(887 days)
Not Found
Not Found
Yes
The device name and description explicitly mention "Genius™ Cervical AI algorithm" and its function in selecting objects of interest.
No.
The device is intended to aid in cervical cancer screening by creating and viewing digital images of scanned ThinPrep® Pap Test glass slides and assisting in the identification of atypical cells and lesions. It is a diagnostic tool, not a therapeutic one.
Yes
The intended use explicitly states, "The Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions... and carcinoma, as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology." This directly indicates its use in identifying diseases or conditions.
No
The device description explicitly includes hardware components: Genius TM Digital Imager, Genius™ Image Management Server (IMS), and Genius™ Review Station. While it includes a software component (Genius™ Cervical AI algorithm), it is part of a larger system that includes hardware.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use explicitly states that the system is "intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia... as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology." This clearly indicates the device is used to examine specimens (digital images of scanned ThinPrep Pap Test glass slides) derived from the human body (cervical cells) to provide information for the diagnosis of a disease (cervical cancer and its precursors).
- Specimen Type: The input imaging modality is "Digital images of scanned ThinPrep® Pap Test glass slides," which are specimens derived from the human body.
- Purpose: The system is used to "aid in cervical cancer screening," which is a diagnostic process.
- Interpretation: The results are interpreted by "qualified cytologists," who are healthcare professionals involved in diagnostic evaluation.
The definition of an IVD generally includes devices used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device fits that definition.
No
The letter mentions identified risks and mitigations and special controls, but it does not contain explicit language stating that the FDA has reviewed and approved or cleared a Predetermined Change Control Plan for this specific device.
Intended Use / Indications for Use
The Genius TM Digital Diagnostics System with the Genius™ Cervical AI algorithm includes the Genius TM Digital Imager, Genius™ Image Management Server (IMS), the Genius™ Review Station, and the Genius™ Cervical AI algorithm. The Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended for the creation and viewing of digital images of scanned ThinPrep® Pap Test glass slides. Objects of interest selected by the Genius™ Cervical AI algorithm from the scanned digital image are presented in a gallery format next to the image of the whole cell spot on the Genius™ Review Station for review and interpretation. The Genius Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions) and carcinoma, as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology1.
After digital review with the Genius Cervical AI algorithm, if there is uncertainty in the diagnosis, then direct examination of the glass slide by light microscopy should be performed. Digital images from the Genius Digital Diagnostics System with the Genius™ Cervical AI algorithm should be interpreted by qualified cytologists in conjunction with the patient's screening history, other risk factors, and professional guidelines which guide patient management.
Product codes
QYV
Device Description
The Genius Digital Diagnostics System includes, Genius Digital Image. Management Server, Genius Review Station(s), and Genius Cervical AI algorithm, as shown in Figure 1 below.
Genius Digital Imager (Digital Imager)
The Genius Digital Imager digitally scans ThinPrep® Pap test slides that have been prepared using the ThinPrep 2000 system. ThinPrep 5000 processor or ThinPrep Genesis processor. stained with the ThinPrep stain (Papanicolaou-based stain) and cover slipped. The Digital Imager is operated using the user interface which is a menu-driven, graphical display touch screen. The Digital Imager consists of the following:
- . Digital Imager processor which images the slides, one at a time.
- Digital Imager computer which captures the images and controls the electromechanical . components of the system.
- . Image Management Server which stores the slide ID and pertinent image data. The Digital Imager requires a connection to the Image Management Server.
Genius Image Management Server (IMS)
The Genius IMS subsystem is responsible for data management and includes a database, an image repository, and an imager web service, which is a HTTPS server for interfacing with the Digital Imager. The IMS hosts web applications for the review station.
Information stored on the IMS's database subsystem is tracked by unique accession IDs, which are read from the microscope slide labels when they are scanned on the Digital Imager. The Digital Imager, IMS, and Review Stations are connected by a local area network. The IMS stores whole slide images in the image repository, (a physical structure of the files on a local storage disk), along with associated information from the review of the slides in a SQL database to facilitate the display of images for cytologist (CTs) and pathologists (PTs) to review. In addition to the network connection between the Digital Imager. IMS and Review Station. another network connection is required for accessing an optional archive storage system. The minimum computer requirements for the IMS are listed in the Table 1.
