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The FiteBac® Cavity Cleanser is a 2% K21 QAS aqueous ethanolic solution intended for cleansing and moistening/re-wetting of cavity preparations.

The FiteBac® Cavity Cleanser is a 2% K21 Quaternary Ammonium Silane-functionalized (QAS) aqueous ethanolic solution intended for cleansing and moistening/re-wetting of prepared dental surfaces. It is recommended for use upon completion of tooth preparation or etching, prior to sealing dentinal tubules. Research has shown that FiteBac® Cavity Cleanser can not only remove debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface. Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes.

The provided document, a 510(k) premarket notification for the FiteBac® Cavity Cleanser, details the device's characteristics and compares it to predicate and reference devices to establish substantial equivalence. However, this document does not describe a study that involves human-in-the-loop performance, multi-reader multi-case studies, or AI assistance. The "Performance Testing" section only lists "Bond Strength Testing." The "Non-Clinical Testing" section lists "Biocompatibility" (Cytotoxicity and Sensitization).

Therefore, based on the provided text, I cannot provide information for many of the requested points, especially those related to AI model performance, expert ground truth establishment for a test set, MRMC studies, or training set details. The document focuses on establishing substantial equivalence through comparison of technological characteristics and non-clinical bench testing.

Here's a breakdown of what can be extracted and what cannot:

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

The document doesn't present "acceptance criteria" in the typical sense of a pre-defined performance threshold for a statistical study (e.g., AUC > X, sensitivity > Y%). Instead, it establishes substantial equivalence by demonstrating that the FiteBac® Cavity Cleanser has similar material properties and performs comparably in bench tests to legally marketed predicate and reference devices.

The "acceptance criteria" are implicitly met if the device demonstrates substantial equivalence to the predicate and reference devices in the evaluated characteristics. The "reported device performance" is essentially that it did achieve this equivalence in the listed non-clinical tests.

Important Note: The document explicitly states: "Clinical studies have not been conducted to demonstrate that this device results in improved clinical outcomes." This reinforces that the acceptance is based on non-clinical, bench-top equivalence, not clinical performance metrics.

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

• Test Set Sample Size: The document does not specify sample sizes for the bench tests (Bond Strength, Cytotoxicity, Sensitization). These are typically described in detailed study reports that are part of the 510(k) submission but are not fully reproduced in this summary letter.
• Data Provenance: The document does not specify the country of origin of the data. It's safe to assume the testing was conducted to support a US FDA submission, but the specific location of the labs isn't stated. The testing is retrospective in the sense that it evaluates the device's properties, not prospective patient outcomes.

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

• This question is not applicable to this document. The device is a "cavity cleanser," a chemical solution, not an AI diagnostic device that requires expert interpretation of images or other data to establish ground truth. The "ground truth" for chemical/physical properties is established by standardized laboratory methods and measurements, not by expert consensus.

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

• This question is not applicable for the same reason as point 3. Adjudication methods are used in reader studies (often for AI or imaging devices) to resolve discrepancies in human interpretations. This device's evaluation is based on objective laboratory measurements.

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, an MRMC comparative effectiveness study was NOT done. This document pertains to a chemical dental product, not an AI-assisted diagnostic tool.

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

• No, this is not an AI algorithm. This question is not applicable.

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

• The "ground truth" for this device's evaluation is based on standardized laboratory measurements and accepted scientific principles for material properties, bond strength, and biocompatibility (cytotoxicity, sensitization). It is not based on expert consensus, pathology, or clinical outcomes data in the context of a diagnostic study.

8. The sample size for the training set:

• Not applicable. This is not an AI device that requires a training set.

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

• Not applicable. This is not an AI device.

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