The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of X-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.

This device is to be used by a trained health care professional to gather metabolic and functional information from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, localization, diagnosis, staging, follow-up, therapeutic planning and therapeutic outcome assessment of (but not limited to) oncological, cardiovascular, neurological diseases and disorders. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

AiCE-i for PET is intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can explore the statistical properties of the signal and noise of an input PET image. The AiCE algorithm can be applied to improve image quality and denoising of PET images.

Device Description

Cartesion Prime (PCD-1000A) V10.8 system combines a high-end CT and a high-throughput PET designed to acquire CT, PET and fusion images. The high-end CT system is a multi-slice helical CT scanner with a gantry aperture of 780 mm and a maximum scan field of view (FOV) of 700 mm. The high-throughput PET system has a digital PET detector utilizing SiPM sensors with temporal resolution of <280 ps (263 ps typical). Cartesion Prime (PCD-1000A) V10.8 is intended to acquire PET images of any desired region of the whole body and CT images of the same region (to be used for attenuation correction or image fusion), to detect the location of positron emitting radiopharmaceuticals in the body with the obtained images. This device is used to gather the metabolic and functional information from the distribution of radiopharmaceuticals in the body for the assessment of metabolic and physiologic functions. This information can assist research, detection, localization, evaluation, diagnosis, staging, follow-up of diseases and disorders, as well as their therapeutic planning, and therapeutic outcome assessment. This device can also function independently as a whole body multi-slice CT scanner.

The subject device incorporates the latest reconstruction technology, AiCE-i for PET (Advanced Intelligent Clear-IQ Engine- integrated), intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can more fully explore the statistical properties of the signal and noise of PET data. The AiCE algorithm will be able to better differentiate signal from noise and can be applied to improve image quality and denoising of PET images.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Canon Medical Systems Corporation's Cartesion Prime (PCD-1000A/3) V10.8 with AiCE-i for PET, based on the provided FDA 510(k) summary:

1. Table of Acceptance Criteria and Reported Device Performance

The document primarily describes a series of tests conducted to demonstrate the improvement provided by AiCE-i for PET rather than explicit "acceptance criteria" with defined numerical thresholds. However, we can infer the performance metrics and the reported outcomes from the "Testing" section.

Acceptance Criteria (Inferred from Test Goals)	Reported Device Performance
Image Quality (NEMA NU 2-2018): Contrast Recovery Coefficient (CRC), Background Variability (BGV), Lung Residual Error meets NEMA standards.	AiCE-i for PET performance measured through phantom experiment following NEMA NU 2-2018 (Indices Measured: CRC, BGV, Lung Residual Error). The document states "the basic performance...is measured" but does not provide specific numerical values for this study. It implies compliance with NEMA NU 2-2018.
Phantom Artifact Check: No creation of artifacts in IEC Body phantom images.	Visual inspection of IEC Body phantom images confirmed that AiCE-i for PET does not create any artifacts.
Quantification Accuracy: Higher contrast than OSEM+Gaussian post-filtering at the same noise level.	A phantom study confirmed that AiCE-i for PET yields higher contrast than OSEM+Gaussian post-filtering at the same noise level. This is also stated as "improved contrast compared to OSEM+ Gaussian at equivalent noise level" in the CaLM section, which AiCE-i seems to be related to or built upon.
Preservation of Quantification: No change in overall quantification of reconstructed image of IEC Body Phantom.	The study confirmed that AiCE-i for PET does not change overall quantification of reconstructed image of IEC Body Phantom (Indices Measured: Background mean, Sum of SUV of the sphere slice, and Sum of SUV of the entire IEC Body Phantom).
Clinical Data Artifact Check: No artifacts created in clinical images, and diagnostic quality maintained.	Visual inspection, including slice-by-slice comparison of AiCE-i for PET and No-Postfiltered images as well as OSEM+Gaussian 6mm images, confirmed AiCE-i for PET creates no artifact. All three physicians determined that all five AiCE-i for PET images were of diagnostic quality.
PSNR Measurements: Higher similarity to long duration images compared to OSEM + Gaussian Postfilter images.	AiCE-i for PET images showed higher similarity to the long duration image compared to OSEM + Gaussian Postfilter images (Indices Measured: Peak Signal to Noise Ratio (PSNR)) using clinical data not used in DCNN training.
Clinical Image Quality (Visual Assessment by Experts): Image quality, sharpness, and noise are improved or maintained as diagnostic.	Three physicians determined that overall image quality, image sharpness, and image noise were either improved or significantly improved in AiCE-i for PET images when compared to Gaussian images, with one exception where a physician found noise to be "about the same." All images were deemed of diagnostic quality. AiCE-i significantly improved Signal to Noise Ratio (SNR) and quantification at the same noise.
Noise Reduction/SNR Improvement: Significant improvement in Signal to Noise Ratio.	AiCE-i for PET significantly improved Signal to Noise Ratio (SNR), improved quantification at the same noise, and reduced the count rates while preserving noise.

