AutoMIStar is a medical image post-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-shel" computer or a virtual platform with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices.

AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module.

The CT Perfusion Module is used for visualization and analysis of contrast enhanced CT Perfusion (CTP) dataset, showing properties of changes in contrast over time. This function includes calculation of various parameters related to tissue flow (perfusion) and tissue blood volume.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.

Device Description

AutoMIStar is a software package that provides visualization and processing of medical imagesacquired by CT (Computed Tomography) and MRI (Magnetic Resonance Imaging) scanners, as an aid to physician diagnosis. It can be installed and run on a PC, laptop or virtual machine running a Microsoft Windows operating system. It provides viewing, quantification, analysis and reporting capabilities.

AutoMIStar also provides processing and analysis of functional and dynamic imaging datasets including CT Perfusion (CTP) and diffusion-weighted MRI (DWI). It provides tools to perform the following type of advanced analysis:

time intensity plots for dynamic time courses;
volumetry of threshold maps;
calculation of mismatch between volumes of different threshold maps;

AutoMIStar can be configured to connect to various DICOM devices (modality scanners, workstations, PACS) via the hospital medical imaging network to receive CT or MRI images as they become available. It supports transfer of DICOM images using the DICOM standard network protocol, and allows import of DICOM images from storage media. It provides automated workflow to processes received data and sends post-processed results to designated DICOM devices. It can also be configured to send post-processed results to designated recipients via email through the hospital email system.

AutoMIStar is a DICOM-compliant PACS softwarethat provides functionality to transfer, process, and display of CT and MR imaging data including dynamically acquired CT perfusion imaging data and diffusion-weighted MRI (DWI).

AutoMIStar runs on a standard "off-the-shelf" computer with Windows operating system, and can seamlessly integrate into an existing radiological data network. AutoMIStar is entirely independent from CT, MRI, or PACS platforms.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly state quantitative acceptance criteria in a structured table. Instead, it describes general performance goals and compares performance to a predicate device and other software packages.

Acceptance Criterion (Inferred from Text)	Reported Device Performance
Accurate calculation of perfusion parameters (CBF, CBV, MTT, DT).	Achieved pre-established performance goals for all perfusion parameters (CBF, CBV, MTT, DT). Regression analysis between AutoMIStar output and ground truth showed strong correlation. Performance was comparable to published results of seven other commercially available and academic CTP software packages.
Accurate calculation of diffusion parameters (ADC).	Achieved pre-established performance goals for all diffusion parameters (ADC). Regression analysis between AutoMIStar output and ground truth showed strong correlation. Performance was comparable to published results of seven other commercially available and academic CTP software packages.
Accurate representation of perfusion threshold maps and volumes.	Performance validation was conducted on perfusion threshold maps and volumes, demonstrating substantial equivalence.
Accurate representation of diffusion threshold maps and volumes.	Performance validation was conducted on diffusion threshold maps and volumes, demonstrating substantial equivalence.
DICOM compliance.	AutoMIStar complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1-3.20.
Satisfy all design requirements and device specifications.	Software verification and validation testing demonstrated that AutoMIStar met all design requirements and specifications. Performance validation testing demonstrated that AutoMIStar provides accurate representation of key perfusion and diffusion parameters associated with the intended use of the software.
Substantial equivalence to predicate device (IschemaView RAPID) for CTP/DWI.	AutoMIStar has the same intended use and similar indications, technological characteristics, and principles of operation as its predicate device (IschemaView RAPID). While it lacks dynamic contrast-enhanced MRI (DCE-MRI) functionality present in the predicate, this minor difference does not alter the intended diagnostic use or affect safety/effectiveness for CTP/DWI. The Delay Time (DT) parameter in AutoMIStar is considered similar to the Tmax parameter in RAPID, both relating to arterial delay effects.

2. Sample Size Used for the Test Set and Data Provenance:

Sample Size: The document does not explicitly state the specific number of cases or images used for the test set. It mentions "published perfusion phantom and diffusion phantom data."
Data Provenance: The data used for testing was derived from "published perfusion phantom and diffusion phantom data." This suggests the data is likely from research studies or publicly available datasets specifically designed for validating perfusion and diffusion analysis software. The country of origin is not specified, but the nature of phantom data implies it's synthetic or laboratory-generated rather than patient-specific. The data would be considered retrospective in the sense that it was pre-existing for testing purposes, not prospectively collected for this device's validation.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

Number of Experts: Not specified.
Qualifications of Experts: Not specified. The ground truth was established by "published perfusion phantom and diffusion phantom data," implying that the ground truth was inherent to the design of these phantoms, which are validated by established methodologies in the field.

4. Adjudication Method for the Test Set:

Adjudication Method: Not applicable/not specified. Since the ground truth was established by phantom data, there was no need for human expert adjudication of individual cases in the traditional sense. The phantom data itself provided the ground truth values.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

Was an MRMC study done? No. The document does not mention an MRMC study or any comparison of human readers with vs. without AI assistance. The performance testing focused on the standalone algorithm's accuracy against phantom data and comparison to other software.
Effect size of human readers improve with AI vs without AI assistance: Not applicable, as no MRMC study was conducted.

