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The Ikoniscope® oncoFISH® her2 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. The Ikoniscope® oncoFISH® her2 Test System is intended to detect and quantify chromosome 17 and the HER-2 gene via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens, probed with the Abbott PathVysion® HER-2 DNA Probe Kit. The Ikoniscope® oncoFISH® her2 Test System is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining Her-2 gene to chromosome 17 signal ratio.

The Ikoniscope oncoFISH her2 Test System is an automated scanning microscope coupled with image analysis, acquisition, and display functions, which is intended to increase the efficiency of current cell analysis methods, by decreasing the amount of time an operator spends scanning slides in search of the cells of interest. In the manual procedure, the operator/reader identifies gene presence and number by identifying the colors provided by the Fluorescence in situ Hybridization ("FISH") probes, and manually counts the number of genes appearing within each cell containing such signals. The Ikoniscope oncoFISH her2 Test System incorporates automated slide loading and handling, bright field H&E equivalent image acquisition, low and high magnification scanning to identify targets of interest and digital image acquisition, coupled with an image analysis workstation. The system is capable of imaging an H&E slide and a FISH slide. The provided desktop scanner supplies an image of the H&E stained slide. By aligning the H&E stained slide with the FISH probed slide, the user can identify which section of the sample they would like the instrument to visit at high magnification. The Ikoniscope system will only visit the selected area at high magnification, greatly decreasing scanning time. Microscope slides, prepared according to the DNA probe (her2/neu PathVysion) manufacturers' specifications are placed into a multiple slide cassette, and loaded into the Ikoniscope oncoFISH® her2 Test System. The system loads each slide, scans each one, and returns it to the cassette automatically. During scanning, images of cells exhibiting the predetermined characteristics for FISH signals are digitally photographed and stored. After all the slides are scanned, the workstation provides an image gallery for each slide that displays the image of each cell meeting predetermined characteristics and quantity, and places scanned nuclei into scorable categories, established according the specifications in the DNA probes FDA approved labeling. The operator/reader can then evaluate the cell nuclei, and make the diagnostic determination accordingly. The Ikonisys oncoFISH her2 Test System combines elements of existing technologies to perform its function.

Here's a summary of the acceptance criteria and the study that proves the Ikoniscope® oncoFISH® her2 Test System meets them, based solely on the provided text:

Acceptance Criteria and Device Performance

The provided text focuses on the concordance and reproducibility of the Ikoniscope oncoFISH her2 Test System compared to the manual PathVysion enumeration method. The acceptance criteria themselves are not explicitly stated as numerical targets in a table, but rather implied by the reported performance.

Implicit Acceptance Criteria and Reported Device Performance:

• PathVysion manual: HER2 ratio range of 0.8-1.91
• Ikoniscope: HER2 ratio range of 0.75-1.98
  Amplified:
• PathVysion manual: HER2 ratio range of 2.02-11.3
• Ikoniscope: HER2 ratio range of 2.04-7.96 |
  | Good reproducibility of HER2 ratio results across different sites and days. | PathVysion manual reproducibility:
• HER2 ratio range for 6 slides: 1.44-2.0; 1.07-1.8; 0.98-1.24; 0.88-1.3; 5.66-12.5; 1.06-2.5
• Classification (NA/A) consistency: e.g., for slide 1: 8NA-1A; for slide 5: 9A.
  Ikoniscope oncoFISH her2 reproducibility:
• HER2 ratio range for 6 slides: 1.37-2.26; 1.14-2.08; 0.96-1.71; 0.76-1.4; 6.19-12.9; 1.06-2.0
• Classification (NA/A) consistency: e.g., for slide 1: 8NA-1A; for slide 5: 9A. |
  | Low scan-to-scan variation within the Ikoniscope system. | For three scans of the same six slides:
• HER2 ratio means: 1.63, 1.63, 1.31, 1.45, 10.36, 1.66
• Coefficient of Variation (C.V.s): 3.06, 4.79, 6.54, 11.49, 5.49, and 6.00 |

Study Details:

1. Sample size used for the test set and the data provenance:

   • Concordance Study: 182 slides. The text states these were "PathVysion slides from four (4) collection sites." The data provenance (e.g., country of origin) is not specified. The study design implies retrospective use of collected slides.
   • Reproducibility Study: A "sponsor supplied panel of clinical slides" was used. Each of three clinical sites tested slides for three non-consecutive days, resulting in 18 results (manual PathVysion) and 18 results (oncoFISH her2) per site for each specific slide in the panel. The exact number of unique slides in the panel is not explicitly stated, but it refers to a "slide panel of clinical slides." The text refers to "panel slides 1, 2, 3, 4, 5 and 6", suggesting 6 unique slides tested repeatedly.
   • Scan-to-scan variation study: One daily panel of 6 slides was re-scanned two additional times.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   The document does not explicitly state the number of experts or their qualifications used to establish the "ground truth." The concordance study compares the Ikoniscope's performance against the "standard PathVysion manual enumeration method." In this context, the results obtained from the manual PathVysion enumeration method serve as the reference standard, implicitly performed by qualified technologists or pathologists, though their specific number and qualifications are not detailed.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   The document does not describe any specific adjudication method used for either the concordance or reproducibility studies beyond stating that the Ikoniscope results were compared to "PathVysion manual enumeration method." There is no mention of multiple readers or a tie-breaking process.

4. 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:
   No MRMC comparative effectiveness study is explicitly described where human readers' performance with and without AI assistance is quantitatively measured. The device is described as an "adjunctive automated enumeration tool, in conjunction with manual visualization," implying human-in-the-loop, but the study focuses on the concordance of the device's output with manual methods, not how human readers' diagnostic accuracy or efficiency changes when using the device.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   Yes, implicitly. The "concordance" study directly compares the results generated by the Ikoniscope system (which uses "pattern recognition algorithms to identify the signal characteristics of interest") to the manual enumeration method. The Ikoniscope's reported performance (e.g., HER2 ratio ranges, classification of Non-Amplified/Amplified) represents its output before the final human "evaluation of the cell nuclei" and "diagnostic determination." The system "places scanned nuclei into scorable categories," and the reported concordance is based on these algorithmic classifications. The device is intended as an aid and "assistant," suggesting a human-in-the-loop for final diagnoses, but the core performance evaluation presented focuses on the algorithm's ability to enumerate and classify, which can be considered standalone performance in its analytical function.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   The ground truth in the concordance study is based on the results from the "standard PathVysion manual enumeration method." This manual method itself relies on expert pathology/technologist assessment of FISH signals. It is essentially expert enumeration/classification using a gold-standard manual method. It is not explicitly stated as "expert consensus" from multiple independent experts, but rather the accepted manual procedure.

7. The sample size for the training set:
   The document does not provide information about the sample size used for the training set of the Ikoniscope's algorithms.

8. How the ground truth for the training set was established:
   The document does not provide information on how the ground truth for the training set was established.

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