(186 days)
Permanent sealing of root canal
One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
The provided text focuses on the 510(k) summary for a dental root canal sealer named "One-Fil." It describes the device, its intended use, and a comparison to a predicate device ("Well-Root™ST"). However, the document does not describe a clinical study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.
Instead, the performance data presented is based on non-clinical tests (bench testing and biocompatibility) against established standards. Therefore, most of the requested information for acceptance criteria and a study demonstrating performance against those criteria is not applicable in this context.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was tested in accordance with existing standards.
| Test Category | Standard / Test Performed | Reported Device Performance |
|---|---|---|
| Performance Tests | ISO 6876 (Appearance, Volume, Packaging, Flow Setting time, Film thickness, Solubility, Radiopaque) | Conformed to ISO 6876 |
| Chemical/Physical | pH Test | Test performed (result not specified but deemed acceptable for SE) |
| Biocompatibility | ISO 10993-3, 5, 6, 10, 11 and USP 34, 151> | Tests performed (results not specified but deemed acceptable for SE) |
| Stability | Shelf Life Test | Test performed (result not specified but deemed acceptable for SE) |
Regarding the study proving the device meets acceptance criteria:
The document does not describe a clinical or comparative effectiveness study of "One-Fil." The demonstration of meeting "acceptance criteria" is based on the device conforming to established international standards (ISO 6876, ISO 10993, USP) and demonstrating substantial equivalence to a predicate device through non-clinical testing.
The remaining points of your request are not applicable to this document as it pertains to a dental filling material, not an AI/ML-driven diagnostic device.
2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing and biocompatibility assessments, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the ISO and USP standards.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established: 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.