Genius Review Station
The Genius Review Station includes a dedicated computer ruming the IMS client software and the Barco MDPC-8127 display which is a high-resolution display that has been validated for diagnostic review of objects of interest (OOIs) or whole cell spot images. The Review Station is used by CTs and PTs to screen the ThinPrep® Pap Test slides that have been imaged using the Digital Imager.
Genius Cervical AI algorithm
The Genius Cervical AI algorithm is a software algorithm which is pre-loaded on the Genius Digital Imager. The Genius Cervical AI algorithm uses Convolutional Neural Network (CNN) technology to analyze ThinPrep® Pap Test whole slide images scanned using the Genius Digital Imager and selects OOIs to be displayed for review by a CT or PT. The Genius Cervical AI algorithm software is separate with its own software subsystem. The user selects the appropriate specimen type [i.e., GYN (Pap test slide)] to be scanned before initiating the scanning process. The analysis of the image is performed automatically by the Genius Cervical AI algorithm after the scanned digital image is generated by the Genius Digital Imager. A typical input image is a high-resolution color scan of a ThinPrep cell spot, containing over 6x10^9 pixels, from 5,000 to 100,000 cells. The output of the algorithm is a set of OOIs. organized into rows and designed to provide information for the reviewer to determine the diagnostic category for that particular image (case) per The Bethesda System for Reporting Cervical Cytology. There are 5 rows of OOIs and 6 primary OOIs per row. There are an additional 6 secondary OOIs available per row that the user can review, as needed. The OOIs are grouped into rows of particular diagnostic categories. Priority is given to abnormal cells when populating the first four rows, followed by cell types needed for assessing specimen adequacy (Endocervical cells and Squamous Metaplasia). The final row shows infectious organisms when present. The algorithm also provides a total count of squamous cells on the slide. This count may be used by the reviewer in assessing specimen adequacy. The cells and cell clusters presented in a gallery format on the Genius Review Station, as shown in Figure 2 below, allows the reviewer to view all OOIs presented by the algorithm. The CT or PT can digitally mark OOIs for subsequent review.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Yes
Input Imaging Modality
Scanned ThinPrep® Pap Test glass slides
Anatomical Site
Cervical
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified cytologists and pathologists in a clinical laboratory setting.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
OOI Reproducibility Study
- Sample Size: 37 ThinPrep Pap test slides from the Genius Digital Diagnostics System with the Genius Cervical AI algorithm clinical study (full range of abnormal diagnostic categories).
- Data Source: ThinPrep 2000 system, ThinPrep 5000 processor, and ThinPrep Genesis processor.
- Annotation Protocol:
- Slides were imaged three times on three different Genius Digital Imagers.
- Three CTs independently reviewed the nine runs of each case on the Genius Digital Diagnostics System, blinded to the reference diagnosis.
- A minimum of a two-week washout period was used between reviews.
- CTs recorded observations in every tile in the gallery.
- Performance was compared to the adjudicated reference diagnosis determined during the clinical study.
Cell Count Study
- Sample Size: 50 ThinPrep Pap test slides (including at least 8 slides with counts near 5000 cells).
- Data Source: ThinPrep 5000 processor, stained and cover-slipped.
- Annotation Protocol:
- Slides were imaged on three Genius Digital Imagers three separate times.
- Manual cell count: A CT viewed the whole slide image on the Genius Review Station, counted cells in a portion, and estimated the total count.
- Genius Cervical AI derived cell counts were compared to the manual estimate.
Clinical Study
- Sample Size: 1994 ThinPrep Pap test slides.
- Data Source: Residual material from clinical sites after cases were signed out, from women screened for cervical cancer. Samples processed on ThinPrep® 2000 system, ThinPrep® 5000 processor, or ThinPrep® Genesis™ processor.
- Annotation Protocol:
- Conducted at 4 clinical sites in the U.S.
- At each site, 3 independent teams (1 CT and 1 PT) reviewed all cases.
- Review phases (in order): manual review of glass slides (Manual review), review of glass slides with ThinPrep Imaging System (TIS review), and review of digital images with Genius Digital Diagnostics System with Genius Cervical AI algorithm (Genius Cervical AI review/Digital Review).
