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510(k) Data Aggregation
(93 days)
SULCUSBLUE is a paste containing aluminium chloride which is intended to be used, in association with compression caps, for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
SULCUSBLUE is a paste containing aluminium chloride which is used, in association with compression caps (SULCUSCAP), for the temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions.
The paste is applied directly into the sulcus thanks to the a cannula. It is left in place between 1 and 2 minutes depending upon the tonicity of the marginal and removed by an air and water spray with simultaneous aspiration. A dry retracted sulcus is obtained.
This document describes the 510(k) premarket notification for SULCUSBLUE, a gingival retraction/hemostatic paste. The information provided heavily focuses on establishing substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria in the typical sense of a medical device performance validation for AI/algorithm-based devices.
Therefore, many of the requested fields regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of an AI/algorithm-based device cannot be directly populated from the provided text. The document is for a physical medical device (gingival paste), and its "performance" is demonstrated through its composition and comparison to predicate devices, and a tolerance study.
I will populate the table and answer the questions based on the information provided, reinterpreting "acceptance criteria" and "device performance" in the context of a 510(k) for a physical product, primarily focusing on safety and equivalence.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Reinterpreted for Physical Device) | Reported Device Performance |
|---|---|
| Safety: Device does not induce significant irritation or systemic toxicity. | Tolerance Study on Hamsters (HEMOSTASYL): - Immediately stopped bleeding on scarified oral mucosa. - Did not induce systemic toxicity signs. - Locally, a benign irritation reaction after 5 days, totally reversible within 14 days. |
| Hemostasis: Device effectively stops bleeding. | Tolerance Study: Stopped bleeding immediately. |
| Gingival Retraction: Device achieves temporary gingival retraction. | Claimed Intended Use & Substantial Equivalence: Implied through equivalence to predicate devices (HEMOSTASYL, EXPASYL, TRAXODENT) that also perform gingival retraction. The study specifically notes immediate bleeding cessation. |
| Substantially Equivalent Composition: Device composition is comparable to legally marketed predicate devices. | Composition Comparison: SULCUSBLUE has an identical composition (Kaolin, 15% Aluminium chloride hexahydrate, Purified water, Dye, Anhydrous colloidal silica, Propylene glycol, Strawberry Aroma) to HEMOSTASYL. |
| Substantially Equivalent Intended Use: Device intended use matches legally marketed predicate devices. | Intended Use: "temporary retraction and hemostasis of the gingival margin during dental procedures such as dental impressions" - stated to be similar to HEMOSTASYL, TRAXODENT, and EXPASYL. |
Note: The term "acceptance criteria" is typical for performance studies of AI/algorithm-based devices, specifying metrics like sensitivity, specificity, or AUC thresholds. For this physical device, "acceptance criteria" are inferred from the safety and equivalence arguments made for 510(k) clearance.
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set:
- The "test set" in the provided document refers to the subjects in the "Tolerance study of a dental paste on the injured oral mucosa in the Hamster."
- Group 1 (control): Number of hamsters not specified, but this group received 0.9% NaCl solution.
- Group 2 (treated): Number of hamsters not specified, but this group received 0.5ml of HEMOSTASYL (same composition as SULCUSBLUE).
- The exact number of hamsters in each group is not provided in the summary.
- Data Provenance: Retrospective for SULCUSBLUE, as it reuses data from a previous study conducted on HEMOSTASYL (dated January 13, 2006). The original study on HEMOSTASYL was prospective. Country of origin not explicitly stated, but the submitter is from France.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The ground truth for this physical device's performance study (tolerance/hemostasis) was established by direct observation and measurement in the hamster study, not by expert interpretation of images or clinical data.
4. Adjudication method for the test set
Not applicable. This was a direct observation study on animal subjects, not a study requiring adjudication of expert interpretations.
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 is a physical dental paste, not an AI/algorithm-based device, so an MRMC study is not relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical dental paste, not an AI/algorithm.
7. The type of ground truth used
The ground truth for the safety and performance claims was established through:
- Direct observation: Bleeding cessation, local irritation reaction in the hamster study.
- Compositional analysis: Comparison of ingredients between SULCUSBLUE and predicate devices.
8. The sample size for the training set
Not applicable. This is a physical dental paste, not an AI/algorithm trained on a dataset.
9. How the ground truth for the training set was established
Not applicable. This is a physical dental paste, not an AI/algorithm.
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