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510(k) Data Aggregation
(15 days)
FILE-EZE
Use File-Eze to aid in instrumentation and debridement of root canals.
File-Eze is a 19% EDTA dentin chelating agent in an aqueous, water-soluble solution with a lubricating base. File-Eze is irrigated and rinsed from canal as with other root canal preparations; ChlorCid and ChlorCid V (more viscous) sodium hypochlorite solution works well for this. Also, a slight effervescent cleansing action occurs when ChiorCid contacts residual File-Eze which helps remove extraneous material from canal.
This is a pre-amendment device, therefore no clinical study was required to prove substantial equivalence. The device leverages a predicate device to prove safety and effectiveness.
Acceptance Criteria and Device Performance Table:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Similar effectiveness in removing dentin smear layer compared to predicate device | File-Eze found similar in effectiveness to RC Prep in removing dentin smear layer (SEM study). |
| Not cytotoxic | File-Eze found not cytotoxic (Agar Diffusion Method). |
| Same intended use as predicate device | "Use File-Eze to aid in instrumentation and debridement of root canals." - Same as predicate. |
| Similar physical properties to predicate device (viscosity, appearance, color, odor) | "The physical properties of File-Eze and the predicate device are similar, i.e. viscosity, appearance, color, and odor." |
| Same active ingredient as predicate device | "File-Eze and the predicate device have the same active ingredient..." |
Study Information:
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Sample size for the test set and data provenance:
- Dentin Smear Layer Removal Study: Not specified.
- Biocompatibility (Cytotoxicity) Study: Not specified.
- Data Provenance: Not specified, but generally, such studies for regulatory submissions are conducted in a controlled lab setting, usually in the country of origin of the manufacturer (USA, in this case). Retrospective or prospective nature is not explicitly mentioned but typically these are prospective lab studies.
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Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable. The studies mentioned (SEM and Agar Diffusion) are laboratory-based and do not typically involve human experts for "ground truth" in the way clinical studies do. The measurements would be objective laboratory readings.
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Adjudication method for the test set: Not applicable for these types of laboratory studies.
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Multi-Reader Multi-Case (MRMC) comparative effectiveness study: No, this was not mentioned. This type of study is more common for diagnostic imaging AI devices, not for dental materials like this product.
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Standalone (algorithm only without human-in-the-loop performance) study: Yes, implicitly. The two studies mentioned (SEM and Agar Diffusion) are standalone laboratory evaluations of the material's properties and performance, not involving human interpretation in a clinical context.
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Type of ground truth used:
- Dentin Smear Layer Removal Study: The "ground truth" would be the objective visual assessment of smear layer removal via Scanning Electron Microscopy (SEM) images, comparing the efficacy of File-Eze to the predicate device.
- Biocompatibility (Cytotoxicity) Study: The "ground truth" would be the observed cellular response (or lack thereof) to the material using the Agar Diffusion Method, likely assessed against established cytotoxicity standards or controls.
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Sample size for the training set: Not applicable. This device is a chemical dental material, not an AI/ML algorithm that requires a training set. The "training" for such a product involves formulation and testing iterations by the manufacturer.
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How the ground truth for the training set was established: Not applicable, as this is not an AI/ML device.
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