- Cases with ASCUS, AGC, LSIL, ASC-H, HSIL, Cancer, or UNSAT results by CT were also reviewed by PT.
- Minimum 14-day washout period between each review phase.
- Cases randomized prior to each review phase.
- Cytological diagnoses and specimen adequacy determined per Bethesda System criteria.
- Adjudicated diagnosis (gold standard):
- Adjudication panel composed of 3 adjudication CT/PT teams (1 CT and 1 PT each).
- Slides reviewed independently by the three teams.
- Consensus result: majority agreement (at least two of three teams).
- If no initial consensus, cases underwent multi-head review by the three adjudication PTs simultaneously.
- Reference result based on consensus or multi-head review.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Technical Performance Assessment
- Study Type: Bench testing and system-level assessments.
- Sample Size: Varies by test (e.g., 18 Pap test slides for SSIM study, 223 slides for whole cell-spot coverage).
- Key Results:
- Slide Feeder, Light Source, Imaging Optics, Z-focal plane acquisition method, Mechanical Scanner Movement, Digital Imaging Sensor, Image Processing and Composition, Image Files Format, Image Review Manipulation Software, Computer Environment, Display: Met product specifications and performance requirements.
- Coverage of Z-depth: Acquired Z-depth was >= 24 microns.
- Color Reproducibility: Colors displayed on Genius Review Stations meet acceptance criteria.
- Structural Similarity Index Measurement (SSIM) Study: All SSIM values were > 0.9, meeting defined criteria for reproducibility across imagers and within imagers/runs.
- Spatial Resolution: Met pre-specified acceptance criteria.
- Focusing Testing: Met acceptance criteria.
- Whole Cell-Spot Coverage: Entire cell spot was included and acceptable based on visual inspection.
- Stitching Error: Met pre-specified acceptance criteria.
- Turnaround Time: Acceptable for various review tasks.
Analytical Performance: Objects of Interest (OOI) Reproducibility
- Study Type: Single site study.
- Sample Size: 37 ThinPrep Pap test slides.
- Key Results:
- Proportion of Abnormal OOIs:
- UNSAT: 31%
- NILM: 16%
- ASCUS+: 100% (for ASCUS, LSIL, ASC-H, AGC, HSIL, Cancer reference Dxs)
- Median # of Abnormal OOIs:
- UNSAT: 0 (Range 0;5)
- NILM: 0 (Range 0;4)
- ASCUS: 6 (Range 2;17)
- LSIL: 10 (Range 3;23)
- ASC-H: 13 (Range 4;22)
- AGC: 12 (Range 3;24)
- HSIL: 18 (Range 12;25)
- CANCER: 14 (Range 5;20)
- All Abnormal: 13 (Range 3;25)
- Proportion Category+ OOIs:
- ASCUS: 100%
- LSIL: 96%
- ASC-H: 100%
- AGC: 100%
- HSIL: 100%
- CANCER: 92%
- All Abnormal: 98%
- Agreement Rates by Threshold:
- ASCUS+: 100% (810 evaluations)
- LSIL+: 98% (540 evaluations)
- ASC-H+: 99% (405 evaluations)
- HSIL+: 99% (270 evaluations)
- CANCER: 92% (135 evaluations)
- OOI Reproducibility:
- Between-instrument: 96% agreement (999 pairs)
- Within-instrument: 99% agreement (999 pairs)
- Proportion of Abnormal OOIs:
Analytical Performance: Cell Count Study
- Study Type: Comparison study.
- Sample Size: 50 ThinPrep Pap test slides.
- Key Results:
- Within-imager precision %CV: 0.6%
- Between-imager precision %CV: 2.7%
- Linear regression analysis: slope was 1.06 (95% CI: 1.01; 1.11), intercept 213 (95% CI: 28: 398).
- Relative systematic difference at 5,000 cells: 10% (95% CI: 4%; 17%).
- Results were acceptable.
Clinical Studies: Genius Digital Diagnostics System with the Genius Cervical AI algorithm Review Compared to Manual Microscope Review of Glass Slides
- Study Type: Multi-center clinical study.
- Sample Size: 1994 slides.
