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510(k) Data Aggregation
(265 days)
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.
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.
Here's a breakdown of the acceptance criteria and the study proving the device meets those criteria, based on the provided text:
Acceptance Criteria and Device Performance
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Endpoint) | Reported Device Performance | Met? |
|---|---|---|
| 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%. | The upper bound of the 95% CI of the estimated difference in major discrepancy rates was 1.69%. | Yes |
| Secondary Endpoint: The upper bound of the 2-sided 95% CI of the major discrepancy rate between WSIR diagnosis and the reference diagnosis shall be |
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(151 days)
For In Vitro Diagnostic Use
Sectra Digital Pathology Module device is a software 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 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.
Sectra Digital Pathology Module is intended for use with Leica's Aperio AT2 DX scanner and Dell MR2416 monitor.
Sectra Digital Pathology Module is a software-only device running under the Microsoft Windows operating system for displaying and manipulating digital pathology images (scanned slides) obtained from the Aperio AT2 DX scanner.
Sectra Digital Pathology Module may only be used in combination with Sectra PACS which consists of Sectra Workstation (K081469) and Sectra Core (identified as a Class I exempt by the FDA in 2000).
The Sectra Pathology Import Server (SPIS) is used for importing digital pathology images (scanned slides) from the scanner. These images are viewed and manipulated by end users in the Pathology Image Window which is displayed on the Sectra Workstation IDS7 (using the Dell MR2416 monitor).
Here's an analysis of the acceptance criteria and the study conducted for the Sectra Digital Pathology Module, extracted from the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Color Reproducibility | Pixel-wise comparison towards Aperio ImageScopeDX (predicate) across multiple tiles, including zooming and panning operations. Sectra Digital Pathology Module was found to reproduce colors adequately and was non-inferior to ImageScopeDX. |
| Turnaround Time (Case Load) | When selecting a case, it should not take longer than 7 seconds until the image is fully loaded, provided system requirements are fulfilled. |
| Turnaround Time (Panning) | When panning the image (one quarter of the monitor), it should not take longer than 0.5 seconds until the image is fully loaded, provided system requirements are fulfilled. |
| Measurements | Measurement accuracy has been verified using a test image containing objects with known sizes. The device was found to perform accurate measurements. |
| Human Factors | Task-based usability tests showed the Sectra Digital Pathology Module user interface to be intuitive, safe, and effective for the range of intended users. The device was found to be safe and effective for the intended users, uses, and use environments. |
2. Sample Size for Test Set and Data Provenance:
The document does not explicitly state the sample size for any specific test set regarding color reproducibility, turnaround time, or measurements. It mentions a "test image containing objects with known sizes" for measurements, and "multiple tiles" for color reproducibility.
The data provenance is not specified (e.g., country of origin). The testing seems to be internal development and verification testing rather than involving external patient data.
3. Number of Experts for Ground Truth and Qualifications:
The document does not mention the use of experts to establish ground truth for the technical performance tests described (color reproducibility, turnaround time, measurements, human factors). These appear to be objective, quantifiable tests directly comparing the device's output to a known standard or the predicate device's output.
For "Human factors testing," it states "Task-based usability tests showed the Sectra Digital Pathology Module user interface to be intuitive, safe, and effective for the range of intended users." While suggesting involvement of intended users (pathologists likely), the number and specific qualifications of these users are not detailed.
4. Adjudication Method for Test Set:
No adjudication method is mentioned. The tests described are primarily objective comparisons or measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC comparative effectiveness study was done. The document explicitly states: "Substantial equivalence determination is not based upon clinical study results."
6. Standalone (Algorithm Only) Performance Study:
Yes, standalone (algorithm only, meaning the software itself without human interaction for diagnostic purposes) performance was done. The studies listed under "Non-clinical test results" (Color Reproducibility, Turnaround times, Measurements) evaluate the technical performance of the software. The device itself is described as a "software-only device."
7. Type of Ground Truth Used:
- Color Reproducibility: Ground truth was implicitly the visual output and pixel data of the predicate device (Aperio ImageScopeDX).
- Turnaround Time: Ground truth was the pre-defined maximum acceptable time limits (7 seconds for case load, 0.5 seconds for panning).
- Measurements: Ground truth was a "test image containing objects with known sizes."
- Human Factors: Ground truth was established by assessing usability (intuitiveness, safety, effectiveness) through "task-based usability tests" likely with intended users.
8. Sample Size for the Training Set:
The document does not mention a training set. The Sectra Digital Pathology Module is described as a "software intended for viewing and management of digital images," rather than an AI/ML algorithm that requires a training set.
9. How Ground Truth for Training Set Was Established:
Since no training set is mentioned for an AI/ML algorithm, this question is not applicable based on the provided text. The device is a viewer and management tool, not an AI diagnostic algorithm.
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