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

NEMA NU 2-2018 & Phantom Studies (Artifact Check, Quantification Accuracy, Preservation of Quantification): These studies used phantoms (e.g., IEC Body phantom, NEMA NU 2-2018 phantom). The number of phantoms is not specified.
Clinical Data Check & PSNR Measurements:
- Test Set Size: 5 patients for visual inspection by physicians.
- Data Provenance: Clinical data was used. For PSNR measurements, "clinical data of long scan duration that is not used in the DCNN training process" was utilized. The country of origin is not specified but is likely internal data from Canon Medical Systems based on the context of the submission. The studies appear to be retrospective as they involve existing clinical data for evaluation.

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

Number of Experts: Three (3) physicians.
Qualifications: "at least 20 years of experience in nuclear medicine".

4. Adjudication Method for the Test Set

The document states: "All three physicians determined that all five AiCE-i for PET images were of diagnostic quality. Overall image quality, image sharpness and image noise were determined to be either improved or significantly improved in AiCE-i for PET images when compared to Gaussian images, with the exception of image noise, where one physician determined that the noise in AiCE-i for PET images is about the same as Gaussian images."

This suggests a consensus or majority opinion approach. While not explicitly stated as "2+1" or "3+1", the fact that "all three physicians determined" diagnostic quality implies a unanimous decision for that criterion. For image quality aspects (sharpness, noise), it acknowledges a single dissenting opinion but emphasizes the overall improvement. So, we can infer a form of consensus-based adjudication, with individual expert opinions recorded.

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

Was it done? A limited MRMC-style evaluation was done with 3 physicians reviewing 5 cases. However, it was focused on assessing image quality improvements and diagnostic utility, not specifically on comparative effectiveness with vs. without AI assistance in terms of diagnostic accuracy or reader performance metrics.
Effect size of human reader improvement: The document does not report a specific effect size in how much human readers improve with AI vs. without AI assistance in terms of diagnostic performance metrics (e.g., AUC, sensitivity, specificity). The physicians assessed image quality and diagnostic utility, concluding improvement and diagnostic quality, but not a quantifiable improvement in diagnostic accuracy compared to a baseline without AI.

6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study

Yes, standalone performance was evaluated through various bench tests and phantom studies:

NEMA NU 2-2018 Image Quality (CRC, BGV, Lung Residual Error measured on phantoms)
AiCE-i for PET Phantom Artifact Check (visual inspection of phantom images)
AiCE-i for PET Quantification Accuracy (phantom study)
AiCE-i for PET Preservation of Quantification (phantom study)
AiCE-i for PET PSNR Measurements (using clinical data, comparing algorithm output to long scan duration images)
Statements like "AiCE significantly improved Signal to Noise Ratio, improved quantification at the same noise, reduced the count rates while preserving noise" demonstrate standalone algorithmic performance.

7. Type of Ground Truth Used

Phantom Studies: The ground truth is the known physical properties and activity distribution within the phantoms.
Clinical Data (Visual Inspection & PSNR):
- For the visual inspection by physicians, the ground truth for diagnostic quality and image characteristics was expert consensus/opinion.
- For PSNR measurements, the ground truth was considered the "long scan duration image," which represents a reference image with higher signal and lower noise due to extended acquisition time, against which the processed images were compared for similarity. This acts as a proxy for an ideal image.

8. Sample Size for the Training Set

The document mentions that "clinical data of long scan duration that is not used in the DCNN training process" was used for PSNR measurements. However, the sample size for the training set itself is not specified in the provided text.

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

The document does not explicitly state how the ground truth for the training set was established. It only implies that a "Deep Learning Artificial Neural Network" (DCNN) was trained. Typically, for such AI systems in medical imaging, training data ground truth is established through:
* Expert annotations/labels: Radiologists or nuclear medicine physicians marking regions of interest, identifying pathologies, or rating image quality.
* Higher quality reference scans: Using longer acquisition times or different imaging modalities as a "gold standard" for what an ideal image should look like for noise reduction and image enhancement tasks (as was partially done for the test set PSNR comparison).

Without further information, the specific method for training ground truth establishment remains undisclosed in this document.

Summary

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April 23, 2021

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath.

