(64 days)
- Repair of Root Perforation
- Repair of Root Resorption
- Root End Filling
- Apexification
- Pulp Capping
iRoot FS Fast Set Root Repair Material (iRoot FS) is a convenient ready-to-use fast setting white hydraulic premixed bioceramic paste developed for permanent root canal repair of root perforation and root resorption, and root end filling, apexification and pulp capping applications. iRoot FS is an insoluble, radiopaque and aluminum-free material based on a calcium silicate composition, which requires the presence of water to set and harden. iRoot FS does not shrink during setting and demonstrates excellent physical properties. iRoot FS is available as a preloaded syringe with disposable tips and a preloaded container.
This document is a 510(k) summary for the iRoot FS device, a root canal repair material. The submission aims to demonstrate substantial equivalence to predicate devices, namely iRoot BP, iRoot BP Plus, iRoot SP, and D-PBS.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This submission does not provide explicit numerical "acceptance criteria" for clinical performance. Instead, it focuses on demonstrating substantial equivalence in chemical and physical properties, and biocompatibility to existing predicate devices.
| Acceptance Criteria (Implied by Substantial Equivalence Claim) | Reported Device Performance (vs. Predicate iRoot BP) |
|---|---|
| Flowability | Comparable |
| Working Times | Comparable |
| Setting Times | Comparable |
| Dimensional Change Following Setting | Comparable |
| Solubility | Comparable |
| Shelf Life | Comparable |
| Biocompatibility (General) | Comparable |
| Biocompatibility (Non-cytotoxicity) | Non-cytotoxic |
| Biocompatibility (Non-mutagenic) | Biocompatibility test data for iRoot BP (which has principal chemical components in common with iRoot FS) provides evidence that iRoot FS is non-mutagenic. |
| Biocompatibility (Non-allergenic potential after multiple uses) | Biocompatibility test data for iRoot BP provides evidence that iRoot FS does not cause an allergenic potential after multiple uses. |
| Biocompatibility (Good tolerance by subcutaneous tissue) | Biocompatibility test data for iRoot BP provides evidence that iRoot FS has a good tolerance by subcutaneous tissue. |
| Equivalent Indications for Use | iRoot FS has the equivalent indications for use as iRoot BP: Repair of Root Perforation, Repair of Root Resorption, Root End Filling, Apexification, Pulp Capping. |
| Comparable Chemical Composition | iRoot FS is a modification of iRoot BP. Additional chemical components found in iRoot FS were found to be safe and effective in iRoot SP and D-PBS. (Implies overall composition is comparable and safe). |
| Comparable Physical Properties | iRoot FS and iRoot BP have comparable physical properties. |
| Comparable Performance Specifications | iRoot FS and iRoot BP have comparable performance specifications. |
| Comparable Packaging Containers and Delivery System | iRoot FS and iRoot BP Plus have equivalent device packaging containers and delivery systems. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a "test set" in the context of a clinical trial or a diagnostic device where a sample size of patient data would be relevant. The testing performed was "shelf life, bench and biocompatibility testing."
- Sample Size for Test Set: Not applicable in the context of clinical data for a diagnostic device. For bench testing, typical laboratory sample sizes would be used, but these are not specified in the summary.
- Data Provenance: The nature of the bench and biocompatibility testing means the data is likely generated in a laboratory setting, not from patient populations. No country of origin for such data is stated, nor is it specified if it's retrospective or prospective, as these terms usually apply to clinical studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided as the submission focuses on non-clinical testing and substantial equivalence, not clinical performance or diagnostic accuracy validated by experts.
4. Adjudication Method for the Test Set
This information is not provided as there is no mention of a diagnostic test set requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices to evaluate human reader performance with and without AI assistance. This submission describes a dental material, not a diagnostic device.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm performance study was not done. The device itself is a material for dental procedures, not an algorithm.
7. The Type of Ground Truth Used
For the "test set" (bench and biocompatibility testing), the "ground truth" would be the established scientific and regulatory standards/methods for evaluating chemical properties, physical properties (e.g., flow, setting time, solubility, dimensional change), and biocompatibility (e.g., cytotoxicity, mutagenicity, sensitization, tissue irritation). These are determined through standardized laboratory protocols and scientific literature, not clinical ground truth like pathology or outcomes data in the typical sense for a diagnostic device.
8. The Sample Size for the Training Set
Not applicable. The iRoot FS is a physical dental material, not an AI algorithm, so there is no "training set."
9. How the Ground Truth for the Training Set was Established
Not applicable. As there is no AI algorithm, there is no training set or associated ground truth establishment process.
In summary, this 510(k) submission for iRoot FS focuses entirely on demonstrating substantial equivalence to predicate devices through non-clinical (shelf life, bench, and biocompatibility) testing, rather than reporting on clinical performance or diagnostic accuracy assessed via expert review or human-in-the-loop studies. Therefore, most of the questions related to clinical study design, expert involvement, and AI performance are not applicable to the information provided in this document.
§ 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.