(122 days)
The MTA2.2 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
The MTA2.2 MATERIAL is designed and developed for dental clinicians to use in contact with vital pulp tissue and periradicular tissue, including sealing and obturation of root canals. This material 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) in primary or secondary teeth.
The dentist will mix the powder and water-based gel of MTA2.2 and place the mixed MTA2.2 MATERIAL into the space created by the procedure. The procedure may be part of caries treatment, root canal treatment, or periapical surgery. These procedures are performed on primary and secondary dentition and are color stable over time. MTA2.2 MATERIAL is tinted yellow, pink and gray.
This document describes the premarket notification (510(k) submission) for the MTA2.2 MATERIAL, a root canal filling resin. However, it does not present a study with acceptance criteria and reported device performance in the way typically expected for a medical imaging or diagnostic device involving statistical metrics like sensitivity, specificity, or reader studies.
Instead, this submission focuses on demonstrating substantial equivalence to a predicate device (MTA2.1 MATERIAL, K140955) based on material properties, design, indications for use, and conformance to established dental standards.
Therefore, many of the requested sections about acceptance criteria, study design, sample sizes for test/training sets, expert ground truth, adjudication, and MRMC studies are not applicable or cannot be extracted from this document, as they pertain to clinical performance evaluations not present here.
Here's a breakdown of what can be extracted based on the provided text:
1. A table of acceptance criteria and the reported device performance
The "acceptance criteria" here are conformance to recognized consensus standards for dental materials. The "reported device performance" refers to the MTA2.2 MATERIAL meeting these standards.
| Acceptance Criteria (Standard Conformance) | Reported Device Performance (MTA2.2 Material) |
|---|---|
| ISO 6876: Endodontic sealing materials | |
| Flow | Conforms to standard |
| Film thickness | Conforms to standard |
| Solubility | Conforms to standard |
| Setting time | Conforms to standard |
| Working time | Conforms to standard |
| Radiopacity | Conforms to standard |
| ADA 57: Endodontic Sealing Material | (Same as above, as 57 relates to ISO 6876) |
| Radiopacity | Conforms to standard |
| Solubility | Conforms to standard |
| Dimensional stability | Conforms to standard |
| Film thickness | Conforms to standard |
| Flow | Conforms to standard |
| Working time | Conforms to standard |
| Setting time | Conforms to standard |
| ISO 9917 | |
| Compressive strength | Conforms to standard |
| Leaching of arsenic and lead | Conforms to standard |
| Biocompatibility | |
| Cytotoxicity | Evaluated, no adverse findings reported |
| Washout tests | Confirmed stability |
| Discoloration tests | Confirmed color stability |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for a "test set" in the context of diagnostic performance. The document describes bench testing of material properties. The specific sample sizes for each bench test (e.g., number of specimens for compressive strength) are not provided.
- Data Provenance: Not specified, but likely from laboratory bench testing conducted by the manufacturer, Avalon Biomed Inc.
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. Ground truth in this context refers to established material properties measured according to standardized laboratory protocols, not expert consensus on clinical findings.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is described for batch testing of material properties.
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
- No. This is a material safety and effectiveness submission, not an AI or diagnostic imaging device. No MRMC study was conducted or is relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an algorithmic device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for the performance data in this document is derived from measurements of physical and chemical properties according to established and recognized consensus standards (ISO 6876, ADA 57, ISO 9917).
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. See point 8.
§ 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.