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510(k) Data Aggregation
(266 days)
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 <4% for local WSI access. | Model 95% CI for Local Difference: (1.23%, 3.99%) The upper bound (3.99%) is <4%. | Yes |
| Secondary Endpoint | Difference in major discrepancy rates (WSIR diagnosis minus MSR diagnosis) for remote 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 <4% for remote WSI access. | Model 95% CI for Remote Difference: (0.78%, 3.57%) The upper bound (3.57%) is <4%. | Yes |
| Precision | ||||
| Intra-system precision (overall) | Overall agreement within individual systems and across all systems. | The lower bounds of the 2-sided 95% CI of the overall agreements for each precision component (intra-system/site, intra-pathologist, and inter-pathologist) were ≥ 85%. | Overall Agreement Rate (Intra-System): 97.1% (95% CI: 95.8%, 98.3%) The lower bound (95.8%) is ≥ 85%. | Yes |
| Inter-system/site precision (overall) | Overall agreement between different systems/sites. | The lower bounds of the 2-sided 95% CI of the overall agreements for each precision component (intra-system/site, intra-pathologist, and inter-pathologist) were ≥ 85%. | Overall Agreement Rate (Inter-System/Site): 96.3% (95% CI: 94.9%, 97.6%) The lower bound (94.9%) is ≥ 85%. | Yes |
| Intra-pathologist precision (overall) | Overall agreement within individual pathologists. | The lower bounds of the 2-sided 95% CI of the overall agreements for each precision component (intra-system/site, intra-pathologist, and inter-pathologist) were ≥ 85%. | Overall Agreement Rate (Intra-Pathologist) for System 1 (single system data used for this test): 93.5% (95% CI: 92.4%, 94.5%) The lower bound (92.4%) is ≥ 85%. | Yes |
| Inter-pathologist precision (overall) | Overall agreement between different pathologists. | The lower bounds of the 2-sided 95% CI of the overall agreements for each precision component (intra-system/site, intra-pathologist, and inter-pathologist) were ≥ 85%. | Overall Agreement Rate (Inter-Pathologist) for System 1 (single system data used for this test): 91.7% (95% CI: 90.6%, 92.8%) The lower bound (90.6%) is ≥ 85%. | Yes |
Note: WSIR = Whole Slide Image Review; MSR = Light Microscope Slide Review
2. Sample Size for Test Set and Data Provenance:
-
Clinical Accuracy Study (Full Cohort):
- WSIR Diagnosis: 3549 cases.
- MSR Diagnosis: 3631 cases.
- The "Full Cohort" combines local and remote cohorts, suggesting data collection may have occurred across multiple sites or access methods. The country of origin is not explicitly stated, but clinical studies for FDA submissions typically involve well-regulated clinical environments, often in the US. The study appears to be retrospective as it compares diagnoses from WSIR and MSR against "reference diagnoses" (original sign-out pathologic diagnoses), suggesting these reference diagnoses were pre-existing.
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Precision Study: The sample sizes vary by substudy:
- Intra-System Precision: 759 comparison pairs (737 pairwise agreements).
- Inter-System/Site Precision: 759 comparison pairs (731 pairwise agreements).
- Intra-Pathologist Precision: 2277 comparison pairs (2129 pairwise agreements).
- Inter-Pathologist Precision: 2277 comparison pairs (2089 pairwise agreements).
- The origin of the data for the precision study is not specified but involves "three independent systems at three different sites" for inter-system/site precision. The nature of the "cases" for precision implies pathologists reviewing slides/images, potentially from similar sources as the accuracy study.
3. Number of Experts and Qualifications for Ground Truth:
- The text refers to "the pathologists" in the context of the device's intended use and the "original sign-out pathologic diagnosis" as the reference diagnosis (ground truth) for the clinical accuracy study.
- The number of pathologists establishing the original sign-out diagnoses for the entire cohort of slides is not explicitly stated.
- The qualifications implied are "qualified pathologist" to ensure the validity of interpretation. Specific years of experience are not provided.
- For the precision study, it refers to "3 pathologists" in the intra- and inter-pathologist precision substudy, but their specific qualifications (e.g., years of experience) are not listed.
