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510(k) Data Aggregation
(266 days)
Leica Biosystems Imaging, Inc.
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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(95 days)
Leica Biosystems Imaging, Inc.
The Aperio AT2 DX System is an automated digital slide creation and viewing system. The Aperio AT2 DX System is intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. The Aperio AT2 DX System is not use with frozen section, cytology, or non-FFPE hematopathology specimens.
The Aperio AT2 DX System is composed of the Aperio AT2 DX scanner, the ImageScope DX review application and Display. The Aperio AT2 DX System is for creation and viewing of digital images of scanned glass slides that would otherwise be appropriate for manual visualization by conventional light microscopy. It is the responsibility of a qualified pathologist to employ appropriate procedures and safeguards to assure the interpretation of images obtained using the Aperio AT2 DX System.
The Aperio AT2 DX System is an automated digital slide creation and viewing system. The system is comprised of an Aperio AT2 DX scanner instrument and a Viewing Workstation with a computer and a calibrated monitor executing ImageScope DX viewer software. The system capabilities include digitizing microscope slides at diagnostic resolution, retrieving and displaying digital slides, including support for remote intra-net access over computer networks, providing tools for annotating digital slides, entering data associated with digital slides and displaying the scanned slide images for primary diagnoses by Pathologists.
Here's a breakdown of the acceptance criteria and study details for the Aperio AT2 DX System, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance | Met? |
|---|---|---|
| Upper bound of the two-sided 95% CI of the difference between overall major discrepancy rates of WSIR diagnoses and MSR diagnoses is |
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(91 days)
LEICA BIOSYSTEMS IMAGING, INC.
The Aperio ePathology eIHC IVD System is an automated digital slide creation, management, viewing and analysis system. It is intended for in vitro diagnostic use as an aid to the pathologist in the display, detection, counting and classification of tissues and cells of clinical interest based on particular color, intensity, size, pattern and shape.
The IHC HER2 Image Analysis application is intended for use as an aid to the pathologist in the detection and semi-quantitative measurement of HER2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue.
The IHC HER2 Image Analysis application is intended for use as an accessory to the Dako HercepTest™ to aid in the detection and semi-quantitative measurement of Her2/neu (c-erbB-2) in formalin-fixed, paraffin-embedded neoplastic tissue. When used with the Dako HercepTest™, it is indicated for use as an aid in the assessment of breast cancer patients for whom HERCEPTIN®(Trastuzumab) treatment is being considered.
The IHC ER Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitative measurement of ER (Estrogen Receptor) in formalin-fixed paraffin-embedded neoplastic tissue.
The IHC PR Image Analysis application is intended for use as an aid to the pathologist in the detection and quantitation measurement of PR (Progesterone Receptor) in formalin-fixed, paraffin-embedded neoplastic tissue.
lt is indicated for use as an aid in the management, prognosis, and prediction of therapy outcomes of breast cancer.
The Aperio ePathology eIHC IVD System ("System") is an automated digital slide creation, management, viewing and analysis system. The Aperio ePathology eIHC IVD System components consist of an automated digital microscope slide scanner, computer, color monitor, keyboard and digital pathology information management software. The system capabilities include digitizing microscope slides at high resolution, storing and managing the resulting digital slide images, retrieving and displaying digital slides, including support for remote access over wide-area networks, providing tools for annotating digital slides and entering and editing data associated with digital slides, and tools for image analysis of digital slides. Image analysis capabilities include the ability to quantify characteristics useful to Pathologists, such as measuring and scoring immunohistochemical stains applied to histology specimens, including the Dako HerceptTest™, Dako ER/PR, which reveal the presence of proteins such as Human Epidermal growth factor Receptor 2 (HER2), ER (Estrogen Receptor) protein and PR (Progesterone Receptor) protein expression.
Below summarizes the acceptance criteria and study information for the Aperio ePathology eIHC IVD System, specifically for its HER2, ER, and PR Image Analysis applications.
1. Table of Acceptance Criteria and Reported Device Performance
For IHC HER2 Image Analysis:
| Acceptance Criteria (Agreement with Predicate Device) | Reported Device Performance (Exact 95% Lower Confidence Interval) |
|---|---|
| Percent agreement (trichotomous: 0 & 1+, 2+, 3+) | Passed acceptance criteria |
For IHC ER and PR Image Analysis:
| Acceptance Criteria (Agreement with Predicate Device) | Reported Device Performance (Exact 95% Lower Confidence Interval) |
|---|---|
| Percent agreement (dichotomous: Positive vs Negative at 1% and 10% thresholds) | Passed acceptance criteria |
2. Sample Size and Data Provenance for Test Set
- Sample Size: Not explicitly stated for either HER2 or ER/PR. The document mentions "slides represented the range of HER2 scores (0, 1+, 2+ and 3+)" and "slides represented the range of ER and PR scores that are observed clinically."
- Data Provenance: The samples were "Paraffin embedded breast tissue slides prepared with the appropriate Dako HER2 IHC test kit" and "Paraffin embedded breast tissue slides prepared with the appropriate Dako ER and PR IHC test kits." The origin (e.g., country) is not specified. The studies were internal system performance tests, implying a retrospective nature where pre-existing clinical samples were used.
3. Number of Experts and Qualifications for Ground Truth
- The document states that the HER2, ER, and PR scores obtained from the updated ScanScope systems were "evaluated for concordance with the scores obtained from the predicate device." This suggests the predicate device's scores served as the reference for comparison, rather than human experts directly establishing ground truth for the test set in these specific performance studies.
- No information is provided about the number or qualifications of experts directly establishing ground truth for the test set used in the system performance testing. The predicate device's output was the reference.
4. Adjudication Method
- Not applicable as the comparison was against the predicate device's scores, not human expert consensus requiring adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. The studies described were system-level performance tests evaluating the updated ScanScope instruments against a predicate device.
- Therefore, no effect size of human readers improving with AI vs. without AI assistance is provided. The device is intended as an "adjunctive computer-assisted methodology to assist the reproducibility of a qualified pathologist."
6. Standalone Performance Study
- Yes, a standalone study (algorithm-only performance) was conducted. The "System Performance Testing" described for both HER2 and ER/PR evaluated the "accuracy of the HER2 image analysis algorithm on the updated ScanScope instruments" and "accuracy of the ER and PR image analysis algorithms on the updated ScanScope instruments," respectively, by comparing their output against the predicate device's scores.
7. Type of Ground Truth Used
- For the system performance testing, the ground truth used was the scores obtained from the legally marketed predicate device (ScanScope XT). The updated ScanScope models' results were evaluated for concordance with the predicate device's scores.
8. Sample Size for the Training Set
- The document does not provide information regarding the sample size specifically used for training the image analysis algorithms. The described studies are performance evaluations of the already developed algorithms.
9. How Ground Truth for Training Set was Established
- The document does not provide information on how the ground truth for the training set was established. The focus of this submission is on the direct comparison of the updated devices' performance to the predicate device.
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