(90 days)
No, The device description explicitly states, "CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis," and no mention of AI, DNN, or ML is found.
No
The device is described as "For In Vitro Diagnostic Use Only" and is intended as an aid to the pathologist for viewing and managing digital images for primary diagnosis, not for treating or preventing a disease or condition.
Yes
The device explicitly states in its "Intended Use / Indications for Use" that it is "For In Vitro Diagnostic Use Only" and is "intended for in vitro diagnostic use as an aid to the pathologist for the purpose of primary diagnosis."
Yes
The device explicitly states "CaloPix is a software only device" and "CaloPix, version 6.1.0 IVDUS, is a web-based software-only device." While it interoperates with specific hardware scanners and displays, the device itself is presented purely as software for viewing and managing digital images.
Yes
The "Intended Use / Indications for Use" section explicitly states "For In Vitro Diagnostic Use Only" and "CaloPix is intended for in vitro diagnostic use". The "Intended User / Care Setting" also specifies "In Vitro Diagnostic (IVD) use".
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use only
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue.
CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis.
CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix.
CaloPix is intended to be used with the interoperable components specified in the below Table:
| Scanner Hardware | Scanner Output File Format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE |
| Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | JVC Kenwood JD-C240BN01A |
Product codes
QKQ
Device Description
CaloPix, version 6.1.0 IVDUS, is a web-based software-only device that is intended to aid pathology professionals in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed on the Dell U3223QE display.
CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.
CaloPix is for viewing digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
As a whole, CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing. CaloPix consists of:
- Integration with Laboratory Information Systems (LIS): Allows to obtain automatically from the LIS patient data associated with the cases, scanned whole slide images and other related medical images to be analyzed. The data stored in the database is automatically updated according to the interface protocol with the LIS.
DataBase: After ingestion, scanned WSI can be organized in the CaloPix database consisting of folders (cases) containing patient identification data and examination results from a LIS.
Ingestion of the slides is performed through an integrated module that allows their automatic indexation based on patient data retrieved from the LIS. After their ingestion, image files are stored in a CaloPix-specific file storage environment, that can be on premises or in the cloud.
- The CaloPix viewer component to process scanned whole slide images, that includes functions for panning, zooming, screen capture, annotations, distance and surface measurement, and image registration. This viewer relies on image servers (IMGSRV) which extract image tiles from the whole slide image file and send these tiles to the CaloPix viewer for smooth and fast viewing.
CaloPix operates as follows:
-
After the WSI image is acquired using one of the intended scanners, in accordance with the WSI scanner Instructional Manual and any additional standard laboratory procedures, the WSI becomes available in the scanner's file system. The WSI is then sent to end-user-provided image storage attached to the local network. (not part of the subject device).
The WSI is then ingested into the CaloPix database at which point the CaloPix workflow is initiated.
-
The reading pathologist selects a case from a worklist within CaloPix, whereby CaloPix fetches the associated images from the image storage.
-
The image quality and other image data must be manually evaluated in the CaloPix viewer by the pathologist, and deemed acceptable, prior to using a whole slide image for diagnosis.
-
The reading pathologist uses the CaloPix viewer to view and interpret the images using the following functionalities:
- Continuous zooming and panning;
- Measuring distances;
- Creating annotations during review using manual annotation tools and manual counting tools;
- Viewing and comparing multiple slide images simultaneously in multiple windows;
- Tracking of visited areas and annotations and digital bookmarks.
-
The above steps are repeated as required.
-
After viewing all images for a case, the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).
-
Upon conclusion of using the system, the pathologist clicks "Sign Out" in the user menu.
CaloPix is designed to be deployed to a customer-managed infrastructure or in a cloud infrastructure and may be accessed on the user's workstation browser. CaloPix operates with and is validated for use with the components specified in the tables below.
Mentions image processing
Yes, "CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing." and "The CaloPix viewer component to process scanned whole slide images"
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned Whole Slide Images (WSI)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Qualified pathologist in an in vitro diagnostic 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
For pixel-wise comparison: A total of 25 H&E-stained and 5 IHC-stained (Masson's trichrome stain, CD8, CD3, or CD20), formalin-fixed paraffin-embedded (FFPE) tissue glass slides, were scanned using both slide scanner systems (Leica Aperio GT450 DX and Hamamatsu NanoZoomer S360MD). For each WSI, 3 regions of interest (ROIs) were identified to highlight relevant pathological features, as verified by a pathologist. Screenshots of these ROIs were captured at two magnification levels (20x and 40x) across multiple displays and browsers.
For measurements of area and distance: Testing was conducted by comparing measurements of markings made in CaloPix viewer to measurements of markings made in NZViewMD viewer and Aperio WebViewer DX, for the same Regions of Interest on slides.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
A series of tests were performed to assess the safety and effectiveness of CaloPix, including pixel-wise comparison, measurements of area and distance, turnaround time, and human factors validation study.
