PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.

Device Description

PerfusionGo Plus is a standalone software package that is comprised of several modules including Login Module, Image List Module, Image Processing Module and Management Configuration Module. PerfusionGo Plus allows a DICOM-compliant device to send files directly from the image modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the results of analysis can be exported manually. The software allows for repeated use and continuous processing of data and can be deployed on a supportive infrastructure that meets the minimum system requirements.

PerfusionGo Plus image analysis includes calculation of the following perfusion related parameters:

Cerebral Blood Flow (CBF)
Cerebral Blood Volume (CBV)
Mean Transit Time (MTT)
Time-to-peak (TTP)
Residue function time-to-peak (Tmax)
Time-density curve (TDC)

The primary users of PerfusionGo Plus are medical imaging professionals who analyze dynamic CT perfusion studies. The results of image analysis produced by PerfusionGo Plus should be viewed through appropriate diagnostic viewers when used in clinical decision making.

AI/ML Overview

The provided document is a 510(k) Premarket Notification from the U.S. FDA for the device "PerfusionGo Plus". It primarily focuses on demonstrating substantial equivalence to a predicate device (Viz CTP, K180161) rather than detailing a specific clinical performance study with acceptance criteria and ground truth for a novel AI device.

Therefore, the document does not contain the information required to fully answer all aspects of your request, particularly regarding specific acceptance criteria for a clinical study, human-in-the-loop performance, or the detailed methodology for establishing ground truth from expert consensus or pathology data for a large test set.

However, I can extract the information that is present and indicate what is missing:

Information Present in the Document:

1. A table of acceptance criteria and the reported device performance: Not explicitly provided as a formal table with acceptance criteria for a clinical study on device performance (e.g., accuracy against ground truth). The document states: "The results of performance testing showed that the PerfusionGo Plus achieved the pre-established performance goals for each perfusion parameters: CBF, CBV, MTT and Tmax." However, the specific pre-established performance goals (acceptance criteria) and the numerical results (reported device performance) are not detailed.
2. Sample sized used for the test set and the data provenance:
- Test Set Sample Size: Not explicitly stated. The document refers to "commercially available simulated datasets (digital phantom)".
- Data Provenance: "commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory." This implies synthetic data rather than real patient data from a specific country or collected retrospectively/prospectively.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth was established by "simulating tracer kinetic theory" for the digital phantoms, not by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable, as ground truth was not expert-based.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: No, an MRMC study was not described. The document focuses on the standalone algorithm's performance against simulated ground truth. The device is described as "image processing software package to be used by trained professionals," suggesting human-in-the-loop use, but a study evaluating the impact of AI assistance on human readers is not presented.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Yes, the described "performance testing" was of the standalone algorithm against simulated ground truth.
7. The type of ground truth used: "commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth." This is simulated/theoretical ground truth.
8. The sample size for the training set: Not mentioned. The document describes verification and validation testing, but does not specify a training set as would be typical for an AI model development. This might imply that the product is a rules-based image processing software rather than a machine learning/AI model that requires a training set. Given the context of "simulating tracer kinetic theory," it's highly likely to be a mathematical model implementation rather than a data-driven AI.
9. How the ground truth for the training set was established: Not applicable, as no training set is described.

Summary of Missing Information (based on the typical requirements for AI/ML device approval when clinical studies are performed):

Specific numerical acceptance criteria for perfusion parameters (CBF, CBV, MTT, Tmax).
Specific numerical results for the device's performance against these criteria.
The exact sample size of the test set (number of simulated cases).
Details on how the "commercially available simulated datasets" were verified or validated themselves to represent clinical reality.
Any information regarding training data, which suggests this is not a traditional machine learning/AI device requiring such data, but rather an implementation of established tracer kinetic theory.
Any details on human expert involvement (e.g., radiologists) in ground truth establishment or human-in-the-loop performance studies.

Conclusion based on the provided document:

The PerfusionGo Plus device underwent performance testing against "commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory." The ground truth for this testing was the theoretical values derived from these simulations. The document states that the device "achieved the pre-established performance goals" for perfusion parameters (CBF, CBV, MTT, and Tmax), demonstrating accurate computation. However, the exact numerical acceptance criteria and the quantitative results are not provided in this 510(k) summary. No details on training data, human expert ground truth, or human-in-the-loop studies are included, indicating that this submission likely pertains to a deterministic image processing algorithm rather than a data-driven AI/ML solution.

