The equipment is intended to obtain position emission tomography (PET) images of parts of the fit in the patient aperture (e.g. head or breast) to detect abnormal pattern of distribution of a positron emitting radiopharmaceutical. This information can assist in diagnosis, therapeutic outcome assessment.

Device Description

The SET-5002 PET scanner is designed to image the patient's breast or head which is placed in the aperture provided. The scanner can be easily switched from head to breast mode and back again with the push of a button on the control panel. When positrons are emitted from the radioactive drug administered to the patient, they annihilate electrons in body tissue. That process emits two annihilation photons (hereinafter "gamma rays") with an energy of 511 keV in the 180-degree direction. The PET System collects data by simultaneously counting both of these gamma rays using detectors arranged in a circular configuration. After collecting data for the specified scan time, an image is then reconstructed from that data based on the quantitative distribution of the radioactive drug. The following corrections are necessary for obtaining a quantitative distribution image: Normalization, Attenuation Correction, Scatter Correction, Random Correction, Decay Correction, Standard Time Correction, Count Losses Correction, and Cross Calibration. Operation of the system requires trained persons. The system is designed to be operated in a controlled medical environment such as a hospital or clinic. The unit is supplied with a computer which acquires and stores patient images. The scintillator type is Lutetium. The detectors are SiPM (Silicon photomultipliers).

AI/ML Overview

The provided text describes the Shimadzu SET-5002 PET scanner and its premarket notification to the FDA. While it mentions performance testing and a clinical reader study, the document does not provide explicit acceptance criteria in a quantitative format, nor does it detail a comparative effectiveness study (MRMC) with human readers or a standalone AI performance study.

The information primarily focuses on demonstrating substantial equivalence to a predicate device (BBX-PET Scanner K210450) based on technological characteristics and general performance metrics, rather than specific acceptance criteria for a new AI/software component within the device.

However, based on the available information, I can infer and reconstruct some aspects relevant to performance validation as described:

Derived Acceptance Criteria and Reported Device Performance (Inferred):

Since no explicit quantitative acceptance criteria for image quality or diagnostic accuracy are listed, the "acceptance" is implied by the study's conclusion: "acceptable diagnostic results" and "supports the determination of substantial equivalence."

Acceptance Criteria (Inferred from Study Conclusion)	Reported Device Performance
Overall image quality demonstrates acceptable diagnostic results for brain images.	Reader attested that her assessments of image quality of the SET-5002 demonstrated acceptable diagnostic results for brain images.
Overall image quality demonstrates acceptable diagnostic results for breast images.	Reader attested that her assessments of image quality of the SET-5002 demonstrated acceptable diagnostic results for breast images.
Performance of the new device is as safe, as effective, and performs as well as or better than the predicate device.	"The performance testing data supports the safety of the device and the validation testing demonstrate that new device should performs as intended in the specified use." Also, "From the result of our risk analysis, software verification and testing discussed above, it is our conclusion that the SET-5002 device is substantially equivalent to the legally marketed predicate devices. Therefore, new device is as safe, as effective, and performs as well as or better than the predicate device."

Study Details based on the provided text:

Sample Size and Data Provenance:
- Test Set Sample Size: 18 images (12 brain images and 6 breast images).
- Data Provenance: U.S. clinical site. The document states, "A clinical reader study using the SET-5002 was conducted at U.S. clinical site." The retrospective or prospective nature is not explicitly mentioned but typically clinical reader studies for regulatory submission are on retrospectively collected and de-identified data.
Number of Experts and Qualifications:
- Number of Experts: One (singular "radiologist" and "reader attested").
- Qualifications: "Board certified radiologist." Specific years of experience are not mentioned.
Adjudication Method:
- Method: None specified in the document. The study was conducted with a single board-certified radiologist reviewing the images.
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- Was it done?: No. The study described is a single-reader study rather than a multi-reader, multi-case comparative effectiveness study.
- Effect Size: Not applicable, as no MRMC study was conducted comparing human readers with and without AI assistance. The study assessed "overall image quality... demonstrated acceptable diagnostic results" rather than an improvement metric for human readers.
Standalone (Algorithm Only) Performance Study:
- Was it done?: No. The described "clinical reader study" involved a human radiologist reviewing images produced by the SET-5002. There is no mention of an AI algorithm within the SET-5002 that would have standalone performance measured independent of human interpretation. The SET-5002 is a PET imaging system, not an AI diagnostic software.
Type of Ground Truth Used:
- Type: The ground truth for the reader study appears to be the assessment by the board-certified radiologist herself regarding "acceptable diagnostic results" and "PET imaging findings related to the progression of dementia, tumor detection, and the extent of spread." It's not stated that the images were confirmed against a definitive ground truth like pathology or long-term clinical outcomes. It implies the radiologist's assessment of image quality for diagnostic purposes served as the "ground truth" for the device's performance in this context.
Training Set Sample Size:
- Sample Size: Not applicable. The SET-5002 is described as an "Emission Computed Tomography System" (PET scanner), not an AI/machine learning software that requires a training set. The performance validation for such a device typically involves demonstrating image quality and physical performance metrics (resolution, sensitivity, etc.) and confirming suitability for diagnostic use by experts.
How Ground Truth for Training Set was Established:
- Method: Not applicable, as there is no mention of a training set for an AI/ML algorithm within the device.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and Human Services logo. To the right of that is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