Canon Medical Systems Corporation % Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc. 2441 Michelle Drive TUSTIN CA 92780

Re: K203314

Trade/Device Name: Cartesion Prime (PCD-1000A/3) V10.8 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: March 23, 2021 Received: March 24, 2021

Dear Mr. Tadeo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting of medical device-related adverse events) (21 CFR 803) for

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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For

Thalia T. Mills, Ph.D. Director Division of Radiological Health OHT7: Office of In Vitro Diagnostics and Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K203314

Device Name Cartesion Prime (PCD-1000A/3) V10.8

Indications for Use (Describe)

The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and X-ray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of X-ray transmission data. The PET component images the distribution of PET radiopharmacenticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.

This device is to be used by a trained health care professional to gather metabolic and function from the distribution of the radiopharmaceutical in the body for the assessment of metabolic and physiologic functions. This information can assist in the evaluation, detection, diagnosis, staging, restaging, follow-up, therapeutic planning and therapeutic outcome assessment of (but not limited to) oncological, cardiovascular, neurological diseases and disorders. Additionally, this device can be operated independently as a whole body multi-slice CT scanner.

AiCE-i for PET is intended to improve image quality and reduce image noise for FDG whole body data by employing deep learning artificial neural network methods which can explore the statistical properties of PET data. The AiCE algorithm can be applied to improve image quality and denoising of PET images.

Type of Use ( Select one or both, as applicable )
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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AL SYSTEMS USA, INC.

Made For life

510(k) SUMMARY

1. SUBMITTER'S NAME:

Fumiaki Teshima Senior Manager, Quality Assurance Department Canon Medical Systems Corporation 1385 Shimoishigami Otawara-Shi, Tochigi-ken, Japan 324-8550

2. ESTABLISHMENT REGISTRATION: 9614698

3. OFFICIAL CORRESPONDENT/CONTACT PERSON:

Orlando Tadeo, Jr. Sr. Manager, Regulatory Affairs Canon Medical Systems USA, Inc 2441 Michelle Drive Tustin, CA 92780 (714) 669-7459

4. Date Prepared:

November 6, 2020

5. TRADE NAME(S):

Cartesion Prime (PCD-1000A/3) V10.8

6. COMMON NAME:

System, X-ray, Computed Tomography System, Emission Computed Tomography

7. DEVICE CLASSIFICATION:

Class II (per 21 CFR 892.1750, Computed Tomography X-ray System and 21 CFR §892.1200, Emission Computed Tomography System)

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8. PRODUCT CODE / DESCRIPTION:

90JAK / Computed Tomography X-Ray System 90KPS / Emission Computed Tomography System

9. PERFORMANCE STANDARD:

This device conforms to applicable Performance Standards for Ionizing Radiation Emitting Products [21 CFR, Subchapter J, Part 1020]

10. PREDICATE DEVICE:

Product	Marketedby	RegulationNumber	RegulationName	ProductCode	510(k)Number	Clearance Date
Cartesion Prime,PCD-1000A, V10.7	CanonMedicalSystemsUSA	21 CFR892.1200	EmissionComputedTomographySystem	KPS	K202349	October 15, 2020

11. REASON FOR SUBMISSION:

Modification of a cleared device

12. DEVICE DESCRIPTION:

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13. INDICATIONS FOR USE:

The device is a diagnostic imaging system that combines Positron Emission Tomography (PET) and Xray Computed Tomography (CT) systems. The CT component produces cross-sectional images of the body by computer reconstruction of X-ray transmission data. The PET component images the distribution of PET radiopharmaceuticals in the patient body. The PET component utilizes CT images for attenuation correction and anatomical reference in the fused PET and CT images.

14. SUBSTANTIAL EQUIVALENCE:

Cartesion Prime (PCD-1000A) V10.8, is substantially equivalent to the primary predicate device, Cartesion Prime, PCD-1000A, V10.7 which received premarket clearance under K191582 and is marketed by Canon Medical Systems USA. Both systems have the same indications for use and intended use. The Cartesion Prime, PCD-1000A, V10.7, incorporates modifications to the cleared device including implementation of AiCE-i for PET images, PET 1-mm reconstruction and Dynamic PET Acquisition/Reconstruction. These changes do not affect the safety or efficacy of the cleared device, as demonstrated in performance testing. The method of operation and manufacturing process for the Cartesion Prime remain unchanged from the cleared device. See below for a brief comparison of the technological characteristics between the subject and the predicate device:

Item	Cartesion Prime(PCD-1000A/3) V10.8	Cartesion Prime,PCD-1000A, V10.7
510(k) Number	This submission	K202349

Advanced Intelligent Clear-IQ Engine- integratedfor PET [AiCE-i for PET]	Option	N/A
PET 1-mm Reconstruction System	Option	N/A
Dynamic PET Acquisition/Reconstruction System	Option	N/A

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15. SAFETY:

The device is designed and manufactured under the Quality System Regulations as outlined in 21 CFR § 820 and ISO 13485 Standards. This device is in conformance with the applicable parts of the following standards IEC60601-1, IEC60601-1-2, IEC60601-1-3, IEC60601-1-6, IEC60601-1-9, IEC60601-2-28, IEC60601-2-44, IEC60825-1, IEC62304, IEC62366, IEC61675-1, NEMA XR-25, NEMA XR-26, NEMA XR-29 and NEMA NU-2. Additionally, this device complies with all applicable requirements of the radiation safety performance standards, as outlined in 21 CFR §1010 and §1020.

