GE LightSpeed™ ACT FP16 is indicated for use in generating fluoroscopic images of SE Elghtopeda. nonedures, and optionally, rotational imaging procedures. It is intended to replace procedures, and optionally, rethnology image intensifier technology and is not intended for mammography applications.

Device Description

The GE LightSpeed ACT FP16 is a modified CT system intended to be located in close proximity to a GE Innova 4100 Single Plane Digital Fluoroscopic Imaging system utilizing a single patient table which can be configured for interventional x-ray or CT imaging procedures. This modification allows the patient to remain on the x-ray table which can be quickly configured for CT scanning via a movable gantry. Both the CT and X-ray systems are used separately, one at a time, in accordance with their respective indications for use.

AI/ML Overview

This submission describes a modification to an existing CT system (GE LightSpeed ACT FP16) and asserts its substantial equivalence to a predicate device (GE HiSpeed X/i Smart Gantry Option). The information provided largely focuses on demonstrating safety and effectiveness for a 510(k) clearance, which is typically achieved through non-clinical testing for modifications of this nature, rather than extensive clinical studies with specific performance metrics against a ground truth as would be common for novel AI/software devices.

Here's the breakdown of the requested information based on the provided text:

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

Acceptance Criteria	Reported Device Performance
Conformance to specifications	Modifications evaluated for conformance to specifications.
Overall performance	Modifications evaluated for overall performance.
Thermal safety	Modifications evaluated for thermal safety.
Electrical safety	Modifications evaluated for electrical safety.
Radiation safety	Modifications evaluated for radiation safety.
Mechanical safety	Modifications evaluated for mechanical safety.
Conformity with applicable medical device safety standards	Product found to conform with applicable medical device safety standards.
Performance of equipment movements	Easily evaluated and confirmed with test equipment and personnel.
Performance of user controls	Easily evaluated and confirmed with test equipment and personnel.
Performance of status display	Easily evaluated and confirmed with test equipment and personnel.
Substantial equivalence to predicate device (GE HiSpeed X/i Smart Gantry Option - K012385) in terms of safety and effectiveness.	The GE LightSpeed ACT FP16 has the same technological characteristics, comparable key safety and effectiveness features, similar design, construction, and materials, and shares the same intended use and clinical purpose with the predicate.

2. Sample size used for the test set and the data provenance

Test Set Sample Size: Not applicable in the context of clinical studies with patient data. The evaluation was done using "bench testing and imaging phantoms". The number of phantoms used is not specified.
Data Provenance: Not applicable, as no human subject data was used for testing. The testing involved hardware and phantom evaluations, not patient data.

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

Number of Experts: Not explicitly stated as "experts for ground truth" in a clinical sense. However, the evaluation was performed by "employees of the manufacturer and by an independent test agency" for safety and conformance, and "test personnel familiar with clinical practice and procedures" for equipment movement, controls, and display.
Qualifications of Experts: Employees of the manufacturer, independent test agency personnel, and test personnel familiar with clinical practice and procedures. Specific degrees or years of experience are not provided.

4. Adjudication method for the test set

Adjudication Method: Not applicable. The evaluation was primarily engineering and performance testing against specifications and safety standards, rather than diagnostic interpretation requiring adjudication of results from multiple readers.

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

MRMC Study: No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Tests: None required." and focuses on non-clinical testing and substantial equivalence to a predicate device.

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

Standalone Performance: Not applicable. This device is a CT system, not an AI algorithm. The performance evaluated was the physical system's functionality and image quality (via phantoms), which inherently operates as a "standalone" system in terms of generating images, but not in the context of an AI algorithm making diagnostic decisions.

7. The type of ground truth used

Type of Ground Truth: For the non-clinical tests, the ground truth was defined by engineering specifications, applicable medical device safety standards, and the expected performance of physical equipment movements, user controls, and status displays. For imaging performance, imaging phantoms were used as a controlled and known standard for evaluation.

8. The sample size for the training set

Training Set Sample Size: Not applicable. This is a hardware modification, not an AI/machine learning device that requires a training set of data.

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

Ground Truth for Training Set: Not applicable, as there is no training set for this device.

