Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:

The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion Option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusion-related parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

Device Description

CT Brain Perfusion for Ziostation is an add-on software feature designed to provide a color map of cerebral blood flow and pictorial illustration of perfusion-related parameters obtained on CT images of the brain. This software is designed to work within the currently cleared Ziostation image management device.

AI/ML Overview

The provided text does not contain detailed information about specific acceptance criteria, comprehensive study results, sample sizes for test or training sets, ground truth establishment methods, expert qualifications, or adjudication methods. The document is primarily a 510(k) summary for a "CT Brain Perfusion for Ziostation" software, describing its intended use, predicate device, and confirming substantial equivalence.

Here's an analysis of what can be extracted and what information is missing based on your request:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states: "All devices met the required specifications for the completed tests." However, it does not detail what those specifications or acceptance criteria were, nor does it provide specific metrics for device performance beyond this general statement.

Acceptance Criteria	Reported Device Performance
Not specified	Met all required specifications for completed tests.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. The document mentions "1000" under the "Testing Summary" section, but it's unclear if this refers to the number of tests performed, the size of a dataset, or something else entirely. It does not explicitly state it as the test set sample size.
Data Provenance (country of origin, retrospective/prospective): Not specified.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication method for the test set:

Adjudication method: Not specified.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size of how much human readers improve with AI vs without AI assistance:

The document does not mention an MRMC comparative effectiveness study. The device is described as an "image analysis software package providing additional image processing capabilities" and "pictorial illustration...to aid in the assessment," suggesting it's a tool for professionals rather than a standalone diagnostic or a direct comparison of human performance with vs. without AI. No effect size is provided.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The document does not explicitly state whether a standalone performance study was conducted. Given its description as "image analysis software package providing additional image processing capabilities" and intended "to aid in their reading and review," it implies human-in-the-loop use.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Type of Ground Truth: Not specified.

8. The sample size for the training set:

Sample Size for Training Set: Not specified.

9. How the ground truth for the training set was established:

Ground Truth Establishment for Training Set: Not specified.

In summary, the provided 510(k) summary is very high-level regarding testing and validation. It states that all specifications were met but does not offer the granular detail about the study methodology, data characteristics, or performance metrics that your questions are looking for.

Summary

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ICOR30+Y

510(k) Summary

19 2008

This 510(k) summary is prepared in accordance with 21 CFR 807.92.

General Information

Trade Name	CT Brain Perfusion for Ziostation
Common Name	Brain Perfusion Software Tool
Classification Name	System, Image Processing, Radiological (21 CFR § 892.2050 - LLZ)
Applicant:	Ziosoft, Inc. 2200 Bridge Parkway, Ste. 103 Redwood City, CA 94065 Tel 650-413-1300 Fax 650-596-7319
Contact	Richard Ball Director, Regulatory and Quality Affairs

Intended Use

Predicate Device

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Device Description

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Materials

CT Brain Perfusion for Ziostation consists entirely of software. No materials are contained in this product.

Testing Summary

1000

All devices met the required specifications for the completed tests.

Summary of Substantial Equivalence

CT Brain Perfusion for Ziostation is substantially equivalent in intended use and function to its predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 9 2008

Mr. Richard Ball Director, RA/QA ZioSoft, Inc. 2200 Bridge Parkway, Suite 103 REDWOOD CITY CA 94065

Re: K083084

Trade/Device Name: CT Brain Perfusion for Ziostation Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: October 14, 2008 Received: October 16, 2008

Dear Mr. Ball:

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 (PMA), 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.

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Page 2

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.

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.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

forque M. Whang

Joyce M. Whang, Ph.D. Acting 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 (if known): ¥083084

Device Name: CT Brain Perfusion for Ziostation

Indications for Use:

Ziostation is an image processing workstation software package designed to run on standard PC hardware. It provides for the viewing, quantification, manipulation, communication, printing, and management of medical images. It is intended for use by trained medical professionals to aid in their reading and review of such data. In addition, Ziostation has the following indication:

The CT Brain Perfusion for Ziostation option is an image analysis software package providing additional image processing capabilities to the basic Ziostation device. The CT Brain Perfusion for Ziostation option is intended for post-processing based on dynamic CT images continuously acquired during the injection of contrast, for the visualization of apparent blood flow in brain tissue and pictorial illustration of perfusionrelated parameters to aid in the assessment of the type and extent of cerebral perfusion disturbances.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hula Reima

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

Page _ of _

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).