4. Adjudication Method for the Test Set:
- The clinical accuracy study established "reference diagnoses" as the "original sign-out pathologic diagnosis." This suggests that the ground truth was based on a primary diagnostic process, which may or may not inherently involve an adjudication method like 2+1 or 3+1 during its initial establishment. The document does not explicitly describe an adjudication method used to establish this "reference diagnosis" or the ground truth for the test set. It implies a single, established diagnostic truth.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Yes, a comparative effectiveness study was done. The clinical accuracy study compared diagnoses made using the Aperio GT 450 DX (WSIR) against traditional light microscope slide review (MSR) diagnoses, both relative to a reference diagnosis. This involved multiple readers (pathologists) examining multiple cases.
- Effect Size of Human Readers Improvement with AI vs. without AI Assistance: This study does not describe an AI assistance scenario. The Aperio GT 450 DX is a Whole Slide Imaging (WSI) system for digital review of slides, not an AI diagnostic aid. It enables pathologists to interpret digital images, which is compared to their interpretation using a physical microscope. Therefore, there is no "AI assistance" component described for improving human reader performance. The study focuses on the equivalence of digital review to traditional microscopy.
6. Standalone (Algorithm Only) Performance:
- No, a standalone (algorithm only) performance study was not described. The Aperio GT 450 DX is a system intended for in vitro diagnostic use as an aid to the pathologist to review and interpret digital images. Its performance is evaluated with a human in the loop, comparing the pathologist's interpretation of digital images to their interpretation of glass slides. The device itself does not provide an automated diagnosis.
7. Type of Ground Truth Used:
- The ground truth for the clinical accuracy study was the "original sign-out pathologic diagnosis." This implies an expert consensus or established diagnostic conclusion based on standard pathological procedures. Other types like pathology reports, outcomes data, or a specific gold standard adjudication were not explicitly detailed beyond being the "original sign-out."
8. Sample Size for the Training Set:
- The document does not provide information regarding a specific training set or its sample size. This is a WSI system, not a device with a machine learning component that requires a labeled training set for its core function of image acquisition and display. The "tissue detection algorithms" are mentioned as part of the technical studies (whole slide tissue coverage), but details on how these were trained are not provided.
9. How the Ground Truth for the Training Set was Established:
- Since a training set and its sample size are not mentioned for the core function of the device, the method for establishing its ground truth is not provided in this document.
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(150 days)
The Barco MDPC-8127 device is intended for in vitro diagnostic use to display digital images of histopathology slides acquired from IVD-labeled whole-slide imaging scanners and viewed digital pathology image viewing software that have been validated for use with this device. It is an aid to the pathologist to review and interpret digital images of histopathology slides for primary diagnosis. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using the MDPC-8127. The display is not intended for use with digital images from frozen section, cytology, or non-formalin-fixed, paraffin embedded (non-FFPE) hematopathology specimens.
The Barco MDPC-8127 is a medical, color-calibrated display, specifically intended for review and interpretation of surgical pathology slides from IVD-labeled whole-slide imaging scanners and digital pathology image viewing software that have been validated for use with the display.
The use of the MDPC-8127 display with scanners and viewing software is determined by using verified test methods to establish the display's capability to meet or exceed the performance specifications and the intended color space specified by the IVD-labeled whole-slide imaging scanners and digital pathology image viewing software.
The display uses built-in techniques and technology to ensure constant accuracy over time.
The MDPC-8127 consists of an 8 mega-pixel, 27-inch color LCD-panel with internal electronics platform. It is calibrated to defined color spaces for whole-slide imaging and is compatible with digital pathology viewinq software that utilizes defined color spaces to ensure images are displayed in intended colors.
The provided text describes the Barco MDPC-8127, a medical display intended for in vitro diagnostic use to display digital images of histopathology slides. The document details the device's technical specifications and performance testing to demonstrate substantial equivalence to a predicate device, the MMPC-4227F1 (PP27QHD).
Here's an analysis of the acceptance criteria and study proving the device meets them, based only on the provided text:
Key Takeaway from the Document: The study primarily focuses on non-clinical bench testing to demonstrate the MDPC-8127's technical characteristics and performance are equivalent to or better than a predicate device. It is not a clinical study involving human readers and a comparative effectiveness assessment with AI assistance. The display itself is a tool for pathologists, not an AI algorithm.
