(246 days)
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.
| Performance Metric | Acceptance Criteria (Implicit from ISO 6876) | Reported Device Performance (White ENDOSEAL MTA) | Reported Predicate Device Performance (ENDOSEAL MTA) |
|---|---|---|---|
| Setting time | Conforms to ISO 6876 | 29 min | 12.31 min |
| Flow | Conforms to ISO 6876 | 22 mm | 21 mm |
| Radiopacity | Conforms to ISO 6876 | 7.7 mm | 10.14 mm |
| Film thickness | Conforms to ISO 6876 | 14 µm | 15 µm |
| Solubility | Conforms to ISO 6876 | 0.3 % | 0.7 % |
| Capacity, pH | Conforms to internal testing methods | Met preset test criteria | N/A (not explicitly compared in table) |
| Package, Extraneous matter | Conforms to ISO 6876 | Met preset test criteria | N/A (not explicitly compared in table) |
| Cytotoxicity (MTT) | Conforms to ISO 10993-5 | Met preset test criteria | N/A (not explicitly compared in table) |
| Skin sensitization (GPMT) | Conforms to ISO 10993-10 | Met preset test criteria | N/A (not explicitly compared in table) |
| Acute systemic toxicity | Conforms to ISO 10993-11 | Met preset test criteria | N/A (not explicitly compared in table) |
| Genotoxicity (Mammalian chromosome aberration test & Bacterial Reverse Mutation) | Conforms to ISO 10993-3 | Met preset test criteria | N/A (not explicitly compared in table) |
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.
§ 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.