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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

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The GenASIs ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern; and shape. The GenASIs ScanView System is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell types:

1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, Paraffin embedded human breast cancer tissue specimens with Vysis® Path Vysion™ HER-2 DNA Probe kit. Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and Pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5fluorouracil (CAF) chemotherapy.
3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus. from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.
4. Gene rearrangements involving the ALK gene (2p23) via fluorescence in situ hybridization (FISH) in formalin-fixed paraffin-embedded (FFPE) non-small cell lung cancer (NSCLC) tissue specimens, using Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit. The Vysis ALK Break Apart FISH Probe Kit is indicated to aid in identifying those patients eligible for treatment with XALKORI® (crizotinib). The GenASIs ALK System is an accessory to Vysis® ALK (Anaplastic Lymphoma Kinase) Break Apart FISH Probe kit.

The GenASIs ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The GenASIs ScanView System is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The system is designed to work with a manual or automated microscope and includes a dedicated, high powered microscope camera combined with state-of-the-art image analysis software for clinical and research oriented image analysis.

The system's modular platform enables automation of a wide range of laboratory selected assays in pathology and cytogenetics applications. This flexible solution may be adapted to the advanced automation and workflow needs of any laboratory or research institution. The system includes a fully automated computer-controlled microscope, motorized 9-slide stage and high powered microscope-camera. This platform also comes with a variety of additional components such as oil dispenser, automated fluorescent illumination control and state-of-the-art image analysis software for clinical and research oriented image analysis and automatic robotic slide loading system, enabling high throughput automated slide analysis for a wide range of pathology applications that provides a true "walk-away" functionality, scanning up to 81 slides consecutively without human intervention. These scanning capabilities presented with the GenASIs High Throughput platform offer an efficient way to optimally use the scanning and analysis system for uninterrupted scanning.

Acceptance Criteria and Device Performance Study for GenASIs ALK System

1. Table of Acceptance Criteria and Reported Device Performance

• For manually counted 61%: Mean 56.9, SD 4.6, %CV 8.0
• For manually counted 52%: Mean 46.9, SD 5.9, %CV 12.6
• For manually counted 85%: Mean 79.6, SD 5.2, %CV 6.5
• For manually counted 18%: Mean 22.2, SD 2.9, %CV 13.2
• For manually counted 27%: Mean 26.7, SD 4.2, %CV 15.9
• For manually counted 31%: Mean 29.6, SD 5.7, %CV 19.2
  Between-Day:
• For manually counted 61%: Mean 56.4, SD 3.7, %CV 6.7
• For manually counted 52%: Mean 47.5, SD 4.3, %CV 9.1
• For manually counted 85%: Mean 80.0, SD 3.8, %CV 4.8
• For manually counted 18%: Mean 25.2, SD 4.8, %CV 19.1
• For manually counted 27%: Mean 27.8, SD 3.8, %CV 13.6
• For manually counted 31%: Mean 32.6, SD 6.4, %CV 19.6
  Between-System:
• For manually counted 61%: Mean 56.2, SD 3.1, %CV 5.5
• For manually counted 52%: Mean 46.1, SD 4.4, %CV 9.5
• For manually counted 85%: Mean 79.4, SD 3.5, %CV 4.5
• For manually counted 18%: Mean 24.4, SD 5.0, %CV 20.5
• For manually counted 27%: Mean 28.3, SD 4.1, %CV 14.4
• For manually counted 31%: Mean 32.2, SD 5.9, %CV 18.2
  Within-day/Within Repeatability for specimens around the cutoff (10-25%):
• For manually counted 12%: Mean 11.6, SD 1.62, %CV 13.9
• For manually counted 19%: Mean 18.6, SD 1.13, %CV 6.0
• For manually counted 22%: Mean 19.7, SD 0.6, %CV 3.1
• For manually counted 18%: Mean 17.6, SD 0.98, %CV 5.6
• For manually counted 19%: Mean 19.6, SD 1.32, %CV 6.7 |

