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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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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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