6. Standalone (Algorithm Only) Performance:

Was standalone performance done? Yes. The entire performance data section describes the evaluation of the AutoMIStar device itself against ground truth from phantom data. This is a standalone algorithm performance assessment. The "regression analysis between the output of the AutoMIStar device and the ground truth values" is a direct measure of its standalone accuracy.

7. Type of Ground Truth Used:

Type of Ground Truth: The ground truth was established using phantom data (specifically, "published perfusion phantom and diffusion phantom data"). This type of ground truth provides precise, known values for the parameters being measured (e.g., CBF, CBV, MTT, ADC), which is ideal for quantitative validation.

8. Sample Size for the Training Set:

Sample Size: The document does not provide any information regarding the sample size of a training set. This suggests that the device, or at least the part being validated, does not rely on a machine learning model that requires a distinct training phase with labeled data in the way a deep learning algorithm would. It appears to be based on established algorithms for perfusion and diffusion analysis.

9. How the Ground Truth for the Training Set Was Established:

How Ground Truth for Training Set Established: Not applicable. As no training set information is provided, the method for establishing its ground truth is also not mentioned.

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" in a larger font and the word "Administration" in a smaller font.

Apollo Medical Imaging Technology Pty. Ltd. % Prithul Bom Official Correspondent Regulatory Technology Services, LLC 1000 Westgate Drive, Suite 510k Saint Paul, Minnesota 55114

December 31, 2019

Re: K192912

Trade/Device Name: AutoMIStar Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: Class II Product Code: LLZ Dated: December 17, 2019 Received: December 18, 2019

Dear Prithul Bom:

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

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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 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 medical devices and radiation-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 Mills, PhD 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)

Device Name

AutoMIStar

Indications for Use (Describe)

AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusion-weighted MRI data.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Applicant:	Apollo Medical Imaging Technology Pty. Ltd.Suite 611, 365 Little Collins StreetMelbourne, Vic 3000, Australia
Contact Person:	Qing Yang, PhDDirectorPhone: 61-3-9995 6190
Date Prepared:	November 27, 2019
Device Trade Name:	AutoMIStar
Common Name:	PACS - Picture Archiving Communications System
Classification:	Regulation Number:Classification Panel:Device Class:Product Code:	21 C.F.R.§892.2050RadiologyClass IILLZ
Predicate Devices:	IschemaView RAPID (K121447)

Device Description:

time intensity plots for dynamic time courses; ●
volumetry of threshold maps;
calculation of mismatch between volumes of different threshold maps; ●

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It can also be configured to send post-processed results to designated recipients via email through the hospital email system.

Intended Use /Indications for Use:

AutoMIStar is a medical image post-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 with Windows operating system, and can be used to perform image viewing, processing and analysis of brain images acquired by DICOM compliant imaging devices.

AutoMIStar provides general viewing of DICOM images, with analysis capabilities for functional imaging data including a CT Perfusion Module and a DWI (diffusion-weighted MRI) Module.

The DWI Module is used to visualize local water diffusion properties from the analysis of diffusionweighted MRI data.

Technical Characteristics:

AutoMIStar provides the following functions:

receive DICOM images from various DICOM devices (CT/MRI scanners, PACS and . Workstations) and send DICOM images to designated DICOM devices;
process DICOM images received from multiple sources to provide visualization of changes of tissue perfusion and diffusion;
send processed results as DICOM images to designated DICOM devices;
. send summary results to designated recipients via customer approved email server using the SMTP protocol with security extensions to provide secure emailing.

The primary users of AutoMIStar software are medical imaging professionals who view and analyse CT and MRI images. The results generated by AutoMIStar provideadditional diagnostic information, which is derived from the temporal/diffusion features of the nativeCT or MRI images.

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Substantial Equivalence:

In comparison with RAPID, AutoMIStar has the same intended use and similar indications, technological characteristics and principles of operation as its predicate device as described in the comparison table below.

Device	AutoMIStar	IschemaView's RAPID
Product Code	LLZ
Regulation	21 CFR §892.2050	21 CFR §892.2050
Intended Use/ Indicationsfor Use	AutoMIStar is a medical image post-processing software package to be used bytrained professionals, including but notlimited to physicians and medicaltechnicians. The software runs on astandard "off-the-shelf" computer or avirtual platform with Windows operatingsystem, and can be used to perform imageviewing, processing and analysis of brainimages acquired by DICOM compliantimaging devices.AutoMIStar provides general viewing ofDICOM images, with analysis capabilitiesfor functional imaging data including a CTPerfusion Module and a DWI (diffusion-weighted MRI) Module.The CT Perfusion Module is used forvisualization and analysis of contrastenhanced CT Perfusion (CTP) dataset,showing properties of changes in contrastover time. This function includescalculation of various parameters related totissue flow (perfusion) and tissue bloodvolume.The DWI Module is used to visualize localwater diffusion properties from the analysisof diffusion-weighted MRI data.	iSchemaView's RAPID is an imageprocessing software package to be used bytrained professionals, including but notlimited to physicians and medicaltechnicians. The software runs ona standard "off-the-shelf" computer or avirtual platform, such as VMware, and canbe used to perform image viewing,processing and analysis of brain images.Data and images are acquiredthrough DICOM compliant imagingdevices.iSchemaView's RAPID provides bothviewing and analysis capabilities forfunctional and dynamic imaging datasetsacquired with CT Perfusion and MRIincluding a Diffusion Weighted MRI(DWI) Module and a Dynamic AnalysisModule (dynamic contrast enhancedimaging data for MRI and CT).The DWI Module is used to visualize localwater diffusion properties from the analysisof diffusion weighted MRI data.The Dynamic Analysis Module is used forvisualization and analysis of dynamicimaging data, showing properties ofchanges in contrast over time. Thisfunctionality includes calculation ofparameters related to tissue flow(perfusion) and tissue blood volume.
PACS Functionality
Basic PACSFunctions	View, process and analyze medical images.Performs standard PACS functions with	Same

