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.

Device Description

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.

AI/ML Overview

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.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

Shanghai United Imaging Healthcare Co., Ltd % Xin Gao Regulatory Affairs Specialist No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA

June 1, 2020

Re: K192601

Trade/Device Name: uWS-MR Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: QIH, LLZ Dated: April 29, 2020 Received: May 4, 2020

Dear Xin Gao:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K192601

Device Name uWS-MR

Indications for Use (Describe)