The Imagen3D™ system is software application that works in conjunction with ImagenPRO® to correct for photon scatter and prompt gamma contamination present in PET 3D data. The resulting 3D datasets can be reconstructed using ImagenPRO® to produce PET and/or PET/CT reconstructed tomograms.

Device Description

Imagen3D™ is a Windows application that works in conjunction with ImagenPRO® as an additional processing step for data acquired in 3D (septa retracted mode). Because of the increase count rate of PET scanners in 3D mode, a lower dosage of the radiopharmaceutical is recommended to avoid dead time issues with the scanners. The resulting 3D sinograms can then be processed in ImagenPRO® to produce 3D tomograms. The use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.

The Imagen3D™ system is designed to take Fourier rebinned sinogram data from commercially available dedicated PET and PET/CT systems acquired in 3D (septa retracted) and scatter correct the data for export into ImagenPRO® for tomographic processing.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Imagen3D™ device:

Based on the provided text, the Imagen3D™ application functions as a pre-processing step for PET 3D data, specifically to correct for photon scatter and prompt gamma contamination before reconstruction by ImagenPRO®. The FDA clearance is based on a determination of substantial equivalence to predicate devices, rather than a clinical trial demonstrating specific performance metrics against pre-defined acceptance criteria.

Therefore, many of the requested elements regarding acceptance criteria, performance metrics, and detailed study methodologies (like sample sizes, expert qualifications, adjudication, effects of AI on human readers, and detailed ground truth establishment methods for large datasets) are not present in this 510(k) summary. This type of summary typically focuses on demonstrating equivalence to legally marketed devices based on similar technological characteristics and intended use.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not applicable in the provided document. The 510(k) summary does not define specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy, or quantitative image quality metrics) that the device had to meet. Instead, the basis for clearance is "substantially equivalent" to predicate devices.

Acceptance Criteria (e.g., minimum accuracy, specific quantitative metric)	Reported Device Performance
Not explicit in this 510(k) summary	Not explicitly reported against numerical criteria
(The approval is based on substantial equivalence to predicate devices, implying similar performance for its intended use.)	(The device is stated to effectively "correct for photon scatter and prompt gamma contamination," which is its functional purpose.)

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

Not explicitly stated for a formal test set with performance metrics. The summary mentions "testing and comparison of technological characteristics" but does not detail the nature or sample size of this testing, nor the provenance of any data used beyond the implicit use of "Fourier rebinned sinogram data from commercially available dedicated PET and PET/CT systems." It doesn't specify if this testing involved a distinct "test set" in the sense of a clinical validation study.

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

Not applicable. Since specific performance metrics based on a defined "test set" and ground truth are not detailed in this 510(k) summary, information about experts for ground truth establishment is not provided.

4. Adjudication Method for the Test Set

Not applicable. As above, a formal adjudication method for a test set is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The summary does not mention an MRMC study or any assessment of how human readers improve with or without AI assistance. The device is a pre-processing software, not directly an AI interpretive assistant for readers.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done

Yes (implicitly, for its intended technical function). The Imagen3D™ is described as a "software application" that "works in conjunction with ImagenPRO® to correct for photon scatter and prompt gamma contamination." Its performance, therefore, is its ability to execute this correction. The statement "Testing and comparison of technological characteristics and intended uses found that all components of the Imagen3D™ system are equivalent to the predicates" implies a standalone assessment of its functional capability as a scatter correction algorithm, even if not quantified with clinical performance metrics in this summary.

7. The Type of Ground Truth Used

Implicitly, the expected output of successful scatter correction. Given the device's function to "correct for photon scatter," the "ground truth" for its operation would be what an ideal, scatter-corrected PET 3D dataset should look like or how it should behave. This is typically established through physics models, phantom studies, or comparisons to established scatter correction methods on relevant data, rather than clinical outcomes or pathology for diagnostic performance. The summary doesn't explicitly state the methodology for establishing this ground truth (e.g., physical phantoms, simulated data, or comparison to established algorithms).

8. The Sample Size for the Training Set

Not applicable / Not provided. The summary does not describe any machine learning or AI models that would require a distinct "training set." The Imagen3D™ appears to be a rule-based or algorithmic scatter correction software rather than a learned model.

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

Not applicable / Not provided. Since there's no mention of a training set, the establishment of ground truth for such a set is not detailed.

Summary

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K122241

OCT 2 4 2012

6. 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.

General Information:

A.	Submitted By:	Cardiovascular Imaging Technologies4320 Wornall Road, Suite 114Kansas City, MO 64111Tel: 816-531-2842Fax: 816-531-0643
	Contact Person:	James A. Case
	Date Prepared:	July 20, 2012
B.	Device Trade Name:	Imagen3D™
	Classification Name:	System, Emission Computed Tomography21 CFR 892.1200 (KPS)System, Image Processing, Radiological21 CFR 892.2050 (LLZ)
C.	Predicate Devices:	ECAT LSO PET/CT 16ImagenPRO®

D. Device Description:

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E. Indications for Use:
The Imagen3D™ system is software application that works in conjunction with ImagenPRO® to correct lower dosage, PET 3D data for photon scatter. The resulting 3D datasets can be reconstructed using ImagenPRO® to produce PET and/or PET/CT reconstructed tomograms.
Comparison of Technical Characteristics to Predicate Device: F.
The Imagen3D™ system and its predicates, the ECAT LSO PET/CT 16 and the ImagenPRO® utilize the same type of data sets for analysis and calculation of data.
H. Summary:
Testing and comparison of technological characteristics and intended uses found that all components of the Imagen3D™ system are equivalent to the predicates.

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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 or bird-like symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular fashion around the symbol. The text is in all caps and appears to be in a sans-serif font.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002

Cardiovascular Imaging Technologies % Ms. Melanie Hasek Manager, Regulatory Affairs PRA 9755 Ridge Drive LENEXA KS 66219

Re: K122241

Trade/Device Name: Imagen3DTM Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: II Product Code: KPS and LLZ Dated: July 20, 2012 Received: July 27, 2012

Dear Ms. Hasek:

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 class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

OCT 24 2012

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). 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 Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to '

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K122241

Device Name:

Imagen3D™

Indications For Use:

Prescription Use
(Part 21 CFR 801 Subpart D)
✓

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of In Vitro Diagnostics and Radiological Health (OIR)

Michael D'Am

Page 1 of

H. Mitchell

Division Of Radiological Health

Office of in Vitr

51000 K1224//

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.