(499 days)
- Treatment of perforations of root canal and furcation caused iatrogenically or by caries lesions;
- Via canal treatment of root perforation due to internal resorption;
- Surgical treatment of root perforation due to internal resorption;
- Periapical surgery with reverse filling;
- Pulp capping;
- Pulpotomy (removal of affected crown portion of the pulp preserving the vitality and function of the remaining radicular portion)
- Apexogenesis (induction of root development in vital teeth with an inflamed coronal pulp)
- Apexification (induction of formation of a mineralized barrier at the root tip of young permanent teeth with incomplete root development and a necrotic pulp)
MTA REPAIR HP is an endodontic bioceramic reparative cement with high plasticity, composed of mineral oxides in the form of fine hydrophilic particles. It is indicated for cases of root perforation (canal and furcation), iatrogenic or by caries, root perforation by internal resorption, retrofilling, direct pulp capping, pulpotomy, apexigenesis, and apexification.
The plasticizer Polyvinylpyrrolidone is added in the subject device to improve the plasticity of the mixture powder/liquid, with plasticity being understood as the quality of being easily shaped or molded. Thus, the new formulation of the subject device improves handling and insertion into the dental cavity since the pasted after mixing becomes a molding putty type consistency.
The radiopacifier CaWO4 is also added in the subject device to prevent discoloration of the tooth, since CaWO4 does not reduce when exposed to sunlight, unlike Bi2O3 found in the predicate device. Overall properties noted for the subject device include the following:
. Setting time: MTA Repair HP solidifies upon being maintained in a wet environment after spatulation. The start setting time is approximately 15 minutes.
. Radiopacity: Similar to gutta-percha and more radiopaque than dentin and bone.
. Absence of dental discoloring due to the radiopacifier CaWO4 used.
The provided document is a 510(k) premarket notification for a dental device, MTA Repair HP. It focuses on demonstrating substantial equivalence to a predicate device, MTA-Angelus, rather than proving the device meets specific acceptance criteria through a standalone study with a defined test set and ground truth.
Therefore, directly answering many of the requested points regarding acceptance criteria, sample size for test sets, expert adjudication, MRMC studies, and ground truth establishment is not possible from this document. The document's purpose is to show that the new device is as safe and effective as a legally marketed predicate device, primarily through comparison and nonclinical testing against recognized standards.
Here's an analysis of the information available in the document, structured to address your questions as much as possible:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a "table of acceptance criteria" in the sense of predefined thresholds for specific performance metrics with corresponding performance results from a dedicated study. Instead, it refers to compliance with recognized standards. The "Device Comparison Table" provides some relevant properties of both the proposed and predicate device.
| Property / Criterion (from recognized standards & comparison) | Predicate Device (MTA-Angelus) Reported Performance | Proposed Device (MTA Repair HP) Reported Performance | Acceptance/Equivalence Indication |
|---|---|---|---|
| Material Composition (Key Components) | Tricalcium silicate, Dicalcium silicate, Tricalcium aluminate, Calcium Oxide, Bismuth Oxide (Bi2O3) | Tricalcium silicate, Dicalcium silicate, Tricalcium aluminate, Calcium Oxide, Calcium Tungstate (CaWO4) | Similar, with CaWO4 replacing Bi2O3 to prevent discoloration, and Polyvinylpyrrolidone added as plasticizer. Changes deemed not to affect critical properties. |
| Liquid Composition | Distilled water | Distilled water, Plasticizer (Polyvinylpyrrolidone) | Similar, with added plasticizer. |
| Biocompatibility | Biocompatible | Biocompatible (Biological Evaluation Report) | Established through ISO 10993-1, 10993-5, 10993-6, 10993-11. |
| Setting Time | Not explicitly stated for predicate in comparison table, but ISO 6876:2012 cited. | Approximately 15 minutes (start setting time) | Tested against ISO 6876:2012 as a guide. One minute difference in working time noted but stated not to affect usability. |
| Radiopacity | Not explicitly stated for predicate in comparison table, but ISO 6876:2012 cited. | Similar to gutta-percha, more radiopaque than dentin and bone. Absence of dental discoloring. | Tested against ISO 6876:2012 as a guide. New radiopacifier (CaWO4) prevents discoloration. |
| Solubility | Not explicitly stated for predicate in comparison table, but ISO 6876:2012 cited. | Not explicitly stated, but "critical properties" (including solubility) are not affected. | Tested against ISO 6876:2012 as a guide. |
| Shelf Life | 3 years | 3 years | Identical. |
| Working Time | Not explicitly stated, but compared to the proposed device. | One minute difference compared to predicate. | The difference does not affect usability. |
| Plasticity / Handling | Not mentioned in comparison table specifically. | High plasticity; improved handling and insertion into dental cavity; molding putty type consistency. | Improved due to plasticizer addition. Considered a beneficial technological characteristic. |
| Standards Compliance | ISO 6876:2012, ANS/ADA No. 57 - 2000, ISO 10993-1:2009 | ISO 6876:2012, ANS/ADA No. 57 - 2000, ISO 10993-1:2009, ISO 10993-5:2009, ISO 10993-6:2007, ISO 10993-11:2006 | Device meets applicable requirements of these FDA recognized standards. |
2. Sample size used for the test set and the data provenance
The document refers to "Nonclinical Testing" and "Bench test results" but does not specify sample sizes for any test sets. It mentions that the technological characteristics were cleared in other devices (predicate) and that the nonclinical tests were conducted by the vendor against FDA recognized standards.
