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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, 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 for the semi-quantitative detection of c-erbB-2 (HER2) antigen in formalin-fixed, paraffin-embedded normal and neoplastic tissue specimens immunohistochemically stained for the presence of HER2 proteins using Ventana® Medical Systems, Inc.'s (Ventana) PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody as well as Ventana's DAB copper chromogen and nuclear hematoxylin.

Ventana's PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody (PATHWAY HER2 (4B5)) 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 (4B5) to assure the validity of the VIAS-assisted HER2.

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

The provided text describes the 510(k) premarket notification for the Ventana Image Analysis System - PATHWAY® HER2 (4B5). While it outlines the device's indications for use and regulatory information, it does not contain specific details about the acceptance criteria, the study proving the device meets those criteria, or the methodology of such a study.

Therefore, I cannot provide the requested information. The document focuses on regulatory approval based on substantial equivalence to a predicate device rather than presenting detailed performance study results against predefined acceptance criteria.

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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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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, 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 paraffin embedded breast cancer tissue specimens immunohistochemically stained for the presence of Ki-67 proteins using Ventana's reagents and nuclear hematoxylin. It is indicated for use in assessing the proliferative activity of normal and neoplastic 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 Ki-67 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 Ki-67 kit to assure the validity of the VIAS-assisted Ki-67 assessment.

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

This document is a 510(k) clearance letter for the Ventana Image Analysis System-Ki-67. It does not contain information about the acceptance criteria or a study that proves the device meets the acceptance criteria. The letter primarily focuses on the regulatory clearance of the device as substantially equivalent to legally marketed predicate devices.

Therefore, I cannot provide the requested information based on the provided text.

Ask a specific question about this device

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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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, classification and counting of cells of interest in tissue 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 paraffin embedded breast cancer tissue immunohistochemically stained for estrogen receptor (ER) or progesterone receptor (PR) proteins using Ventana's DAB copper chromogen and Ventana's ER and PR reagents and nuclear hematoxylin. It is not intended for use as an aid in the management, prognosis, or outcomes of breast cancer when used with in vitro diagnostic reagents marketed for these indications.

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

The provided text describes the 510(k) clearance for the Ventana Image Analysis System (VIAS). While it mentions that the device is "substantially equivalent" to legally marketed predicate devices and is intended to "aid a qualified pathologist," it does not contain a detailed study proving the device meets specific acceptance criteria.

The document is a regulatory approval letter and outlines the "Indications for Use" but does not include the detailed performance data or study design that would demonstrate the device's accuracy or efficacy. Therefore, I cannot extract the specific information requested in your prompt regarding acceptance criteria, study details, sample sizes, ground truth establishment, or human reader improvement with AI assistance from this document.

To answer your specific questions, I would need a different type of document, such as a detailed clinical study report or a summary of safety and effectiveness data submitted to the FDA for the device.

Ask a specific question about this device