- Key Results (Overall, compared to Adjudicated Diagnosis):
- Sensitivity % (Genius / Manual):
- ASCUS+: 91.7% / 90.1% (Difference: 1.6%)
- LSIL+: 89.1% / 84.7% (Difference: 4.4%, statistically significant increase for Genius)
- ASC-H+: 87.8% / 79.6% (Difference: 8.2%, statistically significant increase for Genius)
- HSIL+: 81.5% / 74.0% (Difference: 7.5%, statistically significant increase for Genius)
- Cancer: 66.7% / 66.7% (Difference: 0.0%)
- Specificity % (Genius / Manual):
- ASCUS+: 91.0% / 92.2% (Difference: -1.3%, statistically significant decrease for Genius)
- LSIL+: 91.7% / 94.1% (Difference: -2.4%, statistically significant decrease for Genius)
- ASC-H+: 94.2% / 97.0% (Difference: -2.9%, statistically significant decrease for Genius)
- HSIL+: 94.8% / 97.2% (Difference: -2.4%, statistically significant decrease for Genius)
- Cancer: 98.5% / 98.5% (Difference: -0.0%)
- UNSAT cases (reference UNSAT sensitive/specific):
- Sensitivity % (Genius / Manual): 80.4% / 61.8% (Difference: 18.6%)
- Specificity % (Genius / Manual): 99.7% / 99.7% (Difference: 0.0%)
- False NILM results (Genius vs Manual):
- ASCUS: 24.6% vs 25.7% (reduction for Genius)
- AGC: 33.3% vs 33.3%
- LSIL: 1.9% vs 5.4% (reduction for Genius)
- ASC-H: 9.0% vs 14.3% (reduction for Genius)
- HSIL: 3.0% vs 3.0%
- Cancer: 4.2% vs 1.0% (increase for Genius)
- Overall: 8.3% vs 9.9% (reduction for Genius)
- False positive (LSIL+, etc. for NILM reference) results (Genius vs Manual):
- LSIL: 1.12% vs 0.61% (increase for Genius)
- ASC-H: 1.31% vs 0.85% (increase for Genius)
- HSIL: 0.72% vs 0.29% (increase for Genius)
- Cancer: 0.13% vs 0.03% (increase for Genius)
- Total: 3.28% vs 1.79% (increase for Genius)
- Sensitivity % (Genius / Manual):
Clinical Studies: Genius Digital Diagnostics System with the Genius Cervical AI Algorithm Review compared with TIS Review
- Key Results (Overall, compared to Adjudicated Diagnosis):
- Sensitivity % (Genius / TIS):
- ASCUS+: 91.7% / 91.6% (Difference: 0.1%)
- LSIL+: 89.1% / 87.7% (Difference: 1.4%)
- ASC-H+: 87.8% / 84.3% (Difference: 3.6%, statistically significant increase for Genius)
- HSIL+: 81.5% / 77.9% (Difference: 3.6%, statistically significant increase for Genius)
- Specificity % (Genius / TIS):
- ASCUS+: 91.0% / 92.6% (Difference: -1.6%, statistically significant decrease for Genius)
- LSIL+: 91.7% / 93.3% (Difference: -1.6%, statistically significant decrease for Genius)
- ASC-H+: 94.2% / 96.4% (Difference: -2.2%, statistically significant decrease for Genius)
- HSIL+: 94.8% / 96.6% (Difference: -1.7%, statistically significant decrease for Genius)
- Sensitivity % (Genius / TIS):
Descriptive diagnosis for benign cellular changes
- Key Results:
- Higher percentage of infectious organisms and non-neoplastic findings observed using Genius Cervical AI review compared to both Manual Glass Slide review and TIS review.
Cytologist Screening Time Study
- Study Type: Observational study within the clinical study.
- Sample Size: 12 cytologists, 1994 digital cytology cases.
- Key Results:
- Correlation coefficients between performance (sensitivity/specificity) and review time were low (0.003 and 0.180, respectively), indicating minimal dependence.
