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The Duet™ System 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 color, intensity, size, pattern and shape.

The Duet™ System is intended to:

1. Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with brightfield and fluorescent) prepared from cell suspension.

2. Detect Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X. Y. 13, 18 and 21).

3. Detect Aneuploidy for chromosomes 3,7. 17 and loss of the 9p21 locus via FISH in Urine specimens from subjects with transitional cell carcinoma of the bladder, probed by the Vysis Urovysion Bladder Cancer Kit.

4. Detect and quantify chromosome 17 and the HER-2/neu gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed by the Vysis® Path Vysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual review of the digital image, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.

5. Qualitatively detect rearrangements involving the ALK gene via fluorescence in situ hybridization (FISH) in formalinfixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, probed with the Vysis ® ALK Break Apart FISH Probe Kit. The Duer™ is to be used as an adjunctive autonated enumeration with manual review of the digital image. Note: The pathologist should verify the image analysis software application score.

The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide scanning.

The Duet™ System workstation integrates a microscope, CCD camera, motorized stage / slide-loader, computer, keyboard, mouse, joystick, monitor and a dedicated software program.

The Duet™ System is software controlled and includes features such as: acquisition of images, views, editing, relocation, enhancement capabilities, automatic/manual counting and classification, printing, export of images and backups.

The Duet™ System scans in high resolution cell samples at high speed both in bright light illumination and in fluorescent illumination.

The Duet™ System suggests classification of the cells according to their morphological features, their staining (Giemsa, IHC) and fluorescent signals, and allows the user to quickly examine the results, correct them as needed and generate a report summarizing the sample's data. The Duet™ system allows combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size and Data Provenance for the Test Set

• Reproducibility and Repeatability Study (Study 1):
  • Sample Size: A panel of 16 archived clinical specimen slides. These were categorized into four groups based on positive cell percentage: <10%, 10-25%, 25-50%, and ≥ 50%. There were 4 samples in each of these four value ranges.
  • Data Provenance: The document states "archived clinical specimen slides." No specific country of origin is mentioned, but the manufacturer is based in Israel. The data is retrospective.
• Analytical Performance/Methods Comparison Study (Study 2):
  • Sample Size: 113 specimen slides. Out of these, 32 were positive and 11 were equivocal.
  • Data Provenance: The slides were prepared and probed using the ALK Kit. No specific country of origin is mentioned. The data appears to be retrospective clinical samples.
• Configurations Method Comparison Study (Study 3):
  • Sample Size: Not explicitly stated as a single number. It included "patient slides from each of the four previously cleared indications" and "samples were selected to cover the intended use of both Normal, Abnormal and near the medical decision/cut-off (as applicable)."
  • Data Provenance: Clinical specimens. No specific country of origin is mentioned. The data appears to be retrospective.

3. Number of Experts and Qualifications for Ground Truth

• For the Reproducibility and Repeatability Study (Study 1) and Analytical Performance/Methods Comparison Study (Study 2): The studies compare the Duet™ System's performance to "manual system" or "manual scoring method." The document implies that the manual scoring is performed by pathologists in the intended use. While not explicitly stated, it's typical for the ground truth in such studies to be established by qualified pathologists or clinical laboratory scientists with expertise in FISH analysis. The number of experts is not specified.
• For the Configurations Method Comparison Study (Study 3): The comparison was made between the new and cleared configurations, with the "final interpretation of results" being identical. This suggests the ground truth was established based on the existing standard of interpretation (likely by pathologists) for the previously cleared indications. The number and qualifications of experts are not explicitly detailed.

4. Adjudication Method for the Test Set

• The document does not explicitly describe an adjudication method like 2+1 or 3+1 for resolving discrepancies in the test set.
• For the Analytical Performance/Methods Comparison Study (Study 2), it's a direct comparison against a "manual scoring method." The outcome suggests a high level of agreement, implying that the manual scoring itself served as the reference.
• For the Reproducibility and Repeatability Study (Study 1), variability between runs, days, and sites was measured, not necessarily involving adjudication for a single ground truth.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No specific MRMC comparative effectiveness study is explicitly mentioned to evaluate how much human readers improve with AI vs. without AI assistance. The studies presented focus on the device's accuracy and precision compared to a manual method (Study 2) or its own internal consistency (Study 1). The device is noted as an "adjunctive automated enumeration tool, in conjunction with manual review of the digital image," implying a human-in-the-loop workflow, but a formal MRMC study demonstrating improvement in human performance with the device is not detailed.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)

• Yes, a standalone performance ("algorithm only without human-in-the-loop performance") was done. The Analytical Performance/Methods Comparison Study (Study 2) directly compares the "Duet™ System method" (which is automated imaging and analysis, i.e., the algorithm) to the "manual scoring method." The results presented, such as "Percent Agreement with Manual Negative" and "Percent Overall Agreement," are measures of the algorithm's performance against the human read. The device is intended as an "adjunctive automated enumeration tool," meaning the pathologist verifies the score, but the study assesses the machine's initial analytical performance.

7. Type of Ground Truth Used

• Expert Consensus / Manual Scoring: For the Analytical Performance/Methods Comparison Study (Study 2), the ground truth was established by "manual scoring method." This implies that trained personnel (likely pathologists or clinical laboratory scientists) manually interpreted the slides to establish the reference standard.
• Clinical Specimen Characteristics: For the Reproducibility and Repeatability Study (Study 1), the ground truth for "positive" and "negative" categorizations, as well as the percentage of positive cells, was based on the characteristics of the "archived clinical specimen slides."
• Existing Standards: For the Configurations Method Comparison Study (Study 3), the ground truth was based on the "final interpretation of results" for the previously cleared indications, implying adherence to established clinical criteria and interpretations.

8. Sample Size for the Training Set

• The document does not explicitly state the sample size used for training the Duet™ System's algorithms. The studies described are performance evaluation studies, which would typically use a separate test set, distinct from any training data.

9. How the Ground Truth for the Training Set was Established

• Since the document does not explicitly mention the training set size, it also does not detail how the ground truth for the training set was established. However, for medical imaging analysis systems, training data ground truth is generally established by expert annotation (e.g., pathologists marking regions of interest, classifying cells) or by using slides with known clinical outcomes, often confirmed by pathology or other definitive diagnostic methods.

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