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The GenASIs HiPath IHC Family provides image capture, management, analysis, and viewing of specific immunohistochemically stained slides. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting, review and classification of tissues and cells of clinical interest based on particular morphology, color, intensity, size, pattern and shape:

1. The GenASIs HiPath IHC Family for HER2 (4B5) is for image capture and analysis applications. This particular system is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2 protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to Ventana Medical Systems, Inc. PATHWAY® anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody. The PATHWAY® anti-HER2/ neu (4B5) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN® (Trastuzumab) treatment is being considered.

NOTE: The GenASIs HiPath IHC Family for HER2 (4BS) image capture and analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and semi-quantitative measurement of images from microscope glass slides of breast cancer specimens stained for the presence of HER-2/neu receptor protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results on the quality of the immuchistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the PATHWAY® anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody assay used to assure the validity of the GenASIs HiPath IHC Family for HER2 (4B5) image capture and analysis scores. The actual correlation of PATHWAY® anti-HER-2/neu (4B5) to clinical outcome has not been established.

2. The GenASIs HiPath IHC Family for PR (1E2) is for image capture and analysis applications. This particular system is intended for use as an aid to the pathologist in the detection and qualitative measurement of progesterone receptor (PR) protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to Ventana Medical Systems, Inc. CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay. The CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody assay is indicated for use as an aid in the assessment of breast cancer patients for whom endocrine treatment is being considered (but is not the sole basis for treatment).

Note: The GenASIs HiPath IHC for PR (1E2) image capture and analysis applications are adjunctive computer-assisted methodologies for the qualified pathologist in the acquisition and qualitative measurement of images from microscope glass slides of breast cancer specimens stained for the presence of PR protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results depends on the quality of the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRMTM anti-Progesterone Receptor (PR) (1E2) Rabbit Monoclonal Primary Antibody used to assure the validity of the GenASIs HiPath IHC Family for PR (1E2) image capture and analysis scores. The actual correlation of CONFIRMTM anti-PR antibody to clinical outcome has not been established.

3. The GenASIs HiPath IHC Family for ER (SP1) is for image capture and analysis applications. The particular system is intended for use as an aid to the pathologist in the detection and qualitative measurement of ER (SP1): protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody. The Ventana Medical Systems, Inc. CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody is indicated for use as an aid in the assessment of ER status in breast cancer patients (but is not the sole basis for treatment).

Note: The GenASIs HiPath IHC Family for ER (SP1) image capture and analysis applications are adjunctive computerassisted methodologies for the qualified pathologist in the acquisition and qualitative measurement of images from microscope glass slides of breast cancer specimens stained for the protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results depends on the immuohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody to assure the validity of the GenASIs HiPath IHC Family for ER (SP1) image capture and analysis scores. The actual correlation of CONFIRMTM anti-Estrogen Receptor (ER) (SP1) Rabbit Monoclonal Primary Antibody to clinical outcome has not been established.

4. The GenASIs HiPath IHC Family for Ki67 (30-9) is for image capture and analysis applications. The particular system is intended for use as an aid to the pathologist in the detection and qualitative measurement of Ki67 (30-9): protein in formalin-fixed, paraffin-embedded breast cancer tissue. This device is an accessory to the Ventana Medical Systems, Inc. CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary Antibody assay. The Ventana Medical Systems, Inc. CONFIRMTM anti-Ki67 (30-9) assay is indicated for use in assessing the activity of breast cancer tissue. When used with this assay, the GenASIs HiPath IHC Family for Ki67 (30-9) is indicated for use as an aid in the assessment of Ki-67 status in breast cancer patients (but is not the sole basis for treatment).

Note: The GenASIs HiPath IHC Family for Ki67 (30-9) image capture and analysis applications are adjunctive computerassisted methodologies for the qualified pathologist in the acquisition and qualitative measurement of images from microscope glass slides of breast cancer stained for the presence of Ki67 protein. The pathologist should verify agreement with the Image Analysis software application score by reviewing the glass slide under the microscope. The accuracy of the test results depends on the immunohistochemical staining. It is the responsibility of a qualified pathologist to employ appropriate morphological studies and controls as specified in the instructions for the CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary Antibody assay to assure the validity of the GenASIs HiPath IHC Family for Ki67 (30-9) image capture and analysis scores. The actual correlation of CONFIRMTM anti-Ki67 (30-9) Rabbit Monoclonal Primary antibody assay to clinical outcome has not been established.

