(265 days)
No
The description focuses on image viewing, management, and basic annotation tools, with no mention of AI, ML, or advanced image analysis features that would typically indicate the presence of such technology. The performance studies are focused on display accuracy, loading times, and clinical concordance with traditional microscopy, not on the performance of an AI/ML algorithm.
No
The device is described as software intended for aiding pathologists in viewing and managing digital images of pathology slides for primary diagnosis, explicitly stating it is for In Vitro Diagnostic Use. It does not provide any direct treatment or therapy to a patient.
Yes
The device is described as "an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis," and its intended use is "For In Vitro Diagnostic Use," explicitly indicating its role in the diagnostic process.
Yes
The device is described as a "software device" and its function is viewing and managing digital images. While it requires specific hardware (scanner and display) to function, these are explicitly stated as not being part of the subject device. The core functionality is software-based image display and management.
Yes, this device is an IVD (In Vitro Diagnostic).
Here's why:
- Explicit Statement: The "Intended Use / Indications for Use" section explicitly states: "For In Vitro Diagnostic Use".
- Intended Use: The device is intended for "viewing and management of digital images of scanned surgical pathology slides... as an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis." This directly relates to the examination of specimens derived from the human body for the purpose of providing information for the diagnosis of disease, which is the definition of an in vitro diagnostic product.
- Clinical Study: The document describes a clinical study comparing the performance of the device to light microscopy for primary diagnosis, further supporting its intended use in a clinical diagnostic setting.
N/A
Intended Use / Indications for Use
For In Vitro Diagnostic Use
Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module (3.3).
Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
Product codes (comma separated list FDA assigned to the subject device)
QKQ
Device Description
The Sectra Digital Pathology Module (3.3) [henceforth referred to DPAT (3.3)] is a digital slide viewing system. The DPAT (3.3) is intended for use together with FDA-cleared whole-slide image scanner GT 450 DX and Dell U3223QE display.
The DPAT (3.3) can only be used as an add-on module to Sectra PACS. Sectra PACS consists of Sectra Workstation IDS7 (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). Sectra PACS is not part of the subject device. Sectra Workstation is the viewing workstation in which the Pathology Image Window is run. Pathology Image Window is the client component of the subject device.
The system capabilities include:
- retrieving and displaying digital slides,
- support for remote intranet access over computer networks,
- tools for annotating digital slides and entering and editing metadata associated with digital slides, and
- displaying the scanned slide images for primary diagnosis by pathologists.
The subject device is designed to accurately display colors. The monitor is not part of the subject device.
Digital pathology images originating from WSI scanners other than those listed in the Indications for Use will be marked with the disclaimer "For Non-clinical Use Only" in the Pathology Image Window.
Image acquisition will be managed by the scanner which is not part of the subject device:
- The scanner delivers images with a tag in the file header that identifies the originating scanner.
- The scanner includes applications for controlling the scanning process and performing related quality control (e.g., ensuring that images are sharp and cover all tissue on the slide).
The DPAT (3.3) supports reading digital slides on a Dell U32230E display monitor, enabling pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in performing a primary diagnosis based on viewing the digital slide on a computer monitor. These capabilities are provided by the Pathology Image Window.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Scanned surgical pathology slides
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Pathologist / Not Found
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
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical test results:
Conducted per FDA's Guidance on Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices:
The clinical study was performed using SVS images displayed in UniView Chrome, creating a reference pipeline that could then be used for technical testing with DICOM. IDS7, and UniView in Edge, to support the claims of the subject device. The subject device displayed the same scanned image in both DICOM and SVS formats, in IDS7, Edge or Chrome, with no difference (△E=0).
Turnaround times for panning and zooming have been determined and found to be adequate for the intended use of the subject device.
The subject device has been found to perform accurate measurements with respect to its intended use.
Clinical Study:
Study type: Noninferiority clinical study.
Sample size: 258 cases, leading to 774 diagnoses (258 cases × 3 reading pathologists). 7 WSIR and 10 MSR diagnoses were deferred and excluded from statistical analysis.
Key results:
The estimated difference in major discrepancy rates between the 2 modalities (WSIR and MSR) when compared to the reference diagnosis was -0.01% (95% CI: -1.71% to 1.69%). The upper bound of the 95% CI was 1.69%, which met the predefined acceptance criteria of ≤4% for the primary endpoint.
The upper bound of the 95% CI for the overall estimated major discrepancy rate for WSIR diagnosis was 5.25%, which met the predefined acceptance criteria of ≤7% for the secondary endpoint.
