The CPS LSO PET/CT HiRez Series Scanners are combined positron emission tomography (PET) and X-ray computed tomography (CT) scannesr. The LSO PET/CT scanner is intended to be utilized by appropriately trained health care professionals to 1) image and measure the distribution of injected positron emitting radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body, and 2) to produce cross-sectional images of the body by computer reconstruction of x-ray prounds sion data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to provide high resolution, noise free CT attenuation correction maps for PET images and, additionally, utilized to produce fused CT and PET images, providing detailed anatomic and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

Device Description

The CPS LSO PET/CT Hi-Rez series of scanners are combined Positron Emission Tomography and X-Ray Computed Tomography scanners. These systems are designed for whole-body oncology, neurology and cardiology syotome are a signiture registration and fusion of high-resolution metabolic and anatomic information from the two major components of each system, the and anatomic informanner and the Siemens Somatom CT (either Emotion or Sensation depending on the specific model).

The combined PET/CT scanner is intended for use as a clinical, whole-body oncology machine with high-end spiral CT and PET performance. The CT oncology maonine mans, quiet attenuation correction for PET studies as well as oomponont provided farmer through fused PET and CT images. In addition, the PET / CT system maintains independent functionality of the PET and CT scanning systems, allowing for most standard stand-alone CT and PET clinical diagnostic protocols to be available as well.

Changes incorporated in this system are the result of a cost reduction effort Changes incorporated in this System are the roomtry to be modified easily.
combined with changes that allow the "look" of the gantry to be interest Combined with chunges that and rain and and acturability and Adultional changes were intorporation to inipes were . These changes were
serviceability as well as to deal with parts obsolescence. (RUC) The City Serviceability as well as to deal with parts esset Handling System (PHS). The CT
limited to the PET gantry as well as the Patient Handling System (PHS). The CT illined to the F LT gamry as well as the reviously commercially available systems.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "LSO PET/CT HiRez Series" and predominantly focuses on demonstrating substantial equivalence to existing devices rather than presenting a performance study with acceptance criteria.

While the document details the device's purpose and indications for use, it does not contain information on acceptance criteria or a study proving the device meets acceptance criteria in the way one would expect for a performance evaluation study. The submission is for a new iteration of an already market-cleared device, emphasizing cost reduction and minor physical changes. Therefore, the core of the submission isn't to prove new performance claims against acceptance criteria, but to show that the modified device remains substantially equivalent to its predicates.

Given this, I cannot extract the specific information requested in the prompt, such as:

A table of acceptance criteria and the reported device performance: This information is not present. The document focuses on comparing the new device to predicates based on general safety and effectiveness, not specific quantitative performance metrics against predefined criteria.
Sample size used for the test set and the data provenance: No performance test set is described.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable as no specific performance study is detailed.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No such study is mentioned.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical imaging device, not an AI algorithm.
The type of ground truth used: Not applicable as no specific performance study is detailed.
The sample size for the training set: Not applicable as this is not an AI/algorithm-based device in the context of the 510(k) summary.
How the ground truth for the training set was established: Not applicable.

The document states: "Changes incorporated in this system are the result of a cost reduction effort combined with changes that allow the 'look' of the gantry to be modified easily. Additional changes were incorporated to improve reliability and serviceability as well as to deal with parts obsolescence. These changes were limited to the PET gantry as well as the Patient Handling System (PHS). The CT component of the system remained identical to previously commercially available systems." This indicates that the core imaging performance, particularly for the CT component, was considered unchanged and therefore, not a subject of new performance evaluations for this 510(k) submission.

Therefore, I must state that the provided text does not contain the information required to answer the prompt regarding acceptance criteria and a study proving those criteria were met.

Summary

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K050509

MAR 2 5 2005

510(K) SUMMARY

(As required by 21 CFR 807.87(h))

ldentification of Submitter

Submitter:

M. Alaine Medio, RAC Senior Regulatory Affairs Specialist CTI Molecular Imaging, Inc. 810 Innovation Drive Knoxville, TN 37932 (865)218-2703 (865)218-3019

Telephone Number: Fax Number: Date of Submission:

Identification of the Product

Device Proprietary Name:	LSO PET/CT HiRez Series
Common Name:	Combination Positron Emission Tomography(PET) and Computed Tomography (CT)Systems
Classification Name:	Emission Computed Tomography Systemper 21 CFR 892.1200

Marketed Devices to which Equivalence is Claimed

Device	Manufacturer	510(k) Number
LSO PET/CT HiRez andHiRez16	CTI PET Systems (CPS)	K033431
LSO PET/CT HiRez 64	CTI PET Systems (CPS)	K042467

Device Description:

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Indications for Use:

The CPS LSO PET/CT HiRez Series Scanners are combined positron emission The CF S EOO F ETOT Hillson omputed tomography (CT) scannesr. The LSO tomography \r ET/ and X fay oompatible to hegopriately trained health care PET/CT scannel 13 intended to be atlines and measure the distribution of injected positron professionals to 1) image and mound on the purpose of determining various emiling radiophumabodicale in hysiologic functions within the human body, and 2) to metabolic (moleculur) and physiologie landy by computer reconstruction of x-ray produce cross-sectional images of the same axial plane taken at different angles or spiral planes* taken at different angles.

The PET and the CT functions of this system can also be used in combination to The FET and the OT fanstions of this of this cystems maps for PET images and, additionally, utilized to produce fused CT and PET images, images and, adultionally, and metabolic function information in a single image.

(*spiral planes: the axial planes resulted from the continuous rotation of ( Spiral planes. The uxia, pnd the simultaneous translation of the patient.)

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle or other bird-like figure, with three stylized lines forming the body and wings.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 5 2005

Ms. M. Alaine Medio, RAC Senior Regulatory Affairs Specialist CTI PET Systems, Inc. 810 Innovation Drive KNOXVILLE TN 37932

Re: K050509 Trade/Device Name: LSO PET/CT HiRez Series Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray system Regulatory Class: II Product Code: KPS and JAK Dated: February 28, 2005 Received: March 1, 2005

Dear Ms. Medio:

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 (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 (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.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 510(k) I his ictief with anow you to begin maneeing your and equivalence of your device to a legally premarket notification: "The PDF mainly of oassification 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 specific acvice for your de room 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 Also, prease note the regulation entirely information on your responsibilities under the Act from the 807.77). I ou may ootain other generer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Nancy C. Hodgdon

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 FORM

Page / of /

510(k) Number (if known):

K050509

LSO PET/CT HiRez Series Device Name:

Indications for Use:

(*spiral planes: the axial planes resulted from the continuous rotation of detectors and x-ray tube and the simultaneous translation of the patient.)

(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)

Over the Counter Use - -

(Optional Format 1-2-96)

Nancy L. Brogdon

Division Sian-Off Division of Reproductive. A and Radiological Devices 510(k) Number .

Page 5

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.