.
• Solubility, Dimensional Stability, Film Thickness, Flow, Working Time, Setting Time: Measured according to the methods described in ADA 57.
• Compressive Strength, Leaching of Arsenic and Lead: Measured according to the methods described in ISO 9917.
• Biocompatibility: Evaluated through cytotoxicity tests.

8. The Sample Size for the Training Set

Not applicable. This is a dental material, not an AI/ML model that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. (See #8)

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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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