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 radiopharmaceuticals are used for whole body, brain, 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.

The device includes software that provides a quantified analysis of regional cerebral activity from PET images.

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 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.

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 Condor system, a combined PET/CT scanner, and its 510(k) submission. However, it does not include a detailed study proving the device meets specific acceptance criteria with performance metrics, sample sizes, expert qualifications, or adjudication methods.

The document focuses on:

General Information: Device name, classification, predicate devices, and intended use.
Safety and Performance Standards: Mentions adherence to 21 CFR 1020.30 & 1020.33 (Performance Standards for Ionizing Radiation Emitting Products) and NEMA NU-2 standard for device performance measurement.
Comparison to Predicate Devices: States that the device is substantially equivalent based on similar intended use, technological comparison, and system performance, but without presenting a comparative study.
FDA Clearance Letter: Confirms the 510(k) clearance for marketing.

Therefore, based on the provided text, I cannot complete a table of acceptance criteria and reported device performance, nor can I describe a study that explicitly proves the device meets those criteria with the requested details.

The document implies that the device performance was measured according to NEMA NU-2 standards, which are general performance standards for PET scanners (and combined PET/CT systems). To fulfill your request, specific quantitative acceptance criteria derived from these standards, and the actual measured performance values from a study, would be needed.

If the information were available in the provided text, here's how I would structure the answer:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Metric (e.g., Spatial Resolution)	Acceptance Value/Range	Reported Device Performance	Unit
[Example] PET Performance	Axial Spatial Resolution	< 5.0 mm FWHM	4.8 mm FWHM	mm
[Example] PET Performance	Transaxial Spatial Resolution	< 5.0 mm FWHM	4.7 mm FWHM	mm
[Example] PET Performance	Sensitivity	> 6.0 kcps/MBq	6.2 kcps/MBq	-
[Example] CT Performance	CTDIvol (Head)	< 80 mGy	75 mGy	mGy
[Example] CT Performance	Modulation Transfer Function (MTF)	> X % at Y lp/cm	Z % at Y lp/cm	%
... (Additional metrics as per NEMA NU-2 and CT standards) ...

2. Sample size used for the test set and the data provenance:
Information not available in the provided text. The document refers to "System Performance Test/ Summary of Studies" but doesn't detail specific test sets or data provenance. It only states that performance was "measured in accordance with the NEMA-NU2 standard." This standard typically involves phantom studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Information not available in the provided text. As this is a performance evaluation of the imaging system itself (likely using phantoms and physical measurements), human experts for ground truth establishment are not typically involved in the initial performance characterization described here.

4. Adjudication method for the test set:
Information not available in the provided text. Not applicable for performance testing of a physical system based on physical measurements or phantom images.

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:
Information not available in the provided text. The document describes an imaging device, not an AI-assisted diagnostic tool. Therefore, an MRMC study related to AI assistance would not be expected.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Information not available in the provided text. This is a physical imaging system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Information not available directly in the provided text, but inferred. For a performance evaluation against NEMA NU-2 and CT standards, the ground truth would be based on physical phantom measurements and known characteristics of the phantoms (e.g., known activity concentrations, known lesion sizes, known material densities).

8. The sample size for the training set:
Information not available in the provided text. The document does not describe a machine learning algorithm that requires a training set. The "software that provides a quantified analysis" and cardiac imaging software are features of the device, but there's no mention of a machine learning component requiring a distinct training set for its development.

9. How the ground truth for the training set was established:
Information not available in the provided text. Not applicable given the lack of information on a training set.

In summary, the provided 510(k) document is a regulatory submission for a medical device and confirms its substantial equivalence to predicate devices, focusing on safety, intended use, and general performance standards adherence. It does not contain the detailed study results and performance metrics requested for acceptance criteria.

Summary

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K08/135

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

APR 2 9 2008

Submitter/ Contact Person: A. Philips Medical Systems (Cleveland), Inc. 595 Miner Rd. Cleveland, OH 44143
Melinda Novatny Tel: (440) 483-4255 (440) 483-2300 Fax:
B. Device Trade Name: GEMINI Condor
Common Name: Positron Emission Tomography Computed Tomography X-Ray Classification Name: System, Emission Computed Tomography, (892.1200) System, Computed Tomography X-Ray, (892.1750) Device Class: 21CFR 892.1200, Class II 21 CFR 892.1750, Class II 90 KPS and 90 JAK Product Code:

Classification Panel: Radiology

C. March 17, 2008 Date prepared:
(K052640) D. Predicate Device: GEMINI Raptor System (GEMINI TF) AcQSim Multislice CT Scanner (K033357) (Brilliance CT Big Bore)

E. Performance Standards:

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

F. Intended 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 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, brain, heart and other organ imaging). Attenuation correction is accomplished by CTAC. The device also provides for list mode, dynamic, and gated acquisitions.

Section X.-1

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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.
· The detection, localization, and staging of tumors and diagnosing cancer patients.
· Treatment planning and interventional radiology procedures.

The device includes software that provides a quantified analysis of with regional cerebral activity from PET images.

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.

G. Device Description/ Comparison with Predicate Device:

System Performance Test/ Summary of Studies: H.

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.

Comparison to Predicate Devices: I.

The basic differences in the system include the following:

Different CT subsystem .
Modifications to the patient table .

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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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three curved lines representing its wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

APR 2 9 2008

Philips Medical Systems (Cleveland), Inc. % Mr. Morten Christensen Staff Engineer Underwriters Laboratories, Inc. 455 East Trimble Road SAN JOSE CA 95131

Re: K081135

Trade/Device Name: GEMINI Condor Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS Dated: April 16, 2008 Received: April 21, 2008

Dear Mr. Christensen:

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 such 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.

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Enclosure

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

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office 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" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 vours.

Nancy C. Bragdon

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

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Indications for Use

K081135 510(k) Number (if known): 😍去长的野

Device Name: GEMINI Condor

Indications for Use:

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. O
Treatment planning and interventional radiology procedures. 0

The device includes software that provides a quantified analysis of regional cerebral activity from PET images.

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.

Over-The-Counter Use Prescription Use ✔ AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Amminhthy

ductive, Abdominal a Division of Repro Radiological Device 510(k) Number

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.