(100 days)
ADSEAL Plus is a biocompatible root canal 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 Plus is intended for use by qualified healthcare personnel trained in its use.
ADSEAL Plus root canal sealer is a two component 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 two components, the epoxy resin paste (Paste A) and the amine-containing 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.
The ADSEAL Plus device is similar in design, materials and intended use to other 510(k) cleared devices which are in commercial distribution.
This document describes a 510(k) premarket notification for a dental device, specifically a root canal filling resin named "ADSEAL Plus." The submission aims to demonstrate substantial equivalence to a legally marketed predicate device, "ADSEAL ROOT CANAL SEALER."
However, the provided text does not describe a study involving device performance evaluated against clinical acceptance criteria or human reader performance. The studies conducted are non-clinical and relate to the physical, chemical, and biological properties of the material itself, as well as its shelf life, to ensure it meets established standards for root canal filling materials.
Therefore, many of the requested details about acceptance criteria, study types (MRMC, standalone), sample sizes, ground truth establishment, and expert involvement are not applicable to the information provided in this 510(k) summary.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are derived from the ISO 6876 standard for dental root canal sealing materials. The reported performance is for the "ADSEAL Plus" device.
| Acceptance Criterion (from ISO 6876:2012) | Predicate Device (Adseal) Performance | Subject Device (ADSEAL Plus) Performance |
|---|---|---|
| Flowability (mm) | 44mm | 31mm |
| Radio-opacity (mm) | 5.44mm | 4.25mm |
| Biocompatibility | Yes (conformed to ISO standards) | Yes (conformed to ISO standards) |
| Extraneous Matter and Package | (Implied to conform) | (Conformed to ISO 6876) |
| Setting Time | (Implied to conform) | (Conformed to ISO 6876) |
| Solubility | (Implied to conform) | (Conformed to ISO 6876) |
| Shelf Life | 2 years | 2 years |
Note: The document states that "ADSEAL Plus is different from the predicate devices in raw materials, however, the test results provided in this submission supports that it is substantially equivalent to the predicate device." This indicates that while the numerical values for flowability and radio-opacity differ, they are still considered to be within acceptable limits as per the ISO standard and comparable to the predicate for substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not explicitly stated for each test beyond indicating "tests" were conducted. These are material characteristic tests, not clinical performance studies with a "test set" in the context of imaging or diagnostic devices.
- Data Provenance: The tests were conducted by Meta Biomed Co., LTD. which is based in South Korea. The nature of these tests (e.g., in vitro, benchtop) suggests they are not derived from human subjects or retrospective/prospective clinical data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. The ground truth for material properties is established by adherence to international standards (e.g., ISO 6876) and scientific measurement, not by expert consensus in the diagnostic sense.
4. Adjudication method for the test set
- Not Applicable. No human adjudication process is described for these material characteristic tests.
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 root canal filling resin, not an AI-powered diagnostic tool. No MRMC study was conducted.
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 non-clinical tests is based on established international standards (ISO 10993 and ISO 6876) for biocompatibility and physical/chemical properties of dental materials.
8. The sample size for the training set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device.
9. How the ground truth for the training set was established
- Not Applicable. See point 8.
§ 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.