Search Results

The software, Vipersoft, for extraoral X-ray units is used to process digital images from extraoral X-ray units in order to enable a dentist to diagnose the dental state of the teeth of a patient.

Software for extraoral X-ray units

I am sorry, but the provided text only contains an FDA 510(k) clearance letter and an Indications for Use statement for the "Vipersoft™ (Software for Extraoral X-ray Units)".

This document does not contain any information regarding:

• Acceptance criteria or reported device performance
• Details of any study (sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance studies) for Vipersoft™.

Therefore, I cannot fulfill your request for a table of acceptance criteria and device performance, or any of the study details you've asked for, as this information is not present in the provided text.

Ask a specific question about this device

The intraoral camera system, Vipercam, of Integra Medical Corporation is used to provide a view of the mouth in order to assist the dentist in describing dental procedures and to show a patient before and after views of his mouth showing the patient results of the dental procedures which the dentist has performed on him.

Vipercam, intraoral camera system, and accessories

The provided text is a 510(k) premarket notification letter from the FDA for a device called "Vipercam." This document grants market clearance based on substantial equivalence to a predicate device. It does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample size used for the test set and data provenance.
3. Number of experts used to establish ground truth and their qualifications.
4. Adjudication method.
5. MRMC comparative effectiveness study results.
6. Standalone performance study details.
7. Type of ground truth used.
8. Sample size for the training set.
9. How ground truth for the training set was established.

The document is primarily a regulatory approval letter based on "substantial equivalence" to a predicate device, meaning it's similar enough to an already approved device that a full new trial is not required. It focuses on the legal and regulatory framework for marketing the device, not the detailed technical and clinical performance data that would typically be found in a study report.

Ask a specific question about this device