(264 days)
Permanent sealing of root canal
Well-Root™ ST is a convenient premixed ready-to use 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 describes the regulatory clearance of a root canal filling resin, Well-Root™ ST, and its substantial equivalence to predicate devices. It does not present a study with acceptance criteria and reported device performance in the context of diagnostic accuracy, clinical outcomes, or human-in-the-loop performance, as implied by the request. Instead, the "performance data" section refers to bench testing against ISO standards and biocompatibility tests. These are typically used to demonstrate the physical, chemical, and biological safety of a material, not to evaluate the diagnostic or clinical efficacy of an AI-powered medical device.
Therefore, many of the requested items, particularly those related to diagnostic accuracy, a test set, ground truth, experts, and comparative effectiveness studies, cannot be answered from the provided text.
Here's an attempt to answer the questions based only on the information available in the provided text, highlighting where the information is not present or not applicable to the context of AI device studies:
1. A table of acceptance criteria and the reported device performance
The document lists performance standards it conformed to (ISO 6876 and ISO 10993 series), and mentions that "the test result of the subject device satisfies the requirement of the ISO 6876" and "the results of the bench and the biocompatibility tests performed demonstrates that any of these differences do not raise a new question as to safety and effectiveness." However, specific numerical acceptance criteria and reported performance values for these tests are not detailed in the provided text.
The document mentions compliance with the following ISO standards and specific tests within them:
| Acceptance Criteria (Standard / Test) | Reported Device Performance |
|---|---|
| ISO 6876: Flow | Satisfies requirements |
| ISO 6876: Setting Time | Satisfies requirements |
| ISO 6876: Film Thickness | Satisfies requirements |
| ISO 6876: Solubility and disintegration | Satisfies requirements |
| ISO 6876: Radio-opacity | Satisfies requirements |
| ISO 6876: Working time | Satisfies requirements |
| ISO 10993-5 (Cytotoxicity) | Compliant |
| ISO 10993-10 (Sensitivity-LLNA, GPMT) | Compliant |
| ISO 10993-11 (Acute systemic Toxicity) | Compliant |
| ISO 10993-3 (Genotoxicity: Bacterial reverse mutation (Ames), In vitro mammalian chromosomal aberration) | Compliant |
| ISO 10993-6 (Implantation) | Compliant |
| Shelf Life: Appearance | Compliant |
| Shelf Life: ISO 6876 tests (Flow, Setting Time, Film Thickness) | Compliant |
Note: The text explicitly states, "the test result of the subject device satisfies the requirement of the ISO 6876 and does not raise an issue of safety and/or performance." It also mentions for shelf life "Appearance, ISO 6876 tests (Flow, Setting Time, Film Thickness)" were conducted, implying compliance.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable/Not provided. This document describes physical, chemical, and biocompatibility testing of a root canal filling resin, not an AI-powered diagnostic device that would typically have a "test set" of data (e.g., images, patient records). The testing methods for ISO standards usually involve a defined number of samples for each test (e.g., N=3 or N=5 for flow, setting time, etc.), but these specific numbers are not given in this summary.
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/Not provided. Ground truth, in the context of diagnostic AI, refers to the confirmed correct diagnosis or outcome. For a physical device like a root canal sealer, "ground truth" would relate to the validated methods of the ISO standards themselves, not expert judgment on cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable/Not provided. Adjudication methods are relevant for resolving discrepancies in expert interpretations (e.g., in reading medical images) for establishing ground truth, which is not the type of study described here.
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
No. This is not a study involving human readers or AI assistance. It is a submission for a physical medical device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This is not an algorithm or AI device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the ISO and biocompatibility tests: The "ground truth" is established by the specified methodologies and criteria outlined within the respective ISO standards (e.g., ISO 6876 for physical properties of root canal filling materials, ISO 10993 series for biocompatibility). These standards define the acceptable range or characteristics for the device's performance.
8. The sample size for the training set
Not applicable/Not provided. As this is not an AI device, there is no "training set."
9. How the ground truth for the training set was established
Not applicable/Not provided. As this is not an AI device, there is no "training set" or corresponding ground truth establishment in that context.
§ 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.