(82 days)
The MTA2 ROOT AND PULP MATERIALS are intended for use in dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
The MTA2 ROOT AND PULP MATERIALS are designed and developed for dentists to use in dental procedures that contact with vital pulp tissue and periradicular tissue, as well as obturation and sealing of root canals. The MTA2 ROOT AND PULP MATERIALS can be used for dental procedures such as: pulp capping, cavity lining, base material in a cavity, pulpotomies, root-end filling, apexification, perforation repair, root resorption, and sealing/obturation. The dentist mixes the powder with the provided gel and places the mixed MTA2 material into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. The MTA2 ROOT AND PULP MATERIALS are available in white or gray.
The provided text describes the 510(k) summary for a dental device, the MTA2 ROOT AND PULP MATERIALS. This device is a cement primarily used for root canal procedures and interaction with pulp and periradicular tissues.
Here's an analysis of the acceptance criteria and supporting study details based on the provided input:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Standard / Test) | Reported Device Performance (MTA2 ROOT AND PULP MATERIALS) |
|---|---|
| ADA 57 (Radiopacity) | Met the ADA 57 standard |
| ADA 57 (Solubility) | Met the ADA 57 standard |
| ADA 57 (Dimensional Stability) | Met the ADA 57 standard |
| ADA 57 (Film Thickness) | Met the ADA 57 standard |
| ADA 57 (Flow) | Met the ADA 57 standard |
| ADA 57 (Working Time) | Performed to measure, compared to predicates (results not explicitly stated but implied meeting similar performance) |
| ADA 57 (Setting Time) | Performed to measure, compared to predicates (results not explicitly stated but implied meeting similar performance) |
| ISO 9917 (Compressive Strength) | Tests performed to show conformance to ISO 9917 |
| ISO 9917 (Leaching of Arsenic) | Tests performed to show conformance to ISO 9917 |
| ISO 9917 (Leaching of Lead) | Tests performed to show conformance to ISO 9917 |
| Biocompatibility (Cytotoxicity) | Evaluated (with the gel) |
| Biocompatibility (Implantation Tests) | Evaluated (with the gel) |
| Compositional Analysis (X-ray diffraction) | Performed |
| Compositional Analysis (X-ray fluorescence) | Performed |
| Washout | Performed |
| Particle Size Analysis | Performed |
| Hydroxyapatite Formation | Performed (induced precipitation of hydroxyapatite crystals in synthetic body fluid) |
| Substantial Equivalence to Predicate K011009 (White MTA Material) | Demonstrated through bench testing and similarities in inorganic powder composition, hydration mechanism, and intended use for pulp/periapical tissue contact. |
| Substantial Equivalence to Predicate K080203 (MTA root canal sealer) | Demonstrated through bench testing and similarities in inorganic powder composition, hydration mechanism, and intended use for sealing/obturation of root canals, including presence of a gel. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes non-clinical performance (bench testing). There is no information provided about a "test set" in the context of human subjects or a clinical study. The data provenance is laboratory testing.
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)
Not applicable. This device's evaluation was based on non-clinical, bench testing against recognized standards (ADA 57, ISO 9917). There was no "test set" requiring expert ground truth in the traditional sense of diagnostic accuracy studies. The standards themselves serve as the 'ground truth' for performance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Without a clinical test set or expert evaluation component, there is no adjudication method described.
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
Not applicable. This is not an AI/CAD device. It is a dental material.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an AI/CAD device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance was established by adherence to recognized international and national standards for dental materials: ADA 57, ISO 6876, and ISO 9917. These standards define the acceptable physical, chemical, and biological properties for such materials.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. This is not a machine learning or AI device.
§ 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.