(5 days)
Well-Pex™ is a biocompatible temporary or permanent root canal sealer, for use to stimulate healing process due to the mixture of calcium hydroxide and iodoform and the induction effect of these two ingredients. Used to promote healing effects and to help prevent bacterial contamination of the canal, as the two ingredients improve the induction effect for hard tissue induction and deposition. To be used as a medicament for the treatment of infected root canals and as a permanent, low volume additive to the filling process of a treated root canal to assist in the induction and deposition of hard tissue to make the healing process more rapid and complete. For use in the treatment of infected root canals, or following pulpectorny, or for apexegenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
Well-Pex™ is a temporary root canal filling material after pulpectomy, or for apexogenesis or velifeex is a temporaly root contriming material and the treatment of infected root canals. apexinciation. It is also docu as a good finance shows excellent radiopacity and prevention of microbial contamination. It has high fluidity and excellent accessibility into the root canal. Well-Pex™ is a premixed paste as a non-setting material and is very stable without any soliditication or separation. And it is packaged in a convenient syringe with disposable tips, a plastic holder and disposable tip cap.
The document provided (K080266) is a 510(k) summary for a dental root canal filling material called Well-Pex™. It is not related to a medical device that uses artificial intelligence or requires a clinical study with acceptance criteria for performance metrics like sensitivity, specificity, or F1 score.
The 510(k) summary for Well-Pex™ focuses on demonstrating substantial equivalence to a predicate device (Metapex) based on similar technological characteristics, physical properties (flow, film thickness, radiopacity, solubility, disintegration), and indications for use. It mentions safety tests including biocompatibility, but these are general compliance statements rather than detailed performance studies with specific statistical acceptance criteria.
Therefore, most of the information requested in your prompt (e.g., table of acceptance criteria, sample sizes for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance, ground truth types) is not applicable to this type of device submission.
Here's how the provided information relates to your questions, noting where the information is absent:
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A table of acceptance criteria and the reported device performance
- Not applicable in the context of AI device performance metrics. This document does not present quantitative performance measures like sensitivity, specificity, or AUC against specific acceptance criteria for diagnostic accuracy.
- The document states: "Well-Pex™ has the similar physical properties as the predicate device; flow, film thickness, Radiopacity, slubility and disintegration." This implies the device met internal performance standards comparable to the predicate for these physical properties, but specific numerical acceptance criteria or performance values are not provided in this summary.
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Sample sizes used for the test set and the data provenance
- Not applicable. This submission doesn't describe a "test set" in the context of an AI/diagnostic algorithm. It refers to "extensive safety, performance, and product validations," but details about sample sizes or data provenance for these validations are not included in this summary.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. There is no "ground truth" establishment in the sense of expert consensus on diagnostic outcomes as the device is a dental material, not a diagnostic algorithm.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable.
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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 or diagnostic imaging device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable. The "ground truth" for a dental filling material would involve material science standards and biocompatibility. The summary states "Safety tests including biocompatibility have been performed to ensure the devices comply with the applicable International and US regulations." The specific standards or methods for establishing this "ground truth" are not detailed in this summary document.
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The sample size for the training set
- Not applicable. This device does not involve machine learning or a "training set."
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How the ground truth for the training set was established
- Not applicable.
In summary, the provided document is a 510(k) premarket notification for a traditional medical device (dental filling material), not an AI/ML-based device. Therefore, the detailed requirements for describing AI device validation studies, including acceptance criteria, sample sizes, and ground truth establishment, are not present in this document. The "study that proves the device meets the acceptance criteria" is implicitly the "extensive safety, performance, and product validations" and biocompatibility tests, which demonstrate substantial equivalence to the predicate device based on similar characteristics and properties, rather than a clinical trial validating diagnostic performance metrics.
§ 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.