16. TESTING

Risk analysis and verification/validation testing conducted through bench testing are included in this submission which demonstrates that the established specifications for the device have been met. Bench testing was conducted and it was determined that use of CaLM Reconstruction resulted in images with improvements to image quality, quantification accuracy, count dependency, and preservation of quantification.

A series of bench tests were conducted to support marketing claims associated with image quality, quantification accuracy, count dependency, and preservation of quantification. As demonstrated in these studies, AiCE-i for PET significantly improved Signal to Noise Ratio, improved quantification at the same noise, reduced the count rates while preserving noise, and that it preserves average SUV and activity concentration of the image.

A series of bench tests were conducted to support marketing claims associated with CaLM image quality, quantification accuracy, CaLM count dependency, and CaLM preservation of quantification. As demonstrated in these studies, CaLM improved Signal to Noise Ratio, improved contrast compared to OSEM+ Gaussian at equivalent noise level, and reduced the scan duration or equivalently the counts compared to OSEM+Gaussian postfilter while preserving noise.

Performance Testing - Bench AiCE-i for PET Evaluations

NEMA NU 2-2018 Image Quality

Through the phantom experiment following NEMA NU 2-2018, the basic performance of AiCE-i for PET is measured. (Indices Measured: Contrast Recovery Coefficient (CRC), Background Variability (BGV), and Lung Residual Error.)

AiCE-i for PET Phantom Artifact Check

By visually inspecting the IEC Body phantom images, it is confirmed that AiCE-i for PET does not create any artifacts.

AiCE-i for PET Quantification Accuracy

A phantom study was conducted to confirm that AiCE-i for PET yields higher contrast than OSEM+Gaussian post-filtering at the same noise level.

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AiCE-i for PET Preservation of Quantification

The study confirmed that AiCE-i for PET does not change over all quantification of reconstructed image of IEC Body Phantom. (Indices Measured: Background mean, Sum of SUV of the sphere slice, and Sum of SUV of the entire IEC Body Phantom.)

AiCE-i for PET Clinical Data Check

The visual inspection, including slice by slice comparison of AiCE-i for PET and No-Postfiltered image as well as OSEM+Gaussian 6mm image, confirmed AiCE-i for PET creates no artifact. (Indices Measured: Liver SUV, Live SD, Hotspot SUV, Hotspot SUVmax, and Slice-by-Slice SUV of every slice in the volume)

AiCE-i for PET PSNR Measurements

Using the clinical data of long scan duration that is not used in the DCNN training process, it was confirmed that AiCE-i for PET images show higher similarity to the long duration image compared to OSEM + Gaussian Postfilter images. (Indices Measured: Peak Signal to Noise Ratio (PSNR))

Performance Testing - Clinical AiCE-i for PET Evaluation

Three physicians having at least 20 years of experience in nuclear medicine reviewed the AiCE-i for PET images of five patients. All three physicians determined that all five AiCE-i for PET images were of diagnostic quality. Overall image quality, image sharpness and image noise were determined to be either improved or significantly improved in AiCE-i for PET images when compared to Gaussian images, with the exception of image noise, where one physician determined that the noise in AiCE-i for PET images is about the same as Gaussian images.

Software Documentation for a Moderate Level of Concern, per the FDA guidance document, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices Document" issued on May 11, 2005, is also included as part of this submission. Cybersecurity documentation, per the FDA cybersecurity premarket guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" issued on October 2, 2014, is also included as part of this submission.

Additionally, testing of the subject device was conducted in accordance with the applicable standards published by the International Electrotechnical Commission (IEC) for Medical Devices and CT Systems.

This 510(k) submission was prepared based upon the FDA Guidance for Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems.

17. CONCLUSION

Cartesion Prime (PCD-1000A) V10.8, performs in a manner that is similar to and is intended for the same use as the predicate device, as indicated in product labeling. Based upon this information, conformance to standards, successful completion of software validation, application of risk management and design controls and the performance data presented in this submission it is concluded that the subject device is substantially equivalent in safety and effectiveness to the predicate device.

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.