The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez scanners are 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 transmission 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 LSO PET/CT HiRez is a family of combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. These dual modality tomographs are modified versions of the ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518) and will utilize the same Siemens SOMATOM CT scanner components as their respective predicate PET/CT scanners. However, on this new family of CPS PET/CT HiRez systems, the ACCEL PET scanner electronics has been modified to appreciably increase PET count rate capability, with front-end acquisition electronics processing speed being significantly improved. The modified ACCEL PET scanner component will also incorporate a new version block detector utilizing a 13 by 13 LSO crystal matrix in place of the previously used 8 by 8 LSO crystal matrix which will provide a significant improvement in the spatial resolution of PET images. As with the predicate systems, 2D PET acquisition septa and PET transmission sources are not included in the modified LSO PET/CT HiRez systems. PET emission data are acquired only in 3D and PET attenuation correction map data are obtained from the CT. The PET and CT components of each system are contained within a unified housing similar to the predicate ECAT LSO PET/CT and ECAT LSO PET/CT 16 scanners to create an integrated PET, CT and combined PET/CT, tomographic imaging system.

The outward appearance of this family of modified PET/CT HiRez systems remains the same as the similarly configured preceding models. The LSO PET/CT HiRez gantry structure, patient handling system (PHS), advanced computational system (ACS 3) and workstation will be the same as those used with the LSO PET/CT and ECAT LSO PET/CT 16 systems. Software used in these scanners will be the most recent version of the previously used PET/syngo software with minor changes to accommodate the revised PET acquisition electronics and modified crystal configuration detectors. User operating instructions have been revised accordingly.

The LSO PET/CT HiRez scanners are intended for use primarily as clinical, whole-body oncology machines with medium to high-end spiral CT performance and fast patient-throughput clinical PET performance. As on the predicate systems, the CT component will also enhance PET scans by allowing fast, essentially noise-free attenuation correction for PET studies, and by providing precise anatomical reference through fused PET and CT images. In addition, the LSO PET/CT HiRez scanners will retain mechanical isolation and independent functionality of the PET and CT scanning systems, thereby allowing for most standard CT and PET clinical diagnostic protocols to be available on these PET/CT systems.

The purpose of introducing this family of modified LSO PET/CT HiRez tomographic systems is to offer a series of PET/CT scanners having a varied range of CT performance combined with the fast patient throughput of the modified ACCEL PET, as an even higher performance alternative to the presently distributed ECAT LSO PET/CT and ECAT LSO PET/CT 16 PET/CT systems.

AI/ML Overview

The provided text is a 510(k) summary for the LSO PET/CT HiRez and LSO PET/CT 16 HiRez systems. It describes the device, claims substantial equivalence to predicate devices, and outlines its intended use. However, it does not contain detailed information about acceptance criteria or a specific study proving the device meets said criteria in the format requested.

The document states: "The combined PET/CT system has been tested by CPS and found to meet its predetermined performance requirements." but does not elaborate on what these requirements are, how they were tested, or the specifics of the study.

Therefore, most of the requested information cannot be extracted from this document.

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not specified in document	"The combined PET/CT system has been tested by CPS and found to meet its predetermined performance requirements." (Specific performance metrics are not given.)

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

Test Set Sample Size: Not specified.
Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). While the manufacturer is US-based (Knoxville, TN), the origin of any test data is not mentioned.

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

Number of Experts: Not specified.
Qualifications of Experts: Not specified.

4. Adjudication Method for the Test Set

Adjudication Method: Not specified.

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

Was an MRMC study done? Not mentioned. The document focuses on the technical modifications and substantial equivalence to predicate devices, not on human reader performance with or without AI assistance.
Effect size of human readers with vs. without AI: Not applicable, as no MRMC study or AI assistance is discussed for improving human reader performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Was a standalone study done? Not explicitly stated as a "standalone study" in the context of an algorithm. The text refers to the "combined PET/CT system... tested by CPS and found to meet its predetermined performance requirements," which implies performance testing of the device itself. However, it's not a standalone algorithm performance in the modern sense of AI evaluating images without human intervention, as this is a medical imaging device for human interpretation.

7. Type of Ground Truth Used

Type of Ground Truth: Not specified.

8. Sample Size for the Training Set

Training Set Sample Size: Not applicable. This document describes a medical imaging device (hardware and associated software), not an AI algorithm trained on a dataset. Therefore, there is no "training set" in the context of machine learning.

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

How Ground Truth Was Established: Not applicable (see point 8).

