The HiSpeed X/i Smart Gantry Option CT Scanner System is composed of a gantry, shared patient table, console, computer, and associated accessories. The system is designed to be a head and whole body CT scanner utilizing a solid state detector, an intuitive Operator Console, and the same tube and similar features to the HiSpeed Family of CT Systems (K980169), but now the gantry is on a dolly that travels on rails to provide the capability of scanning by gantry travel instead of cradle travel. The stationary table/cradle to be used is a table that will be shared with a Linear Accelerator. The table/cradle will remain stationary while CT scanning is in progress.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called the "HiSpeed X/i Smart Gantry Option CT Scanner System." This document is a pre-market notification to the FDA to demonstrate that the device is substantially equivalent to a legally marketed predicate device.

It's important to note that a 510(k) summary for a CT scanner primarily focuses on demonstrating substantial equivalence in design, materials, and performance characteristics (like radiation output and image quality parameters) compared to a predicate device, and not on diagnostic acceptance criteria based on clinical outcomes or expert consensus for disease detection, which would be typical for an AI/CADe device.

Therefore, many of the requested items (like expert consensus, MRMC studies, standalone performance with metrics like sensitivity/specificity, and training set information) are not applicable to this type of device and, consequently, not found in the provided document. The acceptance criteria here would relate to engineering, safety, and performance specifications of the CT scanner hardware.

Based on the provided text, here is the information that can be extracted or inferred:

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

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Substantial Equivalence	Device is substantially equivalent to currently marketed Computed Tomography X-ray Systems regarding type, design, material composition, energy source, and radiation characteristics. The device must perform "as well as or better than" devices currently on the market, and not introduce new safety risks.	The HiSpeed X/i Smart Gantry Option CT Scanner System is stated to be of comparable type and substantially equivalent to currently marketed Computed Tomography X-ray Systems. It has equivalent materials and construction to the HiSpeed Family of CT Systems (K980169). The system is designed with the same tube and similar features to the HiSpeed Family of CT Systems (K980169). Conclusion: The device "does not result in any new potential safety risks and performs as well as or better than devices currently on the market." GE "considers the HiSpeed X/i Smart Gantry Option CT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards."
Regulatory Compliance	Compliance with relevant federal regulations and industry/international standards. Specifically mentioned: 21CFR1020.30, 1020.31, 1020.33 (X-ray requirements); UL 2601, IEC 60061-1, IEC 60601 (safety); 21CFR Subchapter J.	Materials and construction are stated to be equivalent to the HiSpeed Family of CT Systems (K980169) and "compliant with UL 2601, IEC 60061-1, and 21CFR Subchapter J." The device "will comply with the X-ray requirements of 21CFR1020.30, 1020.31, and 1020.33, as well as the safety requirements of UL2601, IEC 60601 and collateral standards." Control Measures: "System verification and validation to ensure performance to specifications, Federal Regulations, and user requirements," and "Adherence to industry and international standards. (UL/CSA and IEC)."
Safety	Identification and control of potential electrical, mechanical, and radiation hazards.	Potential hazards are identified in a risk management summary and "controlled by System verification and validation... and Adherence to industry and international standards." The device "does not result in any new potential safety risks."
Intended Use	The device should be suitable for its stated indications for use.	Indicated for head and whole body X-ray Computed Tomography applications. The design description (gantry, table, solid-state detector, intuitive console, tube) supports this intended use.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable / Not mentioned. This document is for a CT scanner's hardware characteristics, not a diagnostic algorithm. There is no "test set" of patient data in the context of clinical performance metrics like sensitivity/specificity for disease detection. The performance testing would relate to engineering specifications and safety, which do not typically involve patient data sets in this way.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable / Not mentioned. Ground truth by experts is not established for this type of device submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable / Not mentioned. Adjudication is not relevant for this type of hardware device submission.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This is a CT scanner, not an AI or CADe device. No MRMC study for improved human reader performance would be conducted or reported here.

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

Not applicable. There is no algorithm to assess independently in this context.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

Not applicable. The "ground truth" for a CT scanner would be its mechanical, electrical, and radiation output specifications meeting engineering standards and regulatory limits, as well as its ability to produce images according to technical specifications (e.g., spatial resolution, contrast resolution, dose). This is demonstrated through engineering verification and validation testing, not clinical ground truth in the diagnostic sense.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI algorithm requiring a training set.

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

Not applicable. As above, no training set for an AI algorithm.

Summary

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Image /page/0/Picture/1 description: The image shows the General Electric (GE) logo. The logo consists of the letters "GE" intertwined within a circular border. The letters are stylized and connected, with the "G" looping around the "E". The border has decorative elements resembling stylized leaves or flourishes.

K012385

GE Medical Systems

General Electric Company PO Box 414, Milwaukee, WI 53201

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

This 510(k) summary of Safety and Effectiveness information is submitted in accordance with the requirement of 21 CFR Part 807.87(h).

