(263 days)
MTA Fillapex is a root canal sealer intended for the permanent sealing of root canals and may be used in combination with root canal obturation materials.
MTA Fillapex is a mineral trioxide aggregate (MTA) and resin root canal sealer used during endodontic treatment to permanently fill the canal system following debridement and disinfection. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. Being hydrophilic in nature, MTA Fillapex is desirable as a root filling material because an isolated dry field is not necessary for use. Moisture does not negatively affect the sealing ability and is required for proper setting. It is used in combination with gutta-percha or silver points during root canal obturation. The device is provided non-sterile.
This document describes the Angelus Indústria de Produtos Odontológicos S/A MTA Fillapex, a root canal sealer. The submission is a 510(k) premarket notification (K113568) and focuses on demonstrating substantial equivalence to previously marketed devices.
Here's an analysis of the provided information regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test Standard | Acceptance Criteria (from ISO 6876) | Reported Device Performance (MTA Fillapex) | Source in Document |
|---|---|---|---|---|
| Biocompatibility | ISO 10993-5 (Cytotoxicity) | Not explicitly stated in approval. Implied: demonstrate non-cytotoxicity or equivalence to predicates. | Testing performed demonstrated substantial equivalence to predicate devices (side-by-side cytotoxicity). | {1} Non-Clinical Testing |
| Physical/Chemical Properties | ISO 6876 (Dental root canal sealing materials) | {1} Non-Clinical Testing | ||
| Flow | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
| Working Time | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
| Setting Time | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
| Film Thickness | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
| Dimensional Change | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
| Solubility | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
| Radiopacity | ISO 6876 | (Specific value not provided in document) | Testing performed; results were reported. | {1} Non-Clinical Testing |
Important Note: The provided document states that "Performance testing that conformed to the protocols and recommended values described in ISO 6876 Dental root canal sealing materials was performed." However, it does not explicitly list the specific acceptance values (e.g., "flow > X mm") for each parameter from ISO 6876, nor does it provide the exact numerical results for MTA Fillapex for each test. It simply states that "Test reports included [list of tests]."
2. Sample Size Used for the Test Set and the Data Provenance
This submission is a 510(k) for a medical device and relies on non-clinical performance testing and biocompatibility data, not a clinical study with a "test set" of patient data.
- Sample Size for Non-Clinical Testing: The document does not specify the exact number of samples (e.g., number of specimens for flow testing) used for each non-clinical test. It broadly states that "side-by-side cytotoxicity testing" and "performance testing" were performed.
- Data Provenance: The testing was performed by or for the manufacturer, Angelus Indústria de Produtos Odontológicos S/A, based in Brazil. The data is thus considered internal manufacturer data from controlled laboratory settings. It is not retrospective or prospective patient data from a clinical setting.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
Not applicable. This submission does not involve human expert interpretation of clinical data or images to establish a "ground truth." The "ground truth" for non-clinical performance tests is determined by the standardized methods and measurements defined in ISO 6876.
4. Adjudication Method for the Test Set
Not applicable. There is no "test set" in the context of clinical data requiring expert adjudication. The non-clinical tests follow direct measurement and evaluation against pre-defined ISO standards.
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 a traditional medical device (root canal sealer), not an AI/Software as a Medical Device (SaMD). Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is relevant or discussed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical medical device, not an algorithm or AI.
7. The Type of Ground Truth Used
For the non-clinical performance tests (flow, working time, setting time, etc.), the "ground truth" is defined by the protocols and recommended values described in the international standard ISO 6876 Dental root canal sealing materials. For biocompatibility, the ground truth is established by the methods outlined in ISO 10993-5 Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity.
8. The Sample Size for the Training Set
Not applicable. There is no concept of a "training set" for physical medical devices of this type. Performance is demonstrated through direct testing against established material science standards.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "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.