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: A total of 179 slides were used in the method comparison study for the test set. This included 9 cases within the equivocal zone (10-50%).
• Data Provenance: The slides were archived formalin-fixed paraffin-embedded (FFPE) tissue specimens from patients with non-small cell lung cancer (NSCLC) that had been previously counted and analyzed manually within the last 6 months at four different clinical sites. Negative cases were selected sequentially from a known bank of negative samples. All available positive and equivocal slides during the comparison studies were included. Patients included in the study were negative for the EGFR test.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

The document states that the ground truth for the test set was established by manual counting results that were performed "in the last 6 months" prior to the study. It does not explicitly state the number of experts used for these manual counts for each individual slide in the test set. However, the study involved four clinical sites, implying that multiple individuals performed these manual counts across the sites. The qualifications of these experts are not explicitly detailed beyond being the standard practice for "manual counting" in a clinical laboratory setting.

4. Adjudication Method for the Test Set

The document does not explicitly describe an adjudication method for the ground truth. It states that the GenAsIs ScanView operator had "no prior knowledge of the manual counting results." This implies that the manual counts served as the primary, pre-established reference standard against which the device's performance was compared, rather than a process of reaching consensus after the device results were obtained.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. The study compares the device's performance against pre-existing manual counts and assesses the device's own precision and reproducibility. There is no information provided about human readers improving with AI vs. without AI assistance. The GenASIs ALK System is described as an "adjunctive automated enumeration tool in conjunction with manual visualization," suggesting it is intended to assist, but the study design does not directly measure the effectiveness of this human-in-the-loop improvement.

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

Yes, a standalone performance study was conducted. The "Analytical Performance" section (Table 1) directly compares the GenASIs ScanView results (algorithm only, as the operator had "no prior knowledge of the manual counting results") against the manual method. This demonstrates the algorithm's performance without direct human intervention in the result determination during the comparative phase. The "Precision/Reproducibility" studies also evaluate the device's standalone consistency.

7. Type of Ground Truth Used

The ground truth used was expert consensus / manual counting results performed by laboratory personnel at the clinical sites. These manual counts were established prior to the device's evaluation and served as the reference standard.

8. Sample Size for the Training Set

The document does not provide any information about the sample size used for the training set. It focuses solely on the validation study using the test set.

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, as details about a training set are not included in this submission summary.

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The ScanView System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The Scan View is indicated as an accessory to the following FDA cleared/approved devices to detect the following cell lypes:

1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe Kit and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.
2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with Vysis® PathVysion™ HER-2 DNA Probe kit. Results from the PathVysion™ Kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The Path Vysion™ kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphanide, doxorubicin, and 5fluorouracil (CAF) chemotherapy.
3. Cells in urine specimens, stained by fluorescence in situ hybridization (FISH) using Vysis UroVysion™ Bladder Cancer Kit to detect aneuploidy for chromosomes 3, 7, 17, and loss of the 9p21 locus, from persons with hematuria suspected of having bladder cancer. The results are intended for use, in conjunction with and not in lieu of current standard diagnostic procedures, as an aid for initial diagnosis of bladder carcinoma in patients with hematuria and subsequent monitoring for tumor recurrence in patients previously diagnosed with bladder cancer.

The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and sean cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The provided document, K110345, is a 510(k) summary for the ScanView device. While it states that "Performance test data demonstrate that the device meets the required specifications," it does not include detailed acceptance criteria or the study data proving these criteria were met. The document focuses on the regulatory submission, device description, and indications for use, rather than a comprehensive performance study report.

Therefore, many of the requested details cannot be extracted from this document.

Here's an attempt to answer based on the available information, with clear indications of what is not present:

1. A table of acceptance criteria and the reported device performance

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

• Sample size for test set: Not provided.
• Data provenance: Not provided.

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)

• Number of experts: Not provided.
• Qualifications of experts: Not provided. The device "is intended for in vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist," implying these are the relevant expert roles.

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

• Adjudication method: Not provided.

