(41 days)
UltraPACS™ system is device that receives digital images and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F Units, computed & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. The device can also assists orthopedic surgeons when doing preoperative planning and post-operative follow-up.
Options make possible reading (including mammography), telecommunications; fast demonstration; etc ; and teleconferencing.
Lossy compressed or digitized screen film mammographic images must not be reviewed for primary image interpretations. Only FFDM manufacturer processed images in DICOM "For Presentation" format can be displayed for primary interpretation. Mammographic images must only be interpreted using a FDA approved monitor that offers at least 5Mpixel resolutions and other technical specifications reviewed and accepted by the FDA.
UltraPACS™ makes possible the capturing, storage, distribution, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to UltraPACS™, the system can acquire medical images using a DICOM gateway, which generates DICOM-type files. For example, film digitizers obtain images from old film and convert them to meet DICOM standards and stored in an archive. Stored files are transmitted using a network and can be viewed or manipulated from an imaging workstation. The orthopedic application is intended to assist orthopedic surgeons when doing preoperative planning and post-operative follow-up. The orthopedic application of the device is used to overlay prosthesis templates on radiological images, tools for repositioning the templates. and tools for measurements in the images.
The provided text does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria. The document is a 510(k) summary for UltraPACS™, a Picture Archiving and Communications system (PACS). It describes the device, its indications for use, and confirms its substantial equivalence to predicate devices.
Specifically, the text does not include:
- A table of acceptance criteria and reported device performance: There are no defined metrics or performance thresholds provided, nor any results of a study against such criteria.
- Sample size used for the test set and data provenance: No details about a test set or its origin are mentioned.
- Number of experts used to establish ground truth and their qualifications: Ground truth establishment is not discussed.
- Adjudication method for the test set: No adjudication methods are described.
- Multi-reader multi-case (MRMC) comparative effectiveness study: This type of study is not mentioned.
- Standalone (algorithm only) performance: As this is a PACS system and not an AI algorithm for diagnosis, standalone performance in the context of AI is not relevant or discussed. The device's function is to handle, store, and display images, and assist with orthopedic planning, not to independently interpret images.
- Type of ground truth used: Ground truth is not discussed.
- Sample size for the training set: There is no mention of a training set, as this is not an AI/machine learning device in the contemporary sense.
- How ground truth for the training set was established: Not discussed.
The document focuses on regulatory compliance, specifically demonstrating substantial equivalence to predicate PACS devices for its intended use, which includes image management and orthopedic planning assistance. It confirms that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This reinforces that the device is a tool for physicians, not an autonomous diagnostic system requiring performance studies against ground truth for diagnostic accuracy.
§ 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).