(29 days)
The SmartSPOT PrimaX enhances the quality of the fluoroscopy image, enables acquisition and display of high quality resolution (1024X1024 pixels) radiographic images and gives the user the possibility to perform advanced studies involving image digital subtraction, such as Road mapping and DSA, that were not possible with conventional technique. Fields of application of the system are: gastrointestinal examinations, interventional procedures, peripheral angiography studies, urology examinations and other routine fluoroscopy studies
The SmartSPOT PrimaX is a high-resolution digital imaging system designed for Digital Spot Imaging. The system is based on a PC Workstation running Windows XT as the operating system. The legally marketed SMARTSPOT K961307 has been modified: To improve its cost effectiveness, aging technologies and components (hardware and software) have been redesigned. The device major functions and principle of operation were not changed.
The provided S510(k) summary for the Koro890 SmartSPOT PrimaX describes the device as a high-resolution digital imaging system for Digital Spot Imaging, indicating it's an update to a previously marketed device (SMARTSPOT K961307). However, the submission does not include specific acceptance criteria or details of a study proving the device meets acceptance criteria in the format explicitly requested.
Instead, the document focuses on demonstrating substantial equivalence to a predicate device by stating: "Tests data demonstrate that the SMARTSPOT PrimaX meets the required specifications. No adverse affects have been detected." and highlighting changes made to improve cost-effectiveness and update aging technologies/components, while asserting that "The device major functions and principle of operation were not changed."
Therefore, it's not possible to populate the requested table and answer the study-related questions based on the provided text. The document is a regulatory submission for a 510(k) clearance, which primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance study results with specific acceptance criteria.
Information NOT available in the provided text:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance (country of origin, retrospective/prospective).
- Number of experts used to establish ground truth.
- Qualifications of experts.
- Adjudication method.
- Results of a multi-reader multi-case (MRMC) comparative effectiveness study or human reader improvement effect size.
- Results of a standalone (algorithm only) performance study.
- Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
The document states that "The device has been designed verified and validated complying with 21 CFR 820.30 regulations," which refers to the Quality System Regulation, outlining general requirements for design controls, but does not provide the specific performance data or 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).