(588 days)
For use in the treatment of root canals, or following pulpectomy, or for the apexogenesis or apexification, and/or for the tip filling of prepared, treated root canals at the time of final filling with gutta-percha.
These indications include application in:
- Apexification
- Periapical Lesions
- Root Resorption ●
- Temporary Root Filling ●
- Perforations ●
- Underdeveloped pulpless teeth ●
iRoot FM Injectable Root Canal Filling Material (iRoot FM) is a convenient premixed ready-to-use injectable, radiopaque, white hydraulic bioceramic paste developed for root canal filling applications. iRoot FM is an aluminum-free material based on a calcium silicate composition, which requires the presence of water to set. iRoot FM is packaged in a pre-loaded syringe and is supplied with disposable tips.
This document is a 510(k) premarket notification for the iRoot FM Injectable Root Canal Filling Material. The provided text, however, does not describe the acceptance criteria or a specific study that proves the device meets those criteria in the typical format of a clinical or analytical performance study. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical bench testing and biocompatibility assessments.
Here's a breakdown of the requested information based on the provided text, acknowledging that many fields will be "Not Applicable" or "Not Provided" due to the nature of this submission document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Bench Tests: | |
| Flow | Met, substantially equivalent to iRoot SP |
| Working Time | Met, substantially equivalent to iRoot SP |
| Setting Time | Met, substantially equivalent to iRoot SP |
| Radiopacity | Met, substantially equivalent to iRoot SP |
| Biocompatibility: | |
| Cytotoxicity | Non-cytotoxic |
| Mutagenicity | Non-mutagenic (based on predicate data) |
| Allergenic Potential | No allergenic potential after multiple uses (based on predicate data) |
| Subcutaneous Tissue Tolerance | Good tolerance (based on predicate data) |
Notes on the table:
- Acceptance Criteria: These are inferred from the types of tests performed. The document states "iRoot FM has undergone extensive bench and biocompatibility NON-CLINICAL TESTS testing to provide evidence that iRoot FM's chemical and physical properties are substantially equivalent to iRoot SP." Specific quantitative thresholds for "acceptance criteria" are not given in this summary; rather, the performance is reported as meeting the criteria because it was found to be "substantially equivalent" to the predicate device, iRoot SP.
- Reported Device Performance: This column reflects the conclusions drawn from the non-clinical tests.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified for the bench tests or biocompatibility tests.
- Data Provenance: Not specified. The submission is from Innovative BioCeramix Inc. in Vancouver, BC, Canada, but the origin of the test data (e.g., where the tests were conducted) is not provided. The study appears to be entirely non-clinical bench testing, not a clinical study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of Experts: Not applicable. This was a non-clinical bench study, not a study involving expert readers to establish ground truth from clinical data.
- Qualifications of Experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. This was a non-clinical bench study.
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
- MRMC Comparative Effectiveness Study: No, this was not a MRMC study. The device is a root canal filling material, and the evaluation was based on non-clinical bench testing and biocompatibility, not on human reader performance with or without AI assistance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Standalone Performance Study: Not applicable. This device is a material, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of Ground Truth: Not applicable in the context of clinical "ground truth." For the non-clinical tests, the "ground truth" was established based on standard material testing methods and biocompatibility assays, comparing the results to those expected for a substantially equivalent device or predicate device (iRoot SP, iRoot FS, BioAggregate, and Diapex).
8. The sample size for the training set
- Sample Size for Training Set: Not applicable. This was a non-clinical evaluation of a material, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established
- How Ground Truth for Training Set was Established: Not applicable.
In summary, the provided document details a 510(k) submission focused on demonstrating substantial equivalence of the iRoot FM Injectable Root Canal Filling Material to existing predicate devices (iRoot SP, iRoot FS, BioAggregate, Diapex) through non-clinical bench testing (flow, working time, setting time, radiopacity) and biocompatibility assessments. It does not describe a clinical study with human subjects, expert readers, or AI performance evaluation.
§ 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.