Summary

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Yukun (Beijing) Technology Co., Ltd. Qi Wang Regulatory Affairs Manager Room 313, 315, Building 3, No.11 Chuangxin Road, Science Park, Changping District Beijing, 102200 China

Re: K221627

Trade/Device Name: PerfusionGo Plus Regulation Number: 21 CFR 892.2050 Regulation Name: Medical Image Management And Processing System Regulatory Class: Class II Product Code: LLZ Dated: December 15, 2022 Received: December 15, 2022

January 19, 2023

Dear Qi Wang:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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.

Jessica Lamb

Jessica Lamb, Ph.D. Assistant Director Imaging Software DHT8B: Division of Radiological Imaging Devices and Electronic Products OHT8: Office of 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)

K221627

Device Name PerfusionGo Plus

Indications for Use (Describe)

PerfusionGo Plus provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological imaging viewers.

Type of Use (Select one or both , as applicable)
----------------------------------------------------------------

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image shows a logo with a stylized letter 'M'. The 'M' is formed by three connected diamond shapes, each in a different shade of purple and blue. To the right of the 'M' is a small, solid circle, also in a shade of blue. The logo has a modern and abstract design.

510(k) Summary

1. Submitter

K221627

510(k) Submitter

Submitter/Company Name: Yukun (Beijing) Technology Co., Ltd. Address: Room 313, 315, Building 3, No.11 Chuangxin Road, Science Park, Changping District, Beijing, 102200, China.

Correspondent

Primary Correspondent: Qi Wang. Title: Regulatory Affairs Manager. Telephone: +86-10-89735152. Email: wangqi@shukun.net.

Date Prepared: 12/15/2022

1. Device

Device Type

Trade Name: PerfusionGo Plus. Common Name: PACS - Picture Archiving and Communications System.

Classification

Classification Regulation: 21 CFR 892.2050; Class: Class II; Panel: Radiology; Product Code: LLZ;

1. Predicate Device
  510 (k) number: K180161; Trade name: Viz CTP; 510(k) submitter/holder: Viz.ai, Inc.
1. Device Description
  PerfusionGo Plus is a standalone software package that is comprised of several modules

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including Login Module, Image List Module, Image Processing Module and Management Configuration Module. PerfusionGo Plus allows a DICOM-compliant device to send files directly from the image modality, through a node on a local network, or from a PACS server. The device is designed to automatically receive, identify, extract, and analyze a CTP study of the head embedded in DICOM image data. The software outputs parametric maps related to tissue blood flow (perfusion) and tissue blood volume that are written back to the source DICOM. Following such analysis, the results of analysis can be exported manually. The software allows for repeated use and continuous processing of data and can be deployed on a supportive infrastructure that meets the minimum system requirements.

PerfusionGo Plus image analysis includes calculation of the following perfusion related parameters:

. Cerebral Blood Flow (CBF)
Cerebral Blood Volume (CBV) ●
Mean Transit Time (MTT) .
. Time-to-peak (TTP)
Residue function time-to-peak (Tmax) .
. Time-density curve (TDC)

1. Indications for Use
  PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing. analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.

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Image /page/5/Picture/1 description: The image shows a logo with a stylized letter 'M' formed by three overlapping shapes in different colors. The left shape is a gradient of purple and blue, the middle shape is a gradient of blue and teal, and the right shape is a solid teal circle. The logo has a modern and abstract design.

Item	Proposed device	Predicate device (K180161)	Analysis
Product Code	LLZ	LLZ	Same
Regulation	21 CFR 892.2050	21 CFR 892.2050	Same
IntendedUse/Indicationsfor Use	PerfusionGo Plus is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.PerfusionGo Plus provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be	Viz CTP is an image processing software package to be used by trained professionals, including but not limited to physicians and medical technicians. The software runs on a standard "off-the-shelf" computer or a virtual platform, such as VMware, and can be used to perform image processing, analysis, and communication of computed tomography (CT) perfusion scans of the brain. Data and images are acquired through DICOM-compliant imaging devices.Viz CTP provides both analysis and communication capabilities for dynamic imaging datasets that are acquired with CT Perfusion imaging protocols. Analysis includes calculation of parameters related to tissue flow (perfusion) and tissue blood volume. Results of image processing which include CT perfusion parameter maps generated from a raw CTP scan are exported in the standard DICOM format and may be viewed on existing radiological	Same

Comparison of Technological Characteristic with the Predicate Device 6.

