(178 days)
The MTA2.3 ROOT & PULP MATERIALS are indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
The MTA2.3 ROOT & PULP MATERIALS are designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. The materials can be used for dental procedures contacting pulpal or periradicular tissue such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and obturation (pulpectomy) including root canal sealing.
MTA2.3 ROOT & PULP MATERIALS were developed in 2 forms (designs): powder with water-based gel, and pastes. The dentist may choose to mix the powder and water-based gel of MTA2.3 (design 1), or choose to use a paste form of MTA2.3 (design 2). The MTA2.3 ROOT & PULP MATERIALS are placed in the space created by the procedure and set in vivo. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. Such procedures are performed on primary and secondary dentition. MTA2.3 ROOT & PULP MATERIALS may be white or tinted yellow, pink or gray. MTA2.3 ROOT & PULP MATERIALS are color stable over time.
The provided text is a 510(k) summary for the MTA2.3 ROOT & PULP MATERIALS. It describes a medical device, its intended use, technological characteristics, and comparison to a predicate device to demonstrate substantial equivalence for regulatory clearance. It does not describe a study that uses a machine learning algorithm or AI for medical image analysis. Therefore, it is unable to provide the requested information regarding acceptance criteria and a study proving a device meets them for an AI/ML context.
The document discusses the physical and chemical properties of a dental material, its biocompatibility, and conformance to international standards (ISO, ADA). It states: "No animal or human clinical tests were performed in the development of the MTA2.3 ROOT & PULP MATERIALS." This explicitly indicates the absence of the type of clinical performance study (e.g., MRMC or standalone) you are asking about, which are common for AI/ML medical devices.
Therefore, I cannot provide the requested information from this document. It does not contain data on:
- A table of acceptance criteria and reported device performance related to an AI/ML algorithm.
- Sample sizes for test sets in an AI/ML context, nor data provenance for such.
- Number of experts, their qualifications, or adjudication methods for ground truth in an AI/ML context.
- MRMC studies or effect sizes of AI assistance.
- Standalone algorithm performance.
- Type of ground truth (expert consensus, pathology, outcomes data) relevant to AI/ML image analysis.
- Sample sizes for training sets in an AI/ML context.
- How ground truth for a training set in an AI/ML context was established.
§ 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.