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The Ventana Image Analysis System (KAS™) 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, classification 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 in the acquisition and measurement of images to quantify the percentage of positively stained nuclei in formalin-fixed, paraffin-embedded breast cancer tissue specimens immunohistochemically stained for the presence of p53 proteins using Ventana's reagents and nuclear hematoxylin. p53 over-expression is indicated for use as a marker of alterations of the p53 gene in breast tissue when used with in vitro diagnostic reagents marketed for these indications.

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 p53 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 p53 assay to assure the validity of the VIAS-assisted p53 assessment.

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The Ventura Image Analysis System (VIAS™) - p53 is intended to aid pathologists in detecting, classifying, and counting breast cancer cells based on marker intensity, size, and shape, specifically quantifying the percentage of positively stained nuclei for p53 proteins in formalin-fixed, paraffin-embedded breast cancer tissue specimens.

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document only explicitly mentions reproducibility as an outcome, not a specific quantitative acceptance criterion (e.g., minimum concordance, specific percentage agreement). The device's performance is stated as being an aid in "reproducibility."

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

The document does not explicitly state the sample size used for the test set or its data provenance (e.g., country of origin, retrospective or prospective).

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document does not specify the number of experts used or their qualifications to establish ground truth for the test set. It mentions the "responsibility of a qualified pathologist" but not in the context of ground truth establishment for a study.

4. Adjudication Method

The document does not describe any specific adjudication method for the test set.

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

The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it provide an effect size for human readers' improvement with AI assistance. The system is described as an "adjunctive computer-assisted methodology" intended to "assist the reproducibility of a qualified pathologist," implying human-in-the-loop use, but a comparative study is not detailed.

6. Standalone (Algorithm Only) Performance Study

The document does not provide information about a standalone study of the algorithm's performance without human-in-the-loop. The system is consistently described as "adjunctive" and "computer-assisted" to aid pathologists.

7. Type of Ground Truth Used

The document implies that the ground truth for p53 assessment is established by a "qualified pathologist" who employs "appropriate morphological studies and controls as specified in the instructions for the Ventana p53 assay." It does not explicitly mention pathology reports or outcome data as the direct ground truth for the study.

8. Sample Size for the Training Set

The document does not specify the sample size used for the training set.

9. How Ground Truth for the Training Set Was Established

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

Summary of Study Information Provided:

The provided 510(k) clearance document focuses on the regulatory approval and indications for use of the Ventana Image Analysis System (VIAS) - p53. While it highlights the device's purpose as an aid to pathologists for reproducibility in p53 assessment, it lacks detailed information regarding specific acceptance criteria, study design parameters (like sample sizes for test or training sets, data provenance), ground truth establishment methodologies, expert qualifications, or specific performance metrics (beyond general reproducibility claims) that would typically be found in a comprehensive clinical study report. The document functions more as a regulatory notice than a scientific publication detailing a study's methodology and results.

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