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Image /page/6/Picture/0 description: The image shows a logo with a stylized letter 'M'. The logo is composed of several geometric shapes in shades of blue, purple, and teal, creating a gradient effect. The shapes are arranged to form the letter 'M', with a small circle to the right of the letter.

	viewed on existing radiologicalimaging viewers.	imaging viewers.
PACS Functionality
Basic PACSFunctions	Yes	Yes	Same
Computer	Standard "Off-the-Shelf" PC	Standard "Off-the-Shelf" PC	Same
Platform	Workstation or Server	Workstation or VMWare	Different 1
DICOMCompliance	Yes	Yes	Same
FunctionalOverview	PerfusionGo Plus is a softwarepackage that provides for thevisualization and study ofchanges of tissue perfusion indigital images captured by CT.PerfusionGo Plus allowsviewing and quantification.	Viz CTP is a software packagethat provides for thevisualization and study ofchanges of tissue perfusion indigital images captured by CT.Viz CTP allows viewing andquantification.	Same
DataAcquisition	Acquires medical image datafrom DICOM compliantimaging devices and modalities.	Acquires medical image datafrom DICOM compliantimaging devices and modalities.	Same
Data/ImageTypes	Computed Tomography (CT)	Computed Tomography (CT)	Same
Acquisition and Modalities Features
CT	CT Perfusion (CTP)	CT Perfusion (CTP)	Same
Computed Parameter Maps
Perfusion CT	Cerebral Blood Flow (CBF)	Cerebral Blood Flow (CBF)	Same
	Cerebral Blood Volume (CBV)	Cerebral Blood Volume (CBV)
	Mean Transit Time (MTT)	Mean Transit Time (MTT)
	Tissue residue function time topeak (Tmax)	Tissue residue function time topeak (Tmax)
Measurements/Tools
CT Tools	Time-density Curve (TDC)	Arterial Input Function (AIF)	Different 2
	Brain mask	Brain mask	Same
	Export perfusion files to PACSand DICOM file systems	Export perfusion files to PACSand DICOM file systems	Same
	Acquire, transmit, process, andstore medical images	Acquire, transmit, process, andstore medical images	Same

Substantial Equivalence Discussion for Different 1:

The platform of the proposed device is different from that of the predicate device. However,

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the difference is in hardware only. The configuration requirements have been provided in instructions of use and the verification and validation tests have been performed on the proposed device and the test results met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Substantial Equivalence Discussion for Different 2:

The CT tools of the proposed device is different from that of the predicate device. The proposed device displays Time density Curve (TDC), including Arterial input function (AIF) and Venous output function (VOF), although the predicate device displays Arterial input function (AIF) only. However, the verification and validation tests have been performed on the proposed device and the test results met the acceptance criteria. Therefore, the difference will not affect the safety and effectiveness of the proposed device.

Performance Data 7.
PerfusionGo Plus complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association. NEM PS 3.1-3.20 (2016).

Yukun performed software verification and validation testing of the device and additional performance testing on a commercially available simulated datasets (digital phantom) generated by simulating tracer kinetic theory, and includes a wide range of clinically relevant values of perfusion parameters as ground truth. Correlations between the output of the PerfusionGo Plus and the ground truth values were calculated.

The results of performance testing showed that the PerfusionGo Plus achieved the preestablished performance goals for each perfusion parameters: CBF, CBV, MTT and Tmax.

Thus, the performance testing demonstrated that the PerfusionGo Plus provides accurate computation of perfusion parameters. Combined with software verification and validation, the performance evaluation demonstrates that the PerfusionGo Plus satisfies all design requirements and specifications.

Conclusion 8.

The proposed device is as safe and effective as the predicate device (K180161). The proposed device has the same intended use as its predicate device with respect to CTP functionalities. In addition, the minor technological differences between the proposed

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Image /page/8/Picture/0 description: The image shows a logo with two stylized letter 'M's. The 'M's are formed by connected lines, with the left 'M' being slightly larger than the right one. The color palette consists of shades of purple, blue, and teal, creating a gradient effect across the logo. A small teal circle is positioned to the right of the second 'M'.

device and its predicate device raise no new issues of safety or effectiveness. Performance data demonstrate that the proposed device is as safe and effective as the predicate for performing CTP analysis. Thus, the PerfusionGo Plus is substantially equivalent.

Regulation Number and Section

§ 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).