(8 days)
- Permanent obturation of the root canal following vital pulp-extirpation.
- Permanent obturation of the root canal following removal of infected or necrotic pulp and placement of intracanal dressings.
iRoot SP is suitable for use in the single cone and lateral condensation technique.
iRoot SP Root Canal Sealer (iRoot SP) is a convenient premixed ready-to-use injectable white hydraulic cement paste developed for permanent root canal filling and sealing applications. iRoot SP 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 SP does not shrink during setting and demonstrates excellent physical properties. iRoot SP is packaged in a pre-loaded syringe and is supplied with disposable Intra Canal Tips.
The provided text describes the iRoot SP Root Canal Sealer and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria for device performance or the study that proves these criteria are met in the way typically associated with AI/ML medical devices (e.g., diagnostic accuracy metrics).
Instead, this document focuses on demonstrating substantial equivalence through a comparison of physical, chemical, and biocompatible properties with established predicate devices. The "studies" mentioned are non-clinical bench and biocompatibility tests.
Therefore, many of the requested sections (sample size, expert ground truth, adjudication, MRMC studies, standalone performance, training set details) are not applicable or cannot be extracted from this type of regulatory submission for a traditional medical device like a root canal sealer.
Here's a breakdown of what can be extracted and what cannot:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the physical-chemical properties of the predicate devices. The "reported device performance" refers to the results of the non-clinical tests demonstrating that iRoot SP's properties are comparable to these predicates.
| Acceptance Criteria (Implicit from Predicates) | iRoot SP Performance (demonstrated by non-clinical tests) |
|---|---|
| Comparable Flow | Tested and found comparable |
| Comparable Working Time | Tested and found comparable |
| Comparable Setting Time | Tested and found comparable |
| Comparable Dimensional Change following setting | Tested and found comparable |
| Comparable Solubility | Tested and found comparable |
| Comparable Radiopacity | Tested and found comparable |
| Comparable Film Thickness | Tested and found comparable |
| Non-mutagenic | Confirmed non-mutagenic |
| Non-cytotoxic | Confirmed non-cytotoxic |
| No allergenic potential after multiple uses | BioAggregate data provides evidence; good tolerance by subcutaneous tissue |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not applicable in the context of human data or AI model output. The "test set" here would refer to the samples used in bench and biocompatibility testing, but specific numbers are not provided.
- Data Provenance: The tests are non-clinical (bench and biocompatibility). The chemical composition is based on BioAggregate, and its biocompatibility data is referenced. This implies laboratory testing on materials, not patient data from specific countries.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- This is not applicable as the "ground truth" for a root canal sealer is its physical, chemical, and biocompatible properties, not a diagnostic interpretation by human experts.
4. Adjudication method for the test set
- Not applicable as there is no human interpretation or diagnostic labeling process.
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. iRoot SP is a physical material (root canal sealer), not an AI/ML diagnostic or assistive device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. iRoot SP is a physical material, not an algorithm.
7. The type of ground truth used
- The "ground truth" in this context is the established physical, chemical, and biocompatibility profiles of legally marketed predicate devices (AH® Plus™ Root Canal Sealer, BioAggregate, Apexit® Root Canal Sealer, Exactech Resorbable Bone Paste, MBCP Gel™, Diapex®). The performance of iRoot SP was compared to these established profiles.
8. The sample size for the training set
- Not applicable as this is not an AI/ML device requiring a training set of data.
9. How the ground truth for the training set was established
- Not applicable as this is not an AI/ML device.
§ 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.