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The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. It is intended for in-vitro diagnosis as an aide to the technologist or pathologist in the detection, classification and enumeration of cells of interest based on particular characteristics such as intensity, size, shape or fluorescence. Following fully automated scanning, the system produces a summary report of the frequency of FISH signals detected from each chromosome of interest as a basis for the diagnostic conclusion. The system also provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion. The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is intended to detect amniotic cells stained by FISH using commercially available direct labeled DNA probes or chromosomes X, Y, 13, 18 and 21.

The Ikoniscope™ fastFISH™ Auto/Amniocyte Test System is an automated scanning microscope coupled with image analysis, acquisition and display functions. Microscope slides, prepared according to the DNA probe manufacturers' specifications, are placed into a multiple slide cassette, and loaded into the Ikoniscope™ fastFISH™ Auto/Amniocyte Test System microscope system. The system loads each slide on the automated stage, scans, and returns it to the cassette automatically. During scanning, images of cells exhibiting the predetermined characteristics for FISH signals are digitally imaged and stored. After all the slides are scanned, the workstation provides a summary of the FISH signals detected from each chromosome of interest and an image gallery that displays the image of each nucleus meeting predetermined characteristics and quantity. The medical professional can review the images to evaluate the condition of the cells, and make the diagnostic determination accordingly.

The provided text describes the Ikoniscope™ fastFISH™ Auto/Amniocyte Test System, its intended use, and its substantial equivalence to predicate devices, but it contains no specific information regarding acceptance criteria, reported device performance data, or detailed study methodology to prove that the device meets acceptance criteria.

The submission is a 510(k) summary, which focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices, rather than presenting a detailed clinical study to establish new performance criteria.

Therefore, many of the requested information points cannot be extracted from 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 a clinical trial was performed to "determine the accuracy of the system compared with manual FISH analysis" and to "demonstrate the reproducibility of results between systems." However, it does not present the specific acceptance criteria (e.g., minimum sensitivity, specificity, or agreement rates) nor the reported device performance data from these studies.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Cannot be provided: The document mentions "a clinical trial" and a trial "to demonstrate reproducibility" but does not specify the sample sizes used for these test sets, nor the data provenance (e.g., retrospective/prospective, country of origin).

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)

• Cannot be provided: The document does not specify the number or qualifications of experts used to establish ground truth for the test set. It mentions comparison with "manual FISH analysis," implying human interpretation, but no details are given.

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

• Cannot be provided: The document does not describe any adjudication method used for the test set's ground truth.

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

• Partially Answered: A "clinical trial" was conducted to "determine the accuracy of the system compared with manual FISH analysis." This suggests a comparison, but it's unclear if it was a multi-reader, multi-case study in the formal sense.
• Effect Size Cannot be Provided: The document does not report any effect size or specific metrics on how much human readers improve with AI assistance from this study.

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

• Implied Yes, but No Data: The device is described as an "automated scanning microscope coupled with image analysis, acquisition and display functions" that "produces a summary report of the frequency of FISH signals detected." This implies a standalone algorithmic assessment. However, no standalone performance metrics are provided. The system is intended as an "aide to the technologist or pathologist," and "provides images of all nuclei scanned for review by the medical professional to confirm the diagnostic conclusion," suggesting it's always intended for human review.

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

• Partially Answered: The ground truth for the study was "manual FISH analysis," which implies expert human interpretation of FISH slides. It does not mention pathology, outcomes data, or a formal expert consensus process.

8. The sample size for the training set

• Cannot be provided: The document does not mention the sample size used for the training set.

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

• Cannot be provided: The document does not describe how the ground truth for any potential training set was established. The focus is on the clinical comparison for substantial equivalence.

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