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Root canal sealers solvent when canal retreatment is required.

ENDOSOLV (new device, K172839/S001) is a solvent used for eugenate-type or phenolic resin-based endodontic cements in the context of endodontic retreatment. This solvent is able to soften conventional zinc oxide eugenol cements and phenolic resin type sealers in the context of endodontic retreatment. It is indicated for use as a root canal sealer solvent when canal retreatment is required. ENDOSOLV (new device, K172839/S001) composition consists of ethyl acetate, amyl acetate and thymol. Ethyl acetate and amyl acetate are the two main components of the formulation that are effective in dissolving zinc oxide-eugenol-based and resin based filling material.

The provided text describes the 510(k) premarket notification for ENDOSOLV (K172839) and compares it to a predicate device, ENDOSOLV E (K980633). The study focuses on demonstrating substantial equivalence, primarily through performance testing of the new device's ability to dissolve root canal sealers.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The text doesn't explicitly state "acceptance criteria" in a quantitative manner (e.g., "must dissolve within X seconds"). Instead, the performance studies aim to show that the new device, ENDOSOLV, is "as effective as" or "comparable to" the predicate device, ENDOSOLV E, and a positive control (ENDOSOLV R) in softening root canal sealers.

Therefore, the reported device performance is framed as a comparison to the predicate and positive control.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Performance Testing: Not explicitly stated. The tables provide softening times for different types of cements, suggesting multiple tests were performed for each, but the exact number of samples or replicates for each test is not provided.
• Data Provenance: The performance testing was performed by Septodont, the manufacturer. No information on the country of origin of the data or whether it was retrospective or prospective is provided beyond the location of the study site (Septodont itself did the performance testing, biocompatibility was outsourced to Envigo and Phycher).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Not applicable. The performance testing involves direct measurements of softening time for root canal sealers, not interpretation by human experts. Biocompatibility testing follows ISO standards and lab protocols.

4. Adjudication Method for the Test Set

Not applicable, as the tests involve objective measurements (softening time) and standardized biocompatibility assays, not expert interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This study is for a medical device (solvent) and involves laboratory performance testing (softening time) and biocompatibility, not an imaging or diagnostic device requiring human reader analysis.

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

Not applicable, as the device is a chemical solvent and does not involve an algorithm. Performance is assessed directly through its chemical and physical properties.

7. The Type of Ground Truth Used

The ground truth for the performance testing is the objectively measured "softening time" of various root canal sealers when exposed to the solvent. For biocompatibility, the ground truth is established by the results of standardized ISO 10993 tests (cytotoxicity, hypersensitivity, irritation).

8. The Sample Size for the Training Set

Not applicable. This device is a chemical solvent, not a machine learning model, so there is no "training set."

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set.

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Softening and removal of root canal fillings

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I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a device called "ENDOSOLV E." This document primarily addresses the regulatory approval of the device and confirms its substantial equivalence to a predicate device.

It does not contain any information regarding specific acceptance criteria, study details, performance metrics, sample sizes, expert qualifications, or ground truth establishment. The document is a regulatory communication, not a performance study report.

Therefore, I cannot fulfill your request for the information outlined in the prompt based on the provided text.

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