(27 days)
PACS Software Solution 2003 is intended to be used by radiologists and other medical professionals for purposes of diagnosis, or for clinical review, by viewing medical images on digital display devices or hard copy printouts. PSS03 provides an efficient interface to medical images and manages the archiving of medical images for short and long term storage. PSS03 is intended to be used with imaging equipment (e.g., Magnetic Resonance Imaging (MRI), Computerized Tomography (CT), Digital Radiography (DR), Ultrasound (US), etc.) and patient information systems (e.g., Hospital Information Systems (HIS), Radiology Information Systems (RIS)) approved for medical use.
PACS Software Solution 2003 is used to acquire, process, display, evaluate, archive, print and distribute DICOM compliant images for clinical purposes. Images may be acquired from imaging modalities such as CR, CT, MR, X-Ray, and other devices.
PACS Software Solution 2003 (PSS03)' is proprietary software used in conjunction with computer hardware to provide a Picture Archiving and Communication System. PSS03 has been designed to manage medical imaging data from various imaging devices (e.g. Magnetic Resonance Imaging, Computerized Tomography, Digital Radiography, Ultrasound, etc.). Management of medical imaging data from these devices, enabled by PSS03, includes display tools, the support of industry standard communication protocols (e.g. Transfer Control Protocol/Internet Protocol, Digital Communication in Medicine, Ethernet, etc.) and archiving of data using hierarchical protocols. The system provides redundant storage of the exam data.
PSS03 accommodates individual user preferences by automatically displaying medical images in a presentation format unique to the user and to the type of exam selected.
PSS03 is highly scalable, providing a small facility or a large enterprise of facilities the same functionality.
This 510(k) submission for "PACS Software Solution 2003" is a traditional clearance based on substantial equivalence to a predicate device, "Paper Film - PACS". As such, it does not contain the kind of detailed performance study data, acceptance criteria, or ground truth establishment that would be present in a submission for a novel AI/ML medical device.
Therefore, many of the requested categories of information cannot be provided from this document. The device in question is a Picture Archiving and Communication System (PACS) software, which is infrastructure for managing medical images, not a diagnostic algorithm itself.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: Not explicitly stated as this is a substantial equivalence submission for a PACS software, not a diagnostic algorithm. Performance is assessed against the predicate device's capabilities.
- Reported Device Performance: The document states that the new system has "equivalent design features, methods of use, and equivalent functional characteristics as the predicate device" and "raises no new safety or effectiveness issues." It highlights improvements like "newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices." It also mentions "smooth" and "sharp" filtering of images using a low-pass blurring kernel, and 8-bit and 12-bit JPEG compression, similar to the predicate.
2. Sample size used for the test set and the data provenance:
- Not applicable/Not provided. This is a PACS software, not a device that runs diagnostic algorithms on a test set of medical images in the way an AI/ML device would. The evaluation is functional and comparative to a predicate PACS.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. No "ground truth" in the diagnostic sense is established for this PACS software.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable/Not provided.
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:
- No. This is a PACS software, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This is a PACS software. Its function is to facilitate human review and management of images, not to perform standalone diagnostic tasks.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Not applicable/Not provided.
8. The sample size for the training set:
- Not applicable/Not provided. This is PACS software, not a machine learning model requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable/Not provided.
Summary based on provided text:
This 510(k) submission for "PACS Software Solution 2003" asserts substantial equivalence to a previously cleared PACS known as "Paper Film - PACS" (K940664). The primary argument for equivalence is based on:
- Same Indications for Use: Both systems are intended for radiologists and other medical professionals to view medical images, for diagnosis or clinical review, and manage the archiving of medical images.
- Equivalent Design Features: Both operate under Open Windows on a Unix-based operating system and consist of image servers, database servers, and workstations for image acquisition, processing, rendering, archiving, printing, and distribution.
- Technological Characteristics: Both provide "smooth" and "sharp" filtering, and utilize 8-bit and 12-bit JPEG compression.
- Improvements: The new system takes advantage of "newer faster systems such as monitor resolution and tape drives as well as allowing for multiple external storage devices." It also enhances patient integrity by assigning a Radiology Information System key in addition to the Medical Record Number and patient's name.
- Calibration: Display devices for both are calibrated using standard SMPTE patterns and/or graphics card software.
The submission confirms that the device "raises no new safety or effectiveness issues" compared to its predicate. The evaluation focuses on functional equivalence and updated technological capabilities of the PACS system rather than diagnostic performance metrics or clinical study outcomes typical for AI/ML diagnostic tools.
§ 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).