(127 days)
The Ikoniscope™ fastFISH™ Amnio 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™ fastFISH™ Amnio Test System is intended to detect amniotic cells stained by FISH using commercially available, FDA approved, direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21.
The Ikoniscope™ fastFISH™ Amnio Imaging system 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. The operator/reader identifies chromosome presence by identifying the colors provided by the Fluorescence In Sites Hybridization ("FISH") probes, and manually counts the number of chromosomes appearing within each cell containing such signals.
The Ikoniscope™ fastFISH™ Amnio Test System is an automated scanning microscope system incorporating automated slide loading and handing, low and high magnificrotion scanning to identify targets of interest and digital image acquisition, coupled with an image analysis workstation. Microscope slides, prepared according to the DNA probe manufacturers' specifications, are placed into a multiple slide cassette, and loaded into the Ikoniscope™ fastFISH™ Amnio Test System microscope system, The system unloads 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. The operator/reader can then evaluate the cell nuclei, and make the diagnostic determination accordingly.
The Ikonisys fastFISH™ Imaging System combines elements of existing technologies to perform its function.
- Fluorescence In-Situ Hybridization (FISH) -- uses commercially available DNA . probes (not supplied with the test system) for marking chromosomes 13, 18, 21, X and Y.
- Automated Cell Locating/Counting using pattern recognition algorithms to identify . the signal characteristics of interest.
The Ikoniscope™ software automatically captures an image of each cell containing FISH signals and stores its location on the slide. These images are then presented to the operator, using a computer workstation, for analysis.
Here's a breakdown of the acceptance criteria and study information for the Ikoniscope™ fastFISH™ Amnio Test System, based on the provided document:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Diagnostic Result Concordance (comparison to manual FISH analysis) | 100% concordance between the Ikoniscope™ fastFISH™ Amnio Test System and standard manual FISH analysis in terms of diagnostic result. |
| Reproducibility (no variability based on operator, instrument, or run) | "This trial demonstrated no variability of results on the basis of operator, instrument or run." |
Study Details
2. Sample Size Used for the Test Set and Data Provenance:
The document does not explicitly state the sample size for the clinical trial that evaluated diagnostic accuracy against manual FISH analysis, nor does it specify the number of samples used for the reproducibility trial. The data provenance (e.g., country of origin, retrospective or prospective) is also not mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
The document does not explicitly state the number of experts or their specific qualifications for establishing the ground truth. It refers to "standard manual FISH analysis" as the comparator method, implying that qualified personnel performed this analysis.
4. Adjudication Method for the Test Set:
The document does not describe any specific adjudication method. The comparison was made "compared with the results of standard manual FISH analysis."
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:
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly conducted as described. The study compared the device's results to manual FISH analysis, with the device acting as an aid to the technologist/pathologist. The document states its purpose is to "increase the efficiency of current cell analysis methods, by decreasing the amount of time an operator spends scanning slides." It does not quantify the improvement of human readers with AI assistance versus without AI assistance in terms of effect size on diagnostic accuracy or specific metrics beyond efficiency.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
Yes, a standalone performance study was implicitly done to establish the device's accuracy. The comparison was directly between the "Ikoniscope™ fastFISH™ Amnio Test System" and "standard manual FISH analysis." The device "automatically captures an image of each cell containing FISH signals and stores its location on the slide" and "the workstation provides an image gallery for each slide that displays the image of each cell meeting predetermined characteristics and quantity." This suggests the system itself performs the initial analysis, with the operator then evaluating the results. While the operator makes the final diagnostic determination, the device's "100% concordance" and "no variability" indicate its standalone processing capabilities were assessed.
7. The Type of Ground Truth Used:
The ground truth used was expert manual FISH analysis. The device's performance was compared against the "results of standard manual FISH analysis."
8. The Sample Size for the Training Set:
The document does not provide any information regarding the sample size used for the training set of the Ikoniscope™'s pattern recognition algorithms.
9. How the Ground Truth for the Training Set Was Established:
The document does not provide any information on how the ground truth for the training set was established. It only mentions that the system uses "pattern recognition algorithms to identify the signal characteristics of interest."
§ 864.5260 Automated cell-locating device.
(a)
Identification. An automated cell-locating device is a device used to locate blood cells on a peripheral blood smear, allowing the operator to identify and classify each cell according to type. (Peripheral blood is blood circulating in one of the body's extremities, such as the arm.)(b)
Classification. Class II (performance standards).