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The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection and counting of cells of interest based on marker intensity. size and shape using appropriate controls to assure the validity of the VIAS scores.

In this application, the VIAS is intended to aid a qualified pathologist for the semi-quantitative detection of c-erbB-2 (HER-2/neu) in formalin-fixed, paraffin embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER-2/neu proteins using Ventana's HER-2/neu reagents as well as Ventana's DAB copper chromogen and nuclear hematoxylin.

This particular application is an accessory to the Ventana PATHWAY™ Her2 (clone CB11) (Ventana Medical Systems, Inc., Tucson, Arizona) and the Ventana PATHWAY™ Her2 is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered.

The VIAS is an adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist in the acquisition and measurement of images from microscope slides of breast cancer specimens stained for the presence of HER2 receptor protein. The accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the Ventana PATHWAY™ Her2 to assure the validity of the VIAS-assisted HER2 score.

The Ventana Image Analysis System (VIAS) is an adjunctive computer-assisted image analysis system functionally connected to an interactive microscope.

The provided document is a 510(k) premarket notification letter from the FDA for the Ventana Image Analysis System – Her2/neu. It mentions the device's indications for use but does not contain any information regarding acceptance criteria, study details, or performance data.

Therefore, I cannot fulfill your request for:

• A table of acceptance criteria and reported device performance.
• Sample size used for the test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method.
• Information on a multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
• Information on a standalone performance study.
• Type of ground truth used.
• Sample size for the training set.
• How the ground truth for the training set was established.

The document only states that the device is "substantially equivalent" to legally marketed predicate devices. To obtain the information you're looking for, you would typically need to refer to the full 510(k) submission summary or a separate clinical study report, which is not included in this text.

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