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510(k) Data Aggregation
(397 days)
INFINITT DPS is a software device intended for viewing and management of whole slide digital images derived from scanned surgical pathology slides prepared from formalin-fixed, paraffin-embedded (FFPE) tissue. It serves as an aid for pathologists to review and interpret these digital images for the purpose of pathology primary diagnosis.
INFINITT DPS is intended for use with Hamamatsu NanoZoomer S360MD scanner and Barco MDPC-8127 display.
It is the responsibility of the pathologist to implement appropriate procedures and safeguards that assure the integrity and accuracy of image interpretation when utilizing the INFINITT DPS. The system is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
INFINITT DPS software provides a more efficient and convenient alternative to reviewing slides with physical microscopes. The primary users of INFINITT DPS are pathologists in histopathology, as well as technologists who handle specimens. Users can access whole slide images directly through a web browser, with no need to install additional software on the client PC.
INFINITT DPS, version 1.1, is a web-based software device that enables qualified pathologists to review digital pathology images (WSIs) of formalin-fixed, paraffin-embedded (FFPE) tissue specimens for pathology primary diagnosis. The device operates through a supported web browser without installing any application locally.
The Operation and Workflow of INFINITT DPS are described below:
- Data Input
- The device accepts WSI files in the NDPI file format generated by a Hamamatsu NanoZoomer S360MD Slide Scanner. The WSI files are internally converted into the Digital Imaging and Communications in Medicine (DICOM) file format using the built-in INFINITT DPS Acquisition module.
- Data Management and Storage
- The converted images are stored on the INFINITT DPS server. The user is highly recommended to back up the original NDPI files. The device can be integrated with an external LIS (Laboratory Information System)/EMR (Electronic Medical Record) system to automate case registration and retrieval.
- Image Access and Navigation
- Users can log in to the device using the INFINITT DPS WebViewer running on a supported web browser (i.e., Chrome, Edge, or Firefox). The stored WSIs can be searched, selected, and opened directly within the INFINITT DPS WebViewer.
- Image Review and Interpretation
- INFINITT DPS WebViewer provides the following interactive features:
- Zoom, pan, and rotate for image navigation
- Measurement tools for length and area analysis
- INFINITT DPS WebViewer provides the following interactive features:
The interoperable components of INFINITT DPS and other system specifications are provided in tables 1 – 3 below.:
Table 1. Interoperable Components for Use with INFINITT DPS
| Components | Manufacturer | Model |
|---|---|---|
| Scanner | Hamamatsu | NanoZoomer S360MD Slide scanner |
| Display | Barco | MDPC-8127 |
Table 2. Computer Environment / System for Use with INFINITT DPS
| Component | Requirement |
|---|---|
| Operating System | Windows 11 |
| Memory | 32GB RAM |
| Processor | Intel Core i7-11800H |
| Supported Browsers | Google Chrome version 90.0 and above |
| Microsoft Edge version 90.0 and above | |
| Mozilla Firefox version 80.0 and above |
Table 3. Server System Requirements
| Component | Web Server | Database Server |
|---|---|---|
| CPU | 2.8GHz 12-core or higher | 2.2GHz 8-core or higher |
| Memory | 64GB or more | 16GB or more |
| Storage | 2TB or more | 4TB or more |
| Software Platforms | Microsoft IIS (Internet Information Services) 10 or higher | Not Found |
| Operating Systems | Microsoft Windows Server 2016 or higher | Not Found |
| Database | N/A | Oracle Database 19c or higher |
| Network | 1Gbps | 1Gbps |
N/A
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