(403 days)
- 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
| Test Parameter | Acceptance Criteria (from referenced standards) | Reported Device Performance |
|---|---|---|
| ISO 6876 | Visual, Capacity, Packaging, Flow, Setting time, Film Thickness, Solubility, Radiopacity | All test results met the preset test criteria. |
| Shelf Life Test | Visual, Packaging, Setting time, Solubility (as per ISO 6876) | All test results met the preset test criteria. |
| ISO 10993-5 (Cytotoxicity) | Not explicitly stated, but implies compliance for biocompatibility | Test results supported substantial equivalence to predicate devices (near identical composition of products after setting with predicate devices, and similar cytotoxicity test results). |
| ISO 10993-10 (Maximization test for delayed hypersensitivity (LLNA)) | Not explicitly stated, but implies compliance for biocompatibility | Test results supported substantial equivalence to predicate devices. |
| ISO 10993-11 (Acute systemic toxicity) | Not explicitly stated, but implies compliance for biocompatibility | Test results supported substantial equivalence to predicate devices. |
| ISO 10993-6 (Implantation) | Not explicitly stated, but implies compliance for biocompatibility | Test results supported substantial equivalence to predicate devices. |
| ISO 10993-3 (AMES & Mammalian Erythrocyte Micronucleus) | Not explicitly stated, but implies compliance for biocompatibility | Test results supported substantial equivalence to predicate devices. |
| Material Composition | Comparable properties to predicate devices, demonstrating similar performance specifications. | The main ingredients are similar to predicate devices. Despite some differences in other ingredients, biocompatibility and performance test results supported substantial equivalence. |
| Indications for Use | Same as predicate devices. | Same as predicate devices. |
| Shelf Life | 2 years | 2 years |
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.
§ 872.3820 Root canal filling resin.
(a)
Identification. A root canal filling resin is a device composed of material, such as methylmethacrylate, intended for use during endodontic therapy to fill the root canal of a tooth.(b)
Classification. (1) Class II if chloroform is not used as an ingredient in the device.(2) Class III if chloroform is used as an ingredient in the device.
(c)
Date PMA or notice of completion of a PDP is required. A PMA or a notice of completion of a PDP is required to be filed with the Food and Drug Administration on or before December 26, 1996 for any root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976, or that has, on or before December 26, 1996 been found to be substantially equivalent to a root canal filling resin described in paragraph (b)(2) of this section that was in commercial distribution before May 28, 1976. Any other root canal filling resin shall have an approved PMA or a declared completed PDP in effect before being placed in commercial distribution.