(73 days)
The SECTRA MS4 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.
The IDS4 series will be used for displaying and handling of radiological images.
This document is a 510(k) summary for the SECTRA-Imtec IDS4 Image Display System series, which was reviewed by the FDA in 1997. It declares substantial equivalence to a predicate device (SECTRA-Imtec TRS 2000, K961983) and outlines the system's intended use for displaying and handling radiological images by trained medical professionals.
Here's an analysis of the provided text with respect to your questions:
1. A table of acceptance criteria and the reported device performance
The provided text does not contain a table of specific numerical acceptance criteria or reported device performance metrics for the IDS4 Image Display System. The 510(k) summary focuses on demonstrating substantial equivalence based on compliance with regulations, voluntary standards, user guides, and hazard analysis, rather than quantitative performance data.
2. Sample size used for the test set and the data provenance
The document does not specify a sample size or data provenance for any test set. The claim of substantial equivalence is based on regulatory compliance and comparison to a predicate device, not on clinical performance testing with a specific dataset.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not mention a test set with corresponding ground truth established by experts.
4. Adjudication method for the test set
The document does not describe any adjudication method for a test set.
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
The document does not mention any MRMC comparative effectiveness study or AI assistance. The device is an "Image Display System," suggesting its primary function is display and handling of images, not AI-driven analysis or interpretation.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The document does not describe any standalone algorithm performance testing. The device is an "Image Display System" intended for use by "trained medical professionals," implying human-in-the-loop operation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The document does not mention the use of any specific type of ground truth data.
8. The sample size for the training set
The document does not mention any training set or its sample size.
9. How the ground truth for the training set was established
The document does not mention any training set or how its ground truth was established.
Summary of what is present in the document:
The provided text is a 510(k) summary submitted to the FDA for the IDS4 Image Display System. It asserts substantial equivalence to a predicate device (SECTRA-Imtec TRS 2000, K961983) by stating:
- Compliance with Federal Performance Standards (21 CFR, part 1000).
- Manufacturing in accordance with voluntary standards.
- Comprehensive information in user guides for safe and effective use.
- Results of a hazard analysis are included.
The FDA's response confirms the device is substantially equivalent based on the provided information and allows marketing of the device. The indications for use are for the manipulation and displaying of x-ray images from different modalities, with options for telecommunications, fast demonstration, prosthesis CAD, 3-D and angiography, etc., and teleconferencing. The typical users are trained medical professionals.
In conclusion, the document is a regulatory submission for pre-market notification (510(k)) and focuses on demonstrating substantial equivalence through compliance with regulations and standards rather than presenting detailed clinical performance studies, acceptance criteria tables, or data provenance. Therefore, most of your specific questions cannot be answered from the provided text.
§ 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).