The provided text is a 510(k) summary for the GE HiSpeed NX/i CT scanner system, indicating that the device is substantially equivalent to previously marketed CT systems. However, this document does not contain the specific acceptance criteria or a study detailing the device's performance against such criteria. The document explicitly states that it does not result in new potential safety risks and performs as well as, or better than devices currently on the market, but it doesn't provide concrete metrics or a study report with performance data.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, ground truth types, or training set information directly from the provided text. This document is a regulatory submission for market clearance based on substantial equivalence, not a detailed performance study report.

In summary, the provided document (K991716) does not contain the information required to answer the prompt regarding acceptance criteria and performance study details.

Summary

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo, which consists of the letters 'g' and 'e' intertwined in a stylized, cursive font. The letters are white and set against a solid black circle. The circle is bordered by four teardrop-shaped white accents, positioned symmetrically around the logo, adding a decorative element to the design.

GE Medical Systems

P.O. Box 414 Milwaukee, WI 53201

510(k) SUMMARY OF SAFETY AND EFFECTIVENES

K991716

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

Submitter: Larry A. Kroger Senior Regulatory Programs Manager who may be contacted at 414-544-3894 or FAX 414-544-3863 Summary prepared May 11, 1999

Device Name:	HiSpeed NX/i CT scanner system.
Classification Name:	Computed Tomography X-ray System
Manufacturer	GE-YMS7-127 Asahigaoka 4-ChomeHino-Shi, Tokyo, Japan 191
Distributor	General Electric Medical Systems3000 North Grandview Blvd.Waukesha, WI 53188

Marketed Devices:

The HiSpeed NX/i CT system and HiSpeed options are of comparable type and substantially equivalent to currently marketed computed tomography systems and options that comply with the same or equivalent standards and have the same intended uses.

Device Description:

The HiSpeed NX/i CT system and HiSpeed options consist of a gantry, patient support, operator console, computer and associated accessories.

Materials: All construction and materials are compliant with 21 CFR Subchapter J and IEC 60601-1 and are equivalent to HiSpeed LX/i, FX/i and DX/i (K980169)

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Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector and an intuitive Operator Console with similar features to the HiSpeed LX/i, FX/i and DX/i (K980169), the LightSpeed QX/i (K980176) and options of the HiSpeed CT/i (K940606).

Options: SmartView (K973168) and SmartScore (K982004) software options will be available on HiSpeed LX/i, FX/i and DX/i and HiSpeed NX/i systems.

Indications for Use:

HiSpeed NX/i CT system and HiSpeed options are indicated for head and whole body x-ray computed tomography applications.

Comparison with Predicate Device:

It is the opinion of GE Medical Systems that the HiSpeed NX/i CT system and HiSpeed options are of comparable type and substantially equivalent to currently marketed head and whole body x-ray computed tomography systems with respect to design, material composition, energy source and radiation characteristics. It will comply with the x-ray performance standards of 21 CFR as well as the safety requirements of the IEC 60601-1 series of standards.

Adverse Effects on Health:

Potential electrical, mechanical, fire and radiation hazards are identified in the attached Risk Analysis and controlled by:

System verification and validation to insure performance to . specifications, regulatory requirements and user requirements.
Adherence to Industry and International Standards (UL/IEC/CSA) .

Conclusions:

Use of the HiSpeed NX/i CT system and HiSpeed options do not result in any new potential safety risks and performs as well as, or better than devices currently on the market.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized image of an eagle with three lines representing its body and head. The logo is surrounded by text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular pattern.

JUN 18 1999

Food and Drug Administration 1 9200 Corporate Boulevard Rockville MD 20850

Larry Kroger Senior Regulatory Programs Manager General Electric Medical Systems P.O. Box 414 Milwaukee, Wisconsin 53201

RE:

K991716 HiSpeed NX/i CT Scanner System Dated: May 18, 1999 Received: Mav 20, 1999 Regulatory Class: II 21 CFR 892.1750/Procode: 90 JAK

Dear Mr. Kroger:

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 reclassified 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 II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. 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.qov/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: HiSpeed NX/i CT system and HiSpeed options

Indications For Use:

The HiSpeed NX/i CT system and HiSpeed options are intended for head and whole body x-ray computed tomography applications.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)
Division of Reproductive, Abdominal, ENT, and Radiological Devices
510(k) Number	K991716

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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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.