Pixel-wise comparison:
- Study type: Comparison of image reproduction between CaloPix and predicate device Image Review Manipulation Software (IRMS).
- Sample size: 25 H&E-stained and 5 IHC-stained (Masson's trichrome stain, CD8, CD3, or CD20), formalin-fixed paraffin-embedded (FFPE) tissue glass slides.
- Key results: The 95th percentile of pixelwise differences between CaloPix and the comparators (NZViewMD and Aperio WebViewer DX) were less than 3 CIEDE2000, indicating that their output images can be considered to be pixel-wise identical. Color images reproduced by CaloPix were visually adequate with respect to its intended use.
Measurements of area and distance:
- Key results: Tests verified that the distance and area measurements made in the CaloPix viewer accurately reflected the distance and area measurements made in the NZViewMD viewer, as well as the distance and area measurements made in the Aperio WebViewer DX viewer. CaloPix performed accurate measurements with respect to its intended use.
Turnaround time:
- Key results: The system requirements for loading, panning, and zooming images were fulfilled within specified time limits (10 seconds for loading, 7 seconds for panning, 7 seconds for zooming). Turnaround times were found to be adequate for the intended use.
Human Factors validation study:
- Key results: CaloPix has been found to be safe and effective for the intended users, uses and use environments.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Pixel-wise comparison metric: CIEDE2000 (
§ 864.3700 Whole slide imaging system.
(a)
Identification. The whole slide imaging system is an automated digital slide creation, viewing, and management system intended as an aid to the pathologist to review and interpret digital images of surgical pathology slides. The system generates digital images that would otherwise be appropriate for manual visualization by conventional light microscopy.(b)
Classification. Class II (special controls). The special controls for this device are:(1) Premarket notification submissions must include the following information:
(i) The indications for use must specify the tissue specimen that is intended to be used with the whole slide imaging system and the components of the system.
(ii) A detailed description of the device and bench testing results at the component level, including for the following, as appropriate:
(A) Slide feeder;
(B) Light source;
(C) Imaging optics;
(D) Mechanical scanner movement;
(E) Digital imaging sensor;
(F) Image processing software;
(G) Image composition techniques;
(H) Image file formats;
(I) Image review manipulation software;
(J) Computer environment; and
(K) Display system.
(iii) Detailed bench testing and results at the system level, including for the following, as appropriate:
(A) Color reproducibility;
(B) Spatial resolution;
(C) Focusing test;
(D) Whole slide tissue coverage;
(E) Stitching error; and
(F) Turnaround time.
(iv) Detailed information demonstrating the performance characteristics of the device, including, as appropriate:
(A) Precision to evaluate intra-system and inter-system precision using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(B) Reproducibility data to evaluate inter-site variability using a comprehensive set of clinical specimens with defined, clinically relevant histologic features from various organ systems and diseases. Multiple whole slide imaging systems, multiple sites, and multiple readers must be included.
(C) Data from a clinical study to demonstrate that viewing, reviewing, and diagnosing digital images of surgical pathology slides prepared from tissue slides using the whole slide imaging system is non-inferior to using an optical microscope. The study should evaluate the difference in major discordance rates between manual digital (MD) and manual optical (MO) modalities when compared to the reference (
e.g., main sign-out diagnosis).(D) A detailed human factor engineering process must be used to evaluate the whole slide imaging system user interface(s).
(2) Labeling compliant with 21 CFR 809.10(b) must include the following:
(i) The intended use statement must include the information described in paragraph (b)(1)(i) of this section, as applicable, and a statement that reads, “It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images obtained using this device.”
(ii) A description of the technical studies and the summary of results, including those that relate to paragraphs (b)(1)(ii) and (iii) of this section, as appropriate.
(iii) A description of the performance studies and the summary of results, including those that relate to paragraph (b)(1)(iv) of this section, as appropriate.
(iv) A limiting statement that specifies that pathologists should exercise professional judgment in each clinical situation and examine the glass slides by conventional microscopy if there is doubt about the ability to accurately render an interpretation using this device alone.
FDA 510(k) Clearance Letter - CaloPix
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
May 14, 2025
Tribun Health
Françoise Veyriac
QARA & Clinical Affairs Director
30 Boulevard de Vaugirard
Paris, 75015
France
Re: K250414
Trade/Device Name: CaloPix
Regulation Number: 21 CFR 864.3700
Regulation Name: Whole Slide Imaging System
Regulatory Class: Class II
Product Code: QKQ
Dated: February 13, 2025
Received: February 13, 2025
Dear Françoise Veyriac:
We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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K250414 - Françoise Veyriac Page 2
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Page 3
K250414 - Françoise Veyriac Page 3
Sincerely,
Shyam Kalavar -S
Shyam Kalavar
Deputy Branch Chief
Division of Molecular Genetics and Pathology
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
Enclosure
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
510(k) Number (if known)
K250414
Device Name
CaloPix
Indications for Use (Describe)
For In Vitro Diagnostic Use only
Indications for Use
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue.
CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis.
CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix.
CaloPix is intended to be used with the interoperable components specified in the below Table:
| Scanner Hardware | Scanner Output File Format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE |
| Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | JVC Kenwood JD-C240BN01A |
Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
FORM FDA 3881 (8/23) Page 1 of 1 PSC Publishing Services (301) 443-6740 EF
Page 5
510(k) Summary
CaloPix
Date of Summary: May 14, 2025
Submitter:
Jean-François Pomerol
CEO
TRIBUN HEALTH
30 boulevard de Vaugirard
75015 PARIS - FRANCE
T: (33) 178967260
Contact Person:
Jean-François Pomerol
CEO
TRIBUN HEALTH
30 boulevard de Vaugirard
75015 PARIS - FRANCE
Secondary Contact Person:
Françoise Veyriac
QARA & Clinical Affairs Director
TRIBUN HEALTH
30 boulevard de Vaugirard
75015 PARIS - FRANCE
T: (33) 178967260
Page 1 of 13
Page 6
Identification of the Subject Device
Trade/Device name: CaloPix
Version: 6.1.0 IVDUS
Regulation number: 21 CFR 864.3700
Classification name: Whole Slide Imaging System
Device Classification: Class II
Product code: QKQ
Review Panel: 88 – Pathology
Common name: Digital Pathology Image Viewing and Management Software
510 (k) Number: K250414
Identification of the Predicates Devices
| Trade/Device name | NanoZoomer S360MD Slide scanner system | Aperio GT 450 DX |
|---|---|---|
| 510(k) number: | K213883 | K232202 |
| Clearance date | September 27, 2022 | April 16, 2024 |
| Regulation number: | 21 CFR 864.3700 | |
| Classification name | Whole slide Imaging System | |
| Device Classification | Class II | |
| Product code: | PSY | |
| Review Panel: | 88 - Pathology | |
| Common name | Digital Pathology Whole Slide Imaging System |
Indications for Use/Intended Use of the device
For In Vitro Diagnostic Use Only
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue.
CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis.
CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
Page 2 of 13
Page 7
It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the quality of the images obtained and the validity of the interpretation of images using CaloPix.
CaloPix is intended to be used with the interoperable components specified in the below Table.
| Scanner Hardware | Scanner Output File Format | Interoperable Displays |
|---|---|---|
| Leica Aperio GT 450 DX scanner | SVS | Dell U3223QE |
| Hamamatsu NanoZoomer S360MD Slide scanner | NDPI | JVC Kenwood JD-C240BN01A |
Description of the Device
CaloPix, version 6.1.0 IVDUS, is a web-based software-only device that is intended to aid pathology professionals in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed on the Dell U3223QE display.
CaloPix does not include any automated Image Analysis Applications that would constitute computer aided detection or diagnosis.
CaloPix is for viewing digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
As a whole, CaloPix is a pathology Image Management System (IMS) which brings case-centric digital pathology image management, collaboration, and image processing. CaloPix consists of:
- Integration with Laboratory Information Systems (LIS): Allows to obtain automatically from the LIS patient data associated with the cases, scanned whole slide images and other related medical images to be analyzed. The data stored in the database is automatically updated according to the interface protocol with the LIS.
DataBase: After ingestion, scanned WSI can be organized in the CaloPix database consisting of folders (cases) containing patient identification data and examination results from a LIS.
Ingestion of the slides is performed through an integrated module that allows their automatic indexation based on patient data retrieved from the LIS. After their ingestion,
Page 3 of 13
Page 8
image files are stored in a CaloPix-specific file storage environment, that can be on premises or in the cloud.
- The CaloPix viewer component to process scanned whole slide images, that includes functions for panning, zooming, screen capture, annotations, distance and surface measurement, and image registration. This viewer relies on image servers (IMGSRV) which extract image tiles from the whole slide image file and send these tiles to the CaloPix viewer for smooth and fast viewing.
CaloPix operates as follows:
-
After the WSI image is acquired using one of the intended scanners, in accordance with the WSI scanner Instructional Manual and any additional standard laboratory procedures, the WSI becomes available in the scanner's file system. The WSI is then sent to end-user-provided image storage attached to the local network. (not part of the subject device).
The WSI is then ingested into the CaloPix database at which point the CaloPix workflow is initiated.
