Search Results

Hydro-Cast Acrylic Varnish is applied to cured materials such as dentures, partial dentures, dental splints and temporary crowns/bridges for the purpose of sealing the acrylic surface.

Acrylic varnish. Preparation of methyl methacrylate monomer, multifunction methacrylates, light sensitizer, polymerization.

Here's an analysis of the provided text, outlining the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Five randomly drawn subgroups, with three samples taken from each subgroup, totaling 15 samples.
• Data Provenance: The document does not explicitly state the country of origin. It is a non-clinical test conducted by the manufacturer, Kay-See Dental, in the USA (Kansas City, MO and Belton, MO are the addresses provided). The study is prospective as it involves direct testing of the device for its performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

• Number of Experts: The document does not specify that experts were used to establish ground truth for the drying time observation. The assessment of "dry to the touch" appears to be a direct physical observation without a formal expert panel consensus for ground truth.
• Qualifications of Experts: Not applicable, as experts are not mentioned for this particular test.

4. Adjudication Method for the Test Set

• Adjudication Method: None stated. The drying time observation seems to be a singular measurement per sample, without the need for multiple observers or an adjudication process for this specific test.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• Was an MRMC study done? No.
• Effect Size of Human Readers' Improvement with AI vs. Without AI Assistance: N/A, as no MRMC study was conducted, and the device is a dental varnish, not an AI-powered diagnostic tool.

6. Standalone Performance Study

• Was a standalone study done? Yes. The non-clinical testing for drying time is a standalone performance study of the "Hydro-Cast Acrylic Varnish" itself.

7. Type of Ground Truth Used

• Ground Truth Type: For the drying time test, the ground truth was based on a direct physical observation (dry to the touch) against a pre-defined performance specification.

8. Sample Size for the Training Set

• Sample Size: Not applicable. This device is a physical product (acrylic varnish) and not an AI/machine learning model, so there is no concept of a "training set" in the context of this document.

9. How the Ground Truth for the Training Set Was Established

• How Ground Truth Was Established: Not applicable, as there is no training set for this type of device.

Ask a specific question about this device