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The Virtuoso system provides automated digital slide creation, management, analysis, and viewing. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape.

The IHC Ki-67 (30-9) Digital Read and Image Analysis applications are intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of Ki-67 protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. Ki-67 results are indicated for use in assessing the proliferative activity of normal and neoplastic breast tissue. When used with Ventana Medical Systems, Inc. CONFIRM™ anti-Ki-67 (30-9) Rabbit Monoclonal Primary Antibody Assay, it is indicated for use as an aid in the assessment of Ki-67 status in breast cancer patients (but is not the sole basis for treatment).

The Virtuoso™ System is an instrument-plus-software system designed to assist the qualified pathologist in the consistent assessment of protein expression in immunohistochemically stained histologic sections from formalin-fixed, paraffinembedded normal and neoplastic tissues. The system consists of a slide scanner (iScan), computer, monitor, keyboard, mouse, image analysis algorithms for specific immunohistochemical markers, and software with a Windows web browser-based user interface. Virtuoso is a web-based, end-to-end, digital pathology software solution that allows pathology laboratories to acquire, manage, view, analyze, share, and report digital images of pathology specimens. Using the Virtuoso software, the pathologist can view digital images, add annotations, make measurements, perform image analysis, and generate reports.

Hardware: The iScan slide scanning device captures digital images of formalin-fixed. paraffin-embedded tissues that are suitable for storage and viewing. The device includes a digital slide scanner, racks for loading glass slides, computer, scanner software, keyboard, mouse and monitor.

Software: The Virtuoso software is designed to complement the routine workflow of a qualified pathologist in the review of immunohistochemically stained histologic slides. It allows the user to select fields of view (FOVs) in the digital image for analysis and provides quantitative data on these FOVs to assist with interpretation. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process.

The Ventana Virtuoso™ System for IHC Ki-67 (30-9) was tested for its performance in both digital reading (DR) and image analysis (IA) of Ki-67 stained slides. The overall acceptance criterion for each measurement was 75% overall percent agreement (OPA) with manual microscopic reads.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Digital Read (DR) Test Set: 120 cases.
• Image Analysis (IA) Test Set: 120 cases.
• Data Provenance: The document does not explicitly state the country of origin. The studies appear to be prospective concordance studies where new data was generated for validation.

3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)

• Digital Read (DR): "one pathologist at one site" established the manual score (reference result). No specific qualifications are provided beyond "pathologist".
• Image Analysis (IA): "three pathologists at three sites" established the manual score (reference result). No specific qualifications are provided beyond "pathologists".

4. Adjudication Method for the Test Set

The document describes concordance studies where manual scores were compared to device scores. It does not mention any formal adjudication method beyond establishing the "manual score (reference result)" by one or more pathologists. This implies a single expert's opinion served as the ground truth for each case initially, rather than multiple experts with a specific adjudication process.

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

No formal MRMC comparative effectiveness study is described where human readers' performance with and without AI assistance is directly compared to quantify an effect size. The studies focus on the agreement between the device alone (digital read or image analysis) and manual reads.

6. Standalone (Algorithm Only) Performance

Yes, standalone performance was done for both Digital Read and Image Analysis:

• Digital Read Performance: This section describes the agreement between the digital image reviewed by a pathologist ("Digital Read") and the manual microscopic read. While a pathologist is involved in the "Digital Read," the intent is to show that replacing the physical microscope with a digital image viewer (which is part of the system) does not negatively impact the pathologist's ability to score the cases.
• Image Analysis Performance: This section directly assesses the agreement between the Virtuoso Image Analysis application's output and the manual microscopic read. This represents the algorithm-only performance in providing a quantitative score before any potential human override.

7. Type of Ground Truth Used

The ground truth used for both the Digital Read and Image Analysis studies was expert consensus (specifically, manual microscopic reads) by qualified pathologists. The manual score was explicitly stated as the "reference result" or "true score."

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set of the Virtuoso™ System's image analysis algorithms. This information is typically found in the development and validation sections, which are not detailed in this 510(k) summary.

9. How Ground Truth for the Training Set Was Established

The document does not provide any information on how the ground truth for the training set was established.

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