(60 days)
Sonendo Filling Material 5C is intended for permanent obturation of the root canal following root canal treatment.
The Sonendo Filling Material 5C is a two-part filling material developed for permanent root canal filling. It is a water-soluble acrylate which is radiopaque and hardens with a chemical curing system. The Sonendo Filling Material 5C is packaged in plastic syringes with a syringe mixer and a dispensing tip. The syringe and dispensing tips are the only patient contacting devices packaged with the Sonendo Filling Material 5C and are commercially available.
Based on the provided text, the device in question is a dental root canal filling material, and the provided document is an FDA 510(k) summary for its clearance. This document type focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving a medical device's performance through a clinical comparative effectiveness study against specific acceptance criteria like an AI algorithm would.
Therefore, the requested information regarding acceptance criteria, sample sizes, expert ground truth establishment, adjudication methods, multi-reader multi-case studies, standalone performance, and training set details cannot be fully provided from this document. This document specifies that no human clinical testing was conducted to support substantial equivalence.
However, I can extract the relevant performance data that was conducted, which focuses on device properties compared to industry standards and the predicate device.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
For a root canal filling material, performance is evaluated based on physical and chemical properties as defined by ISO standards, rather than diagnostic accuracy metrics. The "acceptance criteria" are implied by the ISO standard requirements, and "device performance" is the measured value for the Sonendo Filling Material 5C compared to the predicate and the standard.
| Element (Acceptance Criteria per ISO 6876:2012) | Sonendo Filling Material 5C (Subject Device) | Predicate Device (EndoREZ Dual Cure) | Comparison / Meets Criteria? |
|---|---|---|---|
| Flow (≥ 17mm) | 33.45 mm | 17.31 mm | Passed ISO 6876 test requirements |
| Working Time (implied by predicate & standard) | 32.98 mm | 17.38 mm | Passed ISO 6876 test requirements |
| Setting Time (Between 1 - 24 hours) | 60 minutes, 7 seconds | 25 minutes, 46 seconds | Passed ISO 6876 test requirements |
| Film Thickness (≤ 50 μm) | 5 μm | 5 μm | Passed ISO 6876 test requirements |
| Solubility & Disintegration (≤ 3.0% by mass; No Disintegration) | 2.03% (No disintegration) | 0.77% (No disintegration) | Passed ISO 6876 test requirements |
| Radio-opacity (≥ 3 mm of Aluminum) | 3.10 mm Al | 6.6 mm Al | Passed ISO 6876 test requirements |
Note: The "Working Time" and "Setting Time" acceptance criteria are stated as "Passed ISO 6876 test requirements" rather than specific numeric thresholds for the subject device.
2. Sample sizes used for the test set and the data provenance
- Test Set Sample Size: Not explicitly stated in terms of number of "samples" for each test. The ISO testing involves specific laboratory procedures using test specimens, but the quantity of these specimens is not detailed.
- Data Provenance: The tests were conducted to comply with ISO standards. The location of the testing is not specified, but this is a U.S. FDA submission. These are laboratory/benchtop tests, not clinical data from patients.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. For this type of device (root canal filling material) and the testing performed (physical/chemical properties per ISO standards), human expert "ground truth" as you would define for an AI diagnostic algorithm is not relevant. The "ground truth" is the objective measurement of the material's properties according to the specified ISO standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept relates to reconciling discrepancies in human expert interpretations, which is not part of the ISO standard physical/chemical testing for a dental material.
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. The document explicitly states: "No human clinical testing was conducted to support substantial equivalence." An MRMC study is a clinical study involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
- Not applicable. This device is a physical dental material, not an algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the performance data presented is based on measurements derived from standardized laboratory tests according to ISO 6876:2012, such as flow, setting time, film thickness, solubility, and radio-opacity. Biocompatibility was assessed against ISO 10993 standards.
8. The sample size for the training set
- Not applicable. This is not an AI/machine learning device; it does not have a "training set."
9. How the ground truth for the training set was established
- Not applicable. As above, 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.