(28 days)
MI View&GO is a medical diagnostic application for viewing, manipulation, quantification, analysis and comparison of medical images with one or more time-points. MI View&GO supports functional data, such as positron emission tomography (PET) or nuclear medicine (NM), as well as anatomical datasets, such as computed tomography (CT) or magnetic resonance (MR).
MI View&GO is intended to be utilized by appropriately trained health care professionals to aid in the management of diseases associated with oncology, cardiology, neurology, and organ function. The images and results produced by MI View&GO can also be used by the physician to aid in radiotherapy treatment planning.
MI View&GO is a software-only medical device which will be delivered in conjunction with Siemens SPECT/CT and PET/CT scanners. MI View&GO software provides additional specific capabilities for handling of PET and SPECT as well as CT and MR data directly at the acquisition console.
The MI View&GO software integrates molecular imaging more efficiently in the clinical environment by providing an interface for its users to review, post-process and read medical images immediately after acquisition. The purpose of the MI View&GO is to allow the technologist and reading physician to:
- Review acquired and reconstructed images at the scanner console
- Determine that the acquired data is of sufficient quality for reading, so the patient can be released.
- Prepare images for reading
- Perform a basic read
The provided text is a 510(k) summary for the device MI View&GO VA30. It states that "The device under application, MI View&GO, did not conduct any additional performance testing" for determining substantial equivalence to the predicate device. Therefore, a study proving the device meets acceptance criteria as described in the prompt was not conducted and thus, the requested information (table of acceptance criteria, sample sizes, expert qualifications, etc.) is not available in the provided text.
The substantial equivalence determination was based on:
- Software Verification and Validation: This involved demonstrating continued conformance with special controls for medical devices containing software. The testing supported that all software specifications met predetermined acceptance criteria and substantiated all requirements and functional specifications, including those related to device hazards.
- Risk Analysis: A risk analysis was completed, and risk control was implemented to mitigate identified hazards.
- Comparison to Predicate Device: The device was deemed substantially equivalent to the predicate device (MI View&GO VA20, K201202) because there are no differences in the Indications for Use, Intended Use, or Fundamental Technological Characteristics. The new features implemented (e.g., O Brain AC-PC, PERCIST, VOI Isocontour) did not raise any new issues of safety and effectiveness.
In summary, the document indicates that the device's performance was not evaluated through a specific comparative study against acceptance criteria of the kind typically seen for novel diagnostic algorithms. Instead, its substantial equivalence was primarily established through software verification and validation, risk analysis, and a direct comparison of its technological characteristics and intended use to a previously cleared predicate device.
§ 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).