MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical imaging network, and can receive digital images and data from various sources (including but not limited to CT, MR, NM, and PT).

MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation of parametric parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability changes related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring.

MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.

Device Description

MIStar is a software package, which runs on an Intel-based PC platform. It allows manipulation, visualization and processing of medical images acquired with various clinical scanners and stored in DICOM and for other proprietary formats. MIStar allows transfer of DICOM 3.0 images over a medical imaging network.

MIStar also provides post-processing of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media, where the contrast media acts as a pure intravascular tracer. It allows visual inspection of time intensity curves and calculation of parameters (i.e., area under curve, time to peak, maximum slope of enhancement, etc). It also allows calculation of various perfusion related parameters (i.e. regional blood flow, regional blood volume, mean transit time and capillary permeability) from dynamic CT data. The results are displayed in a user-friendly graphic format as parametric images that provide supplementary information for diagnosis purposes.

AI/ML Overview

The provided document does not contain specific acceptance criteria or a study demonstrating the device meets such criteria.

The document K043350 is a 510(k) premarket notification for the MIStar device, which is a software package for manipulating, visualizing, and processing medical images, particularly for analyzing dynamic CT and MR images to calculate perfusion-related parameters.

Here's what can be inferred from the provided text, and what information is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: Not specified in the document. The submission focuses on demonstrating substantial equivalence to predicate devices rather than meeting predefined performance acceptance criteria.
Reported Device Performance: Not explicitly stated as a table of performance metrics. The document mentions that the algorithms used are "similar to" predicate devices, but no quantitative performance data (e.g., accuracy, sensitivity, specificity for perfusion parameter calculation) is provided.

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

Test Set Sample Size: Not mentioned. No specific test set for evaluating the device's performance is described.
Data Provenance: Not mentioned.

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

Number of Experts: Not mentioned.
Qualifications of Experts: Not mentioned.
Ground Truth Establishment: No information on how ground truth would be established for any performance evaluation.

4. Adjudication Method:

Adjudication Method: Not mentioned, as no study involving expert interpretation or adjudication is described.

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

MRMC Study: No MRMC comparative effectiveness study is mentioned. The document primarily focuses on establishing substantial equivalence based on functional similarity to predicate devices. There is no information about human readers improving with or without AI assistance, as the device itself is a post-processing tool.

6. Standalone (Algorithm Only) Performance Study:

Standalone Study: No standalone performance study is mentioned. The document states that the software "requires the intervention of a physician in setting necessary parameters and in assessing resultant images," implying it's not a fully standalone diagnostic algorithm. While it performs calculations, there's no study to evaluate the accuracy of these calculations against a gold standard.

7. Type of Ground Truth Used:

Type of Ground Truth: Not mentioned. No ground truth is described for any performance evaluation.

8. Sample Size for the Training Set:

Training Set Sample Size: Not applicable/mentioned. The document describes the software development process as including "verification and validation according to the procedures described in the Software Information section: Software Development Process," but details about training data for any machine learning components (if present, which is not explicitly stated in detail for the core algorithms) are absent. This device predates widespread AI/ML regulatory frameworks.

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

Ground Truth for Training Set: Not applicable/mentioned.

Summary of what the document does provide regarding "proof" of meeting criteria:

The "study" presented is a 510(k) Premarket Notification whose primary goal is to demonstrate substantial equivalence to legally marketed predicate devices, not to meet specific quantitative performance acceptance criteria with detailed clinical study data as might be expected today for an AI/ML device.

Comparison with Predicate Devices: The document argues that MIStar is substantially equivalent to:
- Efilm Workstation with Modules (K020995)
- CT Perfusion 2 (K010042)
- Advantage Windows with Functool Option (K960265)
Basis for Equivalence:
- Functional Similarity: MIStar provides digital image processing, measurement capabilities, and DICOM communication, similar to the predicate devices.
- Algorithm Similarity: It states that "The algorithms used to calculate parametric parameters are similar to CT perfusion2 and Functool."
- Intended Use: The indications for use are aligned with the capabilities of the predicate devices for image manipulation, visualization, processing, and calculation of perfusion-related parameters.
- Safety: It asserts that the use of MIStar "does not result in any additional potential hazards when compared to predicate devices."
Software Development and Testing: The document generally states that the "software package was designed, developed, verified and validated according to the procedures described in the Software Information section: Software Development Process." However, these are general assertions of good practice rather than a description of a specific performance study.

