(58 days)
The MTA2.1 MATERIAL is indicated for dental procedures that contact pulp and periradicular tissues, as well as obturation and sealing of root canals.
The MTA2.1 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 and place the mixed MTA2.1 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. MTA2.1 MATERIAL is tinted yellow, pink and gray.
The provided document describes the Avalon Biomed Inc.'s MTA2.1 MATERIAL and its substantial equivalence determination to a predicate device (MTA2 ROOT AND PULP MATERIAL, K122892). This submission is for a material, not an AI/ML powered medical device, therefore, many aspects of the requested information (e.g., sample size for test set, number of experts, adjudication methods, MRMC studies, standalone performance, training set details) are not applicable.
However, I can extract the acceptance criteria and the studies performed to demonstrate the device meets those criteria, focusing on the available non-clinical performance data.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the MTA2.1 MATERIAL are based on established dental material standards, specifically ADA 57 and ISO 9917. The document states that the MTA2.1 MATERIAL meets these standards.
| Acceptance Criterion (Standard) | Reported Device Performance |
|---|---|
| Radiopacity (ADA 57) | Meets standard |
| Solubility (ADA 57) | Meets standard |
| Dimensional Stability (ADA 57) | Meets standard |
| Film Thickness (ADA 57) | Meets standard |
| Flow (ADA 57) | Meets standard |
| Working Time (ADA 57) | Meets standard |
| Setting Time (ADA 57) | Meets standard |
| Compressive Strength (ISO 9917) | Conforms to standard |
| Leaching of Arsenic (ISO 9917) | Conforms to standard |
| Leaching of Lead (ISO 9917) | Conforms to standard |
| Washout Stability | Confirmed stability |
| Discoloration Stability | Confirmed color stability |
| Biocompatibility (Cytotoxicity) | Evaluated, passed |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: Not specified. The document refers to "bench testing" and "design validation" for these non-clinical tests, implying laboratory experiments. The specific number of samples for each test (e.g., radiopacity, solubility) is not detailed.
- Data Provenance: The tests were conducted as part of the device's "design validation." This implies laboratory testing performed by or for the manufacturer (Avalon Biomed Inc.). The country of origin of the data is not explicitly stated beyond the company being in Bradenton, FL, USA, and the submission being to the US FDA. The studies are prospective in the sense that they were conducted specifically for this regulatory submission to evaluate the material's properties against predefined standards.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. The "ground truth" for material properties like radiopacity, solubility, or compressive strength is established through standardized laboratory measurement methods as defined by ADA 57 and ISO 9917, rather than expert consensus.
4. Adjudication Method for the Test Set
Not applicable for material property testing.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is typically relevant for interpretative diagnostic devices where human readers evaluate cases with and without AI assistance. This submission is for a dental material, not an AI system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
No, this is not applicable as the device is a dental material, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for the material's performance relies on standardized measurement methods specified by ADA 57 and ISO 9917. These standards define the procedures and expected ranges for various physical and chemical properties of dental root canal filling and pulp materials. For example:
- Radiopacity: Measured according to the method described in ADA 57.
- Solubility, Dimensional Stability, Film Thickness, Flow, Working Time, Setting Time: Measured according to the methods described in ADA 57.
- Compressive Strength, Leaching of Arsenic and Lead: Measured according to the methods described in ISO 9917.
- Biocompatibility: Evaluated through cytotoxicity tests.
8. The Sample Size for the Training Set
Not applicable. This is a dental material, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. (See #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.