The GenASIs HiPath IHC Family, including software is designed to assist the qualified pathologist in the consistent assessment in inmmohistochemnically stained histologic sections from formalin-fixed, paraffin-embedded breast cancer tissues. The device consists of a slide capture camera, Microscope, computer, monitor, keyboard, mouse, image analysis algorithms for specific immunohistochemical markers, and software with a Graphic User Interface (GUI).

The GenASIs HiPath IHC Family is an intranet-based, end-to-end, digital pathology software solution that allows pathology laboratories, to acquire, manage, view, analyze, share, and report test results of pathology specimens. Using the GenASIs HiPath IHC Family software the pathologist can view captured images, add annotations, make measurements, perform image analysis and generate reports.

Hardware: A camera based acquisition device designed to captures bright-field microscope digital images of formalin-fixed, paraffin-embedded tissues that are suitable for storage and viewing. The device includes a digital slide acquisition camera, X-Y Stage with holder adaptor for loading glass slides on a microscope and a workstation including a computer, keyboard, mouse and monitor.

Software: The GenASIs HiPath IHC Family software is designed to complement the routine workflow of a qualified pathologist in the review of immunohistochemically stained histologic slides. It allows the user to select fields of view (FOVs) in the digital image for analysis and provides quantitative data on these FOVs to assist with interpretation. The software makes no independent interpretations of the data and requires competent human intervention for all steps in the analysis process.

Here's a breakdown of the acceptance criteria and the study details for the GenASIs HiPath IHC Family device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria are implied by the "Overall Agreement," "Positive Agreement," and "Negative Agreement" percentages. These percentages represent the agreement between the device's analysis and manual pathological analysis.

HER2/neu (4B5)

PR (1E2)

ER (SP1)

Ki67 (30-9)

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

The study was conducted across three clinical sites. The data provenance is not explicitly stated (e.g., country of origin), nor is it specified whether the data was retrospective or prospective. However, it involved "stained samples," implying real patient data.

• HER2/neu (4B5): 357 stained samples
• PR (1E2): 385 stained samples
• ER (SP1): 427 stained samples
• Ki67 (30-9): 373 stained samples

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

• Number of Experts: Three (3) pathologists.
• Qualifications: "Pathologist that followed the recommendations of the Ventana user insertions for the different panel antibodies." This implies they are qualified experts in immunohistochemical analysis. Specific experience levels (e.g., years of experience) are not provided.

4. Adjudication Method for the Test Set

The ground truth was established by manual evaluation through microscope eyepieces performed by three different pathologists. The document refers to "comparison to the measures of agreement test of conventional manual evaluation through the microscope eyepieces, performed by pathologist." It then presents "Pooled Results; Frequency distribution of agreement of Manual versus GenASIs HiPath IHC Family." This indicates that the manual reads by the three pathologists were likely combined to form a consensus or reference standard, against which the device's results were compared. An explicit adjudication method like "2+1" or "3+1" is not detailed, but the pooling of results suggests a form of consensus was used to derive the "Manual analysis" column in the tables.

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

The document describes a comparison study where "manual evaluation through the microscope eyepieces, performed by pathologist" was compared to the device's analysis. However, it does not present a MRMC comparative effectiveness study in the sense of evaluating how much human readers improve with AI vs without AI assistance. Instead, it evaluates the agreement between the standalone AI device and the human readers' manual interpretations. There is no mention of human readers using the AI as assistance and then assessing their improved performance.

6. Standalone Performance Study

Yes, a standalone performance study was conducted. The "Analytical Performance" section details the "agreement rates of the comparison between manual and GenASIs HiPath IHC Family system statistical test results." This directly presents the device's performance in categorizing samples (Negative/Positive) against the ground truth established by manual pathological analysis, without human-in-the-loop during the device's diagnostic output generation.

7. Type of Ground Truth Used

Expert Consensus: The ground truth for the test set was established through "conventional manual evaluation through the microscope eyepieces, performed by pathologist that followed the recommendations of the Ventana user insertions for the different panel antibodies." This indicates that the ground truth was based on the consensus or established interpretations of qualified pathologists.