The acceptance criteria were met for all study endpoints. These study results support the conclusion that DPAT (3.3)-UniView is safe and effective when used by pathologists in rendering primary diagnoses of FFPE tissue sections as compared to using light microscopy when used according to the device intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Major Discrepancy Rate:
WSIRD vs Reference: 2.95% (95% CI: 1.64%, 5.25%)
MSRD vs Reference: 2.96% (95% CI: 1.65%, 5.27%)
Difference (WSIRD vs MSRD): -0.01% (95% CI: -1.71%, 1.69%)
Concordance Rate between WSIR Diagnoses and MSR Diagnoses: 95.7% (95% Confidence Interval: 94.2%, 97.1%)
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 16, 2024
Sectra AB % Peter Altman Consultant Medical Device Regulatory Services 14 Mercer Road Savannah, Georgia 31411
Re: K232208
Trade/Device Name: Sectra Digital Pathology Module (3.3) Regulation Number: 21 CFR 864.3700 Regulation Name: Whole slide imaging system Regulatory Class: Class II Product Code: QKQ Dated: July 26, 2023 Received: July 26, 2023
Dear Peter Altman:
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).
1
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 OS 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 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-safetyreporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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.
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-device-safety/medical-device-reportingmdr-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/medicaldevices/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-device-advice-comprehensive-regulatoryassistance/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).
Sincerely,
Shyam Kalavar -S
Shyam Kalavar Deputy Branch Chief Division of Molecular Genetics and Pathology 2 OHT7: Office of In Vitro Diagnostics Office of Product Evaluation and Quality Center for Devices and Radiological Health Center for Devices and Radiological Health
2
Indications for Use
510(k) Number (if known) K232208
Device Name Sectra Digital Pathology Module (3.3)
Indications for Use (Describe) For In Vitro Diagnostic Use
Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens. It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module (3.3).
Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
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) |
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3
510(k) Summary
Sectra Digital Pathology Module (3.3), Sectra AB
Date Prepared: April 15, 2024
Submitter:
Sectra AB Teknikringen 20 SE-583 30 Linköping Sweden Establishment Registration Number: 9615992
Contact Person:
| Name: | Edoardo Mastrovito |
|---|---|
| Title: | Quality and Regulatory Affairs Mgr. |
| Telephone: | +46 13 235206 |
| Facsimile: | n/a |
Device Identification:
| Proprietary/Trade Name: | Sectra Digital Pathology Module |
|---|---|
| Version Number | 3.3 |
| 510(k) Number: | K232208 |
| Classification Name: | Whole Slide Imaging System |
| Regulation Number: | 21 CFR 864.3700 |
| Product Codes: | QKQ |
| Device Class: | Class II |
| Review Panel: | 88 – Pathology |
| Common Name: | Digital Pathology Image Viewing and Management |
| Software |
Predicate Device Identification:
| Proprietary/Trade Name: | The Aperio WebViewer DX component of the Aperio GT
450 DX System |
|-------------------------|---------------------------------------------------------------------|
| 510(k) Number: | K232202 |
| Classification Name: | Whole Slide Imaging System |
| Regulation Number: | 21 CFR 864.3700 |
| Product Codes: | PSY |
| Device Class: | Class II |
| Review Panel: | 88 – Pathology |
| Common Name: | Digital Pathology Image Management System |
4
Device Description:
The Sectra Digital Pathology Module (3.3) [henceforth referred to DPAT (3.3)] is a digital slide viewing system. The DPAT (3.3) is intended for use together with FDA-cleared whole-slide image scanner GT 450 DX and Dell U3223QE display.
The DPAT (3.3) can only be used as an add-on module to Sectra PACS. Sectra PACS consists of Sectra Workstation IDS7 (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000). Sectra PACS is not part of the subject device. Sectra Workstation is the viewing workstation in which the Pathology Image Window is run. Pathology Image Window is the client component of the subject device.
The system capabilities include:
- · retrieving and displaying digital slides,
- · support for remote intranet access over computer networks,
- tools for annotating digital slides and entering and editing metadata associated with digital slides, and
- · displaying the scanned slide images for primary diagnosis by pathologists.
The subject device is designed to accurately display colors. The monitor is not part of the subject device.
Digital pathology images originating from WSI scanners other than those listed in the Indications for Use will be marked with the disclaimer "For Non-clinical Use Only" in the Pathology Image Window.