May 24, 2024

Shimadzu Corporation Medical Systems Division % Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct Naples, Florida 34114

Re: K240827

Trade/Device Name: Set-5002 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS Dated: March 12, 2024 Received: March 26, 2024

Dear Daniel Kamm:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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,

D. R. Califf

Daniel M. Krainak, Ph.D. Assistant Director DHT8C: Division of Radiological Imaging and Radiation Therapy Devices OHT8: Office of Radiological Health Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K240827

Device Name SET-5002

Indications for Use (Describe)

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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Image /page/3/Picture/0 description: The image shows the text "510(k) Summary K240827" with an underline. Below the text is the Shimadzu logo, which includes a square with a plus sign inside a circle on the left and the word "SHIMADZU" in bold, sans-serif font on the right. The text and logo are in black against a white background.

SHIMADZU CORP. 1, Nishinokyo-Kuwabaracho, Nakagyo-ku, Kyoto City, JAPAN 604-8511 Date submitted: May 24, 2024 Prepared by: Koichi Kataoka, General Manager, Quality Assurance Department, Medical Systems Division

1. Identification of the Device: Trade/Device Name: SET-5002 Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS
1. Equivalent legally marketed device: K210450 Trade/Device Name: BBX-PET Scanner Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulatory Class: Class II Product Code: KPS
1. Purpose of Submission: New but Substantially Equivalent Device.
1. Device Description: The SET-5002 PET scanner is designed to image the patient's breast or head which is placed in the aperture provided. The scanner can be easily switched from head to breast mode and back again with the push of a button on the control panel:

Image /page/3/Picture/6 description: The image shows two different types of medical imaging machines. The machine on the left is a bone densitometer, which is used to measure bone density. The machine on the right is an MRI machine, which is used to create images of the organs and tissues in the body. Both machines are white and gray and have a long, flat table where the patient lies down.

Breast Mode

Head Mode

This is the operating principle: When positrons are emitted from the radioactive drug administered to the patient, they annihilate electrons in body tissue. That process emits two annihilation photons (hereinafter "gamma rays") with an energy of 511 keV in the 180-degree direction. The PET System collects data by simultaneously counting both of these gamma rays using detectors arranged in a circular configuration. After collecting data for the specified scan time, an image is then reconstructed from that

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data based on the quantitative distribution of the radioactive drug. The following corrections are necessary for obtaining a quantitative distribution image: Normalization, Attenuation Correction, Scatter Correction, Random Correction, Decay Correction, Standard Time Correction, Count Losses Correction, and Cross Calibration. Operation of the system requires trained persons. The system is designed to be operated in a controlled medical environment such as a hospital or clinic. The unit is supplied with a computer which acquires and stores patient images. The scintillator type is Lutetium. The detectors are SiPM (Silicon photomultipliers).

