Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

Device Description

SmartVA is a software post-processing package for the Advantage Workstation (AW) platform. It is an additional tool for the analysis of 3D angiography data providing a number of display, measurement and batch filming/archive features to study user-selected vessels which include but are not limited to stenosis analysis, pre/post stent planning procedures and directional vessel tortuosity visualization.

AI/ML Overview

The provided document is a 510(k) summary for the GE Smart Vessel Analysis (Smart VA) Option. This type of document is typically submitted to the FDA to demonstrate substantial equivalence to a legally marketed predicate device, rather than to present a full clinical study proving specific performance criteria.

Therefore, the document does not contain the detailed information requested regarding:

A table of acceptance criteria and reported device performance.
Sample sizes used for test sets or their provenance.
Number and qualifications of experts for ground truth.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study results.
Standalone algorithm performance.
The type of ground truth used.
Sample size for the training set.
How ground truth for the training set was established.

Analysis of the document:

The document focuses on establishing substantial equivalence to existing devices (Advantage Windows 3D with Navigator Option and DLX) based on similar functionalities for 3D angiography data analysis. It highlights features like:

Display, measurement, and batch filming/archive features.
Assistance in studying user-selected vessels for stenosis analysis, pre/post stent planning, and directional vessel tortuosity visualization.

Instead of presenting performance metrics, the submission relies on:

Comparison with Predicate: Stating that "The vessel measurements are similar to DLX and the visualization views of the vessel provided are similar to Advantage Windows 3D with Navigator option."
Risk Management: Mentioning a risk management plan, software development and validation process, and software verification plan to control potential hazards.
Image Comparability: Concluding that "This product provides images comparable to the predicate devices."

Conclusion:

Based on the provided text, a comprehensive answer to the request regarding acceptance criteria and a study proving those criteria cannot be formulated because the document does not contain this specific information. The 510(k) summary is designed to demonstrate substantial equivalence, not to detail the clinical validation or performance studies that would typically include the requested data points.

Summary

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Image /page/0/Picture/0 description: The image shows the General Electric (GE) logo. The logo consists of the letters "g" and "e" intertwined inside of a circle. The letters and the circle are black, and the background is white. There are decorative swirls around the inside of the circle.

K993792

GE Medical Systems P.O. Box 414, W-709 Milwaukee, WI 53201 USA

Smart Vessel Analysis (SMART VA) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Part 807.87(h)

Identification of Submitter:

Larry A. Kroger, Ph.D. Senior Regulatory Program Manager Telephone: (414) 544-3894 Date Prepared: September 3, 1999

Identification of Product:

Name :	Smart Vessel Analysis (Smart VA) Option
Manufacturer :	General Electric Medical Systems
	283, rue de la Miniere
	78533 Buc Cedex, FRANCE
Distributor :	General Electric Medical Systems, Milwaukee, WI

Marketed Devices:

The Smart VA is substantially equivalent to the devices listed below: Advantage Windows 3D (K954355) with Navigator Option Model: and DLX (K926258) Manufacturer: General Electric Medical Systems, Buc Cedex, FRANCE

Device Description:

Application examples include:

o automated batch filming and the ability to rotate around a vessel.
o quantitative information on user-selected vessel segments.
o single reports that provide complete 3D context; measurements; crossreferences, and 3D views.
o background auto-filming that replaces manual filming.

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Image /page/1/Picture/0 description: The image shows a black and white logo of General Electric (GE). The logo consists of the letters 'GE' intertwined and enclosed within a circle. There are decorative swirls or flourishes around the circle, adding a touch of elegance to the design. The logo is simple, recognizable, and represents the brand identity of General Electric.

Indications for Use :

Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform, which can be used in the analysis of 3D angiography data. It provides a number of display, measurement and batch filming/archive features and will aid physicians in studying user-selected vessels for stenosis analysis, pre/post stent planning and directional vessel tortuosity visualization.

Comparison with Predicate:

Smart Vessel Analysis (Smart VA) is an additional tool for the analysis of 3D angiography data. The vessel measurements are similar to DLX and the visualization views of the vessel provided are similar to Advantage Windows 3D with Navigator option.

Conclusions :

The potential hazards are controlled by a risk management plan including:

· a Hazard Analysis/Risk Management Summary
· a Software Development and Validation Process
· a Software Verification Plan

This product provides images comparable to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the eagle image.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 4 1999

General Electric Medical Systems C/o Reiner Krumme Division Manager TUV Rheinland of North America, Inc. 12 Commerce Road Newtown, CT 06470

Re:

K993792 Smart Vessel Analysis (Smart VA) Option Dated: November 4, 1999 Received: November 9, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Krumme:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 redassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory action. In addition. FDA may publish further announcements concerning your device in the Federal Recister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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,

CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, 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: Smart Vessel Analysis (SmartVA) Option

Indications for Use

Smart Vessel Analysis (SmartVA) is a software post-processing option for the Advantage Workstation (AW) platform which can be used in the analysis of 3D angiography data. It provides a number of (11 w) plattorn: willer our our our of filming/acchive features and will aid physicians in studying user-selected display, modelient and by st stent planning and directional vessel tortuosity visualization.

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

Concurrence of CDRH, Office of Device Evaluation (ODE) OR Over-The-Counter Use_______________________________________________________________________________________________________________________________________________________ Prescription Use (Per 21 CFR 801-109)

Clint G. Severson

(Division Sign-Off)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K993797

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.