	respect to querying and listing.
ComputerPlatform	Standard off-the-shelf PC workstationVirtual platform such as VMware	Same
DICOMCompliance	Yes	Yes
FunctionalOverview	AutoMIStar is a software package thatprovides for thevisualization and study ofchanges of tissue in digitalimages capturedby CT and MRI. AutoMIStarprovidesviewing and quantification.	Same
DataAcquisition	Receives medical image data from DICOMcompliant imaging devices and modalities	Same
Data/ImageTypes	Computed Tomography (CT)Magnetic Image Resonance (MRI)	Same
	Acquisition and Modalities Features
CT	CT Perfusion (CTP)	Yes
MRI	Diffusion Weighted Image (DWI)	Yes
	Computed Parameter Maps
CT Perfusion	Cerebral blood flow (CBF)	Yes
	Cerebral blood volume (CBV)	Yes
	Mean transit time (MTT)	Yes
	Delay time (DT)	Tmax
	Isotropic DWI (isoDWI)	Yes
Diffusion MRI	Apparent diffusion coefficient (ADC)	Yes
	Exponential ADC (eADC)	Yes
	Measurement Tools
CT and MRITools	Arterial input function (AIF) Venousoutput function (VOF)	Yes
	Time-course	Yes
	Brain mask	Yes
	Region of interest (ROI) and Volumetry	Yes
	Volumetric comparison between 2 ROIs	Yes
	Motion correction	Yes
	Export parameter maps PACS and DICOMfile systems	Yes
	Acquire, transmit, process, and storemedical images	Yes

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Difference in Indications for Use with Respect to the Predicate Device:

AutoMIStar does not include the functionality, and is therefore not indicated for processing or analyzing images acquired through dynamic contrast enhanced Magnetic Resonance Imaging (MRI) protocols. However, AutoMIStar is indicated for the same functionality as the predicate device with respect to CTP or DWI datasets. Such minor differences indications do not alter the intended diagnostic use of the device and do not affect its safety and effectiveness with respect to CTP and DWI functionalities.

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Difference in Technical Performance with Respect to the Predicate Device:

With regards to CT Perfusion analysis, AutoMIStar provides a Delay Time (DT) parameter derived from an improved deconvolution method with delay- and dispersion-correction. While Tmax is derived using a deconvolution method without delay- and dispersion-correction, both DT and Tmax are similar timing parameters related to the same arterial delay effects of blood circulation.

Performance Data:

AutoMIStar complies with DICOM (Digital Imaging and Communications in Medicine), developed by the American College of Radiology and the National Electrical Manufacturers Association. NEMA PS 3.1-3.20.

Apollo performed software verification and validation testing of the device and additional performance testing using published perfusion phantom and diffusion phantom data, which include a wide range of clinically relevant values of perfusion and diffusion parameters respectively as ground truth. Regression analysis between the output of the AutoMIStar device and the ground truth values were performed, and also compared to published results between the ground truth values and the outputs of seven other commercially available and academic CTP software packages. The results of performance testing showed that the AutoMIStar device achieved the pre-established performance goals for all perfusion and diffusion parameters including cerebral blood flow (CBF), cerebral blood volume (CBV), mean transit time (MTT), delay time (DT) and apparent diffusion coefficient (ADC).

Performance validation was also conducted on key device outputs including perfusion and diffusion threshold maps and volumes demonstrating substantial equivalence. Together with software verification and validation, the performance validation demonstrated that AutoMIStar satisfies all design requirements and device specifications.

Conclusions:

AutoMIStar is substantially equivalent to the predicate device RAPID in terms of indications for use, technological characteristics, principles of operation, and safety and/or effectiveness.

Additionally, substantial equivalence was demonstrated via performance validation testing and software verification and validation testing of the AutoMIStar system. The performance validation testing demonstrated that AutoMIStar provides accurate representation of key perfusion and diffusion parameters associated with the intended use of the software. Software verification and validation testing demonstrated that AutoMIStar met all design requirements and specifications. Thus, the AutoMIStar device is substantially equivalent, and at least as safe and effective as the predicate device.

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).