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1. Furcation or root perforation treatment via canal
2. Furcation or root perforation treatment via surgical
3. Internal reabsorption treatment via canal or surgical
4. External reabsorption treatment
5. Retrofilling in parendodontic surgery
6. Direct and Indirect pulp capping
7. Apexification
8. Apexogenesis and Pulpotomy

One-Fil Putty Injectable is a premixed material intended for permanent root canal filling. It is based on a tricalcium silicate composition, which undergoes setting and hardening in the presence of moisture.
The product is packaged in a paper box with four syringes in a vinyl packaging, and the contents in the glass syringe are white paste type.

This FDA 510(k) clearance letter and summary are for a dental material, not an AI/ML device. Therefore, many of the requested categories related to AI/ML device studies (such as MRMC studies, ground truth establishment, training set details, and expert qualifications) are not applicable.

However, I can extract the relevant information regarding the device's acceptance criteria and the study proving it meets them.

Acceptance Criteria and Device Performance for One-Fil Putty Injectable (K251884)

The "One-Fil Putty Injectable" is a dental root canal filling material. Its acceptance criteria are based on conformance to international standards for dental materials, specifically ISO 6876, and comparison to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implicitly defined by conformance to ISO 6876 and the performance of the predicate device (One-Fil Putty, K243353). The reported performance of the subject device is directly compared to the predicate device in the 510(k) summary.

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• 1. Furcation or root perforation treatment via canal
• 2. Furcation or root perforation treatment via surgical
• 3. Internal reabsorption treatment via canal or surgical
• 4. External reabsorption treatment
• 5. Retrofilling in parendodontic surgery
• 6. Direct and indirect pulp capping
• 7. Apexification
• 8. Apexogenesis and Pulpotomy

One-Fil putty is a permanent root canal filling repair material with tricalcium aluminate compound that are premixed and designed to be convenient for use. It is hardened by moisture, has characteristics of adhesion and workability. The product is packaged in a paper box with one or two syringes in a tray, and the contents in the glass syringe are white paste type.

The provided document is a 510(k) summary for the medical device "One-Fil Putty." This device is a dental root canal sealer. The document describes the device's characteristics and compares it to a predicate device to establish substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

The document doesn't explicitly present "acceptance criteria" in a separate table format with pass/fail thresholds. Instead, it lists "Performance Tests in accordance with ISO 6876" as the standards against which the device was evaluated. The results for the "One-Fil Putty" are presented within the "Comparison Chart" (Section 8.1) alongside the predicate device's information for some parameters.

Here's a consolidated table of the performance data extracted from the document, with the understanding that the accepted performance is inferred from compliance with the mentioned ISO standards:

Note: The document only provides the performance results for the subject device and in some cases for the predicate. It does not explicitly state the numerical acceptance criteria for many of these tests. Compliance with the cited ISO standards (e.g., ISO 6876) implies that accepted criteria were met. For "Foreign substance" and "Packaging," the description given serves as the implied acceptance criterion. For "Setting time" and "Solubility," specific numerical limits for ISO 6876 are not provided in this document, only the measured values for the subject device.

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

The document does not provide details on the sample sizes used for the non-clinical performance tests (e.g., how many units were tested for setting time, solubility, etc.).
The data provenance (country of origin of the data, retrospective or prospective) is also not specified in the provided text.

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

This information is not applicable as the document describes performance testing of a physical material (dental root canal sealer) against international standards (ISO 6876, ISO 13116, ISO 10993, etc.), not a diagnostic or AI-based device requiring expert ground truth for interpretation.

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

This information is not applicable as the document describes performance testing of a physical material, not a diagnostic study requiring adjudication of interpretations.

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 as the device is a physical dental material, not an AI-assisted diagnostic tool.

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

This information is not applicable as the device is a physical dental material, not an algorithm.

7. The type of ground truth used:

The "ground truth" for the performance tests (foreign substance, setting time, solubility, radiopacity, pH, biocompatibility, shelf-life) is established by objective measurements and laboratory tests conducted according to recognized international standards (ISO 6876, ISO 13116, ISO 10993).

8. The sample size for the training set:

This information is not applicable as the device is a physical material and does not involve an algorithm or a training set in the context of AI/machine learning.

9. How the ground truth for the training set was established:
This information is not applicable as the device is a physical material and does not involve an algorithm or a training set.

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