Summary of what the document does provide regarding "acceptance criteria" indirectly:

The document primarily proves "substantial equivalence" to existing predicate devices (ECAT LSO PET/CT (K013504) and ECAT LSO PET/CT 16 (K023518)). This is the primary "acceptance criterion" for 510(k) clearance. The study that proves this is the comparison made within the 510(k) submission itself, where the new device's design, material, composition, energy source, radiation safety, and performance characteristics are shown to be similar to legally marketed devices.

The key modifications and performance improvements mentioned are:

Increased PET count rate capability: Due to modified ACCEL PET scanner electronics with significantly improved front-end acquisition electronics processing speed.
Improved spatial resolution of PET images: Due to a new version block detector utilizing a 13 by 13 LSO crystal matrix (vs. the previously used 8 by 8 LSO crystal matrix).

While these are stated as improvements, the specific quantitative acceptance criteria and the detailed study data that verified these improvements are not provided in this summary. The text indicates that these improvements lead to "even higher performance" as an alternative to the predicate systems, implying that performance was assessed and deemed superior or equivalent in relevant aspects.

Summary

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NOV 2 0 2003

510(k) SUMMARY

[As required by 21 CFR 807.87(h)]

Identification of Submitter

Submitter:

Contact Person:

Telephone No: Fax No: Date of preparation:

Identification of the Product

Device Proprietary Name: Common Name:

Classification Name:

CTI PET Systems, Inc. 810 Innovation Drive Knoxville, TN 37932 William Skremsky Senior Regulatory Affairs Specialist (865) 218-2522 (865) 218-3000 October 24, 2003

LSO PET/CT HiRez and LSO PET/CT 16 HiRez Combination Positron Emission Tomography (PET) and X-Ray Computed Tomography (CT) Emission Computed Tomography System per 21 CFR 892.1200

Marketed Devices to Which Equivalence is Claimed

Device	Manufacturer	510(k) Number
ECAT LSO PET/CT	CTI PET Systems (CPS)	K013504
ECAT LSO PET/CT 16	CTI PET Systems (CPS)	K023518

Device Description and Comparison to the Unmodified Device

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510(k) Summary LSO PET/CT HiRes Scanner p. 2

used with the LSO PET/CT and ECAT LSO PET/CT 16 systems. Software used in these scanners will be the most recent version of the previously used PET/syngo software with minor changes to accommodate the revised PET acquisition electronics and modified crystal configuration detectors. User operating instructions have been revised accordingly.

Intended Use

The LSO PET/CT HiRez and LSO PET/CT 16 HiRez tomographic scanner systems are combined positron emission tomography (PET) and X-ray computed tomography (CT) scanners. The LSO PET/CT HiRez and LSO PET/CT 16 HiRez scanners are 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 transmission data from either the same axial plane taken at different angles or spiral planes* taken at different angles.

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

Safety and Effectiveness

The LSO PET/CT HiRez and LSO PET/CT 16 HiRez tomographic scanner systems have been designed to comply with applicable industry safety standards for this type of medical equipment including the international standard IEC 60601-1, General Requirements for the Safety Electrical Medical Equipment. The CT component has been tested and meets the requirements of the applicable US Federal Performance Standards and regulations of 21CFR 1020.30 and 1020.33. The combined PET/CT system has been tested by CPS and found to meet its predetermined performance requirements.

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510(k) Summary LSO PET/CT HiRes Scanner p. 3

Substantial Equivalence Determination

In the opinion of CPS, the ECAT LSO PET/CT 16 system utilizes the same scientific technology as the unmodified ECAT LSO PET/CT system and raises no new questions with regard to its safety and effectiveness. Therefore, we believe the modified ECAT LSO PET/CT 16 is substantially equivalent to the unmodified ECAT LSO PET/CT with respect to design, material and composition, energy source, and radiation safety characteristics.

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Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the caduceus symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 0 2003

Mr. William Skremsky Senior Regulatory Affairs Specialist CPS Innovations 810 Innovation Drive KNOXVILLE TN 37932

Re: K033431

Trade/Device Name: LSO PET/CT Hi Rez and LSO PET/CT 16 Hi Rez Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.1750 Regulation Name: Computed tomography x-ray systėm Regulatory Class: II Product Code: 90 KPS and JAK Dated: October 24, 2003 Received: November 4, 2003

Dear Mr. Skremsky:

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.

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 the letter:

8xx. 1xxx	(301) 594-4591
876.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4616
884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx	(301) 594-4616
892.2xxx, 3xxx, 4xxx, 5xxx	(301) 594-4654
Other	(301) 594-4692

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

510(k) Number (if known):

K033431

Device Name: LSO PET/CT Hi Rez and LSO PET/CT 16 HiRez

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)

	(Division Sign-Off)
	Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number	K033431

Prescription Use (Per 21 CFR 801.109)	OR	Over-The-Counter Use
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(Optional Format 1-2-96)

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.