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510(k) Data Aggregation
(255 days)
uWS-MR is a software solution intended to be used for viewing, manipulation, and storage of medical images. It supports interpretation and evaluation of examinations within healthcare institutions. It has the following additional indications:
The MR Stitching is intended to create full-format images from overlapping MR volume data sets acquired at multiple stages.
The Dynamic application is intended to provide a general post-processing tool for time course studies.
The Image Fusion application is intended to combine two different image series so that the displayed anatomical structures match in both series.
MRS (MR Spectroscopy) is intended to evaluate the molecule constitution and spatial distribution of cell metabolism. It provides a set of tools to view, process, and analyze the complex MRS data. This application supports the analysis for both SVS (Single Voxel Spectroscopy) and CSI (Chemical Shift Imaging) data.
The MAPs application is intended to provide a number of arithmetic and statistical functions for evaluating dynamic processes and images. These functions are applied to the grayscale values of medical images.
The MR Breast Evaluation application provides the user a tool to calculate parameter maps from contrast-enhanced timecourse images.
The Brain Perfusion application is intended to allow the visualizations in the dynamic susceptibility time series of MR datasets.
MR Vessel Analysis is intended to provide a tool for viewing, manipulating MR vascular images.
The Inner view application is intended to perform a virtual camera view through hollow structures (cavities), such as vessels.
The DCE analysis is intended to view, manipulate, and evaluate dynamic contrast-enhanced MRI images.
The United Neuro is intended to view, manipulate, and evaluate MR neurological images.
The MR Cardiac Analysis application is intended to be used for viewing, post-processing and quantitative evaluation of cardiac magnetic resonance data.
uWS-MR is a comprehensive software solution designed to process, review and analyze MR (Magnetic Resonance Imaging) studies. It can be used as a stand-alone SaMD or a post processing application option for cleared UIH (Shanghai United Imaging Healthcare Co.,Ltd.) MR Scanners. It can transfer images in DICOM 3.0 format over a medical imaging network or import images from external storage devices such as CD/DVDs or flash drives. These images can be functional data, as well as anatomical datasets. It can be at one or more time-points or include one or more time-frames. Multiple display formats including MIP and volume rendering and multiple statistical analysis including mean, maximum and minimum over a user-defined region is supported. A trained, licensed physician can interpret these displayed images as well as the statistics as per standard practice.
The provided 510(k) summary for the uWS-MR device from Shanghai United Imaging Healthcare Co., Ltd. does not contain a typical acceptance criteria table with reported device performance metrics in the format usually associated with diagnostic performance studies (e.g., sensitivity, specificity, accuracy).
Instead, this document describes modifications to an already cleared Picture Archiving and Communications System (PACS) named uWS-MR (K183164) and introduces a new advanced application (MR Cardiac Analysis) and a modified existing application (United Neuro). The "acceptance criteria" here are framed around demonstrating substantial equivalence to predicate devices for these functionalities.
Here's a breakdown of the requested information based on the provided text, focusing on the performance verification mentioned, which is the closest to a "study" described.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, a quantitative performance table with metrics like sensitivity or specificity is not present. The "acceptance criteria" are implied by the comparison to predicate devices, focusing on functional parity and safe operation, rather than diagnostic accuracy for a specific disease or condition. The performance is summarized as the device having a "safety and effectiveness profile that is similar to the predicate device and reference devices."
The tables in the document (Table 1 and Table 2) compare the functional features of the proposed device against predicate/reference devices. These tables demonstrate functional equivalence rather than meeting specific quantifiable performance thresholds.
| Item | Acceptance Criterion (Implied) | Reported Device Performance (Implied) |
|---|---|---|
| General Device | Substantial equivalence to predicate device in classification, product code, regulation number, device class, and panel. | All general characteristics are "Same" as the predicate device. |
| Indications for Use | Substantial equivalence in core indications, with additional applications not negatively impacting safety/effectiveness. | The indications for use are supplemented, and additional applications are discussed, with the conclusion that differences "will not impact the safety and effectiveness of the device." |
| Basic Functions | Functional equivalence for image communication, hardware/OS, patient administration, review 2D/3D, filming, fusion, inner view, visibility, ROI/VOI, MIP display, compare, and report. | All basic functions are "Same" as the predicate device, except "Report" which is "Optimized function which will not impact the safety and effectiveness." |
| MR Cardiac Analysis | Functional equivalence to reference devices (cvi42 and Philips IntelliSpace Cardiovascular) for specific cardiac analysis functions (Cardiac Function and Flow Analysis). | All listed functions for Cardiac Analysis ("Type of imaging scans" to "Report") are "Same" as the reference devices. |
| United Neuro | Functional equivalence to predicate device (uWS-MR K183164) for neurological image processing functions, with acceptable modification to MR Segmentation. | Most listed functions for United Neuro are "Same" as the predicate. "MR Segmentation" is a new feature, allowing manual user segmentation, with the note, "does not affect safety and effectiveness." |
| Software V&V | Demonstration of safety and efficacy through software verification and validation. | Software V&V, hazard analysis (moderate LOC), and various software documentation were provided. |
| Other Standards/Guidance | Compliance with relevant standards (DICOM, ISO 14971, IEC 62304). | Compliance with these standards is implicitly claimed by their listing under "Other Standards and Guidance." |
2. Sample Size Used for the Test Set and Data Provenance
The document states "No clinical study was required" and "No animal study was required." The performance verification relies on "Software Verification and Validation" and a "Performance Evaluation Report for MR Cardiac Analysis." Details regarding the specific datasets used for these evaluations (sample size, data provenance like country of origin, or retrospective/prospective nature) are not provided in this summary.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Given that "No clinical study was required," the direct involvement of medical experts for establishing ground truth on a specific test set (for diagnostic performance) is not explicitly mentioned or detailed. The evaluation appears to be primarily focused on software functionality and engineering verification rather than a human reading study to assess diagnostic accuracy.
4. Adjudication Method for the Test Set
Since no clinical study or human reading study is mentioned, there is no information provided regarding an adjudication method for a test set.
5. Multi Reader Multi Case (MRMC) Comparative Effectiveness Study
A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. Therefore, no effect size for human readers improving with or without AI assistance is provided.
6. Standalone Performance Study (Algorithm Only Without Human-in-the-Loop Performance)
The device is described as "a stand-alone SaMD" (Software as a Medical Device) or a "post processing application option." While the device itself is standalone software, the performance verification details do not explicitly detail a standalone performance study (e.g., diagnostic accuracy metrics) for its advanced applications. The evaluation is implicitly focused on the software's functional correctness and safety, rather than its diagnostic performance in a clinical scenario without human interaction to interpret results. The "Performance Evaluation Report for MR Cardiac Analysis" would be the closest to this, but its contents (e.g., metrics, sample size) are not detailed.
7. Type of Ground Truth Used
Given the lack of a clinical study, specific "ground truth" (such as pathology, outcomes data, or expert consensus on clinical cases) for diagnostic performance evaluation is not explicitly stated or detailed in the document. The "ground truth" for the software verification and validation would likely be defined by functional requirements specifications and adherence to design documents. For the cardiac and neuro applications, the "truth" could be defined by expected mathematical outcomes or standardized rendering accuracies.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size. This is typical for submissions focused on software modifications and functional equivalence rather than de novo AI algorithm development requiring extensive data for training and validation.
9. How the Ground Truth for the Training Set Was Established
As no training set is mentioned, no information is provided on how its ground truth would have been established.
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