Image acquisition will be managed by the scanner which is not part of the subject device:
- · The scanner delivers images with a tag in the file header that identifies the originating scanner.
· The scanner includes applications for controlling the scanning process and performing related quality control (e.g., ensuring that images are sharp and cover all tissue on the slide).
The DPAT (3.3) supports reading digital slides on a Dell U32230E display monitor, enabling pathologists to make clinically relevant decisions analogous to those they make using a conventional microscope. Specifically, the system supports the pathologist in performing a primary diagnosis based on viewing the digital slide on a computer monitor. These capabilities are provided by the Pathology Image Window.
Indications for Use/Intended Use:
For In Vitro Diagnostic Use
Sectra Digital Pathology Module (3.3) is a software device intended for viewing and management of digital images of scanned surgical pathology slides prepared from formalin-fixed paraffin embedded (FFPE) tissue. It is an aid to the pathologist to review and interpret these digital images for the purposes of primary diagnosis.
Sectra Digital Pathology Module (3.3) is not intended for use with frozen section, cytology, or non-FFPE hematopathology specimens.
5
It is the responsibility of the pathologist to employ appropriate procedures and safeguards to assure the validity of the interpretation of images using Sectra Digital Pathology Module (3.3).
Sectra Digital Pathology Module (3.3) is intended for use with Leica's Aperio GT 450 DX scanner and Dell U3223QE display, for viewing and management of the ScanScope Virtual Slide (SVS) and Digital Imaging and Communications in Medicine (DICOM) image formats.
| Item | Subject Device | Predicate | ||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Indications | ||||||||||||||||||
| for Use | For In Vitro Diagnostic | |||||||||||||||||
| Use | ||||||||||||||||||
| Sectra Digital Pathology | ||||||||||||||||||
| Module (3.3) is a | ||||||||||||||||||
| software device intended | ||||||||||||||||||
| for viewing and | ||||||||||||||||||
| management of digital | ||||||||||||||||||
| images of scanned | ||||||||||||||||||
| surgical pathology slides | ||||||||||||||||||
| prepared from formalin- | ||||||||||||||||||
| fixed paraffin embedded | ||||||||||||||||||
| (FFPE) tissue. It is an aid | ||||||||||||||||||
| to the pathologist to | ||||||||||||||||||
| review and interpret | ||||||||||||||||||
| these digital images for | ||||||||||||||||||
| the purposes of primary | ||||||||||||||||||
| diagnosis. |
Sectra Digital Pathology
Module (3.3) is not
intended for use with
frozen section, cytology,
or non-FFPE
hematopathology
specimens. It is the
responsibility of the
pathologist to employ
appropriate procedures
and safeguards to assure
the validity of the
interpretation of images
using Sectra Digital
Pathology Module (3.3).
Sectra Digital Pathology
Module (3.3) is intended | 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 GT
450 DX is intended to be used with the interoperable
components specified in Table 1.
Table 1: Interoperable components of Aperio GT 450 DX | | | | | | | | | | | | | | | | |
| | Scanner Hardware Scanner Output
file format Interoperable
Viewing
Software Interoperable
Displays Aperio
GT 450 DX
scanner SVS Aperio
WebViewer DX Barco MDPC-8127
Dell UP3017
Dell U3023E
Dell U3223QE Aperio
GT 450 DX
scanner SVS Sectra Digital
Pathology Module
(3.3) Dell U3223QE Aperio GT
450 DX
scanner DICOM Sectra Digital
Pathology Module
(3.3) Dell U3223QE | | | | | | | | | | | | | | | | | The Aperio GT 450 DX is not intended for use with frozen
section, cytology, or non-FFPE hematopathology |
Table 1: Summary of Technological Characteristics
6
| Item | Subject Device | Predicate |
|---|---|---|
| for use with Leica's | ||
| Aperio GT 450 DX | ||
| scanner and Dell | ||
| U3223QE display, for | ||
| viewing and management | ||
| of the ScanScope Virtual | ||
| Slide (SVS) and Digital | ||
| Imaging and | ||
| Communications in | ||
| Medicine (DICOM) | ||
| image formats. | 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. | ||
| Specimen | ||
| type | Surgical pathology slides | |
| prepared from FFPE | ||
| tissue | Surgical pathology slides prepared from FFPE tissue | |
| Image | ||
| Storage | Images are stored in an | |
| end user provided image | ||
| storage attached to the | ||
| local network. | Images are stored in an end user provided image storage | |
| attached to the local network. | ||
| Image | ||