Larry A. Kroger, Ph.D. Submitter: Senior Regulatory Programs Manager TEL: 262-544-3894, FAX: 262-544-3863 Summary prepared: June 22, 2001

PRODUCT IDENTIFICATION

Name:	HiSpeed X/i Smart Gantry Option
Classification Name:	Computed Tomography X-ray System
Manufacturer:	General Electric YMS7-127 Asahigaoka 4-ChomeHino-Shi, Tokyo, Japan 191
Distributor:	General Electric Medical Systems3000 N. Grandview Blvd.Waukesha, WI 53188
Marketed Devices:	The HiSpeed X/i Smart Gantry Option CT Scanner System is ofcomparable type and substantially equivalent to currently marketedComputed Tomography X-ray Systems that comply with the same onequivalent standards and have the same intended uses.

DEVICE DESCRIPTION

The HiSpeed X/i Smart Gantry Option CT Scanner System is composed of a gantry, shared patient table, console, computer, and associated accessories.

Materials: Materials and construction are equivalent to the HiSpeed Family of CT Systems (K980169) are compliant with UL 2601, IEC 60061-1, and 21CFR Subchapter J.

Design: The system is designed to be a head and whole body CT scanner utilizing a solid state detector, an intuitive Operator Console, and the same tube and similar features to the HiSpeed Family of CT Systems (K980169), but now the gantry is on a dolly that travels on rails to provide

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the capability of scanning by gantry travel instead of cradle travel. The stationary table/cradle to be used is a table that will be shared with a Linear Accelerator. The table/cradle will remain stationary while CT scanning is in progress. No claims related to the table's use outside of CT scanning are being made in this 510(k).

Indications for Use:

The HiSpeed Xi Smart Gantry Option CT Scanner System is indicated for head and whole body X-ray Computed Tomography applications.

Comparison with Predicate:

It is the opinion of GE Medical Systems that the HiSpeed XI Smart Gantry Option CT Scanner System is of a type and substantially equivalent to currently marketed head and whole body Xray computed topography systems with respect to design, material composition, energy source, and radiation characteristics. It will comply with the X-ray requirements of 21CFR1020.30, 1020.31, and1020.33, as well as the safety requirements of UL2601, IEC 60601 and collateral standards.

Adverse Effects on Health:

Potential electrical, mechanical and radiation hazards are identified in a risk management summary (hazard analysis) and controlled by:

. System verification and validation to ensure performance to specifications. Federal Regulations, and user requirements.
. Adherence to industry and international standards. (UL/CSA and IEC).

CONCLUSIONS

The HiSpeed X/i Smart Gantry Option CT Scanner System does not result in any new potential safety risks and performs as well as or better than devices currently on the market. GE considers the HiSpeed X/i Smart Gantry Option CT Scanner System to be equivalent to other marketed devices with the same indications for use and meeting similar standards.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 1 0 2001

GE Medical Systems, Inc. Mr. Reiner Krumme TUV Rheinland of North America 12 Commerce Road NEWTOWN CT 06470

Re: K012385 HiSpeed X/i Smart Gantry Option Dated: July 24, 2001 Received: July 27, 2001 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 abyest We have reviewed your Section 310(x) noutcation of misen to maked to legally marketed precieated on to televices device is substantially equivalent (10) the matterns tor the Mack in the Madical Device Amendments, or to devices of to devices of to devices of to devices of to devices of t marketed in interstate commerce prior in way 25, 1777, and Chatell Food, Drug, and Cosmetic Act (Act). You may, that have been reclassified in accordance will the provisions of the Act. The general controls provisions of the Act of the therefore, market the device, subject on the general of the reacher of any of the research of the may of the misbranding and adulteration.

If your device is classified (see above) into either class III (Special Controls) or class III (Prematet Approval), it may be subjections If your device is classified (see above) nito ethier class it (optom Control in the Code of Feeder Regulations, to such additional controls. Existing major regulations arecemes compliance with the Current Good Manufacturing Title 21, Parts 800 to 895. A substantally cutration assame Medical Devices: Gencral regulation (21 CFR Part Practice requirements, as set four in the Quality of Son togation (PDA) will verify such assumptions. Fallure 820) and that through periodic QS inspections the Programs in addition, FDA may publish further announcements to comply with the UNP regulation in regulation in regulators to your premarket notification summers on the file file filest was we concerning your device in the Federal Register. Teass now response of your from the Electronic Product arroor any Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) nemarket notification for your fourise and I his letter will allow you to begally 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 additionally and to promotion on the promotion on the promotion on the promotion on If you desire specific advice tor your device of Compliance at (301) - Additionally, for questions on the promotion diagnosic devices), please contact the Office of Complance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your entitled, "Misoranting of relevance to premaileri (Strail Manufacturers Assistance at its toll-free number (800) responsibilities under the Act may be octained address "http://www.fda.gov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Nancy C Bogdan

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure (s)

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STATEMENT OF INTENDED USE

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: HiSpeed X/i Smart Gantry Option CT Scanner System

Indications For Use:

The HiSpeed X/i Smart Gantry Option CT Scanner System is indicated 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)

Prescription Use
(Per 21 CFR 801.109)

-OR-

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

Nancy C. Knudson

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.