8. Sample Size for the Training Set

The document does not explicitly state the sample size used for the training set. The "Analytical Performance" section focuses on the validation study (test set).

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

As the training set sample size is not specified, neither is the method for establishing its ground truth. However, given the context of a medical device submission, it would be expected that if a machine learning model was developed, the training data would also be expert-annotated.

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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 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 Scan View 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: 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 Scan View 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. Cytogenetics 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 text describes the regulatory submission for the ScanView device but does not contain detailed acceptance criteria or a comprehensive study plan or results that would allow for a complete answer to all parts of the request.

Here's a breakdown of what can be extracted and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

• Acceptance Criteria: Not explicitly stated. The document mentions "bench and clinical data demonstrate that the device meets the required specifications," but the specifications themselves are not provided.
• Reported Device Performance: No specific performance metrics (e.g., sensitivity, specificity, accuracy, precision, processing speed) are reported in the text.

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

• Sample Size (Test Set): Not mentioned.
• Data Provenance: Not mentioned (e.g., country of origin, retrospective or prospective).

3. Number of Experts and Qualifications for Ground Truth:

• Number of Experts: Not mentioned.
• Qualifications of Experts: Not mentioned. The "Indications for Use" states the device is an "aiding tool to the pathologist or cytogeneticist," implying these are the expected users, but it doesn't specify their role in establishing ground truth for the study.

4. Adjudication Method:

• Not mentioned.

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

• Was it done?: Not indicated. The document focuses on the device as an "aiding tool" but doesn't describe a study comparing human performance with and without AI assistance.
• Effect size: Not applicable as no MRMC study details are provided.

6. Standalone Performance Study:

• Was it done?: Not explicitly stated, but the "Safety & Effectiveness" section notes "bench and clinical data demonstrate that the device meets the required specifications." This implies some form of device performance assessment, but whether it was "standalone" in detail (without human in the loop for assessment) is not clear, nor are the results provided.

7. Type of Ground Truth Used:

• Not mentioned.

8. Sample Size for the Training Set:

• Not mentioned.

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

• Not mentioned.

Summary of available information:

• Device Name: ScanView
• Intended Use: Automated scanning microscope and image analysis system for in-vitro diagnostic use as an aiding tool to the pathologist or cytogeneticist in detecting, classifying, and enumerating cells of interest based on color, intensity, size, pattern, and shape.
• Specific Indication: Detects CEP® X Spectrum Orange™/CEP® Y Spectrum Green™ DNA Probe kit (Vysis, Inc.) and is limited to the analysis of CEP XY probes for assessing bone marrow transplantation effectiveness in opposite-sex transplants.
• Compliance: Designed, verified, and validated complying with 21CFR 820.30 regulations. Bench and clinical data were used.
• Predicate Devices: FISHView K050236 and CytoVision CEP XY K042542.

Conclusion:

The provided 510(k) summary focuses on the regulatory submission, device description, and indications for use. It makes a general claim of demonstrating safety and effectiveness through "bench and clinical data" but does not provide the specific details of the acceptance criteria, study design, sample sizes, ground truth establishment, or performance results that are requested. To answer these questions, one would need to access the full 510(k) submission document or a more detailed technical report.

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The FISHView system is intended to be used for karyotyping with realtime microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples. Specimens suitable for banding analysis are: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment. The FISHView system does not locate metaphase spreads; it does not rank the given cells according to quality; nor does it automatically classify chromosomes.

In addition the FISHView is intended as an aiding tool to the pathologist or cytogeneticist for digital visualizing, processing, counting and classification of stained cells and for storage of FISH multi - dye images of the following specimens: amniotic fluid, peripheral blood, chorionic villus, bone marrow and solid tumor.

The FISHView system does require and relies on the operator to analyze the digitized microscope images.

The FISHView is a modification of the legally marketed (K012103) BANDView system. Digital visualizing, processing and storage of FISH multi dye images has been added to the BANDView original karyotyping features. The FISHVeiw System is a fully integrated digital imaging platform constructed of a microscope, camera, frame grabber and a workstation. It is designed to acquire images of cells and enables identification and examination of cells of interest. Cytological analysis experts can view, manually scan cells and record the image, using both bright field and fluorescent illumination. The acquire images can be enhanced, archived, retrieved and printed.

