The PlaqueView (SurePlaque) tool kit application software package is intended to assist trained physicians in the stratification of patients identified to have coronary disease (CAD). This software post processes images obtained using a multidetector Aquilion CT. The package provides tools for the measurement and visualization (color coded maps) of coronary arteries.

Device Description

The CSPV-001A is an image analysis software package, that will be applied to the Toshiba TSX-101A (Aquilion) CT scanner, that allows the user to process acquired image data. 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 describes a 510(k) submission for "PlaqueView (a.k.a. SurePlaque) CSPV-0001A," an image analysis software package for Toshiba Aquilion CT scanners. However, the document does not contain any information regarding acceptance criteria, performance studies, sample sizes, ground truth establishment, or expert involvement for device validation.

The document focuses on the regulatory aspects of the device, its intended use, technological characteristics, safety and effectiveness concerns (addressed by compliance with Quality System Regulations and IEC-60601 standards), and its substantial equivalence to predicate devices (General Electric Perfusion CT 2 [K0041267] and Siemens Perfusion CT [K990426]).

Therefore, based solely on the provided text, I cannot fill out the requested table or answer the specific questions about acceptance criteria and study details. The document states: "Both this and the prodicate devices are used as post-processing software applied to images collected by the parent CT Scanner." and "This package and the predicate devices are all post-processing and provide the same features of visualization and numeric data." This suggests that the substantial equivalence argument relies on the software performing similarly to existing cleared devices in terms of visualization and data presentation, rather than presenting a new clinical performance study with specific acceptance criteria.

Summary of what can be derived from the text (and what cannot):

1. A table of acceptance criteria and the reported device performance:

Cannot be provided. The document does not define specific acceptance criteria or report performance metrics (e.g., accuracy, sensitivity, specificity).

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

Cannot be provided. No information on specific test sets, sample sizes, or data provenance is mentioned.

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

Cannot be provided. No mention of experts or ground truth establishment for a test set.

4. Adjudication method for the test set:

Cannot be provided. No information on adjudication methods is present.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

Cannot be provided. No MRMC study is described. The submission focuses on substantial equivalence to predicate devices based on shared technological characteristics and intended use.

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

Cannot be provided. No standalone performance study is described.

7. The type of ground truth used:

Cannot be provided. No ground truth information is provided for any dataset.

8. The sample size for the training set:

Cannot be provided. No mention of a training set or its size.

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

Cannot be provided. No information on ground truth establishment for a training set.

In conclusion, the provided 510(k) summary focuses on the regulatory pathway of substantial equivalence rather than presenting a detailed performance study with quantifiable acceptance criteria.

Summary

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	NOV 18 2004		K043111
510(k) Summary
Date:	October 27, 2004
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:	Paul Biggins, Senior Regulatory Affairs Manager,(714) 730-5000
Establishment RegistrationNumber:	2020563
Device Proprietary Name:	PlaqueView (a.k.a. SurePlaque) CSPV-0001A
Common Name:	Scanner, Computed Tomography, X-Ray[Fed. Reg. No. 892.1750, Product Code: 90JAK]
Regulatory Class:	II (per 21 CFR 892.1750)
Performance Standard:	21 CFR Subchapter J,Federal Diagnostic X-ray Equipment Standard
Predicate Device(s):	General Electric Perfusion CT 2 [K0041267]Siemens Perfusion CT [K990426]
Reason For Submission:	Modification of Cleared Device

Description of this Device:

Summary of Intended Uses:

Plaque View/SUREPlaque is a post processing software that facilitates faster and casier visualization of cardiovascular lumens, vessel walls, plaques, and other bodies. This software can lay vessels out in curved planar reformats, cross sectional views, and maximum intensity projection views. Color based on a density range can then be applied to the vanous parts of the anatomy for easier reading.

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Technological Characteristics:

This package is similar in uses and applications as those of the predicate devices. The man difference is in the method used to obtain the final results. Both this and the prodicate devices are used as post-processing software applied 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. 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, Plaque View/SurePlaque, Model Number CSPV-0000 A 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.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The logo is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 1 8 2004

Toshiba America Medical Systems, Inc. % Mr. Mark Job Responsible Third Party Official 'Regulatory Technology Services LLC 1394 25th Street NW BUFFALO MN 55313

Re: K043111

Trade/Device Name: Plaque View. Model Number CSPV-001A Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography ' x-ray system

Regulatory Class: II Product Code: 90 JAK Dated: November 8, 2004 Received: November 10, 2004

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 (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/dsmadsmam.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

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510(k) Number (if known): K043///

Device Name: Plaque View, Model Number CSPV-001 A

Indications for Use:

(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

Daniel M. Layman

(Division Sign-Off) Division of Reproductive, Abdomina 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.