| manipulatio | ||
| n functions | Panning, zooming, | |
| gamma function, | ||
| annotations, and | ||
| measurements (distance | ||
| & area) | Panning, zooming, gamma function, annotations, and | |
| measurements (distance & area) | ||
| Image | ||
| review and | ||
| diagnosis | During review, the | |
| pathologist opens WSI | ||
| images acquired with the | ||
| WSI scanner from the | ||
| image storage, performs | ||
| further QC and reads | ||
| WSI images of the slides | ||
| to make a diagnosis. | During review, the pathologist opens WSI images acquired | |
| with the WSI scanner from the image storage, performs | ||
| further QC and reads WSI images of the slides to make a | ||
| diagnosis. | ||
| End User's | ||
| Interface | Pathology Image | |
| Window (the client | ||
| component of Sectra | ||
| Digital Pathology | ||
| Module 3.3) | Aperio WebViewer DX | |
| Scanner | Sectra Digital Pathology | |
| Module does not include | ||
| a scanner; however, it is | ||
| indicated for use with | ||
| Aperio GT 450 DX | Aperio GT 450 DX |
7
| Table 2: Performance data | |||
|---|---|---|---|
| Performance data | Description | ||
| Clinical Study | A clinical study was conducted to demonstrate that viewing, | ||
| reviewing, and diagnosing whole slide images (WSIs) of FFPE | |||
| tissue slides with DPAT (3.3) on Sectra Workstation UniView | |||
| (referred to as DPAT (3.3)-UniView) is noninferior to diagnoses | |||
| made using light microscopy. | |||
| Pixel-Wise | |||
| Comparison | Pixel-wise comparison study was performed to demonstrate that | ||
| DPAT (3.3) generates identical images in the configurations that | |||
| were not validated in the clinical study. The imaging pipeline | |||
| Aperio GT 450 DX/SVS/DPAT (3.3)-UniView/Chrome | |||
| configuration was validated in the clinical study and was used as | |||
| the reference configuration in the pixelwise comparison study to | |||
| validate the other 4 configurations as described below. | |||
| Configuration | Image | ||
| format | File Viewer/Browser | ||
| DICOM/IDS7 | DICOM | IDS7 | |
| DICOM/UniView/Chrome | DICOM | UniView/Chrome | |
| SVS/IDS7 | SVS | IDS7 | |
| SVS/UniView/Edge | SVS | UniView/Edge | |
| Based on analysis of the testing data, the 4 configurations specified | |||
| in table above were identical, i.e., 3 color difference compared to the predicate device. The clinical study was performed using SVS images displayed in UniView Chrome, creating a reference pipeline that could then be used for technical testing with DICOM, IDS'7, and Edge, to support the claims of the subject device. |
Summary of Studies:
Non-clinical test results:
Conducted per FDA's Guidance on Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices:
The clinical study was performed using SVS images displayed in UniView Chrome, creating a reference pipeline that could then be used for technical testing with DICOM. IDS7, and UniView in Edge, to support the claims of the subject device. The subject device displayed the same scanned image in both DICOM and SVS formats, in IDS7, Edge or Chrome, with no difference (△E=0).
9
Turnaround times for panning and zooming have been determined and found to be adequate for the intended use of the subject device.
The subject device has been found to perform accurate measurements with respect to its intended use.
Clinical Study:
A clinical study was conducted to demonstrate that viewing, and diagnosing whole slide images (WSIs) of FFPE tissue slides with DPAT (3.3) on Sectra Workstation UniView [referred to as DPAT (3.3)-UniView)] is noninferior to diagnoses made using light microscopy.
Clinical accuracy was evaluated by analyzing the concordance of the diagnoses made using DPAT (3.3)-UniView (referred to as WSI review [WSIR] diagnosis) with the original sign-out diagnoses (reference diagnoses), and the concordance of traditional light microscope slide review (MSR) diagnoses with the reference diagnoses. The primary endpoint of the study was the difference in overall major discrepancy rates between the 2 modalities when compared to the reference diagnosis. The secondary endpoint of the study was the major discrepancy rate of WSIR diagnosis relative to the reference diagnosis. The acceptance criteria associated with each study endpoint were as follows:
Primary Endpoint:
- The upper bound of the 2-sided 95% 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%.
Secondary Endpoints:
- . The upper bound of the 2-sided 95% CI of the major discrepancy rate between WSIR diagnosis and the reference diagnosis shall be