(51 days)
- Orthograde root canal filling material
- Repair of root perforations during root canal therapy(endodontic therapy), or as a consequence of internal resorption
- Repair of root canals as an apical plug during apexification
- Root end filling
- Pulp capping
Ortho MTA (Mineral Trioxide Aggregate) is ideal for orthograde root canal filling. Ortho MTA (Mineral Trioxide Aggregate) is compositionally formulated to have the physical properties, setting requirements and characteristics necessary for a clinically effective root canal filling material.
The provided text describes a medical device called Ortho MTA (Mineral Trioxide Aggregate), a root canal filling material, and its substantial equivalence to a predicate device, White MTA Material (K011009). The document focuses on demonstrating that Ortho MTA has similar properties and performance to the predicate device, thus not raising new questions about safety and effectiveness.
However, the provided text does not include specific quantitative acceptance criteria or a detailed study methodology that would typically be used to prove a device meets such criteria in the way a diagnostic AI device would. Instead, it relies on demonstrating "similar physical and biocompatible properties" and "comparable performance specifications" to a predicate device.
Therefore, many of the requested items related to acceptance criteria, sample size, expert ground truth, adjudication, and AI-specific studies cannot be extracted from this document, as they are not present.
Here's a summary based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The concept of specific performance metrics with acceptance criteria, as one might see for a diagnostic AI, is not present here. Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Similar physical properties to predicate device | Ortho MTA has similar physical properties to White MTA Material. (Explicit statement: "Ortho MTA... has similar physical... properties, and demonstrates comparable performance specifications to White MTA Material") |
| Similar biocompatible properties to predicate device | Ortho MTA has similar biocompatible properties to White MTA Material. (Explicit statement: "Ortho MTA... has similar physical and biocompatible properties, and demonstrates comparable performance specifications to White MTA Material") |
| Comparable performance specifications to predicate device | Ortho MTA demonstrates comparable performance specifications to White MTA Material. (Explicit statement: "Ortho MTA... has similar physical and biocompatible properties, and demonstrates comparable performance specifications to White MTA Material") |
| Comparable delivery system to predicate device | Ortho MTA has a comparable delivery system to White MTA Material. (Explicit statement: "In addition, Ortho MTA (Mineral Trioxide Aggregate) has a comparable delivery system to White MTA Material.") |
| Differences do not raise new questions of safety and effectiveness | Bench and biocompatibility testing performed demonstrates that any differences in technological characteristics do not raise any new questions as to safety and effectiveness. |
| Safe and effective for indicated uses | Concluded as safe, effective, and substantially equivalent to the predicate device. |
2. Sample size used for the test set and the data provenance
Not applicable/mentioned. The study is described as "bench and biocompatibility testing," not a test set in the context of data for AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/mentioned.
4. Adjudication method for the test set
Not applicable/mentioned.
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-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used
The "ground truth" here is effectively the accepted properties and performance of the predicate device (White MTA Material). The new device is compared against these established characteristics through "bench and biocompatibility testing."
8. The sample size for the training set
Not applicable/mentioned. This is not an AI device with a training set.
9. How the ground truth for the training set was established
Not applicable/mentioned. This is not an AI device with a training set.
§ 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.