(227 days)
- 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
| Acceptance Criteria (Set by Standard) | Reported Device Performance (as stated) |
|---|---|
| ISO 6876: | All test results met the preset test criteria. |
| - Visual properties | (Implicitly met based on general statement) |
| - Packaging properties | (Implicitly met based on general statement) |
| - Setting time | (Implicitly met based on general statement) |
| - Solubility | (Implicitly met based on general statement) |
| - Radiopacity | (Implicitly met based on general statement) |
| ISO 7405: | All test results met the preset test criteria. |
| - Cytotoxicity | (Implicitly met based on general statement) |
| ISO 10993-10: | All test results met the preset test criteria. |
| - Skin sensitization (Local Lymph Node Assay, LLNA) | (Implicitly met based on general statement) |
| ISO 10993-11: | All test results met the preset test criteria. |
| - Acute systemic toxicity | (Implicitly met based on general statement) |
| Other Bench Testing: | All test results met the preset test criteria. |
| - Capacity | (Implicitly met based on general statement) |
| - pH (Saline Extracts) | (Implicitly met based on general statement) |
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.
§ 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.