1. Table of Acceptance Criteria and Reported Device Performance
The document presents a table comparing the performance of the MDPC-8127 (proposed device) with its predicate device (MMPC-4227F1). While not explicitly labeled as "acceptance criteria," these are the parameters against which the device's performance was evaluated for substantial equivalence. The "Results" column for MDPC-8127 represents the reported device performance.
| Test | MDPC-8127 Reported Performance | Predicate Device Performance (Reference) |
|---|---|---|
| User controls | Luminance target, maximum: 450 cd/m²; Display function: sRGB; White point: 6500K; Color space: sRGB; 10 minutes of warm-up time | Luminance target, maximum: 350 cd/m²; Display function: sRGB; White point: 6500K; Color space: sRGB; 10 minutes of warm-up time |
| Spatial resolution | Both horizontal and vertical MTFs are greater than 85% at Nyquist frequency | Both horizontal and vertical MTFs are greater than 75% at Nyquist frequency |
| Pixel defects | Total number of bright and dark pixels <= 5 with a minimum distance greater than 15 mm. | Total number of bright and dark pixels <= 3 within a circle of 10 mm diameter |
| Artifacts | < 0.65% | < 0.65% |
| Temporal response | The response time ranges from 3.1 ms to 6.2 ms with an average of 5.01 ms. | The response time is maximum 15 ms and typical 8 ms. |
| Maximum and minimum luminance | Maximum: 678.6 cd/m²; Minimum: 0.633 cd/m²; Calibrated target: 450 cd/m²; Contrast ratio: > 1000:1 | Maximum: 550 cd/m²; Minimum: 0.3 cd/m²; Calibrated target: 350 cd/m²; Contrast ratio: 1000:1 |
| Grayscale | Maximum error calculated = 1.4% | Maximum error calculated = 2.1% |
| Luminance uniformity and Mura | <10% non-uniformity on 80% video level | 21% non-uniformity on 80% video level |
| Stability of luminance and chromaticity response | Deviation from target luminance (450 cd/m²): ± 0.44%; Variations for luminance and chromaticity: < 5% deviation | Deviation from target luminance (350 cd/m²): ± 0.2%; Variations for luminance and chromaticity: < 2% deviation |
| Bidirectional reflection distribution function | Specular reflection coefficient: 1.90%; Diffuse reflection coefficient: 2.87% | Specular reflection coefficient: 1.69%; Diffuse reflection coefficient: 2.21% |
| Gray tracking | ± 0.01 Δu'v'; White point at D65: ± 0.01 Δu'v' | ± 0.002 Δu'v'; White point at D65: ± 0.002 Δu'v' |
| Color scale | Average color error < 1 ΔE₀₀; Maximum color error < 3 ΔE₀₀ | Average color error < 2 ΔE₀₀; Maximum color error < 5 ΔE₀₀ |
| Color gamut volume | 2D color gamut wrt sRGB: 137.1%; 2D color gamut overlapped with sRGB: 99.6% | 2D color gamut wrt sRGB: 99.4%; 2D color gamut overlapped with sRGB: 98.4% |
2. Sample Size Used for the Test Set and Data Provenance
The document describes non-clinical bench testing of the display device itself. Therefore, concepts like "test set," "sample size," and "data provenance" in the context of images or patient data are not applicable to the performance study described. The performance tests were conducted on the physical display unit.
3. Number of Experts Used to Establish Ground Truth and Qualifications
Not applicable. The study is a non-clinical bench test of a display's physical and technical performance parameters (e.g., luminance, resolution, color accuracy), not a study involving the interpretation of medical images by experts to establish ground truth for a diagnostic algorithm.
4. Adjudication Method for the Test Set
Not applicable. This was a non-clinical bench test of hardware performance, not an expert-based image interpretation study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size
No MRMC comparative effectiveness study was mentioned. The device is a display, not an AI algorithm. The performance testing described is focused on the technical specifications of the display itself, demonstrating its equivalence or superiority to a predicate display, not on how human readers perform with or without AI assistance.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop) Performance Study was done
Not applicable. The MDPC-8127 is a display device, not a standalone algorithm.
7. The Type of Ground Truth Used
The ground truth for the performance evaluations (e.g., luminance, color accuracy, resolution) would be based on established measurement standards and calibrated equipment (e.g., photometers, colorimeters) as outlined in the test methods (e.g., IDMS v1.03b, AAPM TG-18). It is not "expert consensus," "pathology," or "outcomes data" in the medical diagnostic sense.
8. The Sample Size for the Training Set
Not applicable. This is a hardware device. The concept of a "training set" is relevant for machine learning algorithms, which is not what this approval is about.
9. How the Ground Truth for the Training Set was Established
Not applicable, for the same reason as above.
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