(122 days)
SimpliSeal is a root canal sealer for the 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). SimpliSeal is intended for use by qualified healthcare personnel trained in its use.
SimpliSeal is a root canal sealer delivered in a dual-barrel syringe. This epoxy based resin sealer is easy to use with gutta-percha points and can also be used with established and more recent root canal sealing techniques. SimpliSeal with colaonent obturation of root canals when combined with obturation points.
The provided text describes the "SimpliSeal" root canal sealer and its substantial equivalence to predicate devices, focusing on physical and biocompatibility tests. However, it does not contain a study that proves the device meets specific acceptance criteria in the context of AI or machine learning performance as requested. The document is a 510(k) summary for a medical device approval by the FDA, which relies on demonstrating equivalence to existing legally marketed devices, rather than a clinical study with detailed performance metrics against specific acceptance criteria for AI.
Therefore, many of the requested fields regarding AI/ML study design, sample sizes, ground truth establishment, expert involvement, and comparative effectiveness studies are not applicable to this document.
Here's a breakdown of what can be extracted and what information is missing based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document lists various tests performed on SimpliSeal and states that "All testing is within specification and the device performs as designed." It also compares SimpliSeal's physical properties to predicate devices (Adseal and AH-Plus) implying these shared properties serve as the performance benchmarks. However, the specific quantitative acceptance criteria (e.g., "fluidity must be X-Y mm") are not explicitly stated within the text, only the type of test (e.g., "ISO 6876 fluidity"). The reported performance is a qualitative statement of meeting specifications rather than specific numerical results.
| Acceptance Criteria (Test Type - per ISO 6876 unless specified) | Reported Device Performance |
|---|---|
| Setting time | Within specification |
| Flow | Within specification |
| Film thickness | Within specification |
| Solubility | Within specification |
| Dimensional change following setting | Within specification |
| Cytotoxicity (ISO 10993-5) | Within specification |
| Acute Systemic Toxicity (oral) (ISO 10993-11) | Within specification |
| Irritation (ISO 10993-10) | Within specification |
| Sensitivity (ISO 10993-10) | Within specification |
| Genotoxicity (ISO 10993-3) | Within specification |
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 laboratory tests, not a clinical study involving a test set of data in the context of AI.
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 information is not provided as the device is not an AI/ML diagnostic tool, and the "ground truth" for its performance is based on standardized laboratory testing rather than expert-labeled clinical data.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the device is not an AI/ML diagnostic tool, and no multi-reader adjudication process is mentioned for its performance assessment.
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 information is not provided. The device is a root canal sealer, not an AI-assisted diagnostic tool, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a physical product (root canal sealer), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is established by standardized laboratory test methods (ISO 6876 and ISO 10993 series). The performance is assessed against the specifications outlined in these international standards for dental materials and biocompatibility.
8. The sample size for the training set
This information is not provided and is not applicable as the device is not an AI/ML model.
9. How the ground truth for the training set was established
This information is not applicable as the device is not an AI/ML model.
§ 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.