(213 days)
The RetroMTA-OrthoMTA II is indicated for use as:
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal and external resorption.
- Repair of root canals as an apical plug during apexification
- Root end filling
- Pulp capping
The major compositions of the RetroMTA-OrthoMTA II are dicalcium silicate, tricalcium silicate and tricalcium aluminate, and it has been showing good sealing ability and biocompatibility. It is prepared as a mixture of powder and is used in a putty form which gradually hardens in the oral environment. RetroMTA-OrthoMTA II is ideal for orthograde root canal filling. It is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
Here's a breakdown of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Property | Acceptance Criteria (Predicate) | Reported Device Performance (Subject Device) |
|---|---|---|
| Setting time | 5h 30m | 2m 30s |
| Solubility | 3% | 1.4% |
| Radiopacity | Not less than 3mm of aluminum | Not less than 3mm of aluminum |
| Cytotoxicity | Met preset test criteria (ISO 10993-5) | Met preset test criteria (ISO 10993-5) |
| Oral Mucous Irritation & Sensitization | Met preset test criteria (ISO 10993-10) | Met preset test criteria (ISO 10993-10) |
| Acute systemic toxicity | Met preset test criteria (ISO 10993-11) | Met preset test criteria (ISO 10993-11) |
| Appearance | Met preset test criteria | Met preset test criteria |
| Weight | Met preset test criteria | Met preset test criteria |
| Package integrity | Met preset test criteria | Met preset test criteria |
Note: The provided document primarily references the predicate device's performance as the de facto acceptance criteria for the subject device. The new device is considered "substantially equivalent" if it meets or improves upon these values and doesn't raise new safety/effectiveness questions.
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not include information on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The performance data cited are from non-clinical (bench) testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the study described is a non-clinical (bench) study involving physical and chemical property testing, not an evaluation requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable as the study described is a non-clinical (bench) study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not performed or described in the provided text. The study focuses on comparing the physical and biocompatibility properties of the subject device to a predicate device.
6. Standalone Performance Study
Yes, a standalone study was performed. The "Performance Data (Non-Clinical)" section describes various bench tests conducted on the RetroMTA-OrthoMTA II according to ISO standards and other bench testing. This evaluates the algorithm's (in this context, device's) intrinsic performance against established criteria.
7. Type of Ground Truth Used
The "ground truth" used for this study was established standards and preset test criteria as defined by ISO standards (ISO 6876, ISO 10993-5, ISO 10993-10, ISO 10993-11) and internal "preset test criteria" for other bench tests. For instance, radiopacity had a specific quantitative standard ("Not less than 3mm of aluminum").
8. Sample Size for the Training Set
The provided text does not mention a training set or its sample size. This is a medical device submission based on physical and biological property testing, not an AI/machine learning algorithm that typically requires a training set.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set mentioned in the context of this device submission.
§ 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.