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

• MRMC study: The document states the ScanView System "is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization." This implies human-in-the-loop operation, but it does not describe or provide results from a comparative effectiveness study (MRMC) to quantify improvement with AI assistance.
• Effect size of improvement: Not provided.

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

• The document describes the device as an "aiding tool" and "adjunctive automated enumeration tool in conjunction with manual visualization." This suggests it is not intended for standalone use, and therefore, a standalone performance study is unlikely to have been presented or applicable for this submission. No standalone performance data are provided.

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

• Type of ground truth: Not explicitly stated. Given the "pathologist or cytogeneticist" involvement and the specified FDA-cleared probe kits (CEP XY, PathVysion™ HER-2, UroVysion™ Bladder Cancer Kit), the ground truth for FISH often involves expert interpretation of the FISH signals (which can be considered a form of "expert consensus" or "pathology" within the context of cytogenetics). However, this is an inference, not directly stated.

8. The sample size for the training set

• Sample size for training set: Not provided.

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

• Ground truth establishment for training set: Not provided.

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The ScanView System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in the detection, classification and enumeration of cells of interest based on color, intensity, size, pattern, and shape. The ScanView is indicated to detect the following cell types:

1. CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Abbott Laboratories, Illinois, U.S.A) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants

2. Human breast cancer containing the HER-2/neu gene labeled in Red and the centromere of chromosome 17 labeled in Green via fluorescence in situ hybridization (FISH) in interphase nuclei from formalin-fixed, paraffin embedded human breast cancer tissue specimens with the Vysis® Path Vysion™ HER-2 DNA Probe kit.

The ScanView System is to be used as an adjunctive automated enumeration tool in conjunction with manual visualization.

The ScanView is an integrated digital imaging system constructed of an external microscope, motorized multi slide stage, camera, and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Experts can view and scan cells and record the image, using both bright field and fluorescent illumination. The acquired images can be enhanced, archived, retrieved and printed. The automated microscope enables Z motion of the slide and the motorized stage enables its X-Y motions. The microscope also includes motorized filter turret containing fluorescence filters.

The provided 510(k) summary for the ScanView K101291 device outlines its indications for use and states that "Bench and clinical data demonstrate that the device meets the required specifications." However, it does not provide the specific acceptance criteria or the detailed results of the study to prove that the device meets those criteria.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The specific criteria and performance metrics are not detailed.
• Sample size used for the test set and the data provenance: This information is not provided.
• Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
• Adjudication method for the test set: This information is not provided.
• 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: While the device is intended for "adjunctive automated enumeration," no MRMC study details or effect sizes are given.
• If a standalone (i.e. algorithm only without human-in-the loop performance) was done: No specific standalone performance study details are provided.
• The type of ground truth used: This information is not provided.
• The sample size for the training set: This information is not provided.
• How the ground truth for the training set was established: This information is not provided.

In summary, while the document confirms that studies were performed and that the device met specifications, the specific details of those studies, including acceptance criteria, performance results, and methodologies, are not included in this 510(k) Summary.

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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 Duet™ System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aiding tool 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:

• Detect Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from cell suspension.
• Detect amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
• Detect cells in urine specimens, stained by FISH (using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.
• 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® PathVysion™ HER-2 DNA Probe Kit. The Duet™ is to be used as an adjunctive automated enumeration tool, in conjunction with manual visualization, to assist in determining HER-2/neu gene to chromosome 17 signal ratio.

The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide screening by making a significant reduction in time and labor currently required.
The Duet™ System workstation integrates a microscope, CCD camera, motorized stage, computer, keyboard, mouse, joystick, monitor and a dedicated software program.
The Duet™ System scans in high resolution and in full color cell samples at high speed both in bright 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 unique feature of the Duet™ System allows the combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.