- CT case review time did not impact diagnostic performance at the ASCUS+ threshold.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
OOI Reproducibility:
- Proportion of Abnormal OOIs
- Median # of Abnormal OOIs
- Proportion Category+ OOIs
- Agreement Rate % (by threshold: ASCUS+, LSIL+, ASC-H+, HSIL+, CANCER)
Cell Count Study:
- Within-imager precision %CV
- Between-imager precision %CV
- Linear regression slope and intercept
- Relative systematic difference at 5,000 cells
Clinical Study (Genius vs Manual vs TIS):
- Sensitivity %
- Specificity %
- Difference in Sensitivity (Genius - Manual/TIS)
- Difference in Specificity (Genius - Manual/TIS)
- False NILM results %
- False positive results (LSIL+, etc. for NILM reference) %
- Percentage of benign cellular changes and infectious organisms identified.
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
N/A
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food & Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol is a stylized representation of a staff entwined with a serpent, a common symbol associated with medicine and healthcare. The text is written in a clear, sans-serif font, with "FDA" in a bold, blue color and the rest of the text in a smaller, lighter blue.
EVALUATION OF AUTOMATIC CLASS III DESIGNATION FOR
Genius TM Digital Diagnostics System with the Genius ™ Cervical Al Algorithm
DECISION SUMMARY
I Background Information:
-
A De Novo Number
DEN210035 -
B Applicant
Hologic Inc.
C Proprietary and Established Names
Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm
D Regulatory Information
| Product Code(s) | Classification | Regulation
Section | Panel |
|-----------------|---------------------------------------------------------------------------------------------|-----------------------|-----------|
| QYV | Digital cervical cytology slide
imaging system with artificial
intelligence algorithm | 21 CFR 864.3900 | Pathology |
Submission/Device Overview: II
A Purpose for Submission:
De Novo request for evaluation of automatic class III designation for the Hologic's Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm.
B Measurand:
Not applicable
C Type of Test:
Digital cytology whole slide imaging system with AI algorithm to assist in review of digital images of ThinPrep Pap test slides.
1
III Indications for Use:
A Intended Use(s):
See Indications for Use below.
B Indication(s) for Use:
The Genius TM Digital Diagnostics System with the Genius™ Cervical AI algorithm includes the Genius TM Digital Imager, Genius™ Image Management Server (IMS), the Genius™ Review Station, and the Genius™ Cervical AI algorithm. The Genius™ Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended for the creation and viewing of digital images of scanned ThinPrep® Pap Test glass slides. Objects of interest selected by the Genius™ Cervical AI algorithm from the scanned digital image are presented in a gallery format next to the image of the whole cell spot on the Genius™ Review Station for review and interpretation. The Genius Digital Diagnostics System with the Genius™ Cervical AI algorithm is intended to aid in cervical cancer screening for the presence of atypical cells, cervical neoplasia, including its precursor lesions (Low Grade Squamous Intraepithelial Lesions, High Grade Squamous Intraepithelial Lesions) and carcinoma, as well as all other cytological categories as defined by The Bethesda System for Reporting Cervical Cytology1.
After digital review with the Genius Cervical AI algorithm, if there is uncertainty in the diagnosis, then direct examination of the glass slide by light microscopy should be performed. Digital images from the Genius Digital Diagnostics System with the Genius™ Cervical AI algorithm should be interpreted by qualified cytologists in conjunction with the patient's screening history, other risk factors, and professional guidelines which guide patient management.
C Special Conditions for Use Statement(s):
For in vitro diagnostic (IVD) use only For prescription use only
D Special Instrument Requirements:
- . Genius Digital Imager
- . Genius Image Management Server (IMS)
- . Genius Review Station
- . Genius Cervical AI algorithm
IV Device/System Characteristics:
A. Device Description:
1 Nayar R, Wilbur DC. (eds), The Bethesda System for Reporting Cervical Cytology: Definitions, Criteria, and Explanatory Notes. 3rd ed. Cham, Switzerland: Springer: 2015
2
The Genius Digital Diagnostics System includes, Genius Digital Image. Management Server, Genius Review Station(s), and Genius Cervical AI algorithm, as shown in Figure 1 below.
Image /page/2/Picture/1 description: The image shows three pieces of medical equipment. The first piece of equipment is a Genius machine by Hologic. The second piece of equipment is a black server tower. The third piece of equipment is a computer monitor displaying medical images.
