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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 Virtuoso™ System for IHC PR (1E2) is for digital read and image analysis applications. This particular Virtuoso system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded normal and neoplastic tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRM™ anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment).

Note: The IHC PR (1E2) Digital Read and Image Analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The pathologist should verify agreement with the Image Analysis software application score. The accuracy of the test results depends on 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 CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the Virtuoso System for IHC PR Digital Read and Image Analysis scores. The actual correlation of CONFIRM™ anti-PR antibody to clinical outcome has not been established.

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.

Here's an analysis of the acceptance criteria and study details based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: While PPA and NPA thresholds are not explicitly stated, the context of the 75% OPA suggests that these individual agreement metrics would also be expected to be above this threshold for the overall agreement to be met. The reported performance far exceeds this implied threshold.

2. Sample Size and Data Provenance

• Test Set Sample Size: Approximately 120 cases. The specific numbers reported in the tables are 113 for Digital Read and 114 for Image Analysis, likely due to a slight difference in cases included in the analysis after exclusions or variations in how certain cases were processed.
• Data Provenance: The document does not explicitly state the country of origin. It indicates the study was conducted "at one site." It was a retrospective study since the cases were "evaluated three ways" after staining.

3. Number of Experts and Qualifications for Ground Truth

• Number of Experts: One pathologist.
• Qualifications: "one pathologist" – no further specific qualifications (e.g., years of experience, sub-specialty) are provided in this document.

4. Adjudication Method for the Test Set

• Adjudication Method: "The manual score (reference result) was compared to both the digital read result and the image analysis result." This indicates a single-reader manual interpretation served as the ground truth against which both digital read and image analysis were compared. There was no explicit multi-reader adjudication process mentioned for establishing the "manual score" ground truth itself.

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

• Was an MRMC study done? No, an MRMC comparative effectiveness study, which typically compares human readers with and without AI assistance across multiple readers and cases to quantify improvement, was not explicitly described.
• Effect Size of Human Readers' Improvement with AI: Not applicable, as an MRMC study was not described. The study compared the device (digital read and image analysis) directly to the pathologist's manual read.

6. Standalone (Algorithm Only) Performance

• Was a standalone performance study done? Yes, the "Image Analysis" arm of the study specifically assessed the performance of the algorithm without direct human input beyond selecting fields of view. The results demonstrated a 96.5% Overall Percent Agreement with the manual read. The "Digital Read" arm assesses the pathologist's interpretation using the digital image, which is also a form of standalone performance of the digital viewing system, but with human-in-the-loop.

7. Type of Ground Truth Used

• Type of Ground Truth: Expert consensus, specifically a "manual score (reference result)" established by "one pathologist." This manual score was determined using a routine microscope.

8. Sample Size for the Training Set

• The document does not provide any information regarding the sample size of the training set. The clinical validation section focuses solely on the performance evaluation of the final device.

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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