(80 days)
iPACS Prism™ from RealTimeImage Inc. is a device that receives medical images and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system and or across computer networks at distributed locations. Typical users of this system are trained professionals, including but not limited to physicians, nurses, and technicians.
iPACS Prism™ is a complete PACS solution designed to be Internet friendly for easy deployment over local area networks and/or wide area networks. The system is modular and will be offered under different brand names depending upon customer implementation and which system components of iPACS Prism are needed. iPACS™ handles various images and data objects in a Picture Archive and Communication System (PACS) environment. These objects can be images, requests, patients, examination etc. PACS transmits digital electronic images and generates reports over a high-speed network to centralized storage. After transmission, patient information and images are available throughout the facility to many users simultaneously.
The provided text describes a 510(k) submission for the iPACS Prism™ system. The document focuses on establishing substantial equivalence to a predicate device and does not contain specific acceptance criteria, a detailed study proving device performance against such criteria, or the types of information requested in the prompt related to clinical performance testing (sample sizes, expert qualifications, adjudication, MRMC studies, standalone performance, or ground truth details for training or testing).
The document is a regulatory filing for a Picture Archiving and Communication System (PACS), which primarily handles the storage, communication, processing, and display of medical images and data. Its substantial equivalence is based on its technological characteristics being similar to a legally marketed predicate device (ISITE RADIOLOGY, K013630).
Therefore, based on the provided text:
1. A table of acceptance criteria and the reported device performance:
Not available in the provided text. The document focuses on regulatory equivalence rather than specific performance metrics against pre-defined acceptance criteria.
2. Sample size used for the test set and the data provenance:
Not applicable. No clinical or performance test set is described.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable. No ground truth establishment for a test set is described.
4. Adjudication method for the test set:
Not applicable. No test set or its adjudication is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This device is a PACS system, not an AI-powered diagnostic tool, and no MRMC study is mentioned.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done:
Not applicable. This device is an image management system, not a standalone diagnostic algorithm. The text explicitly states, "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed."
7. The type of ground truth used:
Not applicable. No ground truth for performance evaluation is described.
8. The sample size for the training set:
Not applicable. No training set for an AI algorithm is described.
9. How the ground truth for the training set was established:
Not applicable. No training set or its ground truth establishment is described.
Summary of what the document does provide:
- Device Name: iPACS Prism™
- Common Name: Picture Archiving Communications System
- Device Classification: 892.2050 (System, Image Processing, Radiological)
- Predicate Device: ISITE RADIOLOGY (K013630)
- Indications for Use: Receives medical images and data from various imaging sources; images and data can be stored, communicated, processed, and displayed within the system or across computer networks at distributed locations. Typical users are trained professionals (physicians, nurses, technicians).
- Technological Characteristics: Medical device image software used with computer hardware in a PACS environment. Does not contact the patient, nor does it control any life-sustaining devices. A physician interprets images and information with human intervention.
- Conclusion: The device is substantially equivalent to the 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).