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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.

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

The document does not specify the exact sample sizes used for each individual performance test (Curing Time, pH, Radiopacity, Solubility). These are bench tests conducted in a laboratory setting. The data provenance would be laboratory testing conducted by MEDICLUS Co., Ltd.

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

N/A. This is a material testing study, not a study involving human experts establishing ground truth for diagnostic interpretations. The "ground truth" is defined by the objective measurements according to the specified international standards.

4. Adjudication Method for the Test Set

N/A. Adjudication methods are typically for subjective interpretations by multiple human readers, which is not relevant for objective material performance tests.

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 relevant for AI-assisted diagnostic devices assessing human performance, not for dental material properties.

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

N/A. This is not an algorithm or AI device. The "standalone performance" refers to the device's intrinsic physical and chemical properties as measured in laboratory tests.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics (e.g., curing time, pH, radiopacity, solubility) is established through objective laboratory measurements conducted according to the methodology outlined in ISO 6876: Dental root canal sealing materials. For biocompatibility, the ground truth is established by adherence to ISO 10993-1 and ISO 7405.

8. The Sample Size for the Training Set

N/A. This is not an AI/ML device, so there is no "training set."

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

N/A. As there is no training set for an AI/ML model, this question is not applicable.

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