(114 days)
The MedicVOD System is a picture archival and communications systems (PACS) that is intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The system allows for capture and annotation of the surgical procedure for documentation purposes and for viewing at a later time either locally or on a secure distributed network. The captured audio/video sequences can be broadcasted in real-time with video-conferencing capability during the broadcast. Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis.
The MedicVOD system is intended as a radiological image processing system that allows for the capture, transfer, display, storage, and digital processing of medical images.
The MedicVOD System is a video system enabling medical teams to document, record and broadcast live medical procedures in real time. Its four components are:
- The mediCAST station, attached to the imaging device in an operating theater
- The mediShow application, a real-time monitoring application, displaying sessions from all currently active mediCAST stations
- The mediSearch video archive search and edit application
- The MedicVOD Server which is a central storage system (CSS) for archival of all mediCAST sessions
The MedicVOD key features include:
- Digital recording of medical procedures streamed directly to on-site server for storage and retrieval.
- Live broadcast of a medical procedure to an unlimited number of viewers.
- Archiving of video assets to a controlled storage resource,
- Data fetching with dynamic categories which may be used by other 300 party applications for purposes such as statistical analysis of data usage and/or user operation and report production, and
- Ability to view/review videos from any mediShow location at any time
The mediCAST station is capable of capturing and broadcasting a video stream in real time. MediCAST station captures and stores video and still images locally, and in parallel, uploads the capture images and video streams to the MedicVOD server. The mediCAST station uploads the videos and images when there is communication with the MedicVOD server.
The mediSearch application provides the ability to search within the MedicVOD archive. The mediSearch application allows users to perform searches for video recordings within a captured mediCAST session. Each session could be a combination of several recordings of various kinds. For example, a session could be a combination of several video recordings, several still images (snapshot taken) and several DICOM images that have been stored. MediSearch provides the ability to view the assets which were found, and provides certain editing capabilities.
The mediShow application automatically connects into the MedicVOD server and displays currently active sessions or procedures captured by any mediCAST station on the local network.
Here's a breakdown of the acceptance criteria and study information for the MedicVOD System, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Verification / Validation Description | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Component First Article Inspection | Passing results defined within the test software | Passed all applicable tests |
| Component Functional Verification | Passing results defined within the test software | Passed all applicable tests |
| Electrical safety | As required by the applicable standards (IEC 60601-1, IEC 60950) | Passed all applicable tests |
| Electromagnetic compatibility | As required by the applicable standards (IEC 60601-1-2, IEC 60950) | Passed all applicable tests |
| Software unit test | Compliance with defined requirements, absence of bugs | Passed all tests |
| Software verification test | Compliance with defined requirements, absence of bugs | Passed all tests |
| Software validation test | As defined in the software test description (see section 16, not provided in document) | Passed all tests |
| Integrated System Performance Testing | Passing all defined tests defined by the test protocol and embedded within the test software | Passed all tests |
| Simulated use | Full functionality and satisfactory usability per a defined user questionnaire | Passed all tests |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the test set in terms of number of cases or data provenance. The testing described is primarily focused on hardware, software, and system functionality. For "Simulated use," it mentions "Functional testing in a clinical environment by potential user/s," implying a small set of users and an unspecified amount of data processed during that simulation.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided. The testing described focuses on functional compliance and usability, not on the accuracy of diagnostic interpretations, as the device is not intended for primary diagnosis.
4. Adjudication Method for the Test Set
This information is not provided.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No MRMC comparative effectiveness study is mentioned. This device is a PACS system for image capturing, archiving, displaying, and recording, not an AI-assisted diagnostic tool. Its indication for use explicitly states, "Information captured and stored by the system are for viewing and reference purposes only and are not intended for primary diagnosis."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This concept doesn't directly apply as the device is not an algorithm performing diagnostic tasks. Instead, it's a system that facilitates data management and viewing. The "Software unit test," "Software verification test," and "Software validation test" could be considered standalone algorithm testing in a functional sense, ensuring the software components operate as intended.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The concept of "ground truth" in the diagnostic sense (e.g., pathology for a cancer diagnosis) is not applicable here given the device's function. The "ground truth" for the tests performed is based on:
- Defined requirements and specifications: For hardware and software functionality.
- Applicable industry and safety standards: For electrical safety and electromagnetic compatibility.
- Test protocols and embedded test software: For integrated system performance.
- User questionnaire: For simulated use and usability.
8. The Sample Size for the Training Set
The document does not describe any training sets or machine learning components. This device is a PACS system, not an AI/ML-based diagnostic or analytical tool that would typically involve training sets.
9. How the Ground Truth for the Training Set was Established
Not applicable, as no training set is mentioned for an AI/ML component.
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).