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CalApex is a calcium hydroxide, polymeric resin, root canal filling material that is used in conjunction with gutta percha or silver endodontic points.

Calplus is a temporary or permanent root canal filling material for use following pulpectomy, or for apexogenesis or apexification.

Cerafill RCS is a MTA (mineral trioxide aggregate) based root canal sealer that provides complete and permanent sealing of root canals. It can be used with or without root canal obturation materials.

Endoseal is used for permanent obturation of the root canal space with the aid of obturating points in accordance with ISO 6876 for Dental Root Canal Sealing materials.

Nanoseal S is indicated in patients for permanent obturations of root canal after vital extirpation or after treatment of pulpal gangrene and temporary filling.

Zical Ultra Paste is used for permanent obturation of the root canal space with the aid of obturating points.

Zical Ultra Powder/Liquid is used for permanent obturation of the root canal space with the aid of obturating points.

CalApex is a non-eugenol, radiopaque, calcium hydroxide polymeric resin root canal filling material. It is a two part, base/catalyst – paste/paste system that is mixed in equal portions. The mixture is then carried to the root canal with endodontic obturation points or directly dispensed in the root canal depending on delivery method, e.g. tube or dual-barrel syringe.

Calplus can be used as a temporary or permanent root canal filling material.

Cerafill RCS 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.

Endoseal is a Zinc Oxide/Eugenol root canal sealant. The product is made up of two separate components, a powder base and a liquid catalyst, to form the final device.

Nanoseal S is a permanent root canal filling material which is silicone based (polydimethylsiloxane). It is cold flowable and is in a dual barrel cartridge.

Zical Ultra Paste is a two-part, base/accelerator, paste/paste system that is mixed in equal portions. The mixture is carried to the root canal with endodontic obturation points. The product comes in a dual barrel cartridge.

Zical Ultra Powder/Liquid is a two-part, powder/liquid system for permanent filling of root canals. The mixture is carried to the root canal with endodontic obturation points.

The document describes the acceptance criteria and performance of several root canal sealers developed by Prevest Denpro Limited. The study involved a series of bench tests conducted according to ISO standards to demonstrate substantial equivalence to predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance:

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Permanent root canal obturation

White ENDOSEAL MTA is a root canal sealer conforming to ISO 6876, in a pre-loaded syringe that does not require any pre-mixing and is set by absorbing moisture from the root canal environment. The sealer can be used either alone or in combination with gutta-percha obturating cones, injected gutta-percha material or core-carriers, master cones.

The provided text is a 510(k) summary for a medical device (White ENDOSEAL MTA), which is a premarket notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device. This document does NOT contain information about acceptance criteria or a study proving that a device meets acceptance criteria in the context of an AI/ML medical device.

The document discusses:

• Device Description: A root canal sealer for permanent root canal obturation.
• Performance Testing (Non-Clinical): This section outlines physical and chemical tests (e.g., setting time, flow, radiopacity, solubility, cytotoxicity) conducted according to ISO standards.
• Substantial Equivalence: The primary purpose of a 510(k) is to show that a new device is as safe and effective as a legally marketed predicate device. This is done by comparing technological characteristics and performance data.

The document does NOT contain the information requested in your prompt regarding acceptance criteria and a study proving a device meets acceptance criteria using human readers, ground truth, or AI performance metrics.

Specifically, the following information is NOT present in the provided text:

• Acceptance Criteria Table and Device Performance for specific clinical or AI metrics: The "performance testing" section refers to ISO standards for material properties, not clinical or AI performance.
• Sample size for a test set (clinical or AI): No clinical study with a test set is described.
• Data provenance (country of origin, retrospective/prospective): Not mentioned.
• Number of experts and their qualifications for ground truth: No expert review for ground truth is described.
• Adjudication method for a test set: Not mentioned.
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study: Not conducted or reported.
• Effect size of human reader improvement with AI assistance: Not applicable as it's not an AI device.
• Standalone (algorithm only) performance: Not applicable as it's not an AI device.
• Type of ground truth (expert consensus, pathology, outcomes data): No ground truth for clinical or AI performance is described.
• Sample size for the training set: Not applicable as it's not an AI device.
• How ground truth for the training set was established: Not applicable.

The document focuses on the physical and chemical properties of a dental material and its biocompatibility to demonstrate substantial equivalence to a predicate device, not on diagnostic performance or capabilities involving AI or human interpretation of images.

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Permanent root canal obturation

This product is the root canal sealer conforming to ISO 6876. This is a pre-loaded syringe type that does not require mixing and set by absorbing the moisture around the root canal.

The provided document describes a 510(k) premarket notification for a medical device called "White ENDOSEAL MTA," which is a root canal filling material. This submission focuses on non-clinical performance testing and does not involve a study proving the device meets acceptance criteria related to AI/ML or human-in-the-loop performance.

Therefore, most of the requested information regarding AI/ML-specific study design (such as sample sizes for test and training sets, expert adjudication, MRMC studies, standalone algorithm performance, and ground truth establishment) cannot be found in this document.

However, I can extract information related to the performance testing (non-clinical) performed for this device based on the provided text.

Here's the breakdown of the information that can be extracted, and an explanation of why other requested information is not applicable:

Information available from the document:

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

The document lists performance testing against ISO 6876 standards, which implicitly defines acceptance criteria. The reported performance for the proposed device (White ENDOSEAL MTA) is compared to the predicate device.

Note: The document states "All the test results met the preset test criteria," indicating compliance with the referenced standards (ISO 6876, ISO 10993 series) for the White ENDOSEAL MTA.

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

• Sample Size: Not specified for the non-clinical tests. Non-clinical bench testing often uses small, controlled samples, but the exact number isn't in this summary.
• Data Provenance: The testing was conducted by "MARUCHI" (the manufacturer) or by testing institutions following specific ISO standards. The location is the Republic of Korea (manufacturer's address). The data is from non-clinical bench testing, not patient data.

Information NOT available or NOT applicable to this document:

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)

• This document describes non-clinical laboratory testing (e.g., material properties, biocompatibility), not clinical studies involving expert interpretation of medical images or patient outcomes. Therefore, there is no concept of "ground truth" established by medical experts in this context.

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

• Not applicable. This is for clinical study ground truth establishment, not non-clinical bench testing.

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 document is about a root canal filling material, not an AI/ML device for image interpretation or diagnosis. No human reader studies were mentioned.

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

• Not applicable. This is not an AI/ML device.

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

• For the non-clinical tests described, the "ground truth" is defined by the objective measurement parameters and specifications set forth by the international standards (ISO 6876, ISO 10993 series) and internal testing methods. There is no clinical "ground truth" derived from patients or expert consensus.

8. The sample size for the training set

• Not applicable. This is not an AI/ML device, so there is no training set.

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

• Not applicable. As above, there is no AI/ML component or training set.

Summary:

This 510(k) submission for "White ENDOSEAL MTA" focuses on demonstrating substantial equivalence to a predicate device through non-clinical (bench and biocompatibility) testing, confirming it meets established international standards for root canal filling materials. It does not involve AI/ML technology, clinical performance studies, or the types of expert-driven data collection and analysis that would require answering questions 3, 4, 5, 6, 8, and 9.

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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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