(50 days)
Adseal is a biocompatible root canal sealer for permanent sealing of root canals following established endodontic procedures and may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Adseal is intended for use by qualified healthcare personnel trained in its use.
Adseal root canal sealer is a two component paste:paste device based upon epoxy-amine resin chemistry. This sealer is easy to mix and adapts closely to the walls of the prepared root canal and provides outstanding long-term dimensional stability with minimal shrinkage upon setting. The device consists of tow components, the epoxy resin paste (Paste A) and the aminecontaining paste (Paste B); portions of which are mixed prior to insertion into the root canal. This two component system reacts via an epoxide-amine chemical reaction to cause setting. It may be used in conjunction with the auxiliary materials in the root canal (i.e. gutta percha points). Paste A and Paste B are contained, separately, with the chambers of a two component plastic syringe, packaged with a disposable applicator.
Here's an analysis of the provided 510(k) summary regarding the Adseal Root Canal Sealer, focusing on acceptance criteria and supporting studies:
This 510(k) summary is for a traditional medical device (a root canal sealer), and as such, the nature of its "acceptance criteria" and "study" is different from what one might expect for an AI/ML powered device. For such devices, "acceptance criteria" are typically based on established performance standards for the material, and the "study" is a series of laboratory tests demonstrating compliance with those standards. There is no AI component involved here, so questions related to AI performance, ground truth, expert adjudication, or MRMC studies are not applicable.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are derived from the international standard ISO 6876, "Dental root canal sealing materials." The 510(k) implicitly indicates that Adseal meets these criteria by stating "Similar Physical Properties" and then listing those properties under the Adseal column in the substantial equivalence comparison table.
| Acceptance Criteria (from ISO 6876) | Reported Device Performance (Adseal) |
|---|---|
| Fluidity | Meets ISO 6876 requirements |
| Working Time | Meets ISO 6876 requirements |
| Film Thickness | Meets ISO 6876 requirements |
| Radiopacity | Meets ISO 6876 requirements |
| Solubility & Disintegration | Meets ISO 6876 requirements |
| Biocompatibility | Free from toxicity per ISO/TR 7405 Agar diffusion test |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a 510(k) summary for a material-based device. The "test set" would refer to the samples of the material tested in the laboratory. The document doesn't specify the number of samples or batches tested. The provenance is likely Korea, as the manufacturer is Meta Dental Co. 82-06 Grand Avenue Elmhurst, NY 11373 (US presence but likely manufacturing in Korea, common for medical device companies) and the ultimate letter is addressed to "Meta Biomed Company Limited." The testing would have been prospective to demonstrate compliance with the standard for the specific formulation.
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)
Not applicable. For a root canal sealer, "ground truth" refers to the objective physical and chemical properties of the material, as measured and evaluated according to the specified international standard (ISO 6876). This does not involve expert readers or diagnostic accuracy assessments.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no adjudication method in the context of laboratory testing for material properties. The tests are designed to produce objective, measurable results.
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 device is a material, not an AI-powered diagnostic tool. There are no "human readers" in this context, nor an AI component.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for the performance claims of this device is the objective measurements and observations performed in a laboratory setting according to the methodologies prescribed by ISO 6876 Dental root canal sealing materials. For biocompatibility, it's defined by the outcome of an "Agar diffusion test" per ISO/TR 7405.
8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML device.
9. How the ground truth for the training set was established
Not applicable. There is no "training set" or associated ground truth establishment 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.