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

Acceptance Criteria and Device Performance

The core acceptance criteria for the Duet™ System's expanded indication for HER-2/neu gene amplification detection in breast cancer tissue specimens via FISH appears to be demonstrating high agreement with manual scoring methods. This is quantified through metrics like Negative Predictive Accuracy (NPA), Positive Predictive Accuracy (PPA), Overall Percentage Agreement, and Kappa coefficient.

The following table summarizes the reported performance for the device against these implied acceptance criteria, based on the analysis of all methods comparison studies (Studies 1 and 4 combined):

Additional Implied Acceptance Criteria and Performance:

• Reproducibility and Repeatability: High repeatability coefficients of variation (CV) for within-run, day-to-day, and site-to-site analyses. The reported CV values were generally low (0.56% to 12.90%), with one exception of 31.92% for a highly amplified sample where accurate spot counting was inherently difficult.
• Optimal Number of Fields of View (FOVs): Demonstration that a minimal number of FOVs (e.g., 3) provides sufficient accuracy. The study concluded that 3 FOVs are sufficient, with a correlation of 0.996 and an R-squared of 0.993 between 3 and 6 FOV analyses.

Study Details

The study that proves the device meets the acceptance criteria is a performance evaluation study that comprises four sub-studies:

1. Methods Comparison (Study 1): Compares the Duet™ System to manual scoring.
2. Precision/Reproducibility Performance (Study 2): Evaluates repeatability and reproducibility.
3. The Optimal Number of Fields of View (Study 3): Determines the optimal FOV count.
4. Methods Comparison at the Borderline Range (Study 4): Focuses on performance in challenging cases.

Detailed information for each requested point is provided below:

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

• Study 1 (Methods Comparison): A total of 56 specimen slides were used. These were prepared from human breast cancer tissue specimens in various stages of the disease, representing the entire intended use population. The data provenance is implied to be retrospective as the slides were "prepared from human breast cancer tissue specimens." The country of origin is not explicitly stated.
• Study 2 (Precision/Reproducibility): Five (5) slides were used, representing the range of intended use (two negative controls, two mid-low amplified controls, one highly amplified slide).
• Study 4 (Methods Comparison at the Borderline Range): A total of 21 human breast cancer tissue specimen slides were used. This included the seven (7) borderline samples from Study-1 and an additional fourteen (14) new borderline samples collected from an "additional site." This suggests retrospective data, and the country of origin is not explicitly stated.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• The text frequently refers to the "manual scoring method" as the comparator, which served as the ground truth. However, it does not specify the number of experts who performed the manual scoring nor their specific qualifications (e.g., "radiologist with 10 years of experience"). It implicitly refers to "the trained lab technician operator" for clinical use, suggesting the manual scoring was done by qualified laboratory personnel.

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 between manual readings or between manual and automated readings. The "manual scoring method" is treated as the reference standard against which the Duet™ System is compared.

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:

• No, an MRMC comparative effectiveness study was not explicitly described in terms of human readers improving with AI assistance. This study primarily focuses on the standalone performance of the Duet™ System compared to manual scoring. The device is intended to be an "adjunctive automated enumeration tool, in conjunction with manual visualization," implying it assists. However, the study design does not quantify the improvement of human readers when using the AI compared to when they don't. It assesses the agreement between the AI system and manual reading.

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

• Yes, a standalone performance study was done. The "Methods Comparison" studies (Study 1 and Study 4) directly compare the Duet™ System's results (algorithm only, as it performs automated scanning and image analysis) with the manual scoring method. The reported NPA, PPA, Overall Agreement, and Kappa values reflect the Duet™ System's accuracy as a standalone enumeration tool for the specified task. The text states: "...the Duet™ System method for detection of amplification... in comparison to the manual scoring method." This indicates a standalone evaluation of the device's output.

7. The type of ground truth used:

• The ground truth used was expert consensus / manual scoring. The text consistently refers to the "manual scoring method" as the reference standard against which the Duet™ System's performance was evaluated. 'Amplification' and 'No-Amplification' were defined based on ratios from the Vysis® PathVysion™ Kit's package insert, which guides manual interpretation.

