(77 days)
The Sectra IDS5 device is intended for the manipulation and displaying of x-ray 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.
Typical users of this system are trained professionals, including but not limited to physicians, radiologists, nurses, medical technicians, and assistants.
The Sectra IDS5 Radiology Workstation with Sectra 3D and MPR Packages is mainly a software product. It is used for visualization and processing of digital radiology images. The IDS5 is used as a client together with a Sectra provided server (Class 1 Exempt). The system runs on PCs under the Windows operating systems. Most notably two or more monitors are used.
The Sectra IDS5 Radiology 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. It contains . tools for assisting the radiologist in making a diagnosis.
- . Dedicated workstation for mammography. 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 radiology . images and to read the radiology report.
- "Web" workstation that can be used by remote clinics to view images and radiology . reports.
- . "At-home" workstation that can be used by the radiologist over a low bandwidth connection.
The provided text does not contain any acceptance criteria or the study details to prove the device meets said criteria.
The document is a 510(k) summary and subsequent FDA clearance letter for the Sectra IDS5 Radiology Workstation. It primarily focuses on demonstrating substantial equivalence to a predicate device based on technological characteristics and intended use, rather than presenting performance data against specific acceptance criteria.
Here's what is NOT present in the provided text, which would be necessary to answer the request:
- Acceptance Criteria Table: There is no table outlining specific performance metrics (e.g., accuracy, sensitivity, specificity, speed, image quality standards) that the device was expected to meet.
- Reported Device Performance: Consequently, there are no reported performance results against any such criteria.
- Study Details:
- No mention of a specific performance study (e.g., a clinical trial, validation study, or bench test for specific performance metrics).
- No information on the sample size used for any test set.
- No data provenance (country of origin, retrospective/prospective).
- No number or qualifications of experts used for ground truth.
- No adjudication method described.
- No multi-reader, multi-case (MRMC) comparative effectiveness study mentioned or its effect size.
- No standalone (algorithm only) performance study mentioned.
- No type of ground truth used (pathology, expert consensus, outcomes data).
- No sample size for a training set.
- No information on how ground truth for a training set was established.
The "Performance Data" section in the document states: "The subject device is developed according to ISO 9001:2000 and complies with ACR/NEMA Digital Imaging Communications in Medicine version 3.0." This indicates adherence to quality management systems and communication standards, which are important, but they are not specific performance acceptance criteria for image interpretation or diagnostic accuracy.
The document's conclusion, "Based on the information supplied in this Special 510(k), we conclude that the subject device is safe, effective, and substantially equivalent to the predicate device," relies on the comparison with the predicate device regarding its design, intended use, and general characteristics, not on a new performance study proving it meets specific, quantifiable acceptance criteria.
§ 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).