(62 days)
The ORS Visual is a software-based Picture Archiving and Communication System (PACS) for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and analysis of medical image data from various sources including CT and MRI.
The ORS Visual software is intended for use as a diagnostic, review, and analysis tool by trained professionals such as physicians, technologists, and nurses. When interpreted by a trained physician, reviewed images are intended to be used to aid in diagnosis. It is the users' responsibility to ensure that the software is installed on appropriate hardware and that image quality is sufficient for the clinical application. Object Research Systems (ORS) recommends that users of the ORS Visual software consult the appropriate American College of Radiology (ACR) guidelines for the clinical setting and pathology being studied.
Mammographic and compressed images are not supported for viewing.
The software is not intended to replace the skill and judgment of a qualified medical professional. Users should be appropriately trained in the software's functions, capabilities and limitations. Users should be aware that certain views, and on the make use of interpolated data. This is data that is created by the software based on the original data set. Interpolated data may give the appearance of healthy tissue in situations where pathological conditions or limited original data set resolution may be present.
ORS Visual software must be installed on a suitable commercial computer platform. It is the users' responsibility to ensure that the hardware and display configurations are consistent with the clinical applications.
Typical users of ORS Visual are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
The ORS Visual is a software-based Picture Archiving and Communication System (PACS) for the display and 3D visualization of medical image data. It provides for communication, storage, reformatting, rendering, and analysis of medical image data from various sources including CT and MRI.
This a 510(k) premarket notification for ORS Visual, a Picture Archiving and Communication System (PACS). No clinical study was performed to justify substantial equivalence. Since this is for a PACS device, the FDA often does not require specific clinical study data as they are not typically diagnostic devices themselves but rather display and communication systems for medical images. The substantial equivalence is therefore claimed using legally marketed predicate devices, as stated in the letter.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
Not applicable in this context. The document does not describe performance criteria based on a clinical study for the ORS Visual device. Its substantial equivalence is based on its similarity to previously cleared PACS devices.
2. Sample Size Used for the Test Set and Data Provenance:
Not applicable, as no specific test set or clinical study for performance was conducted or reported in this 510(k) submission.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:
Not applicable, as no specific test set or ground truth establishment process is described for performance evaluation.
4. Adjudication Method for the Test Set:
Not applicable, as no specific test set or adjudication process is described for performance evaluation.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No. An MRMC comparative effectiveness study was not performed or reported in this document. The device is a PACS system for displaying and visualizing medical images, not a diagnostic AI algorithm that would typically undergo such a study to quantify human reader improvement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. The ORS Visual is described as a "software-based Picture Archiving and Communication System (PACS)" intended for use "as a diagnostic, review, and analysis tool by trained professionals." It is explicitly stated that "The software is not intended to replace the skill and judgment of a qualified medical professional." This indicates it's a human-in-the-loop system, and a standalone algorithm-only performance study would not be relevant for this type of device.
7. Type of Ground Truth Used:
Not applicable. There is no mention of a ground truth being established for the performance evaluation of the ORS Visual device.
8. Sample Size for the Training Set:
Not applicable. As no independent clinical study was performed for the performance evaluation of the ORS Visual, there is no mention of a training set or its size.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there is no mention of a training set or ground truth establishment for it.
Summary based on the document:
The provided document is a 510(k) clearance letter for a PACS device (ORS Visual). It highlights that the device is substantially equivalent to legally marketed predicate devices. The review process for such devices often focuses on functional equivalence, technical specifications, and safety, rather than extensive clinical performance studies with acceptance criteria, ground truth, and expert adjudication, which are more common for diagnostic algorithms. The document explicitly states that the device is "not intended to replace the skill and judgment of a qualified medical professional," reinforcing its role as a tool rather than an autonomous diagnostic system.
§ 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).