(10 days)
Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans for the purpose of assisting in patient review and detection of colon polyps, cancers and other lesions by providing display and reporting facilities to enhance workflow. It is intended for use by radiologists, clinicians and referring physicians to process, render, review, store, print and distribute DICOM 3.0 compliant image studies, utilizing standard PC hardware.
Voxar Colonscreen is a software application for the display and 3D visualization of medical image data derived from CT and MR scans.
I am sorry, but the provided text does not contain the acceptance criteria or the details of a study proving the device meets those criteria. The provided text is a 510(k) clearance letter from the FDA for a device called "Voxar Colonscreen."
This letter primarily focuses on:
- Correction of an earlier letter: Amending the "Indications for Use" from "patient screening" to "patient review" to clarify its scope.
- Substantial Equivalence: Stating that the device is substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
- Regulatory information: Providing guidance on general controls, classification, and other FDA regulations.
- The device's intended use: As a software application for display and 3D visualization of CT/MR data to assist in patient review and detection of colon polyps, cancers, and other lesions by radiologists, clinicians, and referring physicians.
It explicitly does not include:
- Quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets).
- Details of a performance study (sample sizes, data provenance, ground truth establishment methods, expert qualifications, adjudication, MRMC studies, standalone performance, training set details).
Therefore, I cannot fulfill your request as the necessary information is absent from the provided document.
§ 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).