(30 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.
iRoot SP Plus Root Canal Sealer (iRoot SP Plus) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP Plus is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot SP Plus demonstrates substantially equivalent physical properties to iRoot SP. iRoot SP Plus is packaged in a pre-loaded syringe and is supplied with disposable Tips.
The provided text is a 510(k) summary for a dental device (iRoot SP Plus), specifically a root canal filling resin. It addresses the substantial equivalence to a predicate device based on non-clinical tests and the predicate device's clinical history.
However, the document does not contain information about acceptance criteria or a study proving that an AI/ML-based device meets acceptance criteria.
The request asks for information related to an AI/ML device's performance, such as:
- A table of acceptance criteria and reported device performance (for an AI/ML device)
- Sample sizes and data provenance for an AI/ML test set
- Number and qualifications of experts for AI/ML ground truth
- Adjudication method for AI/ML test set
- MRMC study details and effect size for AI assistance
- Standalone performance of an AI algorithm
- Type of ground truth used for an AI/ML device
- Sample size for AI/ML training set
- How ground truth for AI/ML training set was established
Since the provided text is for a root canal filling resin and not an AI/ML device, none of the requested information regarding AI/ML device performance and testing is present. The document focuses on chemical composition, physical properties, and equivalence to existing root canal sealers.
Therefore, I cannot provide the requested details based on the given input.
§ 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.