(37 days)
In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.
In-Vision View with Measurements Module supports JOMED DICOM files only. The software will not read DICOM images or loops stored using any other manufacturers' system.
In-Vision View with Measurements Module is a software device intended to be used by qualified medical professionals, after proper installation on an appropriate hardware platform, for retrieving, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive.
In-Vision View with Measurements Module provides an effective solution for physicians and interventional labs to review JOMED's In-Vision Gold digital IVUS DICOM video loops on a desktop PC or notebook. In addition, video loops and still frames can be exported to PowerPoint presentations for conferences, in-hospital training and lectures.
This document is a 510(k) summary for the In-Vision View with Measurements Module, a software device for processing medical IVUS images. It confirms the device's substantial equivalence to a predicate device, but does NOT contain information regarding acceptance criteria, study details, or ground truth establishment. The provided text primarily focuses on device description, intended use, and substantial equivalence to a predicate device (QCU ANALYTICAL SOFTWARE PACKAGE K011582).
Therefore, I cannot fulfill your request for the specific details outlined, as those details are not present in the provided text.
Based on the provided text, the following information is available:
- Device Name: In-Vision View with Measurements Module
- Manufacturer: Intelligent Images S.r.l.
- Predicate Device: QCU ANALYTICAL SOFTWARE PACKAGE (K011582) by MEDIS MEDICAL IMAGING SYSTEMS, B.V.
- Intended Use: To be used by qualified medical professionals for retrieving, viewing, and processing medical IVUS images stored using the JOMED In-Vision Gold or JOMED In-Vision Plus's CDR storage drive. It only supports JOMED DICOM files.
- Classification Name: System, Image Processing
- Classification Number: LLZ
The document DOES NOT provide the following requested information:
- A table of acceptance criteria and the reported device performance
- Sample size used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and their qualifications
- Adjudication method for the test set
- If a multi reader multi case (MRMC) comparative effectiveness study was done, or the effect size of human readers improve with AI vs without AI assistance
- If a standalone performance study was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- The sample size for the training set
- How the ground truth for the training set was established
§ 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).