Figure 1. The Genius Digital Diagnostics System
Genius Digital Imager (Digital Imager)
The Genius Digital Imager digitally scans ThinPrep® Pap test slides that have been prepared using the ThinPrep 2000 system. ThinPrep 5000 processor or ThinPrep Genesis processor. stained with the ThinPrep stain (Papanicolaou-based stain) and cover slipped. The Digital Imager is operated using the user interface which is a menu-driven, graphical display touch screen. The Digital Imager consists of the following:
- . Digital Imager processor which images the slides, one at a time.
- Digital Imager computer which captures the images and controls the electromechanical . components of the system.
- . Image Management Server which stores the slide ID and pertinent image data. The Digital Imager requires a connection to the Image Management Server.
Genius Image Management Server (IMS)
The Genius IMS subsystem is responsible for data management and includes a database, an image repository, and an imager web service, which is a HTTPS server for interfacing with the Digital Imager. The IMS hosts web applications for the review station.
Information stored on the IMS's database subsystem is tracked by unique accession IDs, which are read from the microscope slide labels when they are scanned on the Digital Imager. The Digital Imager, IMS, and Review Stations are connected by a local area network. The IMS stores whole slide images in the image repository, (a physical structure of the files on a local storage disk), along with associated information from the review of the slides in a SQL database to facilitate the display of images for cytologist (CTs) and pathologists (PTs) to review. In addition to the network connection between the Digital Imager. IMS and Review Station. another network connection is required for accessing an optional archive storage system. The minimum computer requirements for the IMS are listed in the Table 1.
3
| Dual Intel Xeon Silver 4214 2.20 GHz processor | |
|---|---|
| 64 GB memory | |
| 240 GB SSD for OS (boot) | |
| RAID 10 Array configuration | |
| Server Hardware | 30 TB configured storage capacity |
| Two 10 GB Ethernet ports | |
| 3 USB 2.0 (or faster) ports | |
| Display interface (HDMI or Display Port) | |
| Dual, hot plug, redundant power supply (1+1), 750 W or greater | |
| Operating System | Windows 64-bit minimum; Windows Server 2016 recommended |
| Display | A minimum resolution of 1366 by 768 pixels |
Table 1. Genius Image Management Server (IMS) Minimum Requirements
Genius Review Station
The Genius Review Station includes a dedicated computer ruming the IMS client software and the Barco MDPC-8127 display which is a high-resolution display that has been validated for diagnostic review of objects of interest (OOIs) or whole cell spot images. The Review Station is used by CTs and PTs to screen the ThinPrep® Pap Test slides that have been imaged using the Digital Imager. The minimum specifications for the dedicated computer and specifications of the high-resolution display are listed in Tables 2 and 3.
Table 2. Review Station Computer Minimum Requirements
| Hardware | • x86 processor, Intel® Core i7 2.4Ghz (4C, 8T) |
|---|---|
| • 16 GB DDR4 Memory or greater | |
| • 256 GB Drive or greater | |
| • 1Gb or faster network connection | |
| • Barco MXRT display control card | |
| • PCIe Gen3 x 16 slot for the display control card | |
| • A keyboard and a mouse | |
| Operating System | Windows 10, 64-bit |
| Browser | Google Chrome, Version 85 (1.3.35.451) or greater |
| Environmental | • Operating temperature range: 16-32°C |
| • Non- Operating temperature range: -28°C to 50°C | |
| • Operating humidity range: 20-80% RH, noncondensing | |
| • Non- operating humidity range: 15-95% RH, noncondensing |
4
| Manufacturer | Barco |
|---|---|
| Model number | MDPC-8127 |
| Hologic part number | CMP-01669 |
| Screen technology | IPS LED |
| Active screen size (diagonal) | 684 mm (27") |
| Active screen size (H x V) | 569 x 335 mm (22.4 x 13.2") |
| Aspect ratio (H:V) | 16:9 |
| Resolution | 8 MP (3840 x 2160 pixels @ 120 Hz) |
| Pixel pitch | 0.155 mm |
| Color imaging | Yes |
| Power rating | 100-240 Vac, 50/60 Hz, 3.6-1.6 A |
| Power consumption | 75 W (nominal) @ calibrated luminance of 450 cd/m |