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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:

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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