In essence, the "proof" described is the regulatory argument for substantial equivalence based on functional and algorithmic similarity to existing cleared devices, rather than a detailed performance study against predefined acceptance criteria for the output of its advanced features (like perfusion parameter calculations).

Summary

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K043350

Submitter:	Apollo Medical Imaging Technology Pty. Ltd26 Hood Street, North BalwynMelbourne, Vic 3104, AustraliaPhone: 61-3-9859 9316Fax: 61-3-9859 5701
Date Prepared:	September 30, 2004
Contact Person:	Qing Yang
Device Trade Name:	MIStar
Device Common Name:	Picture Archiving Communications System (PACS)
Regulation Number:	892.2050
Device Classification:	Class II
Classification Name:	Image Processing System

Predicate Device:

Manufacturer	Product	510(k) Number	Clearance Date
Efilm Medical, Inc.	Efilm Workstation with Modules	K020995	04/12/2002
General Electric	CT Perfusion 2	K010042	01/30/2001
GE Medical Systems	Advantage Windows with Functool Option	K960265	07/03/1996

Device Description

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Indications for Use

MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.

Conformance to Standard

MIStar provides DICOM functionality in conformance to the ACR-NEMA DICOM 3.0 standard as documented in the MIStar DICOM 3.0 Conformance Statement.

Software Development and Testing

The MIStar software package was designed, developed, verified and validated according to the procedures described in the Software Information section: Software Development Process.

Comparison with Predicate

MIStar is a stand-alone software package that operates on an Intel-based PC platform that satisfies the minimum system requirements. MIStar provide digital image processing and measurement capability. It can also communicate DICOM images with remote viewing stations or server systems over a medical imaging network.

MIStar also provides image post-processing as such does not have contact with the patient, nor does it control any devices that acquire medical images or sustain life. The algorithms used to calculate parametric parameters are similar to CT perfusion2 and Functool. It further requires the intervention of a physician in setting necessary parameters and in assessing resultant images.

The functional features of this package are substantially equivalent to that of eFilm Workstation with Modules (K020995), CT Perfusion 2 (K010042) and Advantage Windows with Functool option (K960265). The use of M1Star does not result in any additional potential hazards when compared to predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes extending from its wing, symbolizing health, hope, and service. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 5 2004

Apollo Medical Imaging Technology Pty Ltd. % Ms. Laura Danielson Responsible Third Party Official 510(k) Program Manager TÜV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891 Re: K043350 Trade/Device Name: MIStar Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: November 12, 2004 Received: December 6, 2004

Dear Ms. Danielson:

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. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 892.xxxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number: _Koy3350

Device Name: MIStar

Indications For Use:

MIStar is a software package that provides manipulation, visualization and processing of medical images in a diagnostic imaging setting. It allows transfer of DICOM 3.0 images over a medical images in a diagnostic maging couligital images and data from various sources (including but not limited to CT, MR, NM, and PT).

MIStar supports the analysis of dynamic CT and MR images acquired during and after the injection of a compact bolus of contrast media. It allows visual inspection of time intensity curves and calculation a Computer of contines freana under curve, time to peak, maximum slope of enhancement, etc). It also calculates various blood perfusion related parameters such as blood flow (BF), blood volume (BV), mean transit time (MTT) and capillary permeability from dynamic CT images. This software provides supplemental information to those images extracted from CT and MR temporal datasets and will aid in the assessment of the extent and type of perfusion, blood volume and capillary permeability whates related but not limited to stroke or tumor angiogenesis and be helpful in therapy monitoring.

MIStar is intended to be used by trained medical professionals, including but not limited to licensed radiologists, technologists and clinicians, and for the rendering clinical diagnosis.

Prescription Use (Part 21 CFR 801 Subpart D) ATTB/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

David h. Lyonn

(Division Sian-Off) Division of Reproductive, Abdomin and Radiological Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________

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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).