OpenCV Python

Description

OpenCV is a highly optimised computer vision and image processing library. Known for its computational efficiency and real-time capabilities, OpenCV supports a wide array of algorithms related to image processing, including but not limited to facial recognition, object detection, and augmented reality. It serves as a foundational tool for applications in numerous sectors such as automotive, security, medical, and more.

OpenCV Python is the Python wrapper package for OpenCV.

General details

Developer(s): Originally developed by Intel, now maintained by a community of contributors.
Open Source: Yes
Language(s): The core is written in C++ for performance optimization, with the opencv-python package serving as a set of Python bindings to the C++ library.
Repository: https://github.com/opencv/opencv-python
License: MIT
Operating system(s): OS Independent (can run on any operating system that supports Python)
Actively maintained: Yes (three months ago)

Intended use on the device

The SOUP is used in the medical device for the following specific purposes only:

Use CPU-intensive image processing operations, such as mask binarization, color conversion, image blending, or contour drawing. Mainly, these operations are of particular interest in segmentation post-processing tasks.

Requirements

For the integration and safe usage of this SOUP within a software system, it's important to outline both functional and performance requirements. These requirements help mitigate risks and ensure compatibility and performance standards are met.

Functional

Image processing: Ability to perform operations such as filtering, transformation, and geometric manipulations.
Feature detection: Include functions for identifying and describing visual features in images, such as edges, corners, and blobs.
Image format compatibility: Enable the decoding and encoding of image data in formats such as JPEG, PNG, and others.
Error handling: Implement robust mechanisms for handling errors related to image loading, processing, and manipulation, providing informative error messages to aid in debugging.

Performance

Speed: High computational efficiency for real-time applications, leveraging optimization and parallel processing techniques.
Scalability: Ability to process images of various sizes and resolutions, from small-scale to high-definition.

System requirements

Establishing minimum software and hardware requirements is important to mitigate risks, such as security vulnerabilities, performance issues, or compatibility problems, and to ensure that the SOUP functions effectively within the intended environment.

Software

After evaluation, we find that there are no specific software requirements for this SOUP. It works properly on standard computing devices, which includes our environment.

Hardware

After evaluation, we find that there are no specific hardware requirements for this SOUP. It works properly on standard computing devices, which includes our environment.

Documentation

The official SOUP documentation can be found at https://docs.opencv.org/4.x/index.html

Additionally, a criterion for validating the SOUP is that all the items of the following checklist are satisfied:

The vendor maintains clear and comprehensive documentation of the SOUP describing its functional capabilities, user guidelines, and tutorials, which facilitates learning and rapid adoption.
The documentation for the SOUP is regularly updated and clearly outlines every feature utilized by the medical device, doing so for all integrated versions of the SOUP.

We catalog the interconnections between the microservices within our software architecture and the specific versions of the SOUP they utilise. This mapping ensures clarity and traceability, facilitating both the understanding of the system's dependencies and the management of SOUP components.

Although the title of the section mentions software items, the relationship with SOUP versions has been established with microservices (also considered software items, by the way) because each one is inside a different Docker container and, therefore, has its own isolated runtime environment.

SOUP version	Software item(s)
4.9.0.80	APASI-SEGMENTER APASI-CLASSIFIERASCORAD-SEGMENTER ASCORAD-CLASSIFIER ICD BINARY CLASSIFIER BINARY REFERRER

The following are risks applicable to this SOUP from the table found in document R-TF-013-002 Risk management record_2023_001:

58. SOUP presents an anomaly that makes it incompatible with other SOUPs or with software elements of the device.
59. SOUP is not being maintained nor regularly patched.
60. SOUP presents cybersecurity vulnerabilities.

Lists of published anomalies

The incidents, anomalies, known issues or changes between versions for this SOUP can be found at:

History of evaluation of SOUP anomalies

28 Feb 2024

Reviewer of the anomalies: Alejandro Carmena Magro
Version(s) of the SOUP reviewed: 4.9.0.80

No anomalies have been found.

Record signature meaning

Author: JD-004
Reviewer: JD-003
Approver: JD-005

Description​

General details​

Intended use on the device​

Requirements​

Functional​

Performance​

System requirements​

Software​

Hardware​

Documentation​

Related software items​

Related risks​

Lists of published anomalies​

History of evaluation of SOUP anomalies​

28 Feb 2024​

Record signature meaning​