(26 days)
The Sectra IDS4 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 IDS4 v3.2 Image Display System is mainly a software product. It is used for visualization and processing of digital radiology images. The system runs under both Window NT and HP-UX operating systems and still provide a common "look and feel" on both platforms.. The requirements on hardware are quite ordinary for a system used for displaying images. Most notably two or more monitors are used.
Here's an analysis of the provided 510(k) summary for the K991643 device, structured to answer your questions regarding acceptance criteria and the supporting study:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the provided 510(k) summary, the acceptance criteria are primarily focused on safety, performance standards compliance, and substantial equivalence to a predicate device, rather than specific quantitative performance metrics for image interpretation (e.g., sensitivity, specificity). The reported device performance centers on its compliance with these standards and its functional equivalence.
| Aspect of Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety and Functional Equivalence to Predicate Device | "The IDS4 v3.2 system does not contact the patient, nor does it control any life sustaining devices." |
| "Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention." | |
| "The device and the predicate device share the same certification or conformance to performance standards and both function as Image Management Systems." | |
| Error Detection | "The subject and predicate devices both use standard data communications controls to detect errors." |
| Compliance with Safety Standards (IEC) | "The subject device complies with IEC 950 - Safety of Information Technology Equipment." |
| Compliance with Electromagnetic Compatibility (EMC) Standards | "CISPR 22, class A - Electromagnetic Compatibility, IEC-801-2, IEC-801-3 - Electromagnetic Compatibility." |
| Compliance with Information Processing Standards | "IEEE 1003.1 - POSIX standard for Information Processing." |
| Compliance with FCC Regulations | "FCC Part 15 sub-part B class A." |
| Compliance with Network and Communication Standards | "IEEE 802.3 - Ethernet, LAN Interface Standard, ACR/NEMA Digital Imaging Communications In Medicine version 3.0." |
| Data Recovery Mechanisms | "Device failures, which might result in partial or failed transmissions, images, or data, may be recovered from storage or re-transmission after correcting the problem(s)." |
| Security Measures | "Passwords are required for operation and to protect against unauthorized use." |
| Substantial Equivalence Conclusion | "Based on the information supplied in this 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and the Data Provenance
The provided 510(k) summary does not mention a specific "test set" in the context of image analysis performance. The performance data presented refers to compliance with various technical and safety standards, not a clinical validation study with a defined dataset of patient images.
For this type of device (an image display system), the focus of the 510(k) is typically on demonstrating that the system accurately displays images and functions reliably according to its intended use and prevailing standards, rather than proving diagnostic accuracy.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable and not provided in the 510(k) summary. Since there's no mention of a clinical test set requiring expert interpretation for ground truth, there's no information about experts or their qualifications.
4. Adjudication Method for the Test Set
This information is not applicable and not provided in the 510(k) summary for the same reasons as point 3.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided 510(k) summary. This type of study is more common for AI/CADe devices that directly aid in diagnosis or detection, rather than a general image display system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not mentioned. The device, an "Image Display System," is inherently a tool for human review and interpretation. The summary explicitly states: "Images and information being reviewed, processed, relayed, and or transmitted are interpreted by a physician or trained medical personnel, providing ample opportunity for competent human intervention."
7. The Type of Ground Truth Used
The concept of "ground truth" as typically applied to diagnostic algorithms (expert consensus, pathology, outcomes data) is not applicable to the data provided in this 510(k) summary. The ground truth, in the context of this device, would be the accuracy and fidelity of image display and system functionality which is assessed through compliance with technical standards and internal testing.
8. The Sample Size for the Training Set
This information is not applicable and not provided. The device described is an "Image Display System" (software for visualization and processing) and does not inherently involve machine learning models that require a "training set" in the typical AI sense.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable and not provided for the same reasons as point 8.
Summary of Findings:
The K991643 510(k) summary for the "IDS4 v3.2 Image Display System" primarily focuses on demonstrating substantial equivalence to a predicate device (K971368) by showing compliance with relevant safety, technical, and communication standards. It explicitly states that human users (physicians, radiologists, etc.) are responsible for image interpretation. Therefore, the document does not contain information related to clinical performance studies, AI algorithms, training/test sets, expert ground truth establishment, or human-AI comparative effectiveness, as these types of studies are typically required for devices that provide diagnostic interpretations or automated analysis rather than merely displaying images.
§ 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).