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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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The Ikoniscope® oncoFISH™ Bladder 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™ Bladder Test System is intended to detect cells, derived from urine samples, stained by FISH using commercially available direct labeled DNA probes for chromosomes 3, 7, 17 and loss of 9p21 locus. Following identification, a summary report is generated which may provide the basis for a diagnostic determination by the genetics professional and a gallery of the images scanned is presented for review to permit the professional to confirm or deny the diagnosis.

The Ikoniscope® oncoFISH™ Bladder Test 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 Situ Hybridization ("FISH") probes, and manually counts the number of chromosomes appearing within each cell containing such signals. The Ikoniscope® oncoFISH™ Bladder Test System is an automated scanning microscope system incorporating automated slide loading and handing, low and high magnification 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® oncoFISH™ Bladder 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 nucleus meeting predetermined characteristics and quantity in scorable categories. The operator/reader can then evaluate the cell nuclei, and make the diagnostic determination accordingly. The Ikonisyscope® oncoFISH™ Imaging System combines elements of existing technologies to perform its function, Fluorescence In-Situ Hybridization (FISH) uses commercially available, . FDA cleared, DNA probes (not supplied with the test system) for marking chromosomes 3. 7. 17. and the loss of 9p21 locus. Automated Cell Locating/Counting using pattern recognition algorithms to identify the signal characteristics of interest and sort them into scorable categories as defined in the Instructions for Use for the Vysis UroVysion™ DNA Probe Kit. 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 in a gallery that displays cells in scorable categories and stores each image for review by the cytotechnologist, cytogeneticist or pathologist for final diagnostic determination.

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state numerical acceptance criteria in a dedicated section. However, it implies performance expectations based on comparison to its predicate device and manual FISH analysis. The primary performance metric reported is concordance.

2. Sample Sizes and Data Provenance:

• Test Set (Clinical Comparison):

  • Sample Size: 100 patient samples (for comparison with manual analysis).
  • Data Provenance: Not explicitly stated, but likely from a clinical setting, presumably in the US. The study is described as a "clinical trial," suggesting prospective data collection for this particular evaluation.

• Test Set (Inter-system Reproducibility):

  • Sample Size: 50 individual patient slides.
  • Data Provenance: Not explicitly stated, but likely from a clinical setting, presumably in the US.

• Test Set (Reproducibility for Predicate K062755):

  • Sample Size: 100 samples.
  • Data Provenance: Not explicitly stated, but this refers to a prior study for the predicate device.

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: The document does not explicitly state the number of experts used to establish the ground truth for the test set. However, it mentions "standard manual analysis to perform the FISH analysis" and "the genetic professional," "cytotechnologist, cytogeneticist or pathologist" as the individuals who would make the final diagnostic determination. This implies that qualified professionals perform the ground truth evaluation.
• Qualifications of Experts: The qualifications are implied to be a "genetics professional," "cytotechnologist, cytogeneticist or pathologist." The specific level of experience (e.g., "10 years of experience") is not provided.

4. Adjudication Method for the Test Set:

The document does not explicitly describe an adjudication method (e.g., 2+1, 3+1). The "ground truth" for the clinical trial was established by "standard manual analysis." It is not clear if multiple readers were involved in the manual analysis for each case or how discrepancies, if any, were resolved.

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

No explicit MRMC comparative effectiveness study is described where human readers' performance with AI assistance is compared to without AI assistance to measure an effect size. The study compares the system's performance (Ikoniscope® oncoFISH™ Bladder Test System) to standard manual evaluation. The system is intended to "assist the operator" and "increase the efficiency of current cell analysis methods," but a direct comparison of human performance improvement with AI aid is not provided. The system itself essentially performs initial identification and presents images for human review and final diagnostic determination.

6. Standalone (Algorithm Only) Performance:

Yes, a standalone performance evaluation was done implicitly for the "Nucleus Specific Accuracy Test (Fish dot counting)" and the comparison to manual analysis. The device itself performs the "automated cell locating/counting using pattern recognition algorithms to identify the signal characteristics of interest and sort them into scorable categories." The reported 99% concordance reflects the performance of the system's output (which is then reviewed by a human for final diagnosis) against the full manual process.

7. Type of Ground Truth Used:

The ground truth used was expert consensus / manual evaluation. The "standard manual analysis to perform the FISH analysis" by genetics professionals, cytotechnologists, cytogeneticists, or pathologists served as the reference standard.

8. Sample Size for the Training Set:

The document does not provide information regarding the sample size used for the training set of the Ikoniscope® oncoFISH™ Bladder Test System's algorithms.

9. How 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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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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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

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."

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