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FiteBac® CC OrthoSeal with K18 QAMS is a light cure primer intended to prepare the tooth surface prior to bonding orthodontic appliances to etched enamel.

The FiteBac® CC OrthoSeal is a 5% K18 Quaternary Ammonium Methacrylate (QAMS) functionalized, light cured orthodontic sealant used to prepare etched enamel for orthodontic bonding.

The provided text describes the 510(k) summary for the FiteBac® CC OrthoSeal device. Here's a breakdown of the requested information:

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

The document doesn't explicitly state "acceptance criteria" in a quantitative, pass/fail format for the device's performance characteristics. Instead, it categorizes performance testing, and the reported performance is described as being "acceptable" and not raising "any new issues of safety or effectiveness" in comparison to predicate devices. The primary performance characteristic mentioned is "Bond Strength Testing."

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

The FiteBac® Antimicrobial Cavity Cleanser is an antimicrobial 2% K21 Quaternary Ammonium Silanefunctionalized (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. FiteBac® Antimicrobial Cavity Cleanser acts on the microorganisms in the table below, and not only removes debris in carious lesion preparations but can penetrate exposed dentin tubules allowing restorative adhesives to tightly bind to the prepared dentin surface.

The provided text describes the 510(k) premarket notification for the "FiteBac® Antimicrobial Cavity Cleanser." This submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed acceptance criteria and a study design for a novel device. The core of the submission emphasizes that the subject device is identical in formulation and manufacturing to the predicate device, with the only addition being an expanded antimicrobial claim.

Because the submission is for substantial equivalence and not a de novo clearance or PMA, the typical structure for reporting acceptance criteria and a study for a new device's performance against specific metrics is not present. Instead, the focus is on a comparative analysis with a legally marketed predicate.

Here's an analysis based on the provided document, addressing your questions to the extent possible:

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

The document does not explicitly state "acceptance criteria" in the traditional sense of a performance study for a new device. Instead, it relies on demonstrating that the subject device (FiteBac® Antimicrobial Cavity Cleanser) is substantially equivalent to its predicate device (K190271 FiteBac® Cavity Cleanser) in all aspects except for an expanded antimicrobial claim.

The "performance" reported is related to the antimicrobial effectiveness shown in referenced literature.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

The document refers to "in vitro studies" in referenced literature to demonstrate antimicrobial effectiveness. It does not explicitly state custom sample sizes or data provenance for a new test set specifically conducted for this 510(k) submission. Instead, it refers to existing published studies and "Data on File."

• Sample Size: Not specified for a single comprehensive study. The studies cited are in vitro (likely laboratory-based) using "dentin blocks impregnated with each microorganism."
• Data Provenance: The referenced studies are peer-reviewed publications (e.g., Dent Mater. 2018, Clin Oral Investig. 2020) and "Data on File." This suggests the data is likely from research institutions or internal company tests. The country of origin is not specified but commonly, such journals have international contributions. The studies are by nature prospective in their experimental design.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This question is not applicable in the context of this 510(k) submission. The "ground truth" for antimicrobial effectiveness in in vitro studies is established through standardized microbiological testing methods, not through expert consensus in a clinical setting with human readers. The experts involved would be microbiologists and researchers conducting the experiments. Their qualifications are inherent in their authorship of peer-reviewed scientific publications.

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

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to clinical studies where discrepant readings or diagnoses need to be resolved by a consensus panel of experts. The studies mentioned here are in vitro laboratory experiments on antimicrobial efficacy, which do not involve such adjudication processes.

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 device is a cavity cleanser, not an AI-powered diagnostic tool. Therefore, MRMC studies involving human readers and AI assistance are not relevant.

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

Not applicable. This device is a chemical cleanser and does not involve an algorithm.

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

The ground truth for the "antimicrobial effectiveness" claim is based on microbiological assay results (i.e., direct measurement of microorganism reduction) from controlled in vitro experiments. This is the scientific standard for validating antimicrobial claims.

8. The sample size for the training set

Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set."

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

Not applicable. As there is no training set for an AI algorithm, this question is not relevant.

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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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