(108 days)
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.
| Metric/Trait | Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (Subject Device) |
|---|---|---|
| Formulation | Identical to Predicate | 2% K21 QAS |
| Manufacturing Process | Identical to Predicate | Same as Predicate |
| Intended Use | Equivalent to Predicate, with expanded claim | Cleansing and moistening/re-wetting of cavity preparations, antimicrobial |
| Principle of Operation | Equivalent to Predicate | Cleansing and re-wetting of carious preparations |
| Material Performance | Equivalent to Predicate | Same as Predicate |
| Biocompatibility | Equivalent to Predicate | Yes (Same as Predicate) |
| Antimicrobial Activity | Effective reduction of specified microorganisms | Demonstrated reduction of Streptococcus mutans, Actinomyces naeslundii, Lactobacillus acidophilus, and Candida albicans |
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.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.