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The BandView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. 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 BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.

The BandView system aids the cytogenetic specialist in the preparation of karyotypes of human cells in their metaphase. By transferring images of chromosome spreads from the microscope to a computer, the labor-intensive manual processing of photographs, data archiving and document preparation is eliminated. Karyotypes are assembled by the operator with the support of the Band View analysis software.

The BandView system does not locate metaphase spreads, it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the cytogeneticist to manipulate the digitized microscope images.

The provided text does not contain a study that demonstrates the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the BandView system, an automated cell-locating device. The summary focuses on establishing substantial equivalence to predicate devices and outlining the device's intended use and limitations.

Therefore, I cannot populate the table or answer most of the questions as the information about a performance study, acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's what can be extracted from the text:

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

The document does not specify any quantitative "acceptance criteria" or provide "reported device performance" against such criteria. It states that "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." It only mentions compliance with voluntary standards related to electromagnetic compatibility and risk analysis (EN 55022:1998, EN 55024:1998, IEC 61000-4-2:1995, EN-1441: Medical devices Risk Analysis). These are general engineering/safety standards, not specific performance criteria for karyotyping accuracy.

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 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 document.

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

This information is not provided 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

The document states that the "BandView system does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images." This indicates it's an assistive device, not one for which an MRMC study comparing AI vs. human performance would typically be presented for its 510(k) submission. No such study is mentioned.

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

The device is explicitly stated to "require and relies completely on the operator to manipulate the digitized microscope images," meaning it's not a standalone algorithm. Its performance is intrinsically linked to human interaction.

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

This information is not provided in the document. Given the nature of the device assisting in karyotyping, the implicit "ground truth" during clinical use would be the cytogenetic specialist's final interpretation, but how this was used for validation (if any was performed and documented here) is unknown.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

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