(244 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 videoconferencing 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.
Orpheus Medical MedicVOD System is a picture archiving and communication system intended for image capturing, archiving, displaying and recording of audio/video sequences and patient data during a procedure. The MediVOD System contains the following modules/components: mediCast (ie mediCast Live) - a video stream / image capture device which is connected to a medical scope camera. mediCast App - real-time compression and archiving application displaying session from mediCast Box or from any USB attached camera and broadcast it in real time. mediCast Mobile App - a smart phone application for uploading medical images and videos. mediCast Box - a video stream / image capture device which receives a video signal from various video sources. Connected to a computer via a USB adaptor and uses the mediCast App to display video. mediShow a viewer for real-time broadcasting from a mediCast System. mediSearch – a search utility application which allows the user to search for and view videos and still images previously captured by mediCast. mediWeb - a web based application that provides access to the mediSearch and mediShow applications. The MedicVOD System 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 for statistical analysis and multiple report production, and Ability to view/review videos. The mediCAST box is capable of capturing and broadcasting a video stream in real time. MediCAST box captures and stores video and still images, and in parallel, uploads the captured images and video streams to the MedicVOD server. The mediCAST box 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.
The provided document is a 510(k) premarket notification for the MedicVOD System, asserting its substantial equivalence to a previously cleared predicate device (K123426). As such, it focuses on demonstrating that the modified device is as safe and effective as the original device, rather than proving the device meets acceptance criteria through a traditional clinical study with performance metrics like sensitivity, specificity, or accuracy.
The document states: "No clinical testing was required to support the substantial equivalence to the predicate device." This immediately tells us that the standard study design elements for evaluating diagnostic performance (like sample size, ground truth, expert adjudication, MRMC studies, or standalone performance) are not present in this submission.
Instead, the "acceptance criteria" here are framed as demonstrating substantial equivalence to a predicate device, and the "study" is a series of non-clinical performance tests proving the new components or modifications do not raise new questions of safety or effectiveness.
Here's an analysis based on the document, addressing your points where information is available:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (Implied by Substantial Equivalence and Testing) | Reported Device Performance (Summary from Document) |
|---|---|---|
| Substantial Equivalence | Demonstrate that the modified MedicVOD System is as safe and effective as the predicate (K123426) and shares the same indications for use and similar technological characteristics. | Indications for Use: Identical to predicate. |
| Technological Characteristics: Similar to predicate, with new modules (mediCast App, mediCast Mobile App, mediCast Box) and expanded OS compatibility (iOS, Android). The changes were considered "Substantially Equivalent" for hardware configuration and operating system, and "Identical" for other key specifications (Device Name, System Configuration, Clinical Application, Data Storage, Image Sources, Signal Encryption, Resolution, Audio Compression, DICOM Support). | ||
| Software Validation Testing | Software testing at the unit level to ensure functionality and safety of new/modified components. | Performed at the unit level for mediCast Box (subject device). Identified as "Identical" in scope to the software testing done for the predicate device. Results demonstrated that the MedicVOD System design met all specifications. |
| Electrical Safety Testing | Compliance with IEC 60601-1 3rd Edition. | Testing performed to ensure compliance for both the mediCast Box (subject device) and the mediCast Station (predicate device). Results determined to be "Identical." |
| Electromagnetic Compatibility Testing | Compliance with IEC 60601-1-2:2007. | Testing performed to ensure compliance for both the mediCast Box (subject device) and the mediCast Station (predicate device). Results determined to be "Identical." |
| Emissions Testing | Compliance with FCC Part 15, Subpart B, Class B. | Tested for both the mediCast Box (subject device) and the mediCast Station (predicate device). Results determined to be "Identical." |
2. Sample size used for the test set and the data provenance
- Sample Size: Not applicable. No clinical test set of patient data was used. The testing described is non-clinical (software, electrical, EMC, emissions).
- Data Provenance: Not applicable.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. No ground truth based on expert review was established for a test set, as no clinical testing was performed or required.
4. Adjudication method for the test set
- Not applicable.
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
- Not applicable. No MRMC study was done, and the device (a PACS system for archiving and displaying, not for primary diagnosis) does not involve AI or human-in-the-loop performance augmentation for diagnostic tasks.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is not an algorithm making standalone diagnostic assessments. Its purpose is for capturing, archiving, displaying, and recording, with information "for viewing and reference purposes only and are not intended for primary diagnosis."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The equivalence determination relied on non-clinical testing against engineering and regulatory standards and a feature comparison to a predicate device.
8. The sample size for the training set
- Not applicable. This document describes a PACS system, not a machine learning or AI model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable.
In summary: The submission for the MedicVOD System is a 510(k) demonstrating substantial equivalence to an existing cleared device. The "acceptance criteria" are the successful completion of non-clinical tests (software validation, electrical safety, EMC, emissions) to show that the modified device retains the same safety and effectiveness profile as the predicate. No clinical studies were conducted or required, meaning all the elements related to clinical performance evaluation (sample size, ground truth, expert review, MRMC, standalone performance) are not applicable to this particular FDA submission.
§ 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).