(113 days)
ViscoStat Clear is intended for sulcus retraction prior to impression making and to control bleeding and gingival oozing in restorative and operative dentistry used with gingival retraction cord and/or the Dento Infusor. The gel facilitates the insertion of the cord into the sulcus.
ViscoStat Clear is a 25% Aluminum Chloride gel in a viscous, aqueous vehicle which leaves no residue or stain and makes it ideal for use in the esthetic zone. The product is contained within a 30mL or 1.2mL plastic syringe. The 30mL syringe is a bulk container and, prior to application, will be dispensed into provided, empty 1.2mL plastic syringe for delivery to the patient. Dento-Infusor application tips are included and are used to apply the product to the prepared area.
The provided document is a 510(k) summary for a medical device (ViscoStat® Clear) and does not contain information about acceptance criteria for device performance or a study demonstrating that the device meets such criteria in the context of an AI/human-in-the-loop system.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device (Racegel™ K093711) for regulatory clearance. This involves comparing the new device's intended use, chemical composition, physical properties, and safety/efficacy profile to that of an already cleared device.
Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, or training set info) from this document. The document describes a comparison study against a predicate device, focusing on:
- Biocompatibility testing: Showing the product is safe.
- In-house comparison testing: Performed on ViscoStat Clear and Racegel to support the functionality of ViscoStat Clear. This likely involved direct comparison of their effects rather than measuring against predefined acceptance criteria for a novel performance claim.
No study proving acceptance criteria is described in the provided text. The study mentioned is a comparison to a predicate device to establish substantial equivalence.
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