(98 days)
· Permanent obturation of the root canal following vital pulp-extirpation
· Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings
CeraSeal is suitable for use in the single cone and lateral condensation technique.
CeraSeal is used for root canal filling after the removal of infected pulp tissue in the root canal. CeraSeal is in the form of a flowable paste and can be immediately applied inside the root canal using a disposable tip. material, and a thickening agent. This product characteristically cures slowly by absorbing the ambient water inside the root canal. It is white and aesthetic.
The provided text is a 510(k) summary for a medical device called CeraSeal, a root canal filling resin. It describes the device, its intended use, and compares it to a predicate device to establish substantial equivalence.
Based on the content, here's an analysis regarding acceptance criteria and supporting studies:
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A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative format for specific performance metrics that would be typically seen in an AI/algorithm performance study. Instead, it lists performance tests conducted according to ISO 6876:2012, which is an international standard for root canal sealing materials. The reported device performance is that CeraSeal "conformed" to ISO 6876.
Performance Test Category Acceptance Criteria (Implicit: Conformance to ISO 6876:2012) Reported Device Performance Visual Conforms to ISO 6876:2012 Conformed Capacity Conforms to ISO 6876:2012 Conformed Package Conforms to ISO 6876:2012 Conformed Flow Conforms to ISO 6876:2012 Conformed Setting Time Conforms to ISO 6876:2012 Conformed Film Thickness Conforms to ISO 6876:2012 Conformed Solubility Conforms to ISO 6876:2012 Conformed Radio-opacity Conforms to ISO 6876:2012 Conformed Additionally, biocompatibility tests were conducted according to ISO 10993 series and a Shelf Life test was performed, confirming conformance.
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Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
The document does not specify a "sample size" in the context of a dataset for an AI/algorithm. The tests mentioned (biocompatibility, performance characteristics like flow, setting time, etc.) are laboratory-based and pertain to the physical and chemical properties of the material itself, not to the performance of an AI model on a dataset of patient data. Therefore, this information is not applicable to an AI device.
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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 applicable. The device is a physical root canal filling material, not an AI/software device that requires expert-established ground truth on a dataset.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not applicable, as there is no test set in the context of AI/algorithm performance requiring adjudication.
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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
This information is not applicable. The device is a physical medical material, not an AI system intended to assist human readers.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This information is not applicable. The device is not an algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not applicable. The "ground truth" for this device would be its physical and chemical properties as measured against international standards (ISO 6876 for root canal filling materials and ISO 10993 for biocompatibility), rather than a clinical ground truth like pathology or outcomes data for an AI.
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The sample size for the training set
This information is not applicable, as there is no AI algorithm with a training set for this device.
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How the ground truth for the training set was established
This information is not applicable, as there is no AI algorithm with a training set for this device.
In summary, the provided document is a 510(k) summary for a root canal filling material. It does not describe an AI/software as a medical device (SaMD) and therefore, most of the questions related to AI acceptance criteria and studies are not applicable. The "acceptance criteria" discussed are compliance with international standards for material properties and biocompatibility.
§ 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.