8. The sample size for the training set:

• The document does not specify the sample size for the training set. The performance evaluation study focuses on the test set used to validate the already developed system after "minor software changes, including new algorithm for the automatic calculation of the overall amplification ratio of HER-2/neu gene, were made." It also states "All these changes were fully verified and validated through software verification and validation," implying a development and training phase occurred, but the details are not provided in this summary.

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

• As the document does not specify the training set size, it also does not detail how the ground truth for the training set was established. However, given the nature of the application (HER-2/neu FISH analysis) and the reliance on "manual scoring method" as ground truth for the validation studies, it is highly probable that the training data's ground truth was also established through expert manual scoring and adherence to the Vysis® PathVysion™ Kit instructions.

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The Duet™ System is an automated scanning microscope and image analysis system. It is intended for in-vitro diagnostic usc as an aiding tool 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 detect:

1. Hematopoietic cells stained by Giemsa stain, Immunohistochemistry or ISH (with bright field and fluorescent) prepared from ccll suspension.
2. Amniotic cells stained by FISH (using direct labeled DNA probes for chromosomes X, Y, 13, 18 and 21).
3. Cells in urine specimens, stained by FISH (using the Vysis UroVysion™ Bladder Cancer Recurrence Kit for chromosomes 3, 7, 17 and 9p21 locus), from subjects with transitional cell carcinoma of the bladder.

The Duet™ System is a fully integrated imaging and scanning platform that automates time-consuming and difficult laboratory tasks of slide screening by making a significant reduction in time and labor currently required. The Duet™ scans in high resolution and in full color cell samples at high speed both in bright light illumination and in fluorescent illumination. Duet™ 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 unique feature of the Duet system allows the presents combined presentation of morphological and specific staining information of the same cell, for all the cells of the sample.

Here's a detailed breakdown of the acceptance criteria and the studies performed for the Duet™ system, based on the provided 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

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Ariol™ 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 particular color, intensity, size, pattern, and shape.

This particular Ariol application is an accessory to the PathVysion® HER-2/neu DNA Probe kit (PathVysion, Vysis, Inc., Downers Grove, IL). PathVysion is designed to detect amplification of the HER-2/neu gene via fluorescence in situ hybridization (FISH) in formalin-fixed, paraffinembedded human breast cancer tissue specimens. Results from the PathVysion kit are intended for use as an adjunct to existing clinical and pathologic information used as prognostic factors in stage II, node-positive breast cancer patients. The PathVysion kit is further indicated as an aid to predict disease-free and overall survival in patients with stage II, node positive breast cancer, treated with adjuvant cyclophosphamide, doxorubicin, and 5-fluorouracil (CAF) chemotherapy. The PathVysion kit is also indicated as an aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered. While the PathVysion kit provides the probes that offer direct visualization and manual enumeration of the HER2 and Chromosome 17 genes with a fluorescent microscope, the Ariol may be used as an accessory that provides automated enumeration.

Ariol™ is an automated scanning microscope and image analysis system.

This looks like a medical device submission, specifically a 510(k) for an automated HER-2/neu FISH enumeration system called Ariol™. The provided text is a letter from the FDA acknowledging the substantial equivalence of the device and an "Indications for Use" statement.

Unfortunately, the provided text does not contain the acceptance criteria or a detailed study description with reported device performance. The FDA letter is an approval document, not the study results or the criteria themselves. The "Statement of Intended Use" only describes the device's purpose and its accessory nature to the PathVysion® HER-2/neu DNA Probe kit.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance
2. Sample sizes used for the test set and data provenance
3. Number of experts and their qualifications for ground truth
4. Adjudication method
5. MRMC comparative effectiveness study results or effect size
6. Stand-alone performance results
7. Type of ground truth used
8. Training set sample size
9. How ground truth for the training set was established

This information would typically be found in the scientific study report(s) submitted as part of the 510(k) application, which are not included in the provided document. The provided text only states that the device is "substantially equivalent" to predicate devices, implying that its performance has been demonstrated to be comparable, but it doesn't detail how that demonstration was done or the specific metrics achieved.