1. Indications for Use: The equipment is intended to obtain positron emission tomography (PET) images of parts of the human body that fit in the patient aperture (e.g. head or breast) to detect abnormal pattern of distribution of radioactivity after injection of a positron emitting radiopharmaceutical. This information can assist in diagnosis, therapeutic planning and therapeutic outcome assessment.
1. Comparison of Technological Characteristics with the predicate device:

ITEM	Predicate Device K210450 BBX Pet	SET-5002
Indicationsfor Use	BBX™-PET scanner is intended to obtainpositron emission tomography (PET) images ofparts of the human body that fit in the patientaperture ( e.g., head) to detect abnormalpattern of distribution of radioactivity afterinjection of a positron emittingradiopharmaceutical. This information canassist in research, diagnosis, therapeuticplanning and therapeutic outcome assessment.	The equipment is intended to obtain positronemission tomography (PET) images of parts of thehuman body that fit in the patient aperture (e.g.head or breast) to detect abnormal pattern ofdistribution of radioactivity after injection of apositron emitting radiopharmaceutical. Thisinformation can assist in diagnosis, therapeuticplanning and therapeutic outcome assessment.SAME
Imagingsection ofthe bodyparts	Head only	Head and breast only
DetectorModule	Detector module consists of Lutetium FineSilicate crystals (LFS) optically coupled to solidstate silicon photomultiplier. The size of crystalis 1.76 (X) × 1.76 (Y).	Detector module consists of Lutetium includedcrystals (e.g. LGSO) optically coupled to solidstate silicon photomultiplier. The width of crystalis 2.1 (X) × 2.1 (Y).
DetectorArrangement	The detector modules are arranged in acylindrical shape with an inner diameter of 29cm and an axial length of 10 cm in the in-section direction.	The detector modules are arranged in acylindrical shape with an inner diameter of 30 cmand an axial length of 16.2 cm in the in-sectiondirection.
Bore/Opening Size	28.8 CM	28.3 CM
TransaxialField of View	250 mm	264 mm
Axial Field ofView	100 mm	162 mm (SET-5002)

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ITEM	Predicate Device K210450 BBX Pet	SET-5002
Principle ofdetection	The detectors detect two gamma rays almostsimultaneously that are emitted oppositelyfrom radioactivity inside the patient body. Thedetected informations such as timing, energy,and position of the crystal are formed as acoincidence events and recorded.	SAME
DataCorrections	Attenuation CorrectionCalculation based method from emissiondata.Scatter CorrectionSingle scatter point based method.Dead-Time CorrectionCount-rate based method.	SAME
Resolution(Specification)	3 mm FWHM	2.5 mm FWHM (Better)
PerformanceData	Resolution(@1cm) : 2.6mm FWHMSensitivity (@0cm) : 3.7 cps/kBqNECR : 9.72 kcps@3.94 kBq/mL	Resolution(@1cm) : 2.4mm FWHMSensitivity (@0cm) : 7.2 cps/kBqNECR : 35.8 kcps@5.9 kBq/mL
PowerSource	AC Line	SAME

1. Performance Testing Information (Bench testing)
- a. Electrical Safety Testing was done in accordance with IEC 60601-1 Edition 3.2 2020-08 CONSOLIDATED VERSION Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, FDA Recognition 19-49
- b. EMC Testing was done in accordance with IEC 60601-1-2 Edition 4.1 2020-09 CONSOLIDATED VERSION Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard, FDA Recognition 19-36.
- c. Performance testing was done in compliance with NEMA Standards Publication NU 2-2018 Performance Measurements of Positron Emission Tomographs (PETS) FDA Recognition 12-326
- d. Performance testing was done according to the FDA Guidance Document: Guidance for the Submission of Premarket Notifications for Emission Computed Tomography Devices and Accessories (SPECT and PET) and Nuclear Tomography Systems
1. Clinical Performance Test: A clinical reader study using the SET-5002 was conducted at U.S. clinical site. The study included review by board certified radiologist to assess whether overall image quality of the SET-5002 demonstrated acceptable diagnostic results for brain and breast. The board-certified radiologist reviewed 12 brain images and 6 breast images, providing PET imaging findings related to the progression of dementia, tumor detection, and the extent of spread. The results of the reader study support the determination of substantial equivalence with predicate device. A reader attested that her

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assessments of image quality of the SET-5002 demonstrated acceptable diagnostic results.

1. Conclusion: The performance testing data supports the safety of the device and the validation testing demonstrate that new device should performs as intended in the specified use. Based on our risk analysis and bench testing, the differences do not affect its clinical safety or effectiveness. From the result of our risk analysis, software verification and testing discussed above, it is our conclusion that the SET-5002 device is substantially equivalent to the legally marketed predicate devices. Therefore, new device is as safe, as effective, and performs as well as or better than 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.