-
The reading pathologist selects a case from a worklist within CaloPix, whereby CaloPix fetches the associated images from the image storage.
-
The image quality and other image data must be manually evaluated in the CaloPix viewer by the pathologist, and deemed acceptable, prior to using a whole slide image for diagnosis.
-
The reading pathologist uses the CaloPix viewer to view and interpret the images using the following functionalities:
- Continuous zooming and panning;
- Measuring distances;
- Creating annotations during review using manual annotation tools and manual counting tools;
- Viewing and comparing multiple slide images simultaneously in multiple windows;
- Tracking of visited areas and annotations and digital bookmarks.
-
The above steps are repeated as required.
-
After viewing all images for a case, the pathologist will make a diagnosis. The diagnosis will be documented in another system, e.g., a Laboratory Information System (LIS).
-
Upon conclusion of using the system, the pathologist clicks "Sign Out" in the user menu.
CaloPix is designed to be deployed to a customer-managed infrastructure or in a cloud infrastructure and may be accessed on the user's workstation browser. CaloPix operates with and is validated for use with the components specified in the tables below.
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Page 9
Table 1: Interoperable Components for Use with CaloPix
| Manufacturer | Model |
|---|---|
| Hamamatsu Photonics K.K. | Scanner: NanoZoomer S360MD Slide scanner |
| Display: JVC Kenwood JD-C240BN01A | |
| Leica Biosystems Imaging, Inc. | Scanner: Aperio GT 450 DX scanner |
| Display: Dell U3223QE |
Table 2: Computer environment / System requirements
| Environment | Component | Minimum Requirements |
|---|---|---|
| Hardware | Computer | PC computer |
| Processor | Minimum: Intel® Core™ i5 / AMD Ryzen 5 | |
| Recommended: Intel® Core™ i7 / AMD Ryzen 7 | ||
| Graphics card | Nvidia GeForce RTX 2060 / AMD Radeon RX 480 | |
| Memory | Minimum: 4GB / Recommended: 8GB | |
| Network connectivity | 10 Mbit/s between the client and the server | |
| Keyboard / Mouse / Trackpad | Standards keyboard and mouse supported by Windows 10 and higher versions | |
| Optional: 3D SpaceMouse Wireless, 3D SpaceMouse Pro from 3D connection | ||
| Software | Operating system | Windows 10 or higher |
| Supported browsers | Google Chrome (version 91 and above) | |
| Microsoft Edge (version 106 and above) |
Summary of Performance Testing
A series of tests were performed to assess the safety and effectiveness of CaloPix. All the test results demonstrate that the subject device meets the requirements of its pre-defined acceptance criteria and intended use.
The following performance tests were conducted per FDA guidance "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Device (2016)" and "Applying Human Factors and Usability Engineering to Medical Devices (2016)".
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Page 10
| Test | Result |
|---|---|
| Pixel-wise comparison | Pixel-wise comparison testing was conducted to compare images reproduced by CaloPix and the comparators (the predicate device's Image Review Manipulation Software (IRMS, as defined in FDA guidance document, "Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices" dated April 20, 2016") as described below for the same image file format generated from the same intended use scanner to validate identical image reproduction on the same intended displays. |
Scanner/Image File Format/Subject Device/Comparator (Predicate device IRMS)/Displays:
- Hamamatsu NanoZoomer S360MD Slide scanner/NDPI/CaloPix/Chrome/NZViewMD/Display JVC Kenwood JD-C240BN01A
- CaloPix/Edge/NZViewMD
- Leica Aperio GT450DX scanner/SVS/CaloPix/Chrome/Aperio WebViewer DX/Chrome/Display Dell U3223QE
- CaloPix/Edge/Aperio WebViewer DX/Chrome
A total of 25 H&E-stained and 5 IHC-stained (Masson's trichrome stain, CD8, CD3, or CD20), formalin-fixed paraffin-embedded (FFPE) tissue glass slides, were scanned using both slide scanner systems. The slides scanned with the Leica Aperio GT450 DX scanner were saved in SVS format, while the slides scanned with the Hamamatsu NanoZoomer S360MD Slide Scanner were saved in NDPI format. For each WSI, 3 regions of interest (ROIs) were identified to highlight relevant pathological features, as verified by a pathologist. Screenshots of these ROIs were captured at two magnification levels (20x and 40x) across multiple displays and browsers as specified in the above table. The testing process ensured comprehensive evaluation across display variations, with all image pairs registered and cropped for analysis. Every pixel of each screenshot was sampled to calculate the pixel-wise color difference using the CIEDE2000 (ΔE00) metric. |
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The acceptance criterion for this testing required that the 95th percentile of the pixel-wise color differences in any image pair between CaloPix and the predicate device IRMS must be less than 3 CIEDE2000 (i.e.,