(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.
§ 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.