(90 days)
Permanent obturation of root canals of the secondary dentition in combination with root canal points.
AH Plus Endodontic Sealer is a two-component paste-paste permanent root canal sealer based on epoxyamine resin. It is available in two delivery forms: AH Plus Endodontic Sealer in tubes, for an easy manual mix, or as AH Plus Jet Endodontic Sealer double-barrel syringe with a disposable mixing tip for intraoral use, offering a more precise, convenient, and faster procedure. It functions as part of the endodontic treatment, allowing for restoration of tooth integrity. It adapts closely to the walls of the prepared root canal and presents permanent sealing ability and radiopacity. AH Plus Endodontic Sealer does not stain teeth.
This document is a 510(k) summary for the AH Plus Endodontic Sealer. It primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving device performance against specific acceptance criteria in the context of an AI-powered diagnostic device.
Therefore, many of the requested categories for AI/digital health devices are not directly applicable or are not explicitly detailed in this type of submission for a traditional medical device like an endodontic sealer.
However, I can extract the information related to performance testing as described for this device, specifically those aspects that function as "acceptance criteria" for the device's physical properties.
Acceptance Criteria and Study for AH Plus Endodontic Sealer (K243546)
1. Table of Acceptance Criteria and Reported Device Performance
| Test Performed | Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|---|
| Radiopacity | ISO 6876:2012 Dentistry-Root Canal Sealing Materials | Pass |
| Solubility | ISO 6876:2012 Dentistry-Root Canal Sealing Materials | Pass |
| Setting Time | ISO 6876:2012 Dentistry-Root Canal Sealing Materials | Pass |
| Film Thickness | ISO 6876:2012 Dentistry-Root Canal Sealing Materials | Pass |
| Flow | ISO 6876:2012 Dentistry-Root Canal Sealing Materials | Pass |
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 the document. The document describes non-clinical bench testing, not a clinical study involving patients or data provenance in that sense.
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 is not applicable as the ground truth for the performance tests (radiopacity, solubility, etc.) is established by the physical and chemical properties measured against the ISO standard, not by expert interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The "test set" here refers to samples of the device material undergoing physical and chemical tests, not diagnostic cases requiring adjudication.
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
This is not applicable. This is a submission for an endodontic sealer, which is a physical material, not an AI-powered diagnostic device. No human reader or AI assistance is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is not an algorithm or software.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the performance tests is the specified limits and methodologies defined within the ISO 6876:2012 standard for dentistry-root canal sealing materials. For biocompatibility, the ground truth is adherence to the specified ISO 10993 series and USP standards.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI model. There is no concept of a "training set."
9. How the ground truth for the training set was established
This is not applicable.
§ 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.