(30 days)
The Sectra IDS device is intended for the manipulation and displaying of x-ray images. It can show images from different modalities and interfaces to various image storage and printing devices using DICOM or similar interface standards.
Device options make possible telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
The IDS5 10.1 Radiology Workstation is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under the Window 2000 and Windows XP operating system. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably up to four monitors can be used.
This document describes a 510(k) submission for the Sectra IDS5 Radiology Workstation - Version 10.1, a Picture Archiving and Communications System (PACS).
Here's an analysis of the acceptance criteria and study information provided in the input, specifically focusing on what is present and absent from the document:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| ISO 9001:2000 Compliance | Developed according to ISO 9001:2000 |
| ACR/NEMA Digital Imaging Communications in Medicine (DICOM) version 3.0 Compliance | Complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0 |
| Substantial Equivalence to Predicate Device (Sectra IDS5 Radiology Workstation - Version 7, K002936) | Concluded to be safe, effective, and substantially equivalent to the predicate device based on shared certification/conformance to standards and functional similarity as an Image Processing System (LLZ). |
| Ability to manipulate and display x-ray images from different modalities, interface with image storage and printing using DICOM/similar standards. | The device is intended for this purpose and its functions support it. |
| Supports telecommunications, fast demonstration, prosthesis CAD, 3-D, angiography, and teleconferencing through device options. | The device options make these functions possible. |
| Operates on Windows 2000 and Windows XP operating systems. | The system runs under these operating systems. |
| Protection against unauthorized use (passwords). | Passwords are required for operation. |
| Image/data recovery mechanisms in case of transmission failure. | Device failures may be recovered from storage or retransmission. |
2. Sample size used for the test set and the data provenance
- Absent. The document does not describe a clinical study or a test set of images with a defined sample size. The performance data section refers to compliance with standards rather than a specific study involving image data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Absent. Since there is no described clinical study or test set for evaluation of image interpretation performance, there is no mention of experts establishing ground truth for such a set. The document states that images and information are "interpreted by a physician or trained medical personnel," implying human oversight during clinical use, but not in the context of device validation.
4. Adjudication method for the test set
- Absent. No test set or corresponding adjudication method is described.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and if so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Absent. The device described is a PACS workstation, an image processing and display system. It does not appear to incorporate AI or CAD (Computer-Aided Detection/Diagnosis) directly for interpretation assistance. Therefore, an MRMC study comparing human readers with and without AI assistance is not applicable and not mentioned.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Absent. As noted above, this device is a workstation for displaying and manipulating images, not a standalone AI algorithm for diagnostic interpretation. Its performance is related to its ability to correctly process and present images according to standards, leaving interpretation to human users.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Absent. This information is not relevant in the context of the provided performance data, which focuses on compliance with technical standards (ISO, DICOM) and substantial equivalence to a predicate device for its intended function as an image display and processing system. The core function is presenting images, not independently deriving diagnostic conclusions that would require a ground truth comparison.
8. The sample size for the training set
- Absent. This device is a software product for viewing and manipulating images; it does not explicitly use a "training set" in the context of machine learning for diagnostic tasks. Its development followed ISO 9001:2000, which is a quality management system standard.
9. How the ground truth for the training set was established
- Absent. As there is no described training set for a machine learning model, the establishment of ground truth for such a set is not applicable.
§ 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).