(8 days)
Citric Acid 20%, a root canal cleanser, is intended to etch root canal walls just prior to obturation to allow an optimum seal.
Citric Acid 20% is a slightly thickened, water-soluble solution. It is slightly orange-tinted for easy identification and is provided in a 30 ml IndiSpense® Syringe. Citric Acid facilitates removal of calcium hydroxide materials (e.g., UltraCal®) from canal walls. It can also be used as a mild etchant/conditioner for smear layer removal.
The Ultradent Citric Acid 20% Solution is a "Special 510(k)" device, which typically means it's a modification of an existing device and demonstrates substantial equivalence to a predicate device. For such submissions, extensive clinical studies or novel performance criteria as seen with entirely new devices are often not required. The information provided focuses on demonstrating substantial equivalence rather than establishing new performance acceptance criteria through a standalone study with detailed metrics like accuracy, sensitivity, or specificity.
Here's an analysis of the provided text based on the requested information:
1. A table of acceptance criteria and the reported device performance
The document doesn't explicitly define 'acceptance criteria' in terms of numerical performance metrics for the device (e.g., accuracy, sensitivity, specificity). Instead, the acceptance criteria are implicitly tied to demonstrating substantial equivalence to the predicate device (Citric Acid 10% Solution). The reported "performance" is a comparative assessment.
| Property | Acceptance Criteria (Implicit - Substantial Equivalence to Predicate) | Reported Device Performance (Citric Acid 20% Solution) |
|---|---|---|
| Intended Use | Same as predicate: Facilitates removal of calcium hydroxide from canal walls, and functions as a mild etchant/conditioner for smear layer removal. | Same as predicate: Facilitates removal of calcium hydroxide from canal walls, and functions as a mild etchant/conditioner for smear layer removal. |
| Active Ingredient | Same active ingredient as predicate: Citric acid. | Same active ingredient as predicate: Citric acid. |
| Biocompatibility/Safety | Clinical literature demonstrates that citric acid (generally) is safe and non-cytotoxic. | Clinical literature demonstrates that citric acid (generally) is safe and non-cytotoxic (as stated in Section VII, Literature Review – not provided in full). |
| Technological Characteristics (Effectiveness) | To be effective in cleaning, chelating, and exposing dentinal tubules; comparable to or better than predicate. | A scanning electron microscope study showed 20% citric acid and EDTA were "slightly more effective than 10% citric acid; however, these differences did not appear to be significant." This supports equivalence. |
| Physical Properties | Orange-tinted, slightly thickened. | Orange-tinted, slightly thickened. |
| How Supplied | Supplied in a 30 mL IndiSpense® Syringe. | Supplied in a 30 mL IndiSpense® Syringe. |
The "study that proves the device meets the acceptance criteria" is the scanning electron microscope (SEM) study mentioned. This study compared the 20% citric acid solution to 10% citric acid (the predicate) and EDTA.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size for the SEM study (e.g., number of tooth samples, number of sections analyzed). It also doesn't specify the data provenance (e.g., country of origin, retrospective or prospective nature of sample acquisition). The study appears to be an in vitro laboratory test rather than a clinical human study.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention the use of experts to establish ground truth or interpret the results of the SEM study. SEM analysis typically involves direct observation of physical characteristics, often interpreted by materials scientists or dental researchers, but no details are provided.
4. Adjudication method for the test set
Not applicable. The SEM study is a direct observation/measurement, not an interpretation requiring an adjudication method like those used for reader studies.
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 chemical solution (citric acid), not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies involving human readers or AI assistance are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm or AI device. The standalone performance is the inherent performance of the chemical solution itself as assessed by the SEM study, which evaluated its effectiveness in cleaning and exposing dentinal tubules.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the SEM study, the "ground truth" would be the direct visual evidence from the scanning electron microscope images regarding the presence/absence of smear layer, exposure of dentinal tubules, and cleanliness of root canal walls. This is an objective physical observation, not expert consensus, pathology, or outcomes data in the usual clinical sense.
8. The sample size for the training set
Not applicable. This is not a machine learning or AI device that requires a training set.
9. How the ground truth for the training set was established
Not applicable. As above, no training set is relevant for this type of device.
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