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The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

This particular CytoVision software application is an accessory to the CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc. Downer's Grove, IL) and is limited to the analysis of CEP XY probes via high magnification capture and analysis of interphase nuclei. CEP XY is indicated for use to assess the effectiveness of bone marrow transplantation in opposite-sex transplants.

The Applied Imaging CytoVision™ system is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use as an aid in chromosomal analysis. Cyto Vision assists in the location of interphase and metaphase nuclei on standard microscope slides using both brightfield and fluorescent microscopy.

This letter does not provide the detailed study results needed to complete all sections of your request. It's a 510(k) clearance letter, which confirms substantial equivalence to a predicate device, not a full summary of performance studies.

However, based on the provided text, here's what can be extracted:

1. A table of acceptance criteria and the reported device performance

This information is not provided in the given document. The letter states "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent," implying that performance data was submitted, but the specific acceptance criteria and reported device performance are not detailed here.

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

This information is not provided in the given document.

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)

This information is not provided in the given document.

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

This information is not provided in the given document.

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

This information is not provided in the given document. The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei," suggesting it operates as an aid, but no MRMC study details or effect sizes are mentioned.

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

The device is described as an "automated scanning microscope and image analysis system" that "assists in the location of interphase and metaphase nuclei." The "Indications For Use" state it is an "aid in chromosomal analysis" and "assists in the location of interphase and metaphase nuclei." This implies it's not a fully standalone diagnostic device but rather a tool to support human analysis. However, a standalone performance study of the algorithm within its assisting role is not explicitly described or quantified in this document.

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

This information is not provided in the given document. The device is used with the "CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit" for "analysis of CEP XY probes" to "assess the effectiveness of bone marrow transplantation." This suggests the ground truth would likely be related to the actual chromosomal status or transplant success, but how that ground truth was established for a study is not detailed.

8. The sample size for the training set

This information is not provided in the given document.

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

This information is not provided in the given document.

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The Vysis® AutoVysion™ System is an automated scanning microscope and image analysis system. It is intended for in vitro diagnostic use with the Vysis® PathVysion® HER-2 DNA Probe Kit to aid in the detection and enumeration of FISH signals in interphase nuclei. and to determine the LSI® HER-2 to CEP® 17 signal ratio of the HER-2/neu gene via FISH in formalinfixed, paraffin-embedded human breast cancer tissue specimens. The AutoVysion System is intended to reduce overall hands-on time by performing automated enumeration. For a small percentage of samples (less than 7%) manual enumeration may be required.

The Vysis® AutoVysion™ System is an adjunctive computer-assisted methodology to assist in the acquisition and measurement of images from microscope slides of formalin-fixed, paraffin-embedded breast cancer tissue sections for the presence of amplified HER-2/neu gene. The Vysis® AutoVysion™ System is intended for use as aid in determining HER-2/neu amplification status. in coniunction with optional manual visualization directly through the fluorescence microscope.

When used with the Vysis® PathVysion® HER-2 DNA Probe Kit, the Vysis® AutoVysion™ System is indicated for use as
a) an adjunct to existing clinical and pathologic information currently used as prognostic factors in stage II, node-positive breast cancer patients
b) an aid to predict disease-free and overall survival in patients with stage II. node positive breast cancer treated with adjuvant cyclophosphamide, doxorubicin and 5-fluorouracil (CAF) chemotherapy; and,
c) aid in the assessment of patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered (see HERCEPTIN package insert).

The Vysis® AutoVysion™ System consists of an automated fluorescence microscope with motorized scanning stage, a large-format monochrome CCD camera, computer and scanning and assay specific analysis software. The microscope is equipped with a mercury arc lamp for fluorescence epi-illumination; three single-pass fluorescence filter sets for DAPI, SpectrumGreen™ (SG) and SpectrumOrange™ (SO) and a triple-pass fluorescence filter set for DAPI/SG/SQ, all mounted in a motorized filter turret; 10x and 40x objectives in a motorized objective turret; 10x eyepieces; a CCD camera; and a motorized scanning stage that holds up to 8 slides. Images of single fluorescence colors are captured by the CCD camera and transferred to the computer. All functions are controlled by the System software.

