The software allows for the calculation of blood flow, blood volume and permeability from sets pf images reconstructed from dynamic CT data acquired after the injection of a contrast bolus.

The package also allows for the independent calculation of arterial and portal venous component of hepatic perfusion. It supports the evaluation of regions of interest and the visual inspection of time density curves.

Device Description

The CSBP-001A is post-processing software that does not affect the operation of the parent CT System. This software provides analysis tools that are used on a series of dynamic images (images collected over time) to provide numerical values related to tissue perfusion of organs, tumors lesions, etc. Additionally, this software will allow for the display of perfusion maps.

AI/ML Overview

The provided text does not contain detailed acceptance criteria for the Toshiba CSBP-001A Body Organ Perfusion System, nor does it describe a specific study that proves the device meets such criteria in terms of performance metrics.

The document is a 510(k) summary for a new device, focusing on demonstrating substantial equivalence to predicate devices rather than proving specific performance against quantitative acceptance criteria through a dedicated study.

However, based on the information provided, we can infer some details related to the device and the nature of its submission to the FDA.

Here's an attempt to structure the answer based on the available text, with explanations for what is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated in the document. The FDA 510(k) process for this device focuses on "substantial equivalence" to predicate devices. This typically means the new device functions similarly and is as safe and effective as existing legally marketed devices, rather than meeting specific quantitative performance thresholds.	The document states: "This software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner that is similar to the predicate devices, or in a manner that is a combination of the predicate devices." It further states that "Bench test data is provided in the submission to provide evidence of the safety and effectiveness of this device," but no specific performance metrics or acceptance criteria are detailed in this public summary.

Acceptance Criteria

Reported Device Performance

Not explicitly stated in the document. The FDA 510(k) process for this device focuses on "substantial equivalence" to predicate devices. This typically means the new device functions similarly and is as safe and effective as existing legally marketed devices, rather than meeting specific quantitative performance thresholds.

The document states: "This software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner that is similar to the predicate devices, or in a manner that is a combination of the predicate devices." It further states that "Bench test data is provided in the submission to provide evidence of the safety and effectiveness of this device," but no specific performance metrics or acceptance criteria are detailed in this public summary.

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

Sample Size for Test Set: Not mentioned. The document refers to "Bench test data" being provided in the submission, but it does not specify the sample size of this test set.
Data Provenance: Not mentioned. The submission does not specify the country of origin of any data or whether it was retrospective or prospective.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Not mentioned. There is no information provided about the establishment of a "ground truth" using experts for any test set. The submission focuses on demonstrating substantial equivalence, which often relies on comparison to existing clinically validated methods or predicate devices rather than an independent expert-derived ground truth.

4. Adjudication Method for the Test Set

Not mentioned. Since no specific test set or expert involvement in establishing ground truth is described, no adjudication method is provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No evidence of an MRMC study. The document does not mention an MRMC comparative effectiveness study or any effect size related to human readers improving with AI vs. without AI assistance. The device is described as "post-processing software" for analysis and display, not necessarily an AI-assisted diagnostic tool in the sense of an MRMC study comparing human performance with and without its aid.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Implied standalone performance for software functions. The device is described as "post-processing software that does not affect the operation of the parent CT System." It "provides analysis tools" and "allows for the display of perfusion maps." While not explicitly termed a "standalone study" in the modern sense of AI algorithm evaluation, the "bench test data" would inherently evaluate the software's ability to calculate and display perfusion parameters from dynamic CT data, which is essentially its standalone function. No human-in-the-loop performance is described or evaluated in this summary.

7. The Type of Ground Truth Used

Not explicitly stated. Given the nature of a perfusion system, the "ground truth" for evaluating its calculations (blood flow, blood volume, permeability) would typically involve comparison to established quantitative methods, phantom studies, or other clinically accepted perfusion imaging techniques and their derived values. However, the document does not specify how the ground truth was established for the "bench test data."

8. The Sample Size for the Training Set

Not applicable / Not mentioned. The document describes the CSBP-001A as "post-processing software" that "provides analysis tools." This phrasing suggests a rule-based or model-based approach to calculating perfusion parameters rather than a machine learning or AI model requiring a "training set" in the contemporary sense. Therefore, a training set sample size is not relevant or mentioned.

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

Not applicable. As a training set is not mentioned, the method for establishing its ground truth is also not.

Summary

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Koriysz

Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSBP-001A Body Organ Perfusion System

510(k) Summary

Date:	May 12, 2008
Submitter's Name:	Toshiba America Medical Systems, Inc.JUN 11 2008
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:	CSBP-001A; Body Organ Perfusion System
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:Standard	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment
Predicate Device(s):	GE CT Perfusion 4 (K052839)Siemens Symgo Perfusion (K073373)Philips Brilliance CT (K060397)
Reason For Submission	New Device

Description of this Device:

Summary of Intended Uses:

The CSBP-001A is a non-invasive post processing package that can be used to evaluate perfusion of the organs, tissue, turnors and lesions; this type of application is useful in assisting in the diagnosis of disease and providing information for following treatment.

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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSBP-001A Body Organ Perfusion System

Safety and Effectiveness Concerns:

This device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820. Bench test data is provided in the submission to provide evidence of the safety and effectiveness of this device.

Substantial Equivalence:

This software package provides information to the user that is similar to that which is provided by the predicate devices. The information is obtained in a manner that is similar to the predicate devices, or in a manner that is a combination of the predicate devices. Additionally, the indications for use and intended uses are identical to the predicate devices. There are no new indications for use that are not already available in devices already marketed in the U.S.

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling three stylized birds in flight, depicted with bold, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 1 1 2008

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1395 25th Street NW BUFFALO MN 55313

Re: K081482

Trade/Device Name: CSBP-001A, Body Organ Perfusion System Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK Dated: May 27, 2008 Received: May 28, 2008

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. Isting 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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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 madon outs not 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 CPR 100-1050.

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 logally marketed predicate device results in a classification for your device and this, perited 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance a to the of the following numbers, based on the regulation number at the top of this lotter.

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" (21CFR Part 807.97). For questions regarding postmarket surveillance, release contact CDDF 3 Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 24/02/6 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 Smy of 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/cdrhindustry/suport/industry/suport/index.php?title=

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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Toshiba America Medical Systems, Inc. Pre-Market Notification 510(k) for CSBP-001A Body Organ Perfusion System

Indications for Use

510(k) Number (if known):

Device Name: CSBP-001A, Body Organ Perfusion System

Indications for Use:

This software package has been designed to evaluate the perfusion of organs and turnors.

The software allows for the calculation of blood flow, blood volume and permeability from sets pf images reconstructed from dynamic CT data acquired after the injection of a contrast bolus.

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)

Page 1 of

Arni Mkhag

(Divisi Division of Reproductive, Abdominal and Radiological Devices 510(k) Number

Regulation Number and Section

§ 892.1750 Computed tomography x-ray system.

(a)
Identification. A computed tomography x-ray system is a diagnostic x-ray system intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data from the same axial plane taken at different angles. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.