(37 days)
The MMS Video option is intended to acquire, view, record, process, print, archive and retrieve video images such as of gastroenterology and urology procedures.
Not Found
I am sorry, but the provided text does not contain the information required to answer your request about acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter for a device called "MMS Video Option," indicating it has been deemed substantially equivalent to a predicate device.
Specifically, the document does not include:
- A table of acceptance criteria and reported device performance.
- Details about a study (sample size, data provenance, ground truth establishment, expert qualifications, adjudication methods).
- Information on MRMC comparative effectiveness studies or standalone performance.
- Sample sizes for training or test sets.
The letter primarily focuses on the regulatory clearance of the device for marketing based on its substantial equivalence to a predicate, and its stated "Indications For Use" (acquiring, viewing, recording, processing, printing, archiving, and retrieving video images for gastroenterology and urology procedures). It does not delve into the specific performance metrics or studies used to validate new technological claims.
§ 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).