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EPIEN DENTAL CLEANSER is indicated for the following uses:

1. Caries Restoration Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of exposed dentin surfaces in cavity preparations to assist in the removal of contaminated debris and smear-layer.

2. Chronic Periodontitis Treatment Procedures - EPIEN DENTAL CLEANSER is indicated for use as an adjunctive rinse of tooth root surfaces during periodontal debridement procedures (scaling and root planing) to help with the removal of contaminated debris from the sulcus.

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I am sorry, but the provided text does not contain any information about acceptance criteria for a device, nor does it describe a study that proves a device meets such criteria.

The document is a 510(k) clearance letter from the FDA to EPIEN Medical, Inc. for their device, the "EPIEN Dental Cleanser." It primarily confirms that the device is substantially equivalent to legally marketed predicate devices and outlines the regulatory obligations for the manufacturer. It specifies the "Indications for Use" for the dental cleanser.

Therefore, I cannot provide the requested information, including the table of acceptance criteria, sample sizes, expert qualifications, ground truth methods, or MRMC study details, as these are not present in the provided text.

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EPIEN ROOT CANAL CLEANSER is indicated for use as an adjunctive rinse of tooth root canal systems and adjacent tooth surfaces during standard professional dental procedures to enhance the removal of post-instrumentation dentinal debris and smear-layer within the root canal systems.

EPIEN ROOT CANAL CLEANSER is an aqueous, moderately viscous and dense solution that is used to irrigate root canals to provide a rinse to tooth surfaces as an adjunctive to professional mechanical dental procedures. The EPIEN ROOT CANAL CLEANSER is applied onto tooth root canal surfaces for a brief duration using standard dental irrigation syringes. It is then rinsed away with saline or water. EPIEN ROOT CANAL CLEANSER cleanses the root canal system by enhancing the removal of the post-instrumentation smear layer.

The EPIEN ROOT CANAL CLEANSER consists of hydroxybenzenesulfonic acid, hydroxymethoxybenzenesulfonic acid, sulfuric acid, and water, in addition to a colorant.

The provided text does not contain acceptance criteria related to a device's performance in a clinical or diagnostic setting, nor does it describe a study that directly proves the device meets such criteria.

This document is a 510(k) Summary for a medical device called "EPIEN ROOT CANAL CLEANSER." A 510(k) premarket notification is submitted to the FDA to demonstrate that the device is at least as safe and effective as a legally marketed device (predicate device). The evaluation focuses primarily on comparisons to predicate devices and results of non-clinical studies.

Here's an analysis of the provided text based on your request, highlighting what is and isn't present:

1. A table of acceptance criteria and the reported device performance

• Not Applicable. The document does not define specific "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy, or a specific level of smear layer removal effectiveness in patients) that the device must meet. Instead, the performance data provided supports the safety and effectiveness for its intended use through various non-clinical studies.

2. Sample size used for the test set and the data provenance

• Animal Performance Testing (Test Set):
  • Specific sample sizes for the animal studies (Canine Oral Mucosa Metabolism and IV ADME of c14-ERCC, Canine Vital Pulp ERCC Exposure Study, and Canine Periodontal tissue ERCC Exposure Study) are not provided in this summary.
  • Data Provenance: The studies are described as "Animal Performance Testing." The country of origin is not specified, and they are inherently prospective in nature, as they are conducted specifically to test the device.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• Not Applicable. The studies described are primarily laboratory-based (in vitro, chemical/physical characterization, biocompatibility) and animal studies. There is no mention of human subject testing, clinical trials, or expert-based adjudication to establish a "ground truth" as would be relevant for a diagnostic device's clinical performance. The "ground truth" in these studies would be derived from the experimental results themselves (e.g., cytotoxicity levels, erosion measurements, biofilm disruption percentages in a lab setting, or histological findings in animal tissues).

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Applicable. As no expert-based ground truth establishment or human reader study is described, there is no adjudication method mentioned.

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. This device is a chemical cleanser for root canals, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not relevant and was not performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Applicable. This device is a manual chemical cleanser, not an algorithm. Therefore, "standalone algorithm performance" is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

• For the biocompatibility studies, the "ground truth" would be established by standardized laboratory tests (e.g., ISO 10993-1 methods) that objectively measure cytotoxicity, sensitization, mutagenicity, irritation, and intracutaneous reactivity.
• For chemical and physical characterization studies, the "ground truth" is determined by established analytical methods (e.g., chromatographic analyses, acid titration, viscosity measurements, enamel and dentin erosion assays).
• For in vitro microbial biofilm disruption assays, the "ground truth" would be quantitative measurements of biofilm reduction or removal using laboratory techniques.
• For animal performance testing, the "ground truth" would be derived from physiological measurements, histological examinations of tissues, and pharmacokinetic/pharmacodynamic analyses in the animal models, interpreted by veterinary pathologists or relevant specialists.

8. The sample size for the training set

• Not Applicable. The device is not an AI/machine learning model, so there is no concept of a "training set" in the context of its development or validation.

9. How the ground truth for the training set was established

• Not Applicable. As there is no training set, this question is not relevant.

Summary of Device Performance Data Provided (not an acceptance criteria table):

Note: c14-ERCC likely refers to a ¹⁴C-labeled version of the "EPIEN ROOT CANAL CLEANSER" for metabolic and distribution studies.

In conclusion, the provided document focuses on premarket notification requirements, establishing substantial equivalence to predicate devices through non-clinical laboratory and animal studies, not on clinical performance criteria or studies in human subjects often associated with AI/ML devices.

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