(239 days)
DIA-ROOT BIO MTA is used for pulp capping (direct pulp capping or partial pulpotomy) and repair of root perforation. Other indications for use include: repair of root resorption, root end filling, apexification and pulpotomy.
DIA-ROOT BIO MTA is a hydraulic product that hardens by reacting with water. It is designed for the protection of pulp such as direct pulp capping, pulpotomy, and perforation. The subject device is packaged with Cap & Body, Mixing pad, and Spatula.
The provided document is a 510(k) Premarket Notification from the FDA regarding a dental device called "DIA-ROOT BIO MTA". This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving novel clinical effectiveness or "human-in-the-loop" performance with AI.
Therefore, many of the requested criteria (e.g., number of experts, adjudication methods, MRMC studies, AI effect size, training set details) are not applicable to this specific type of device submission and the information available in the document. The document describes a biomaterial (root canal filling resin), not an AI-powered diagnostic or therapeutic device.
Here's an analysis of the available information based on the request:
1. A table of acceptance criteria and the reported device performance
The document does not specify "acceptance criteria" in the sense of predefined thresholds for clinical performance metrics (like sensitivity, specificity, accuracy) for a diagnostic AI. Instead, the "acceptance criteria" for this device, as implied by the FDA 510(k) process, are demonstrating substantial equivalence to a predicate device based on:
- Intended Use: Similar indications for use.
- Technological Characteristics: Similar materials, physical, and mechanical properties.
- Performance Data: Conformance to relevant industry standards and non-clinical bench testing, showing similar safety and effectiveness.
The document reports performance against non-clinical harmonized standards.
| Criteria Type (Implied) | Specific Criteria (from ISO standards & bench testing) | Reported Device Performance | Comments |
|---|---|---|---|
| Physical Properties | ISO 6876:2012 (Dentistry Root canal sealing materials) | Conforms | Includes properties like Setting time, Solubility, Radio-opacity. Stated as "similar" to predicate and "Equivalent" in comparison table. |
| Mechanical Properties | Bench Testing (details not specified) | Conforms | Stated as "similar" to predicate and "Equivalent" in comparison table. |
| Biocompatibility | ISO 7405:2018 (Evaluation of biocompatibility of medical devices used in dentistry) ISO 10993 series (various parts) | Biocompatible | Confirmed via conformance to the listed ISO 10993 standards. Stated as "Biocompatible" and "Equivalent" to predicate. |
| Safety & Effectiveness | Non-clinical bench testing (additional) | Demonstrated | General statement that additional testing demonstrates safety and effectiveness. |
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- This information is not applicable as there was no "test set" in the context of clinical performance data collection (e.g., patient cases for a diagnostic study). The testing performed was non-clinical bench testing (material properties, biocompatibility).
- The document states: "No clinical data was collected or provided to support substantial equivalence between the subject and predicate devices."
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)
- This information is not applicable. There was no expert-derived "ground truth" for a clinical test set because no clinical data was collected.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- This information is not applicable. No clinical test set.
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
- This information is not applicable. DIA-ROOT BIO MTA is a dental material, not an AI or a device that assists human readers. No MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This information is not applicable. This is a material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- For the non-clinical performance evaluation, the "ground truth" would be established by the harmonized ISO standards themselves (e.g., the specific parameters and methodologies defined in ISO 6876 for setting time, solubility, radiopacity, or the tests for biocompatibility in the ISO 10993 series).
- The study proves the device meets the criteria specified by these international standards for dental materials, not against clinical outcomes or expert consensus on patient data.
8. The sample size for the training set
- This information is not applicable. This is a material, not an AI. No training set was used.
9. How the ground truth for the training set was established
- This information is not applicable. No training set.
Summary of what the document focuses on:
The entire submission is built around demonstrating that "DIA-ROOT BIO MTA" is substantially equivalent to a previously cleared predicate device ("MTA ANGELUS"). This is achieved by comparing their:
- Intended Uses
- Technological Characteristics (composition, physical/mechanical properties)
- Performance (conformance to the same non-clinical ISO standards for dental materials and biocompatibility).
The document explicitly states that no clinical data was collected for this submission. The "study that proves the device meets the acceptance criteria" refers to a series of non-clinical bench tests and biocompatibility evaluations conducted according to recognized international standards (ISO 6876, ISO 7405, and various parts of ISO 10993). The "acceptance criteria" are simply the successful demonstration of conformance to these standards and the similarity of the device's properties to the predicate.
§ 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.