The device is a Positron Emission Tomography (PET) Imaging System. It is intended to produce images depicting the anatomical distributions of single photon and positron emitting radioisotopes with the human body for interpretation by medical personnel.

Device Description

The C-PET Plus Imaging System is a Positron Emission Tomography (PET) system, a nuclear medical imaging system with capabilities to acquire, process, and display clinical images that can be utilized in both conventional, fixed installations or mobile environments. It is intended to produce attenuation and non-attenuation corrected images depicting the anatomical distribution of single photon and positron emitting radioisotopes within the head, body, or total body for interpretation by medical personnel.

AI/ML Overview

Acceptance Criteria and Study for the C-PET Plus Imaging System

1. Table of Acceptance Criteria and Reported Device Performance

The provided document indicates that the device performance was measured in accordance with the NEMA-NU2 standard. However, specific quantitative acceptance criteria values from the NEMA-NU2 standard are not explicitly listed in the submission, nor are the detailed reported performance values for the C-PET Plus Imaging System directly presented in a table format.

Based on the available information, the acceptance criteria are implicitly met by adherence to the NEMA-NU2 standard. The summary states: "The device performance was measured in accordance with NEMA-NU2 standard," and the FDA's clearance implies that the device met the necessary performance expectations relative to its predicate.

Therefore, a detailed table cannot be constructed with the provided text due to the lack of specific numerical acceptance criteria and reported performance values.

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

The document does not specify the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation conducted under the NEMA-NU2 standard. NEMA-NU2 is a standard for measuring performance characteristics of PET scanners, typically involving phantom studies rather than patient data in the context of this summary.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The document indicates that the device is intended for "interpretation by medical personnel." However, for the NEMA-NU2 standard performance evaluation, no human "experts" are typically involved in establishing ground truth. NEMA-NU2 measures objective physical characteristics of the scanner (e.g., spatial resolution, sensitivity, uniformity, count rate performance) using phantoms with known properties.

4. Adjudication Method

For the NEMA-NU2 standard performance evaluation, adjudication methods are not applicable as the measurements are objective physical characteristics rather than subjective interpretations requiring consensus from experts.

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

No MRMC comparative effectiveness study was performed or described. The evaluation focused on the physical performance of the imaging system according to the NEMA-NU2 standard, not on the improvement of human reader performance with or without AI assistance. The device predates the common integration of AI in medical imaging.

6. Standalone Performance Study

Yes, a standalone performance study was done. The "System Performance Test/Summary of Studies" section explicitly states: "The device performance was measured in accordance with NEMA-NU2 standard." This describes the objective, standalone performance of the PET imaging system itself (the algorithm being the reconstruction software), without human interaction for the purpose of the performance measurements.

7. Type of Ground Truth Used

The ground truth used for the performance evaluation was based on the known physical properties of phantoms as defined by the NEMA-NU2 standard. This typically involves phantoms with known concentrations of radioisotopes, known dimensions, and known spatial arrangements, allowing for objective measurement of the scanner's ability to accurately represent these properties.

8. Sample Size for the Training Set

The document does not mention a training set or its sample size. The C-PET Plus Imaging System is described as an "evolution of the features and functionalities" with "enhancements in image reconstruction and NEMA NU 2 calculation software." This suggests that the development involved engineering improvements to existing algorithms rather than a machine learning model requiring a distinct training set.

9. How Ground Truth for the Training Set Was Established

As no training set is mentioned for a machine learning model, this question is not applicable based on the provided text. The "enhancements in image reconstruction" likely refer to classical image processing and reconstruction algorithms tuned and validated against expected physical outputs rather than ground truth established through data labeling.

Summary

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OCT 2 9 2004

K042839

510(k) SUMMARY OF SAFETY AND EFFECTIVENESS

General Information

Submitter/ Contact Person: A.

Philips Medical Systems (Cleveland), Inc.595 Miner Rd.Cleveland, OH 44143				Rae Ann Farrow
			Tel:	(440) 483-3585
			Fax:	(732) 352-6897
B.	Device Trade Name:	C- PET Plus Imaging System
	Common Name:	Positron Emission Tomography
	Classification Name:	System, Emission Computed Tomography, (892.1200)
	Device Class:	21CFR 892.1200, Class II
	Product Code:	90 KPS
C.	Date prepared:	August 20, 2004
D.	Predicate Device:	Sentry Imaging SystemAllegro Imaging System		(K973396, 01/21/1998)(K033782, 12/19/2003)

E. Performance Standards: NEMA NU-2

F. Intended Use:

G. Device Description:

H. System Performance Test/ Summary of Studies:

To minimize electrical, mechanical and radiation hazards, Philips Medical Systems, Inc. adheres to recognized and established industry practice. 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 NEMA-NU2 standard.

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I. Comparison to Predicate Device

The C-PET Plus Imaging System software is an evolution of the features and functionalities of the Sentry (K973396, 01/21/1998). Design modifications include enhancements in image reconstruction and NEMA NU 2 calculation software. Similarities and differences between the device and its predicates are described within the 510(k) submission. 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 seal of the Department of Health and Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

OCT 2 9 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Philips Medical Systems (Cleveland), Inc. c/o Ms. Denise Klinker Program Reviewer Underwriters Laboratories Inc.® 1655 Scott Blvd. SANTA CLARA CA 95050

Re: K042839

Trade/Device Name: C-PET Plus Imaging System Regulation Number: 21 CFR §892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: 90 KPS Dated: October 11, 2004 Received: October 14, 2004

Dear Ms. Klinker:

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 as host reguirements 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 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); 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.

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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 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" (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) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Nancy C. Brogdon

Nancy C. I rogdon 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

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

510(k) Number (if known): ~~Not Known~~ K042839

Device Name: C-PET Plus

Indications for Use.

Prescription Use ✓ (Part 21 CFR 801 Subpart D)

AND/OR

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. Hogdon

vision Sian-Off) ision of Reproductive, Abdomi I Radiological Devices . O(k) Number _

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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.