(28 days)
The Sectra IDS5 device is intended for the manipulation and displaying of medical images, including mammograms. 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 mammography reading, telecommunications; fast demonstration; prosthesis CAD; 3-D and angiography, etc .; and teleconferencing.
Lossy compressed mammographic images are not intended for diagnostic review. Mammographic images should only be viewed with a monitor approved by FDA for viewing mammographic images.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
The Sectra IDS5 Workstation is mainly a software product. It is used for visualization and processing of digital medical images. The IDS5 is used as a client together with a Sectra provided server (Class I Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra IDS5 Workstation is in fact a family of devices, including several workstations or types of workstations, e.g. the following:
- . Primary diagnostics workstation and the most powerful version of IDS5 -IDS5/dx.net. It contains tools for assisting advanced users, e.g. the radiologists, in making a diagnosis.
- Dedicated workstation for mammography IDS5/mx.net. It has all functionality as an . IDS5/dx.net but with an additional mammography package.
- Quality assurance workstation, mainly used by the technologists to prepare the images . for the reviewing radiologist.
- Clinicians workstation used by the clinicians within the hospital to view the medical ● images and to read the report.
- "Web" workstation that can be used by remote clinics to view images and reports. .
- "At-home" workstation that can be used by users, e.g. radiologists, over a low . bandwidth connection.
The provided document is a 510(k) summary for the Sectra IDS5 Workstation, a Picture Archiving and Communications System (PACS). This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than presenting comprehensive performance studies with acceptance criteria and detailed study results typical for novel devices.
Therefore, the document does not contain the requested information regarding acceptance criteria, device performance, sample sizes for test/training sets, ground truth establishment, expert qualifications, adjudication methods, or MRMC studies.
The key takeaway from this document regarding performance is that the device is deemed "safe, effective, and substantially equivalent to the predicate device" based on a comparison to its predecessor, K040376, which was also a Sectra IDS5 Workstation.
Here's a breakdown of why the specific information requested is not present in this type of submission:
- Acceptance Criteria and Reported Device Performance: This document describes the device's functions and purpose but does not contain a quantitative performance evaluation with predefined acceptance criteria. This is common for PACS workstations, which are tools for displaying and managing images, rather than diagnostic AI algorithms that generate specific findings.
- Sample Sizes (Test/Training) and Data Provenance: Not applicable as no specific performance study is detailed.
- Number of Experts and Qualifications: Not applicable.
- Adjudication Method: Not applicable.
- Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned, as the focus is on equivalence in functionality for a PACS workstation, not improved diagnostic accuracy with AI assistance.
- Standalone Performance: Not explicitly detailed as an algorithm-only performance study would be. The device's performance is tied to "competent human intervention."
- Type of Ground Truth: Not applicable, as there isn't a diagnostic algorithm being evaluated against a ground truth. The device facilitates viewing and processing images, and the interpretation is by human professionals.
- Training Set Sample Size and Ground Truth Establishment (for training): Not applicable for this type of device.
Conclusion stated in the document:
The conclusion emphasizes that the device:
- Does not contact the patient.
- Does not control any life-sustaining devices.
- Images and information are interpreted by a physician or trained medical personnel, allowing for "competent human intervention."
- Shares the same certification or conformance to performance standards as the predicate device.
- Functions as an Image Processing System (LZ).
- Device failures can be recovered.
- Requires passwords for operation and security.
This re-affirms that the evaluation relies on functional equivalence and human oversight rather than quantitative performance metrics against a medical condition's ground truth.
§ 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).