Summary

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KC91673

Special 510(k) Premarket Notification GE LiahtSpeed ACT FP16 Modification Revised June 15, 2009

Attachment B:

JUN 2 4 2009

Summary of Safety and Effectiveness Prepared in accordance with 21 CFR Part 807.92(c).

		GE Healthcare, P.O. Box 414, Milwaukee, WI 53201
Section a):
1.	Submitter:	GE Medical Systems, LLC doing business as GE Healthcare3000 N. Grandview Blvd.Waukesha, WI 53188
	Contact Person:	Allen Schuh, Regulatory Affairs Manager9900 Innovation Drive, Mail Stop RP2138Wauwatosa, WI 53226
	Date Prepared:	June 16, 2009
2.	Device Name:	GE LightSpeed ACT FP16Computed Tomography X-Ray System, 21 CFR 892.1750, 90J--AK
3.	Marketed Device:	GE HiSpeed X/i Smart Gantry Option

1. Device Description: The GE LightSpeed ACT FP16 is a modified CT system intended to be located in close proximity to a GE Innova 4100 Single Plane Digital Fluoroscopic Imaging system utilizing a single patient table which can be configured for interventional x-ray or CT imaging procedures. This modification allows the patient to remain on the x-ray table which can be quickly configured for CT scanning via a movable gantry. Both the CT and X-ray systems are used separately, one at a time, in accordance with their respective indications for use.
1. Indications for Use: When configured as a CT System, the GE LightSpeed ACT FP16 is indicated for head and whole body X-ray computed tomography applications. When configured as a fluoroscopic system, the GE LightSpeed ACT FP16 is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, cardiology, diagnostic and interventional procedures, and optionally, rotational imaging procedures. It is intended to replace fluoroscopic images obtained through image intensifier technology and is not intended for mammography applications.
1. Comparison with Predicate Device: GE LightSpeed ACT FP16 is substantially equivalent in tems of safety and effectiveness to the GE HiSpeed X/i Smart Gantry Option (K012385). Both systems utilize a movable CT gantry to scan the patient while placed on a stationary table. They have the same technological characteristics, are comparable in key safety and effectiveness features, utilize similar design, construction, and materials and share the same intended use and clinical purpose.

Section b):

Non-clinical Tests: The modifications have been evaluated for conformance to specifications and overall performance as well as for thermal, electrical, radiation and mechanical safety as part of the design verification by employees of the manufacturer and by an independent test agency. The product has been found to conform with applicable medical device safety standards.
Clinical Tests: None required. Verification of conformance to specifications for the modification was completed with bench testing and imaging phantoms on a fully configured installation. Performance of the equipment movements, user controls and status display was easily evaluated with test equipment and test personnel familiar with clinical practice and procedures.
Conclusion: Intended uses and other key features are consistent with traditional clinical practice, FDA guidelines, and established methods of patient examination. The design and development process of the manufacturer conforms to 21 CFR 820, ISO 9001 and 13485 quality systems. The device conforms to applicable medical device safety standards and compliance is verified through independent evaluation with ongoing factory surveillance. Therefore, it is the opinion of GE Healthcare that the GE LightSpeed ACT FP16 is substantially equivalent with respect to safety and effectiveness to devices currently cleared for market.

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Image /page/1/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES ..

Public-Health-Service_

JUN 2 4 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

GE Medical Systems LLC % Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLS 1394 25" Street NW BUFFALO MN 55313

Re: K091673

Trade/Device Name: GE LightSpeed™ ACT FP16 Modification Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: JAK, JAA Dated: June 5, 2009 Received: June 9, 2009

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 (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Jadine M. Morris

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification GE LightSpeed ACT FP16 Modification Revised June 15, 2009

Attachment E

Indications for Use

510(k) Number (if known): K091673

Device Name: GE LightSpeed™ ACT FP16 Modification

Indications For Use of GE LightSpeed™ ACT FP16 when configured as a CT System:

The GE LightSpeed™ ACT FP16 is indicated for head and whole body X-ray computed tomography applications.

Indications For Use of GE LightSpeed™ ACT FP16 when configured as a Fluoroscopic System: .

Prescription Use(Part 21 CFR 801 Subpart D)	X	AND/OR	Over-The-Counter Use(21 CFR 801 Subpart C)
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(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 andRadiological Devices
510(k) Number	K091673

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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.