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Ariol™ is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.

This particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffinembedded human breast cancer tissue specimens. Results from the PathVysion kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The PathVysion kit is also indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the PathVysion kit provides the probes that offer direct visualization and manual enumeration of the HER2 and Chromosome 17 genes with a fluorescent microscope, the Ariol may be used as an accessory that provides automated enumeration.

Ariol™ is an automated scanning microscope and image analysis system.

This looks like a medical device submission, specifically a 510(k) for an automated HER-2/neu FISH enumeration system called Ariol™. The provided text is a letter from the FDA acknowledging the substantial equivalence of the device and an "Indications for Use" statement.

Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with reported device performance. The FDA letter is an approval document, not the study results or the criteria themselves. The "Statement of Intended Use" only describes the device's purpose and its accessory nature to the PathVysion® HER-2/neu DNA Probe kit.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Stand-alone performance results
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

This information would typically be found in the scientific study report(s) submitted as part of the 510(k) application, which are not included in the provided document. The provided text only states that the device is "substantially equivalent" to predicate devices, implying that its performance has been demonstrated to be comparable, but it doesn't detail how that demonstration was done or the specific metrics achieved.

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The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

This letter does not provide the detailed study results needed to complete all sections of your request. It's a 510(k) clearance letter, which confirms substantial equivalence to a predicate device, not a full summary of performance studies.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the given document. The letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent," implying that performance data was submitted, but the specific acceptance criteria and reported device performance are not detailed here.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not provided in the given document.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not provided in the given document.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not provided in the given document. The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei," suggesting it operates as an aid, but no MRMC study details or effect sizes are mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei." The "Indications For Use" state it is an "aid in chromosomal analysis" and "assists in the location of interphase and metaphase nuclei." This implies it's not a fully standalone diagnostic device but rather a tool to support human analysis. However, a standalone performance study of the algorithm within its assisting role is not explicitly described or quantified in this document.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This information is not provided in the given document. The device is used with the "CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit" for "analysis of CEP XY probes" to "assess the effectiveness of bone marrow transplantation." This suggests the ground truth would likely be related to the actual chromosomal status or transplant success, but how that ground truth was established for a study is not detailed.

8. The sample size for the training set

This information is not provided in the given document.

9. How the ground truth for the training set was established

This information is not provided in the given document.

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Ariol™ is an automated scanning microscope and image analysis system. It is intended for in virro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.

This particular Ariol software application is intended to measure, count, and quantitate the percentage and intensity of positively stained nuclei in formalin-fixed paraffin-embedded tissue specimens immunohistochemically stained for Estrogens Receptors or Progesterone Receptors (ER/PR). ER/PR results are indicated for use as and aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.

Ariol™ is an automated scanning microscope and image analysis system.

The provided text is a 510(k) premarket notification approval letter for the Ariol™ ER/PR application. While it describes the intended use and regulatory classification of the device, it does not contain the detailed study information, acceptance criteria, or performance data requested in your prompt.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria, study details, sample sizes, ground truth establishment, or MRMC studies. The document is an approval letter, not the dossier or study report itself.

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The Applied Imaging Ariol™ is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the detection, classification, and counting of cells of interest based on particular color, intensity, size, pattern, and shape.

This Hersight application is intended for use as an accessory to the HercepTest™ (DAKO USA, Carpinteria, CA) and is intended to provide semi-quantitative immunohistochemical (IHC) results to aid in the determination of HER-2/neu (HER2) over-expression in breast cancer tissues routinely processed for histological evaluation.

When used with DAKO HercepTest, it is indicated for use as an aid in the assessment of breast cancer patients for whom Herceptin® (Trastuzumab) treatment is being considered. Note: The actual correlation of the DAKO HercepTest to Herceptin clinical outcome has not been established.

The Ariol system 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 DakoCytomation HercepTest to assure the validity of the Ariol-assisted HER2 score.

The Applied Imaging Ariol™ is an automated scanning microscope and image analysis system.

The provided document is limited in the detail it provides regarding acceptance criteria and study particulars. However, I can extract the information that is present and indicate where details are missing.

Acceptance Criteria and Device Performance (Limited Information Available)

The document primarily states the device's intended use and substantial equivalence to a predicate device, rather than explicit acceptance criteria and corresponding performance metrics for a de novo marketing authorization. It presents performance in relation to a Human Reader (Pathologist) as an adjunctive computer-assisted methodology.

Based on the information provided, here's a table of what can be inferred/extracted:

Study Information from the Document:

1. Sample size used for the test set and the data provenance:

   • Test Set Sample Size: Not specified in the provided text.
   • Data Provenance: Not specified in the provided text (e.g., country of origin, retrospective/prospective).

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: Not specified.
   • Qualifications of Experts: The document refers to the role of a "qualified pathologist," but does not specify the number or specific qualifications (e.g., years of experience) for establishing ground truth in any study for this submission.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

   • Not specified.

4. If a multi-reader multi-case (MRMC) comparative effectiveness study was done. If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • The document describes the Ariol system as an "adjunctive computer-assisted methodology" to "assist the reproducibility of a qualified pathologist." This strongly suggests the device is intended for use with a human-in-the-loop. However, the document does not provide details of an MRMC comparative effectiveness study or any effect size quantifying human improvement with AI assistance. It indicates the device provides "semi-quantitative immunohistochemical (IHC) results."

5. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

   • The document implies the device is not standalone. It is an "accessory" and an "adjunctive computer-assisted methodology" that assists a pathologist, and the "accuracy of the test result depends upon the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist...to assure the validity of the Ariol-assisted HER2 score." This indicates a human-in-the-loop system where the pathologist retains ultimate responsibility and oversight. No standalone performance data is presented.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The document does not explicitly state the type of ground truth used for any studies validating the device. However, given its intended use with HercepTest™ and pathologists, it highly implies that pathological assessment or expert consensus would be the basis for ground truth, but this is not detailed.

7. The sample size for the training set:

   • Not specified.

8. How the ground truth for the training set was established:

   • Not specified.

Summary of Missing Information:

The provided document is a 510(k) clearance letter, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical study reports or comprehensive performance data like a PMA submission would. Much of the specific information requested about acceptance criteria, study design parameters (sample sizes, expert details, adjudication methods), and detailed performance metrics (especially quantifying assist or standalone accuracy) is not present in this document. The emphasis is on the device's role as an aid or accessory to a pathologist, where the pathologist ultimately assures the validity of the score.

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WinSCAN is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC).

The WinSCAN System is an automated imaging system that scans peripheral blood smears for nucleated blood cells. WinSCAN software provides for operator interaction and decision making to identify nucleated red blood cells (nRBC), and enumerate them as #nRBC/100 white blood cells (WBC). The operator selects the recommended parameters for nucleated cells, starts the scan and can walk away. The system locates and stores color images of the nucleated cells for each slide, the operator reviews the data on the WinSCAN monitor, and classifies the nucleated cells as nRBC or WBC based on stain and nuclear characteristics. Identification parameters include light adsorption, size and shape.

Automatic relocation, capture and archiving of the cell images are performed by the instrument based upon operator selection. The instrument also can be used in the manual mode to systematically scan a slide and examine each field.

The WinSCAN System consists of the following components:

• Intel-based PC with Windows operating system .
• Monitor, kevboard, mouse .
• Switchstick control unit t
• Color printer for images and texts .
• Microscope with brightfield capability and 10x, 20x, 40x and 50x . objectives
• Set of transmission and excitation filters .
• Camera and image acquisition board t
• Motorized devices: stage, filter wheels, focus drive 0
• Motor controller unit and manual controls .

The Intel-based PC operates the instrument through the software program that coordinates control of the automated microscope. The base operating system of the PC consists of MicroSoft Windows 3.1 and DOS version 6.0. When the WinSCAN icon is selected from the Program Manager, WinSCAN software is downloaded and operation of the system can begin. The WinSCAN program includes all facilities to scan, relocate, and acquire images from a microscope slide. The WinSCAN software also performs image acquisition and scan functions, as well as archiving and relocation of images and facilitates operator review of cells. Classification of cells is performed by the operator.

The Monitor. Kevboard, Mouse, and switchstick control unit provide user interfaces to the system. The monitor displays all information to the user, including menus for navigating through the WinSCAN operation, image acquisition results and allows for operator visual review for operator classification of the nucleated cells found on a slide. The keyboard allows for user entry of scan parameters, slide numbers, user identification, comments, and annotation of results. The mouse/keyboard is used to interact with the instrument and software, including selecting menus and functions of the WinSCAN software and instrument.

A color printer is included with the system that allows the user to print results of scanning or acquired images of cells.

Here's a breakdown of the acceptance criteria and study information for the WinSCAN Automated Imaging System, based on the provided text:

Acceptance Criteria and Device Performance

Study Details

2. Sample sizes for the test set and data provenance:

The document does not explicitly state the sample size used for the test set. It mentions "30 samples" for precision testing but doesn't specify if this is the full test set for correlation.

Data Provenance: Not specified.

3. Number of experts used to establish the ground truth for the test set and their qualifications:

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set. The device itself relies on "operator interaction and decision making to identify nucleated red blood cells" and "operator review," implying human classification is integral, but it doesn't specify how the ground truth for testing was established.

4. Adjudication method for the test set:

The document does not specify an adjudication method. Given that cell classification is performed by an operator even in the device's intended use, it's possible that the "manual microscopy method" against which the device was compared served as a form of ground truth or reference, but no formal adjudication process is described.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:

The document mentions a comparison to the "standard manual microscope method" and states that "Results of studies demonstrate that WinSCAN is an effective tool that aids the operator in locating and classifying nucleated cells." It does not explicitly describe an MRMC study designed to measure the improvement in human readers' performance with AI assistance. The study focuses on the correlation of the device's output (when used by an operator) with manual methods, and the precision of the system.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

No, a standalone study was not performed. The WinSCAN system is explicitly designed for "operator interaction and decision making" and "operator review" for cell classification. The device "aids the operator in locating" cells, but the final classification is human-driven.

7. The type of ground truth used:

The ground truth appears to be based on the "standard manual microscope method." This implies human expert classification from traditional microscopy.

8. The sample size for the training set:

The document does not specify a sample size for a training set. Given the date (1998) and the description of the device as an "automated imaging system" that aids an operator in classification rather than an autonomous decision-making AI, it's likely that the "AI" component is more geared towards image processing, cell location, and presentation, rather than complex machine learning that requires a distinct training phase as understood today.

9. How the ground truth for the training set was established:

As no training set is mentioned (or implied in a modern AI sense), the method for establishing its ground truth is not applicable/not provided. The device's "identification parameters include light adsorption, size and shape," suggesting rule-based or conventional image processing techniques, rather than supervised machine learning requiring labeled training data.

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