The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces cross-sectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radiopharmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.

Image processing and display workstations provide software applications to process, analyze, display, quantify and interpret medical images/data. The PET and CT images may be registered and displayed in a "fused" (overlaid in the same spatial orientation) format to provide combined metabolic and anatomical data at different angles. Trained professionals use the images in:

The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
The detection, localization, and staging of tumors and diagnosing cancer patients.
Treatment planning and interventional radiology procedures.

Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not limited to myocardial perfusion for the display of wall motion and quantification of left-ventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

Device Description

The device is a hybrid diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) scanners that can be utilized in fixed installations or mobile environments. The device is comprised of the following system components/subsystems: Positron Emission Tomography (PET), X-ray Computed Tomography (CT), a patient table, gantry separation unit, and the acquisition and processing workstations.

AI/ML Overview

The provided text describes the Gemini GXL, a combined PET/CT system, but it does not include a study that proves the device meets specific acceptance criteria in the context of clinical performance or diagnostic accuracy. The document focuses on regulatory compliance, hardware specifications, and comparison to a predicate device.

Here's an analysis based on the information provided, highlighting what is present and what is missing concerning your request:

Acceptance Criteria and Device Performance Study

The document does not detail specific "acceptance criteria" related to diagnostic performance (e.g., sensitivity, specificity, accuracy for detecting a disease) or a study proving the device meets such criteria. Instead, it refers to industry performance standards for the hardware and safety.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criterion	Reported Device Performance/Compliance
Radiation Safety	Compliance with Performance Standards for Ionizing Radiation Emitting Products	- Adherence and certification to 21CFR 1020.30 and 21CFR 1020.33 (Computed Tomography Equipment).- Radiation safety product report filed in accordance with 21CFR 1002.10 with the Center for Device and Radiological Health (CDRH).
Electrical and Mechanical Safety	Compliance with Applicable Safety Standards	- Adherence and certification to the applicable standards in the IEC 60601-1 series.
PET/CT System Performance	Measurement of device performance	- Device performance measured in accordance with the NEMA-NU2 standard. (Specific results of this measurement are not provided, only that it was conducted according to the standard).
Substantial Equivalence	Comparison to Predicate Device (Gemini System K041955) based on intended use, technological comparison, and system performance	- Intended use is similar.- Technological differences noted: option of 6, 10, or 16 slice CT; larger PET bore size; removal of Cs-137 transmission source; modification of various PET performance specifications; modifications to reconstruction.- Conclusion: Substantially equivalent to predicate devices based on similar intended use, technological comparison, and system performance (implies that modifications did not raise new questions of safety or effectiveness, and the device performs comparably to the predicate).

Missing Information:

There are no specific performance metrics (e.g., image resolution, contrast, artifact levels, clinical accuracy, sensitivity, specificity, AUC) and corresponding acceptance thresholds for these metrics.
The results of the NEMA-NU2 standard measurements are not provided. NEMA-NU2 details methods for measuring PET scanner performance, but the document only states it was measured "in accordance" with the standard, not the specific results obtained.

2. Sample Size Used for the Test Set and Data Provenance:

Not Applicable. The provided text does not describe a clinical study with a "test set" of patient data for evaluating diagnostic performance. The performance tests mentioned (radiation, electrical/mechanical safety, NEMA-NU2) are related to the physical properties and technical performance of the device, typically using phantoms or engineering tests, not patient data for diagnostic evaluation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

Not Applicable. As there is no clinical test set described for diagnostic performance evaluation, there is no mention of experts establishing ground truth for such a set.

4. Adjudication Method for the Test Set:

Not Applicable. No clinical test set or adjudication process is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No. The document does not describe an MRMC study or any study comparing human reader performance with or without AI assistance. The device description is for the PET/CT system itself, not an AI software component for image interpretation.

6. Standalone (Algorithm Only) Performance Study:

No. The document does not describe any standalone algorithm performance study. The Gemini GXL is a hardware imaging system.

7. Type of Ground Truth Used:

Not Applicable. For the technical performance tests mentioned (NEMA-NU2), the "ground truth" would be the known physical properties of the phantoms used or the established specifications of the test equipment. For clinical diagnostic performance, no such ground truth is discussed.

8. Sample Size for the Training Set:

Not Applicable. The document describes a medical imaging device (hardware and its inherent software for image acquisition and reconstruction), not a machine learning or AI algorithm that would typically require a "training set." The software mentioned for image processing, analysis, and display is likely rule-based or conventional algorithmic software, not deep learning requiring large training datasets.

9. How the Ground Truth for the Training Set Was Established:

Not Applicable. As no training set is mentioned, this question is not relevant.

In summary, the provided document is a 510(k) summary focused on demonstrating the substantial equivalence of a new PET/CT system (Gemini GXL) to a previously cleared predicate device. It addresses regulatory compliance for safety and technical performance standards (like NEMA-NU2) but does not include a clinical study with acceptance criteria related to diagnostic accuracy, patient data analysis, or the use of expert ground truth, which are typically found in submissions for AI/ML-based diagnostic software.

