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The ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types:

1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) 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

2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path Vysion™ HER-2 DNA Probe kit.

The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The provided 510(k) summary for the ScanView K101291 device outlines its indications for use and states that "Bench and clinical data demonstrate that the device meets the required specifications." However, it does not provide the specific acceptance criteria or the detailed results of the study to prove that the device meets those criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The specific criteria and performance metrics are not detailed.
• Sample size used for the test set and the data provenance: This information is not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• Adjudication method for the test set: This information is not provided.
• 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: While the device is intended for "adjunctive automated enumeration," no MRMC study details or effect sizes are given.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No specific standalone performance study details are provided.
• The type of ground truth used: This information is not provided.
• The sample size for the training set: This information is not provided.
• How the ground truth for the training set was established: This information is not provided.

In summary, while the document confirms that studies were performed and that the device met specifications, the specific details of those studies, including acceptance criteria, performance results, and methodologies, are not included in this 510(k) Summary.

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