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The FISHView system is intended to be used for karyotyping with realtime microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.

In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.

The FISHView system does require and relies on the operator to analyze the digitized microscope images.

The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.

The provided text is a 510(k) summary for the FISHView device. It outlines the device description, indications for use, and a general statement about safety and effectiveness. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in the prompt regarding a study that proves the device meets acceptance criteria.

The 510(k) summary states: "Bench and clinical data demonstrate that the FISHView meets the required specifications. No adverse affects have been detected." This is a general statement and does not provide the detailed evidence requested.

Therefore, an exhaustive answer for all requested points cannot be provided based on the given text.

Here's a breakdown of what can and cannot be answered:

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

• Cannot be provided. The document states that the device "meets the required specifications," but it does not list those specifications (acceptance criteria) or specific performance metrics.

2. Sample sized used for the test set and the data provenance:

• Cannot be provided. The document mentions "Bench and clinical data" but does not specify the sample sizes or the provenance (country of origin, retrospective/prospective) of this data.

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

• Cannot be provided. This information is not present in the document.

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

• Cannot be provided. This information is not present in the 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:

• Cannot be provided. The document mentions the FISHView system is an "aiding tool" and "relies on the operator to analyze the digitized microscope images," implying human involvement. However, it does not describe a comparative effectiveness study or any effect size for human reader improvement with AI assistance.

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

• Likely no, or not relevant for the primary function. The document explicitly states: "The FISHView system does require and relies on the operator to analyze the digitized microscope images." This contradicts a standalone (algorithm only) performance claim for its primary purpose of analysis.

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

• Cannot be provided. While it's implied that expert analysis (cytogeneticists) is central to the process, the specific method for establishing ground truth within the undisclosed "clinical data" is not detailed.

8. The sample size for the training set:

• Cannot be provided. The document refers to "Bench and clinical data" but does not distinguish between training and test sets, nor does it provide sample sizes for either.

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

• Cannot be provided. As with the training set size, this information is not disclosed.

In summary, the provided 510(k) document serves as a regulatory submission confirming substantial equivalence to predicate devices, but it does not include the detailed scientific study information requested.

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