Summary

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

A.	Submitter/ Contact Person:Philips Medical Systems (Cleveland), Inc.595 Miner Rd.Cleveland, OH 44143	Rae Ann FarrowTel: (440) 483-2647Fax: (440) 483-7339
B.	Device Trade Name: Gemini GXLCommon Name: Positron Emission TomographyComputed Tomography X-RayClassification Name: System, Emission Computed Tomography, (892.1200)System, Computed Tomography X-Ray, (892.1750)Device Class: 21CFR 892.1200, Class II21 CFR 892.1750, Class IIProduct Code: 90 KPS and 90 JAKClassification Panel: Radiology
C.	Date prepared: October 8, 2004
D.	Predicate Device: Gemini System	(K041955)

Performance Standards: E.

21 CFR 1020.30 1020.33 Performance Standards for Ionizing Radiation . Emitting Products, Computed Tomography Equipment (Applicable Sections)
NEMA NU-2 .

F. Intended Use:

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o The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to cancer, cardiovascular disease, and neurological disorders.
o The detection, localization, and staging of tumors and diagnosing cancer patients.
· Treatment planning and interventional radiology procedures.

Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

G. Device Description/ Comparison with Predicate Device:

H. System Performance Test/ Summary of Studies:

To minimize electrical, mechanical and radiation hazards, Philips Medical System adheres to recognized and established industry practice. Radiation safety is assured by compliance and certification to the performance standards for ionizing radiation emitting product, 21CFR 1020.30 and 21CFR 1020.33. The radiation safety product report will be filed in accordance with 21CFR 1002.10 with the Center for Device and Radiological Health. Electrical and mechanical safety is assured by adherence and certification to the applicable standards in the IEC 60601-1 series. The device performance was measured in accordance with the NEMA-NU2 standard.

I. Comparison to Predicate Devices:

The basic differences in the system include the following:

. The option of either a 6, 10, or 16 slice CT.
Larger bore size for the PET subsystem. O
Removal of the Cs-137 transmission source. O
Modification of various performance specifications for the PET subsystem. O
Modifications to reconstruction. 0

In conclusion, the device is substantially equivalent to the predicate devices based upon similar intended use, technological comparison, and system performance.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines representing the bird's body and wings. The symbol is black, and the background is white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV - 9 2004

Philips Medical Systems (Cleveland), Inc. Re: K042935 % Mr. Morten Simon Christensen Reviewer, Medical Device Services Underwriters Laboratories, Inc. 1655 Scott Boulevard SANTA CLARA CA 95050-4169

Trade/Device Name: Gemini GXL Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulatory Name: Computed tomography x-ray system

Regulatory Class: II

Product Code: 90 KPS and JAK Dated: October 20, 2004 Received: October 25, 2004

. Dear Mr. Christensen:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave review your betthe secce is substantially equivalent (for the indications for use stated in above and nave determinorarketed predicate devices marketed in interstate commerce prior to the cherosate) to regarly mantone of the Medical Device Amendments, or to devices that have been May 20, 1776, the charmers
reclassified in accordance with the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the do not require approval or a provisions of the Act. The general controls provisions of the Act ut rice, subjoct to the general 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 it your de rice to such additional controls. Existing major regulations affecting your Apploral), It they of casyler 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 I rease be advised that i Dr tion 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 I cacal statues and regulations withited 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) (21 CFR Part 820); and if applicable, the electronic product radiation control provisions of (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) I mis lotter will and h your hyding of substantial equivalence of your device to a legally prematicate 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 11 you desire 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) 638-2011 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmaldsmamain.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

K-042935

510(k) Number (if known): Not Known

Device Name: Gemini GXL

Indications for Use:

The device is a diagnostic imaging system for fixed or mobile installations that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT subsystem produces crosssectional images of the body by computer reconstruction of x-ray transmission data. The PET subsystem produces images of the distribution of PET radiopharmaceuticals in the patient body (specific radionarmaceuticals are used for whole body, head, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.

The evaluation, detection and diagnosis of lesions, disease and organ function such as but not limited to O cancer, cardiovascular disease, and neurological disorders.
The detection, localization, and staging of tumors and diagnosing cancer patients. O
Treatment planning and interventional radiology procedures. o

Cardiac imaging software provides functionality for the quantification of cardiology images and datasets including but not fimited to myocardial perfusion for the display of wall motion and quantification of leftventricular function parameters from gated myocardial perfusion studies and for the 3D alignment of coronary artery images from CT coronary angiography onto the myocardium.

Both subsystems (PET and CT) can also be operated independently as fully functional, diagnostic imaging systems including application of the CT scanner as a radiation therapy simulation scanner.

Prescription Use √ AND/OR (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C hoadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K042935

Page of

Regulation Number and Section

§ 892.1200 Emission computed tomography system.

(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.