The provided text is a 510(k) summary for the FISHView device. It outlines the device description, indications for use, and a general statement about safety and effectiveness. However, it does not contain specific acceptance criteria, detailed study results, or the other specific information requested in the prompt regarding a study that proves the device meets acceptance criteria.

The 510(k) summary states: "Bench and clinical data demonstrate that the FISHView meets the required specifications. No adverse affects have been detected." This is a general statement and does not provide the detailed evidence requested.

Therefore, an exhaustive answer for all requested points cannot be provided based on 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 the device "meets the required specifications," but it does not list those specifications (acceptance criteria) or specific performance metrics.

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

• Cannot be provided. The document mentions "Bench and clinical data" but does not specify the sample sizes or the provenance (country of origin, retrospective/prospective) of this data.

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

• Cannot be provided. This information is not present in the document.

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

• Cannot be provided. This information is not present in the 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:

• Cannot be provided. The document mentions the FISHView system is an "aiding tool" and "relies on the operator to analyze the digitized microscope images," implying human involvement. However, it does not describe a comparative effectiveness study or any effect size for human reader improvement with AI assistance.

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

• Likely no, or not relevant for the primary function. The document explicitly states: "The FISHView system does require and relies on the operator to analyze the digitized microscope images." This contradicts a standalone (algorithm only) performance claim for its primary purpose of analysis.

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

• Cannot be provided. While it's implied that expert analysis (cytogeneticists) is central to the process, the specific method for establishing ground truth within the undisclosed "clinical data" is not detailed.

8. The sample size for the training set:

• Cannot be provided. The document refers to "Bench and clinical data" but does not distinguish between training and test sets, nor does it provide sample sizes for either.

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

• Cannot be provided. As with the training set size, this information is not disclosed.

In summary, the provided 510(k) document serves as a regulatory submission confirming substantial equivalence to predicate devices, but it does not include the detailed scientific study information requested.

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The BandView system is intended to be used for karyotyping with real-time microscope images from cultured and stained cell specimens in their metaphase. The system works with bright field and fluorescent samples with all currently applied banding techniques including G-banding and DAPI-banding. All specimens suitable for banding analysis including from amniotic fluid, peripheral blood, chorionic villus, bone marrow, and tissue can be used without limitation to specific diseases. Karyotyping is normally applied for the pre and postnatal diagnosis of birth defects, chromosome abnormalities, genetic diseases (such as Down's syndrome), cancer, and for the follow up of cancer treatment.

The BandView system does not locate metaphase spreads; it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images.

The BandView system aids the cytogenetic specialist in the preparation of karyotypes of human cells in their metaphase. By transferring images of chromosome spreads from the microscope to a computer, the labor-intensive manual processing of photographs, data archiving and document preparation is eliminated. Karyotypes are assembled by the operator with the support of the Band View analysis software.

The BandView system does not locate metaphase spreads, it does not rank the given cells according to quality; it does not automatically classify chromosomes; it does require and relies completely on the cytogeneticist to manipulate the digitized microscope images.

The provided text does not contain a study that demonstrates the device meets specific acceptance criteria. Instead, it is a 510(k) summary for the BandView system, an automated cell-locating device. The summary focuses on establishing substantial equivalence to predicate devices and outlining the device's intended use and limitations.

Therefore, I cannot populate the table or answer most of the questions as the information about a performance study, acceptance criteria, sample sizes, expert involvement, and ground truth establishment is not present in the provided document.

Here's what can be extracted from the text:

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

The document does not specify any quantitative "acceptance criteria" or provide "reported device performance" against such criteria. It states that "No performance standards have been established for such device under Section 514 of the Federal Food, Drug, and Cosmetic Act." It only mentions compliance with voluntary standards related to electromagnetic compatibility and risk analysis (EN 55022:1998, EN 55024:1998, IEC 61000-4-2:1995, EN-1441: Medical devices Risk Analysis). These are general engineering/safety standards, not specific performance criteria for karyotyping accuracy.

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 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 document.

