The Cerebral Blood Perfusion Package is an application software that permits cerebral perfusion imaging based upon dynamic CT images that are acquired after the injection of contrast. The software allows for visualization of apparent blood flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR -CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.

Device Description

The CSCP-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) and TSX-021A (Asteion) CT schanners, that allows the user to process dynamic scan image data that are acquired in conjunction with a contrast bolus. The package allows visualization of the data in image map formats. Additionally, the package allows the display of numeric data via the image analysis software that is integral to the package. The software is post processing and does not control the x-ray features of the system.

AI/ML Overview

The provided text is a 510(k) summary for the Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A. It focuses on demonstrating substantial equivalence to predicate devices rather than proving specific performance against acceptance criteria through a detailed study. As such, the document does not contain the detailed information necessary to answer all aspects of your request.

Specifically, there is no mention of:

A table of acceptance criteria and reported device performance.
Sample sizes for a test set, data provenance, or the number/qualifications of experts for ground truth establishment.
Adjudication methods.
A multi-reader multi-case (MRMC) comparative effectiveness study or its effect size.
A standalone (algorithm-only) performance study.
The type of ground truth used (e.g., pathology, outcomes data) for a test set.
Sample size for the training set.
How ground truth for the training set was established.

The document primarily describes the device, its intended use, and its technological characteristics in relation to predicate devices. It states: "Based upon the above considerations TAMS believes that this upgrade package, Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A is substantially equivalent to the predicate devices. This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data. Additionally this package and the predicate devices have the same indications for use."

This indicates that the primary "study" or justification for approval was a comparison to predicate devices, focusing on similar features and intended uses, rather than a quantifiable performance study against specific acceptance criteria as you've requested.

Therefore, I cannot populate the table or answer the specific questions about study methodology, sample sizes, expert involvement, or ground truth that you've asked based on the provided text.

Summary

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K013214
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OCT = 5 2001

510(k) Summary

Date:	September 15, 2001
Submitter's Name:	Toshiba America Medical Systems, Inc.
Submitter's Address:	P.O. Box 2068, 2441 Michelle Drive,Tustin, CA 92781-2068
Submitter's Contact:(714)730-5000	Paul Biggins, Regulatory Affairs Specialist,
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	Cerebral Blood Flow Analysis System(CBP), Model Number CSCP-001A
Common Name:	Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Pro. Code:90JAK]
Regulatory Class:	II (per 21 CFR 892.1750)
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray EquipmentStandard
Predicate Device(s):	General Electric Perfusion CT 2 [K010042]Siemens Perfusion CT [K982536]
Reason For Submission	Modification of cleared device

Description of this Device:

Summary of Intended Uses:

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flow in brain tissue and pictorially illustrates perfusion parameters (CBP- cerebral blood perfusion, CBV cerebral blood volume, mtt - mean transit time, and ERR -CBP residual difference SD map) from a set of dynamic images. This package when used by a trained physician will assist in the assessment of the type and extent of cerebral perfusion disturbances. Additionally, the software allows for measurement of various values such as mean value, standard deviation, area and distance.

Technological Characteristics:

This package is similar in uses and applications as those of the predicate devices. The main difference is in the method used to obtain the final results. Both this and the predicate devices are used as post-processing software to images collected by the parent CT Scanner.

Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. All requirements of the Federal Diagnostic Equipment Standard, as outlined in 21 CFR § 1020.30 and 1020.33, that apply to this upgrade, will be met and reported via a supplement to the initial report for the predicate device. Additionally this system is in conformance with the applicable parts of the IEC-60601 - Medical Device Safety standards.

Substantial Equivalence:

Based upon the above considerations TAMS believes that this upgrade package, Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-001A is substantially equivalent to the predicate devices. This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data. Additionally this package and the predicate devices have the same indications for use.

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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 stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The eagle is positioned within a circular border that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA".

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2001

Toshiba America Medical Systems, Inc. Re: K013214 % Mr. Mark Job TUV Product Service 1775 Old Highway 8 NW, Suite 104 NEW BRIGHTON MN 55112-1891

e: K013214

Trade/Device Name: Cerebral Blood Flow Analysis Syster (CBP), Model Number CSCP-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: 90 JAK Dated: September 15, 2001 Received: September 26, 2001

Dear Mr. Job:

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 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 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:

8xx.1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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. Snogdon

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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510(k) Number (if known):

Device Name: Cerebral Blood Flow Analysis System (CBP), Model Number CSCP-00TA

Indications for Use:

Carolyn Y Neubnel

(Division Sign-Off)
Division of Reproductive, Abdominal
and Radiological Devices
510(k) Number K013214

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109) (Optional Format 1-2-96)

Over-The-Counter Use

SKIF

Regulation Number and Section

N/A