(14 days)
The system is intended for use by Nuclear Medicine (NM) or Radiology practitioners and referring physicians for display, processing, archiving, printing, reporting and networking of NM data, including planar scans (Static, Whole Body, Dynamic, Multi-Gated) and tomographic scans (SPECT, Gated SPECT, dedicated PET or Camera-Based-PET) acquired by gamma cameras or PET scanners.
The system can run on dedicated workstation or in a server-client configuration.
The NM or PET data can be coupled with registered and/or fused CT or MR scans, and with physiological signals in order to depict, localize, and/or quantify the distribution of radionuclide tracers and anatomical structures in scanned body tissue for clinical diagnostic purposes.
DaTQUANT optional application enables visual evaluation and quantification of 131ioflupane (DaTscan™)) images. DaTQUANT Normal Database option enables quantification relative to normal population databases of 1231-ioflupane (DaTscan TM) images.
These applications may assist in detection of loss of functional dopaminergic neuron terminals in the striatum, which is correlated with Parkinson disease.
The Xeleris 3.1 is a Nuclear Medicine Workstation system intended for general nuclear medicine processing & review procedures for detection of radioisotope tracer uptake in the patient body, using a variety of processing modes supported by various clinical applications types and various features designed to enhance image quality. The components of the Xeleris 3.1 NM Workstation system are: operation console, monitor and peripherals. The Xeleris 3.1 is a modification of its predicate device Xeleris 3 while providing enhanced workflow to existing operations and enabling broader access to Xeleris applications in supporting PACS and GE AW Server and in offline client server configuration. Xeleris 3.1 also enables the use of normal data base comparison together with the quantification analysis of 123I-ioflupane brain NM images. Similar functionality for NM/PET brain image analysis also resides in the predicate devices K021656 and K123528.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Xeleris 3.1 Processing and Review Workstation, specifically focusing on the DaTQUANT application:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state formal acceptance criteria with specific numerical thresholds for the DaTQUANT application's accuracy. Instead, it describes a
The study for the DaTQUANT application compared "DaTQUANT analysis results to manual analysis results." The reported performance is that "DaTQUANT results were found to be as accurate as manual results."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| DaTQUANT analysis results are accurate compared to manual analysis results. | DaTQUANT results were found to be as accurate as manual results. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that the data used for testing was "taken from brain phantoms injected symmetrically and asymmetrically." It does not specify the number of phantoms or the number of acquisitions/images used.
- Data Provenance: The data was derived from "brain phantoms injected symmetrically and asynchronously," simulating normal and abnormal uptakes, with "different contrast levels used to simulate different signal to noise ratio levels." This indicates a controlled, artificial data set (phantoms) rather than human clinical data. It is a retrospective analysis of phantom data. The country of origin for the phantom data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth in this specific test was established by "manual analysis results," which inherently implies human expert involvement. However, the document does not specify the number of experts who performed the manual analysis, nor their specific qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It simply states that the DaTQUANT results were compared to "manual analysis results," implying a direct comparison without detailing how discrepancies in manual analysis (if multiple experts were involved) would have been resolved.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned for the DaTQUANT application in this document. The testing described focuses on comparing the algorithm's output to manual analysis, not on how human readers' performance might improve with or without AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone performance test was done for the DaTQUANT application. The description, "Testing the accuracy of using the DaTQUANT application by comparing DaTQUANT analysis results to manual analysis results," indicates that the algorithm's output (DaTQUANT results) was directly evaluated against a ground truth (manual analysis) without an explicit human-in-the-loop interaction for the DaTQUANT itself during this specific accuracy test.
7. Type of Ground Truth Used
The ground truth used for the DaTQUANT accuracy testing was expert consensus / manual analysis results derived from phantom data.
8. Sample Size for the Training Set
The document does not specify the sample size or details regarding a training set for the DaTQUANT application. The description focuses solely on the accuracy testing using phantom data.
9. How the Ground Truth for the Training Set Was Established
Since a training set is not mentioned, the method for establishing its ground truth is also not provided in this document.
§ 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).