(59 days)
When installed on an appropriate PC-based platform, VIEWSEND Medical software is intended to provide the medical professional with the capability to view, retrieve, store, import, process, collaborate, and/or transmit medical images in order to render a diagnosis. Options allow for teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security. castommande and ass, suase, can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, and/or plain old telephone system (POTS). The DICOM 3.0 option allows for query, satchire, and, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or server.
When integrated into an appropriate PC-based platform, VIEWSEND Medical imaging software contains several modules to enable the medical professional to view, retrieve, store, import, process, collaborate, and transmit medical images in order to render a diagnosis. VIEWSEND Medical software can include teleradiology, telemedicine, and videoconferencing in an open system that runs under the Microsoft Windows 98/2000/NT operating system.
VIEWSEND Medical software is modular and able to provide one or more of the VIEWSEND standard features to match clinical needs - teleradiology, telemedicine, videoconferencing, collaboration, DICOM 3.0, communications, viewer, customizable database, stand-alone or client/server or web-based, compression, or security.
Existing medical films can be digitized, scanned, and stored as DICOM 3.0 images. Communications between systems can be performed over wireless/wired LAN, ISDN, T1, ATM, satellite, or plain old telephone system (POTS). The DICOM option allows for query, retrieve, send, receive, print, or DICOM Dir actions with DICOM 3.0 compliant modalities or servers.
VIEWSEND Medical software allows medical professionals in remote locations to view, discuss and consult on the same images of a patient case file. This can be done with live cameras and scopes or by sending high-resolution files that have been scanned into the remotely located PC.
VIEWSEND Medical software allows images to be sent from the archive files of one machine, and be transported to a different server, so that images from previous examinations may be compared with new more up-to-date images. These stored images can be at the physician request, sent in advance to save time and bandwidth during crucial consultations. Communications between VIEWSEND systems can use industry standard 128-bit encryption, and/or JPEG or JPEG2000 compression.
The provided text does not contain detailed information about acceptance criteria or a specific study that proves the device meets those criteria in a quantitative sense. The submission is for a software update to an existing device (VIEWSEND Medical Model 1200, K-962225) and focuses on demonstrating substantial equivalence to the original device.
Here's an analysis based on the information provided:
1. Table of Acceptance Criteria and Reported Device Performance:
No specific performance metrics or acceptance criteria (e.g., accuracy, sensitivity, specificity, processing speed targets) are mentioned for the VIEWSEND Medical software. The submission emphasizes that:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Functional Equivalence | The intended use for VIEWSEND Medical is the same as the original device. |
| The technological characteristics have been described in sufficient detail to demonstrate that they are the same as the original device. | |
| Software Quality Procedures | Testing of incremental software revisions followed KLT's normal procedures. A test plan was developed with relevant procedures. Test results were documented (what was tested, expected results, who performed, resources used). |
2. Sample Size Used for the Test Set and Data Provenance:
No information is provided regarding a specific "test set" in the context of image analysis or diagnostic performance. The "testing" mentioned refers to internal software quality assurance procedures, not a clinical validation study with a defined dataset of patient images.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical expert-driven ground truth establishment is mentioned for this submission.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set or adjudication process is mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was performed or mentioned. The submission is not focused on comparing human readers with and without AI assistance, but rather on the software's functional capabilities for image viewing, manipulation, and transmission.
6. Standalone Performance Study:
No standalone (algorithm-only) performance study was conducted or described in the provided text. The device is a "Picture Archiving and Communications System" (PACS) software designed to aid medical professionals, not to provide automated diagnoses independently.
7. Type of Ground Truth Used:
Not applicable. The submission does not detail any clinical ground truth (expert consensus, pathology, or outcomes data) being used for performance evaluation. The "ground truth" for the software testing would likely be the expected functional behavior of the software modules.
8. Sample Size for the Training Set:
Not applicable. The VIEWSEND Medical software described is a PACS system, not an AI or machine learning model that relies on a "training set" of images to learn diagnostic patterns.
9. How the Ground Truth for the Training Set Was Established:
Not applicable.
Summary of the Study (Based on Provided Text):
The submission describes a premarket notification (510(k)) for VIEWSEND Medical, which is an update to an existing software device. The "study" mentioned is not a clinical performance study in the typical sense of evaluating diagnostic accuracy. Instead, it refers to internal software development and testing procedures to demonstrate that the incremental revisions to the software maintain the same intended use and technological characteristics as the previously cleared predicate device (VIEWSEND Medical Model 1200, K-962225).
The core of the submission is to demonstrate substantial equivalence to the predicate device, not to prove new clinical performance metrics. The testing focused on:
- Functional verification: Ensuring the software modules for viewing, retrieving, storing, importing, processing, collaborating, and transmitting medical images function as intended.
- Adherence to quality procedures: Following KLT's established software development and testing protocols, including documenting test plans, expected results, and resources used.
The FDA's letter confirms that based on the provided information, the device is "substantially equivalent" to legally marketed predicate devices, allowing it to proceed to market.
§ 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).