(9 days)
Exam-PACS™ is a device that receives digital images (including mammograms) and data from various sources (e.g. CT scanners, MR scanners, ultrasound systems, R/F units, computer & direct radiographic devices, secondary capture devices, scanners, imaging gateways or other imaging sources). Images and data can be communicated, processed, manipulated, enhanced, stored, and displayed within the system and or across computer networks at distributed locations.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.
Typical users of this system are trained professionals, physicians, nurses, and technicians.
Exam-PACS™ is comprised of various software modules that can be configured to provide image capture, storage, distribution, enhancement, manipulation, and networking of medical images at distributed locations. In cases where DICOM images are not directly available to IntelePACS™, the system can acquire medical images using a DICOM image gateway, which generates DICOM-type files. For example, film digitizers obtain images from original film and convert them to meet DICOM standards and stored. Stored files are transmitted using a network and can be viewed or manipulated from imaging workstation.
The provided 510(k) summary for the CoActiv Exam-PACS describes a Picture Archiving Communications System (PACS) and does not contain the kind of detailed study or performance data typically associated with acceptance criteria for an AI/CADe device.
Therefore, the following information fields cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance
- Sample sized used for the test set and the data provenance
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Adjudication method for the test set
- 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
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The sample size for the training set
- How the ground truth for the training set was established
Explanation:
The Exam-PACS is a PACS system, which primarily handles the archival, communication, and display of medical images. It is explicitly stated that "A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed." This indicates it's a tool for managing images that are interpreted by humans, not a device that provides an independent interpretation or diagnosis (like an AI/CADe system would).
The 510(k) summary focuses on demonstrating substantial equivalence to a predicate PACS device (INTELEPACS™ K032533) by describing its technological characteristics (image capture, storage, distribution, enhancement, manipulation, and networking) and its indications for use. The "Conclusion" states that the submission contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device," and mentions "the results of a hazard analysis."
The "Indications for Use" section also explicitly states a limitation regarding mammograms: "Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA." This further reinforces that the device's role is not diagnostic interpretation, especially for critical studies like mammography.
In summary, the provided document does not describe a device that performs diagnostic analysis requiring performance metrics against specific acceptance criteria in the way an AI/CADe device would. It's a foundational PACS system, and its market clearance would be based on its ability to safely and effectively handle and display medical images, demonstrating equivalence to already cleared PACS systems.
§ 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).