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• A root end filling material
• For the repair of repair of root canals as an apical plug during apexification
• For repair of root perforations during root canal therapy or as a consequence of internal resorption
• As a pulp capping material
• Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations

ProRoot MTA White and ProRoot MTA Gray is a powder consisting of fine hydrophilic particles that set in the presence of moisture. Hydration of the powder creates a colloidal gel that solidifies to form a strong impermeable barrier that fully cures over a four-week period.

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided text is a 510(k) premarket notification for a dental device, ProRoot MTA White/Gray (Pediatric Pulpotomy). It focuses on establishing substantial equivalence to previously cleared predicate devices and adding a new indication for use: "Pulpotomy of primary teeth in the child (ages >2-12 years) and adolescent (ages >12-21 years) pediatric patient populations."

It's important to note that this document is not a standalone study report with explicit acceptance criteria and detailed performance metrics as one might find for a diagnostic or imaging AI/software device. Instead, it's a regulatory submission demonstrating the safety and effectiveness of expanding the indications for an existing material based on clinical literature. Therefore, the information requested will be interpreted within this context.

1. Table of acceptance criteria and the reported device performance

The document doesn't explicitly state "acceptance criteria" in a quantitative sense (e.g., "sensitivity must be >90%"). Instead, the acceptance criterion for the new indication is demonstrating safety and effectiveness for pulpotomy in pediatric patients, supported by existing clinical literature.

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

• Sample Size (Test Set): The filing mentions "completed studies (pulpotomy in 171 pediatric patients covering 408 primary teeth)." This represents the total number of patients and teeth across the summarized clinical literature.
• Data Provenance: The data originates from "independently reviewed medical literature" and "relevant clinical data available in independently reviewed medical literature." One specific reference is provided: Srinivasan, V, et al "Mineral trioxide aggregate in paediatric dentistry" International Journal of Paediatric Dentistry, 19:34-47, 2009. The studies are retrospective as they are existing published literature. The country of origin of the data is not specified but is presumably international given the nature of scientific literature.

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

The document does not specify the exact number of experts involved in establishing the ground truth for the collected literature. It refers to studies conducted by "dental professionals." The provided reference is to an "International Journal of Paediatric Dentistry," suggesting the experts involved would be pediatric dentists or dental professionals specializing in pediatric dentistry. Their specific years of experience are not detailed.

4. Adjudication method for the test set

The document does not describe a specific adjudication method (like 2+1, 3+1, none) for the clinical literature review or for establishing ground truth within those studies. The assessment relies on the conclusions and methods presented in the published scientific literature.

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, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is not an AI/software device designed to assist human readers. It is a dental material used directly in treatment.

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

N/A. This is a dental material, not an algorithm or software. Its performance is evaluated based on its clinical outcomes after application by a dental professional.

7. The type of ground truth used

The ground truth used in the referenced clinical literature would be clinical outcomes data relevant to pulpotomy procedures, such as:

• Clinical success (e.g., absence of pain, swelling, mobility)
• Radiographic success (e.g., absence of periapical or furcal radiolucency, normal root development)
• Histological findings (if biopsies were taken, though less common for outcome assessment in pulpotomy for regulatory purposes).
• Retention rates of the teeth.

8. The sample size for the training set

N/A. This device does not use an "algorithm" in the traditional sense that requires a training set for machine learning. The clinical experience and data from the 171 pediatric patients (408 teeth) constitute the evidence base, not a training set for an algorithm.

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

N/A. As above, there is no training set for an algorithm. The ground truth for the clinical studies (evidence base) was established through standard clinical and radiographic follow-up protocols within the individual studies published in the medical literature.

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