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

This information is not provided in the 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

The document states that the "BandView system does not automatically classify chromosomes; it does require and relies completely on the operator to manipulate the digitized microscope images." This indicates it's an assistive device, not one for which an MRMC study comparing AI vs. human performance would typically be presented for its 510(k) submission. No such study is mentioned.

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

The device is explicitly stated to "require and relies completely on the operator to manipulate the digitized microscope images," meaning it's not a standalone algorithm. Its performance is intrinsically linked to human interaction.

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

This information is not provided in the document. Given the nature of the device assisting in karyotyping, the implicit "ground truth" during clinical use would be the cytogenetic specialist's final interpretation, but how this was used for validation (if any was performed and documented here) is unknown.

8. The sample size for the training set

This information is not provided in the document.

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

This information is not provided in the document.

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An accessory to a Fundus camera providing spectrally resolved images of the retina and optic disc and providing high contrast visualization of the blood vessels.

The Retinal Cube is an accessory to a standard fundus camera which enables the acquisition, processing, and display of spectrally resolved images with high contrast visualization of blood vessels. The Retinal Cube consists of the following three major components. - The imager unit which mounts on a standard fundus camera and actually acquires the ● spectrally resolved images - A controller unit which contains the electronics that control the imager - . A computer which performs display processing and provides the user interface for the system The imager unit produces a three dimensional data set consisting of a spectrum for each pixel. The 'data is processed using an algorithm which takes advantage of the spectral information to produce a two dimensional image containing high contrast visualization of the blood vessels.

Here's a breakdown of the acceptance criteria and study information for the Retinal Cube device, based on the provided text:

Acceptance Criteria and Device Performance

The document doesn't explicitly define a table of acceptance criteria with numerical targets. Instead, the acceptance criterion for the Retinal Cube appears to be demonstrated substantial equivalence to the predicate device, the Topcon IMAGEnet 640 digital ophthalmic imaging system. This equivalence is primarily based on comparable performance in visualizing blood vessels and meeting general safety standards.

The document claims the device meets this criterion based on the following:

Study Information

The document describes two types of studies: Bench Data and Clinical Data. It lacks specific details on sample sizes, expert qualifications, or detailed methodology commonly found in modern submissions.

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

• Bench Data: No specific sample size is mentioned. The nature of "bench data" typically implies internal testing, not necessarily a patient-based test set. Data provenance is not specified other than it being "bench data."
• Clinical Data: No specific sample size (number of patients or images) is mentioned for the clinical data. The data provenance (country of origin, retrospective/prospective) is not specified.

2. Number of experts used to establish the ground truth for the test set and qualifications of those experts:
The document does not provide any information regarding the number or qualifications of experts used to establish a ground truth for either the bench or clinical data. The assessment appears to be a direct comparison of image quality, rather than an expert- adjudicated assessment against a defined ground truth label.

3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
The document does not specify any adjudication method for the test set. It implies a direct comparison of enhanced visualization to the predicate device.

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, an MRMC comparative effectiveness study was not done (or at least not reported in this document). The submission focuses on device equivalence, not on the improvement of human readers with AI assistance. The device is described as an "accessory" that provides "high contrast visualization," implying it produces enhanced images for clinicians to interpret, but not explicitly as an AI assistance tool for human readers in a quantitative MRMC sense.

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

• Yes, in essence. The "bench data" and "clinical data" primarily assess the device's capability to produce images with enhanced visualization. The statement "The clinical data indicate that the system produces images with enhanced visualization of the blood vessels which are comparable to those produced by the predicate device" describes the algorithm's output (the enhanced images) directly, without explicitly mentioning a human reader's performance with or without that output. This is effectively a standalone assessment of the device's image generation capability.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
The document does not explicitly state the type of ground truth used. Instead, the comparison is made against the output of the predicate device (Topcon IMAGEnet 640). The "ground truth" for demonstrating equivalence appears to be the visual quality and enhancement produced by the predicate device. For technical specifications, "ground truth" would be derived from physical measurements and calibrations.

7. The sample size for the training set:
The document does not mention any training set or the use of machine learning models that would require one. The "algorithm" described is for processing spectrally resolved images to produce a 2D image with high-contrast visualization, which sounds more like a signal processing or image processing algorithm rather than a machine learning algorithm requiring a separate training set.

8. How the ground truth for the training set was established:
As no training set is mentioned, this information is not applicable.

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