Here is a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and the Data Provenance

• Reproducibility Test Set: 36 specimen slides prepared from four human breast tissue specimens (one normal, one borderline, one moderate, one high amplification). Each site received three of each specimen randomized over three days.
• Method Comparison Test Set: 234 clinical slides from 39 tumors with varying levels of HER-2/neu copy number.
• Data Provenance: Not explicitly stated, but it conducted at "3 clinical sites" and refers to "clinical slides from 39 tumors," implying a source from a clinical setting. It is a retrospective analysis in the sense that the slides were prepared "prior to shipment to the study sites" and then retrospectively analyzed using both methods. However, the exact country of origin or broader demographic information is not provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

• For the reproducibility and method comparison studies, the "ground truth" or reference method was conventional manual microscopy performed in accordance with Vysis® PathVysion® HER-2 DNA Probe Kit.
• The study states: "A qualified user visually inspects the tumor regions...identifies areas of tumor invasion...and records the coordinates." and "Final review and reporting of sample results is performed by a qualified user."
• It also states that the predicate method was "manual microscopy performed in accordance with Vysis® PathVysion® HER-2 DNA Probe Kit." This implies that the standard manual reading by trained personnel using the established kit constitutes the reference.
• The number of experts/manual readers for the comparison is not explicitly given, but it implies standard clinical practice where at least one "qualified user" would perform the manual enumeration. For the "two false positive results," the "manual" repetition implies multiple manual reads.
• Qualifications of experts: Described as "qualified user" or standard manual enumeration. Specific qualifications (e.g., "radiologist with 10 years of experience") are not provided.

4. Adjudication Method for the Test Set

• No formal adjudication method (e.g., 2+1, 3+1) is explicitly described for the initial ground truth establishment. The "ground truth" is defined by the results of "conventional manual microscopy performed in accordance with Vysis® PathVysion® HER-2 DNA Probe Kit." This suggests a single or standard manual read serves as the reference.
• For the two "false positive" discrepancies, a re-testing protocol was used where samples were "repeated six times manually and by the scanner," which could be considered a form of informal adjudication/re-evaluation for specific discrepant cases.

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

• No, a MRMC comparative effectiveness study was not performed in the context of human readers improving with AI vs without AI assistance.
• This study is a standalone performance study that compares the automated system's performance directly against the manual enumeration (the gold standard at the time).
• The device is described as an "adjunctive computer-assisted methodology to assist in the acquisition and measurement of images...in conjunction with optional manual visualization directly through the fluorescence microscope." However, the study presented compares the automated system's result to manual enumeration rather than measuring how human performance changes when using the system as an aid.

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

• Yes, a standalone performance study was done. The "Method comparison" section directly compares the "Vysis® AutoVysion™ System produced HER-2 to CEP 17 signal ratio" to "manually enumerated... HER-2 to CEP 17 signal ratio."
• The system operates "fully automatically" once target areas are identified by a user, then "hybridization signals in each area are detected and enumerated automatically." Final review and reporting are performed by a qualified user, but the core enumeration is automated. The performance metrics reported (concordance, agreement, bias) are for this standalone automated enumeration process compared to manual.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• The ground truth used was expert manual enumeration (or "conventional manual microscopy") following the Vysis® PathVysion® HER-2 DNA Probe Kit protocol. This is considered the established clinical method for determining HER-2/neu amplification status at the time.

8. The Sample Size for the Training Set

• The document does not specify the sample size for the training set for the AutoVysion™ System. It only describes the test sets used for analytical performance evaluations.

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

• The document does not describe how the ground truth for any potential training set was established. It focuses solely on the validation/performance evaluation of the already developed system.

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