- Sample Size: Not specified.
- Data Provenance: The tests were nonclinical (bench tests) conducted by the manufacturer (Angelus Industria De Productos Odontologicos) or its agents, with results submitted to the FDA. The country of origin for the data is Brazil, where the submitter is located. The tests are prospective in the sense that they were performed on the new device, but the results are for substantiation purposes within a regulatory application rather than a clinical trial.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document does not describe "ground truth" established by experts in the context of a diagnostic or predictive device like an AI algorithm. The device is a dental material, and its performance is evaluated against physical and chemical properties and biocompatibility standards. Expert consensus or qualification of experts for ground truth is not applicable here.
4. Adjudication method for the test set
Similarly, an "adjudication method" for interpreting results from diagnostic tests or subjective assessments is not applicable to the nonclinical bench testing described for this dental material. Performance is measured objectively against standard specifications.
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. An MRMC comparative effectiveness study is not relevant for this type of device (a dental material). This is not an AI-assisted diagnostic or imaging device used by human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. This question pertains to AI algorithms, which is not applicable to a root canal filling resin. The document describes a physical material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
As discussed, the concept of "ground truth" for a diagnostic algorithm is not applicable here. The device's "truth" or performance is assessed by meeting physical, chemical, and biological specifications set forth by recognized national and international standards (e.g., ISO 6876, ANSI/ADA Specification no. 57, ISO 10993 series). These standards define objective measurements for properties like setting time, radiopacity, and cytotoxicity.
8. The sample size for the training set
This question is related to machine learning and AI, which are not relevant to this device. There is no training set for a dental material.
9. How the ground truth for the training set was established
Again, this question is not relevant as the device is not an AI or machine learning product.
Summary of what the document indicates regarding "acceptance":
The device MTA Repair HP is deemed acceptable and substantially equivalent to its predicate based on:
- Identical Indications for Use: The applications for both devices are the same.
- Similar Operating Principle: Both are endodontic bioceramic reparative cements.
- Similar Material and Design: While there are minor compositional changes (changing radiopacifier from Bi2O3 to CaWO4 to prevent discoloration, and adding Polyvinylpyrrolidone as a plasticizer to improve handling), these changes were evaluated.
- Nonclinical Testing: The device meets applicable requirements of FDA recognized standards for biocompatibility (ISO 10993 series) and dental materials (ISO 6876:2012, ANSI/ADA Specification no. 57:2000). The "Bench test results allowed us to conclude that MTA Repair HP is well suited for its intended use."
- Critical Properties Maintained: The "critical properties (setting time, solubility and radiopacity)" were not affected by the compositional changes. A minor difference in working time (1 minute) was noted but determined not to affect usability.
- No New Concerns: The FDA concluded that "Any differences in the technological characteristics do not raise new concerns."
In essence, the "acceptance criteria" here are the requirements for demonstrating substantial equivalence to a predicate device and compliance with relevant performance and safety standards for dental materials. The "study" is the nonclinical testing performed by the manufacturer to prove this equivalence and compliance.
§ 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.