(126 days)
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:
- A table of acceptance criteria and the reported device performance
- Sample sizes used for the test set and data provenance
- Number of experts and their qualifications for ground truth
- Adjudication method
- MRMC comparative effectiveness study results or effect size
- Stand-alone performance results
- Type of ground truth used
- Training set sample size
- 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.
§ 866.4700 Automated fluorescence
in situ hybridization (FISH) enumeration systems.(a)
Identification. An automated FISH enumeration system is a device that consists of an automated scanning microscope, image analysis system, and customized software applications for FISH assays. This device is intended for in vitro diagnostic use with FISH assays as an aid in the detection, counting and classification of cells based on recognition of cellular color, size, and shape, and in the detection and enumeration of FISH signals in interphase nuclei of formalin-fixed, paraffin-embedded human tissue specimens.(b)
Classification. Class II (special controls). The special control is FDA's guidance document entitled “Class II Special Controls Guidance Document: Automated Fluorescencein situ Hybridization (FISH) Enumeration Systems.” See § 866.1(e) for the availability of this guidance document.