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510(k) Data Aggregation
(83 days)
To be used for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment.
Zircon-F Prophylaxis Paste
The provided text is a 510(k) summary for the Zircon-F Prophylaxis Paste. It focuses on establishing substantial equivalence to predicate devices rather than presenting performance data from a specific study against predefined acceptance criteria. Therefore, most of the requested information about device performance, study details, and ground truth establishment is not available in the provided document.
Here's an attempt to answer based on the available information:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria or report device performance in the typical sense (e.g., sensitivity, specificity, accuracy). Instead, it relies on demonstrating substantial equivalence to legally marketed predicate devices. The "performance" assessment is implicitly an assessment of sameness in intended use, technological characteristics, and materials.
| Acceptance Criteria (Implicitly based on Substantial Equivalence) | Reported Device Performance |
|---|---|
| Same Intended Use as predicate devices | Met: Zircon-F Prophylaxis Paste has the same intended use: "for cleaning and polishing procedures as part of a professionally administered dental prophylaxis treatment" as cleared 510(k) devices. |
| Same Technological Characteristics as predicate devices | Met: "The technological characteristics for this product are the same as those for the predicate devices and other paste products currently on the market except for minor variations in the same or similar components." |
| Substantially Equivalent Materials to predicate devices | Met: "Descriptive information provided shows that the materials from which Pascal Co., Inc.'s Zircon-F Prophylaxis Paste is made are substantially equivalent (nearly identical with some) to those of similar products, used for identical purposes, currently on the market." The document explicitly references "Oral cavity abrasive polishing paste" (CFR 872.6030) as the originally classified device and lists specific 510(k) cleared products (K033449, K024343, K000169) as predicate devices for comparison. |
2. Sample sized used for the test set and the data provenance
Not applicable. The document does not describe a performance study with a test set. The assessment is based on a comparison to predicate devices and their established characteristics.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. No ground truth establishment for a test set is described as there is no specific performance study.
4. Adjudication method for the test set
Not applicable. There is no test set or adjudication method described.
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 prophylaxis paste, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a medical device (prophylaxis paste), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable for a performance study. The "truth" in this context is the regulatory determination of substantial equivalence based on comparison to existing predicate devices' intended use, technological characteristics, and materials.
8. The sample size for the training set
Not applicable. This is not a machine learning model, so there is no training set mentioned.
9. How the ground truth for the training set was established
Not applicable. There is no training set mentioned.
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