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510(k) Data Aggregation
(266 days)
Aperio GT 450 DX
The Aperio GT 450 DX is an automated digital slide creation and viewing system. The Aperio GT 450 DX is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images of surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio GT 450 DX is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy.
Aperio GT 450 DX is comprised of the Aperio GT 450 DX scanner, which generates images in the Digital Imaging and Communications in Medicine (DICOM) and in the ScanScope Virtual Slide (SVS) file formats, the Aperio WebViewer DX viewer, and the displays. The Aperio GT450 DX is intended to be used with the interoperable components specified in Table 1.
The Aperio GT 450 DX is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. 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 the Aperio GT 450 DX.
The Aperio GT 450 DX is a Whole Slide Imaging (WSI) system, including image acquisition and image viewing components.
Aperio GT 450 DX is a WSI system comprised of an image acquisition subsystem known as the Aperio GT 450 DX scanner and Aperio WebViewer DX image viewing software which is accessed from a workstation and a display.
Image Acquisition Subsystem: The image acquisition subsystem of the Aperio GT 450 DX captures the information from surgical pathology glass slides prepared from FFPE tissue and saves it as a high-resolution digital image file. This subsystem is comprised of the Aperio GT 450 DX scanner and corresponding scanner configuration software, Aperio GT 450 Scanner Administration Manager DX (SAM DX).
The Aperio GT 450 DX scanner is a semi-automated benchtop brightfield WSI scanner that can achieve a scan speed of 32 seconds at the 40x scanning magnification for a 15 mm x 15 mm area. The scanner supports continuous glass-slide loading (Up to 15 racks with a total of 450-slide capacity), priority rack scanning, and automated image quality checks during image acquisition. The Aperio GT 450 DX scanner can be used with Leica Biosystems Imaging, Inc .--manufactured slide racks (Product No. 23RACKGT450) and other supported slide racks (e.g., Prisma® 20-slide basket from Sakura Finetek USA, Inc). The Aperio GT 450 DX scanner detects the racks once loaded in the scanner and scans the slides automatically. Users operate the scanner via a touchscreen interface.
The Aperio GT 450 DX scanner can save digital images in a unique Aperio ScanScope Virtual Slide (SVS) image format or Digital Imaging and Communications in Medicine (DICOM) image format. The digital images are sent to end-user-provided image storage attached to the scanner's local network, where they can be cataloged in image storage software (non-medical device, external to the WSI), including Image Management System (IMS), such as Aperio eSlide Manager, or a Picture Archiving and Communication System (PACS), such as Sectra PACS software.
Aperio GT 450 SAM DX is centralized scanner management software external to the connected scanner(s). This software application enables IT implementation, including configuration, monitoring, and service access of multiple scanners from a single desktop client location. Aperio GT 450 SAM DX is installed on a customer-provided server that resides on the same network as the scanner(s) for image management.
Image Viewing Subsystem: The image viewing subsystem of the WSI device displays the digital images to the human reader. This subsystem comprises Aperio WebViewer DX image viewing software, a workstation PC, and monitor(s). Both the workstation and display are procured by the customer from commercial distributors and qualified for in vitro diagnostic use by Leica Biosystems Imaging, Inc. The Aperio WebViewer DX software is a web-based image viewer that enables users to perform Quality Control of images and to review and annotate digital images for routine diagnosis. The Aperio WebViewer DX also incorporates monitor display image validation checks, which provide the user with the ability to ensure the digital slide images are displayed as intended on their monitor, and that browser updates have not inadvertently affected the image display quality. Aperio WebViewer DX is installed on a server and accessed from an IMS (e.g., Aperio eSlide Manager) or a customer's Laboratory Information System (LIS) using compatible browsers.
Here's a summary of the acceptance criteria and the study proving the device meets them, based on the provided text:
Acceptance Criteria and Device Performance for Aperio GT 450 DX
1. Table of Acceptance Criteria and Reported Device Performance:
| Criterion Category | Specific Criterion | Acceptance Criteria | Reported Device Performance | Met? |
|---|---|---|---|---|
| Clinical Accuracy | ||||
| Primary Endpoint | Difference in overall major discrepancy rates (WSIR diagnosis minus MSR diagnosis) for the full cohort (local and remote combined) compared to the reference diagnosis. | The upper bound of the 2-sided 95% confidence interval (CI) of the difference between the overall major discrepancy rates of WSIR diagnosis and MSR diagnosis when compared to the reference diagnosis shall be ≤4%. | Model 95% CI for Difference: (1.40%, 3.39%) | |
| The upper bound (3.39%) is ≤4%. | Yes | |||
| Secondary Endpoint | Major discrepancy rate of WSIR diagnosis relative to the reference diagnosis (full cohort). | The upper bound of the 2-sided 95% CI of the major discrepancy rate between the WSIR diagnosis and the reference diagnosis shall be ≤7%. | Model 95% CI for WSIRD Major Discrepancy Rate: (5.01%, 6.80%) | |
| The upper bound (6.80%) is ≤7%. | Yes | |||
| Secondary Endpoint | Difference in major discrepancy rates (WSIR diagnosis minus MSR diagnosis) for local WSI access compared to the reference diagnosis. | The upper bound of the 2-sided 95% CI of the difference between the major discrepancy rates of the WSIR diagnosis and MSR diagnosis when compared to the reference diagnosis shall be |
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