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510(k) Data Aggregation
(186 days)
Permanent sealing of root canal
One-Fil is a convenient premixed ready-to use, injectable calcium silicate composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
The provided text focuses on the 510(k) summary for a dental root canal sealer named "One-Fil." It describes the device, its intended use, and a comparison to a predicate device ("Well-Root™ST"). However, the document does not describe a clinical study that proves the device meets specific acceptance criteria in the way a diagnostic AI/ML device would.
Instead, the performance data presented is based on non-clinical tests (bench testing and biocompatibility) against established standards. Therefore, most of the requested information for acceptance criteria and a study demonstrating performance against those criteria is not applicable in this context.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't define explicit "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy). Instead, it states that the device was tested in accordance with existing standards.
| Test Category | Standard / Test Performed | Reported Device Performance |
|---|---|---|
| Performance Tests | ISO 6876 (Appearance, Volume, Packaging, Flow Setting time, Film thickness, Solubility, Radiopaque) | Conformed to ISO 6876 |
| Chemical/Physical | pH Test | Test performed (result not specified but deemed acceptable for SE) |
| Biocompatibility | ISO 10993-3, 5, 6, 10, 11 and USP 34, 151> | Tests performed (results not specified but deemed acceptable for SE) |
| Stability | Shelf Life Test | Test performed (result not specified but deemed acceptable for SE) |
Regarding the study proving the device meets acceptance criteria:
The document does not describe a clinical or comparative effectiveness study of "One-Fil." The demonstration of meeting "acceptance criteria" is based on the device conforming to established international standards (ISO 6876, ISO 10993, USP) and demonstrating substantial equivalence to a predicate device through non-clinical testing.
The remaining points of your request are not applicable to this document as it pertains to a dental filling material, not an AI/ML-driven diagnostic device.
2. Sample size used for the test set and the data provenance: Not applicable. This document describes bench testing and biocompatibility assessments, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for clinical data is not relevant here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable to a clinical test set. For the non-clinical tests, the "ground truth" would be the specifications and requirements defined by the ISO and USP standards.
8. The sample size for the training set: Not applicable. There is no training set mentioned, as this is not an AI/ML device.
9. How the ground truth for the training set was established: Not applicable.
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