(49 days)
SurgicalAR is a software device for display of medical images and other healthcare data. It includes functions for image review image manipulation, basic measurements and 3D visualizations and 3D volume rendering).
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA cleared display that meets technical specifications reviewed and accepted by FDA or displays accepted by the appropriate regulatory agency for the country in which it is used.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
SurgicalAR software is indicated for use by qualified healthcare professionals including, but not restricted to radiologists, non-radiology specialists, physicians and technologists.
When accessing SurgicalAR software from a wireless stereoscopic head-mounted display (HMD) or mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
SurgicalAR is a software platform to be used by clinicians for the visualization of medical images in 3D to allow for surgical planning activities. The device takes pre-acquired 2D medical images and reconstructs 3D models that a clinician can then view on a stereoscopic, holographic display.
The software application is used to:
• Load patient CT/MR DICOM data
• View DICOM data using a traditional computer monitor or in Augmented Reality (AR) using a head-mounted display, HMD.
The provided document K190764 for the device SurgicalAR is a 510(k) premarket notification and details the device's substantial equivalence to a predicate device. It does not contain information about acceptance criteria and a study proving the device meets those criteria, as typically found in clinical validation studies.
The document primarily focuses on demonstrating that SurgicalAR has the same intended use and similar technological characteristics to its predicate device (VitreaView K163232). It highlights differences in features that do not introduce new safety or effectiveness concerns.
Therefore, I cannot extract the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC study, etc.) from the provided text, as this type of information is generally part of a separate clinical validation study report, not a 510(k) summary demonstrating substantial equivalence.
The "Tests conducted" Section 5.9 mentions "design verification" and "design validation, including human factors and usability engineering." However, it only provides high-level statements about their success ("met the design input requirements," "met all predetermined acceptance criteria") without detailing specific performance metrics or the methodology of the validation studies in a way that would address your questions.
§ 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).