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• Permanent obturation of the root canal following vital pulp-extirpation
• Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.

ENDOSEAL MTA is an endodontic sealer based on MTA, providing a biocompatible and effective root canal filling. It is premixed and pre-loaded in a syringe, which allows a complete filling of the entire root canal including accessory and lateral canals. The product is eugenol-free and will not impede adhesion inside the root canal.

Below is a summary of the acceptance criteria and study information for the Endoseal MTA device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance

The provided text does not specify the sample sizes used for the test set in any of the performance or biocompatibility tests.
The data provenance is from non-clinical testing conducted by MARUCHI, as presented in the 510(k) submission. The country of origin of data is implicitly the Republic of Korea, where MARUCHI is located. The studies are retrospective in the sense that they are summary test results, not prospective trials.

3. Number of Experts and Qualifications for Ground Truth

This information is not applicable to this type of device submission. The "ground truth" for this medical device (a root canal filling resin) is established by adherence to recognized international standards (ISO) for material properties and biocompatibility, as well as by comparison to legally marketed predicate devices. The performance is assessed through laboratory testing, not through expert consensus on diagnostic images or patient outcomes in the same way an AI diagnostic device would be.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or studies involving expert review of data (e.g., imaging) where there might be disagreement in interpretations. For performance and biocompatibility testing of a material, the results are typically quantitative or qualitative based on established standard methods, and adjudication is not usually applied in this context.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted for this device. This type of study is relevant for diagnostic or AI-assisted devices where human readers interpret medical images or data. The Endoseal MTA is a material used in a dental procedure.

6. Standalone Performance Study

Yes, a standalone performance study was done in the sense that the device was subjected to a series of bench and biocompatibility tests without human intervention or interpretation of the material's properties by human operators with respect to its performance against the set standards. The tests were performed on the device itself to verify its physical, chemical, and biological properties.

7. Type of Ground Truth Used

The ground truth used for this device is based on established international standards (ISO 6876, ISO 10993 series) for the physical, chemical, and biological properties of root canal filling materials. The device's performance is measured against the criteria defined by these standards, and its safety and effectiveness are supported by demonstrating substantial equivalence to legally marketed predicate devices that also comply with these standards.

8. Sample Size for the Training Set

This information is not applicable. This device is a medical material, not an AI or machine learning algorithm that requires a training set. The "training set" concept is not relevant for evaluating the performance of a physical material.

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

This information is not applicable, as there is no training set for this type of device.

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• Repair of perforation
• Root canal filling

The raw materials of the ENDOSEAL are Natural Pure Cement, Zirconium dioxide, and Citric acid anhydrous, and the device has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and water, and it is used in a putty form which gradually hardens in the oral environment.

The provided text describes the submission of a 510(k) premarket notification for a medical device called ENDOSEAL, a root canal filling resin. The document focuses on demonstrating substantial equivalence to a predicate device (ENDOCEM MTA) rather than proving the device meets specific performance criteria through a clinical study.

Here's an analysis of the provided information concerning acceptance criteria and studies:

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

Note: The document explicitly states: "All the test results met the preset test criteria." It does not provide the specific numerical acceptance criteria for each test or the specific numerical results obtained for the ENDOSEAL device. It relies on a general statement of compliance.

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

The document does not describe any human-subject study or "test set" in the context of clinical performance. The "tests" mentioned are non-clinical bench and biocompatibility tests. Therefore, sample sizes for a test set, data provenance, and related information are not applicable to the studies described.

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

Not applicable, as no human-subject clinical test set is described.

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

Not applicable, as no human-subject clinical test set is 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 submission for a root canal filling material, and the studies described are non-clinical bench and biocompatibility tests. There is no mention of AI or human readers.

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

Not applicable. This is a medical device (root canal filling material), not an algorithm or AI system.

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

For the non-clinical tests described, the "ground truth" would be the established methods and criteria within the referenced ISO standards (ISO 6876, ISO 7405, ISO 10993-10, ISO 10993-11) and standard bench testing protocols for capacity and pH. These standards define the acceptable range or outcome for the specific properties being tested.

8. The sample size for the training set

Not applicable. No training set for an algorithm is described.

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

Not applicable. No training set for an algorithm is described.

Summary of the Study:

The study described is a non-clinical evaluation of the ENDOSEAL device, focusing on bench testing and biocompatibility assessments to demonstrate substantial equivalence to a predicate device (ENDOCEM MTA).

• Objective: To show that ENDOSEAL has similar physical and biocompatible properties and comparable performance specifications to ENDOCEM MTA. The primary goal is to address whether adding Zirconium dioxide and Citric acid anhydrous and removing Bismuth Trioxide from the formulation raises new questions of safety and effectiveness.
• Methodology: The device underwent a series of tests based on international standards:
  • ISO 6876: Visual inspection, packaging integrity, setting time, solubility, and radiopacity.
  • ISO 7405: Cytotoxicity.
  • ISO 10993-10: Skin sensitization (Local Lymph Node Assay, LLNA).
  • ISO 10993-11: Acute systemic toxicity.
  • Other bench testing: Capacity and pH (Saline Extracts).
• Results: The submission states, "All the test results met the preset test criteria."
• Conclusion: Based on these non-clinical tests, the manufacturer concluded that ENDOSEAL is substantially equivalent in safety and effectiveness to the predicate device.

Key takeaway: This 510(k) summary primarily demonstrates that the new device's material composition changes do not negatively impact its performance or biocompatibility compared to a legally marketed predicate device, as evidenced by non-clinical testing. It does not involve human-subject clinical trials or AI performance evaluations.

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