Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images

AI/ML Overview

This 510(k) submission (K032866) for the Clarity PET device does not contain a study demonstrating that the device meets specific acceptance criteria based on its performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices already on the market.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

There is no table of acceptance criteria or reported device performance metrics in the provided document. The submission relies on establishing equivalency rather than meeting new performance benchmarks.

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

Not applicable. No new performance study (test set, data provenance) is conducted for this 510(k) submission.

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

Not applicable. No new performance study is conducted that involved establishing ground truth with experts.

4. Adjudication Method:

Not applicable. No new performance study requiring adjudication is conducted.

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

No, an MRMC comparative effectiveness study was not done. The submission does not present a study comparing human reader performance with and without AI assistance, as the device is image review software, not an AI-assisted diagnostic tool in the sense of providing automated interpretations.

6. Standalone (Algorithm Only) Performance Study:

No, a standalone performance study was not done. The Clarity PET is described as image review software and thus its "performance" is implicitly tied to its ability to display and manipulate images, similar to predicate devices. It's not an algorithm providing a diagnostic output independently.

7. Type of Ground Truth Used:

Not applicable. No ground truth for a new performance study is established or used in this submission.

8. Sample Size for the Training Set:

Not applicable. The provided document does not describe a training set for an algorithm, as the device is image review software, not a machine learning model.

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

Not applicable.

Summary of the K032866 Submission's Approach:

The K032866 submission for Clarity PET establishes substantial equivalence by demonstrating:

Equivalent Indications for Use: The device can "detect or image the distribution of radionuclides in the body or organ, using the following techniques: Multiplanar Reconstruction (MPR), Maximum/Minimum Intensity Projection (MIP), Image Contrast Manipulation, Image Zoom Manipulation, Automatic registration with Mutual Information Technique." These are explicitly stated as equivalent to the Medical Image Merge™ device.
Equivalent Technological Characteristics, Performance Characteristics, and Instructions for Use: The submission asserts that Clarity PET shares these equivalencies with the Medical Image Merge™ device and other predicate devices like Syngo Multi-Modality Workstation, ADAC Laboratories Image Fusion and Review System, and GE Advantage Windows Workstation.

The core of this 510(k) is a comparison to legally marketed predicate devices, asserting that Clarity PET performs the "same functions" and has "equivalent" characteristics, rather than providing new performance data against a specific set of acceptance criteria. The FDA's letter confirms that they reviewed the 510(k) and determined the device is substantially equivalent to legally marketed predicate devices for the stated indications for use.

Summary

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K032866

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7.0 PREMARKET NOTIFICATION 510(K) SUMMARY

Sponsor:

Shared P.E.T. Imaging, LLC 4912 Higbee Ave.NW, Ste 100 Canton OH 44718 Telephone: (330) 491-0480 Fax: (330) 491-0488 Contact: Randy W. Skiles, CEO

Registration:

To be assigned

Clarity PET Trade Name of Device: Clarity PET Common Name: System, Image Processing, Radiological Classification name: LLZ Product Code: II Regulation Class: 8892.2050 Regulation Number:

Device Description and Intended Use: .

Technological Characteristics: .

The Clarity PET Device supports various medical image manufacturer's image format and DICOM formatted images. Clarity PET is designed to run on the Microsoft Windows family of operating systems

General Safety and Effectiveness Concerns: .

The device labeling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device. Serving primarily as an aid in image display, this device has no direct adverse effect on health as the results are to be integrated into all of the information a physician will use to form a final interpretation.

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Marketing History .

Clarity PET performs the same functions as several other medical device image programs marketed in the past. Some of the programs are Medical Image Merge(K001276), Syngo Multi-Modality Workstation(K010938), ADAC Laboratories Image Fusion and Review System(K973233) and the GE Advantage Windows Workstation(K960613). All of the aforementioned devices are used to display medical images from multiple modalities in multiple image formats.

Substantial Equivalence: .
- The Shared PET Imaging Clarity PET has indications for use equivalent to those for . the Medical Image Merge™ device.
- The Shared PET Imaging Clarity PET has technological characteristics, performance . characteristics, and instructions for use equivalent to those for the Medical Image Merge™ device.

510(k) Cleared Indications for Use: .

To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

Multiplanar Reconstruction (MPR) .
Maximum/Minimum Intensity Projection (MIP) .
Image Contrast Manipulation .
Image Zoom Manipulation .
Automatic registration with Mutual Information Technique .

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 1 2 2003

Shared P.E.T. Imaging, LLC % Russ Pagano, Ph.D. M Squared Associates, Inc. 719 A Street, NE WASHINGTON DC 20002

Re: K032866 Trade/Device Name: Clarity PET Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 KPS and LLZ Dated: September 12, 2003 Received: September 15, 2003

Dear Dr. Pagano:

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. Ilisting 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 vours.

Nancy C. bogden

Nancy C. Brogdor 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

5 10(k) Number (if known): K.032866

Device Name: Clarity PET

Indications for Use:

To detect or image the distribution of radionuclides in the body or ergan, using the following techniques:

Multiplanar Reconstruction (MPR) .
Maximum/Minimum Intensity Projection (MIP) .
Image Contrast Manipulation .
Image Zoom Manipulation *
Automatic registration with Mutual Information Technique .

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED):

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use do
(Per 21 CFR 801.109) the The Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number

Labels	Values
510(k) Number	K032866

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.