The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, restaging, treatment planning and treatment response evaluation for diseases and disorders in, but not limit to, oncology, cardiology and neurology.

Device Description

The uMI 550 PET/CT system is a combined multi-slice X-Ray Computed Tomography and Positron Emission Tomography scanner. This system is intended to be operated by qualified healthcare professionals for performing diagnostic imaging examinations. The spatial alignment and precise image registration between PET and CT ensure the PET and CT images of the same region can be fused accurately for reading. PET measures the distribution of PET radiopharmaceuticals inside the human body quantitatively. CT produces the anatomical information of the same scanned region, and provides accurate localization for the findings in the PET images. The attenuation information contained in the CT images can be utilized in the PET image reconstruction to ensure quantitation accuracy. The PET system has time-of-flight capability with a timing resolution of 395ps. It has a 240mm-long axial field of view (FOV) and a system sensitivity ~11cps/kBq.

The uMI 550 PET/CT system also includes a patient table, a workstation with associated software installed. The software is used for patient management, data management, scan control, image reconstruction and image reading. All patient images produced by the system conform to the DICOM 3.0 standard.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (uMI 550 PET/CT System) and primarily focuses on demonstrating substantial equivalence to a predicate device (uMI 780). It outlines technical specifications, intended use, and general safety/performance testing.

However, the document specifically states: "No Clinical Study is included in this submission." This means that a clinical study proving the device meets specific performance acceptance criteria based on human-in-the-loop or standalone AI performance, as outlined in the questions, was not conducted or presented in this submission.

Therefore, many of the requested details, such as acceptance criteria met by a specific study, sample sizes for test sets, expert involvement for ground truth, adjudication methods, MRMC studies, standalone AI performance, and ground truth establishment for clinical data, cannot be extracted from this document, as a clinical study was not performed for this submission.

The document focuses on non-clinical testing, electrical safety, electromagnetic compatibility, and conformance to various industry standards for imaging performance, software, biocompatibility, and risk management to demonstrate substantial equivalence to a predicate device.

Based on the provided text, here's what can be answered:

1. A table of acceptance criteria and the reported device performance
The document does not present specific acceptance criteria in the format of pass/fail clinical thresholds or a table demonstrating performance against such criteria. It lists technical specifications for the PET and CT components and states conformance to various electrical safety, EMC, and imaging performance standards. It mentions "The testing results show that all the software specifications have met the acceptance criteria" in relation to software verification and validation, but these specific criteria or results are not detailed.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. No clinical test set data from a clinical study is provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No clinical test set and thus no experts establishing ground truth for such a set are mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No clinical test set requiring adjudication is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No. The document explicitly states: "No Clinical Study is included in this submission." Therefore, no MRMC study was conducted or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
No. The document explicitly states: "No Clinical Study is included in this submission." Therefore, no standalone performance evaluation of an algorithm (likely AI, though the document doesn't detail AI components beyond general "software") was conducted or reported here. The device itself is an imaging system, not an AI algorithm for image interpretation.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. As no clinical study was performed, there's no mention of ground truth for patient data. The ground truth for non-clinical performance (e.g., image quality, system calibration) would be based on phantoms and physical measurements, and conformance to industry standards like NEMA NU 2-2012.

8. The sample size for the training set
Not applicable. No AI algorithm requiring a training set is discussed or evaluated in terms of its performance in a clinical setting.

9. How the ground truth for the training set was established
Not applicable. As no AI algorithm and training set are discussed, how ground truth for such a set was established is not relevant to this submission.

In summary, this 510(k) submission for the uMI 550 PET/CT System relies on demonstrating substantial equivalence to a predicate device (uMI 780) through non-clinical performance data (phantom studies, electrical safety, EMC, software validation, etc.) and conformance to relevant industry standards, rather than through a clinical study that evaluates human reader performance or AI algorithm performance.

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). The logo consists of two parts: the Department of Health & Human Services seal on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name, "U.S. Food & Drug Administration," written in a clear, sans-serif font.

Shanghai United Imaging Healthcare Co., Ltd. Shumei Wang Qm & RA VP No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, 201807 Cn

October 12, 2018

Re: K182237

Trade/Device Name: uMI 550 PET/CT System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: Class II Product Code: KPS, JAK Dated: August 16, 2018 Received: August 17, 2018

Dear Shumei Wang:

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

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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 devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara For

Robert A. Ochs, Ph.D. 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)

K182237

Device Name uMI 550

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
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X 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/1 description: The image contains the logo for United Imaging. The words "UNITED IMAGING" are stacked on top of each other in a bold, sans-serif font. To the right of the words is a stylized logo that appears to be a combination of the letters "U" and "I". The logo is a dark color, possibly dark blue or gray, and the background is white.

510(k) SUMMARY

1. Date of Preparation: August 16, 2018

2. Sponsor Identification

Shanghai United Imaging Healthcare Co.,Ltd. No.2258 Chengbei Rd. Jiading District, 201807, Shanghai, China

Contact Person: Shumei Wang Position: QM&RA VP Tel: +86-021-67076888-6776 Fax: +86-021-67076889 Email: shumei.wang@united-imaging.com

3. Identification of Proposed Device

Trade Name: uMI 550 Common Name: Emission Computed Tomography System

Model(s): uMI 550

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

4. Identification of Predicate Device(s)

Predicate Device

510(k) Number: K172143 Device Name: uMI 780 Model(s): uMI 780

Regulatory Information Regulation Number: 21 CFR 892.1200 Regulation Name: Emission Computed Tomography System Regulatory Class: II Product Code: KPS, JAK, Review Panel: Radiology

1. Device Description

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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in a bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is also in a bold font. The logo is simple and modern, and the use of a bold font gives it a strong and confident look.

6. Indications for Use

The uMI 550 PET/CT is a diagnostic imaging system that combines two existing imaging modalities - PET and CT. The quantitative distribution information of PET radiopharmaceuticals within the patient body measured by PET can assist healthcare providers in assessing the metabolic and physiological functions. CT provides diagnostic tomographic anatomical information as well as photon attenuation information for the scanned region. The accurate registration and fusion of PET and CT images provides anatomical reference for the findings in the PET images.

This system is intended to be operated by qualified healthcare professionals to assist in the detection, localization, diagnosis, staging, treatment planning and

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Image /page/5/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized symbol that resembles a shield or a stylized letter "U" with a white line running vertically through the center, creating a negative space that looks like the letter "I".

treatment response evaluation for diseases and disorders in, but not limit to, oncology,

cardiology and neurology.

7. Comparison of Technological Characteristics with the Predicate Devices

The uMI 550 PET/CT has the same indications for use as the predicate device uMI 780 PET/CT. The fundamental scientific technology of the proposed device is same as the predicate device.

Table 1 below provides a comparison of the technological characteristics of the proposed device in comparison to the predicate device.

ITEM	Proposed Device	Predicate Device
Product Code	KPS, JAK	KPS, JAK
Regulation No.	21 CFR 892.1200	21 CFR 892.1200
Class	Class II	Class II
Intended Use	The uMI 550 PET/CT isa diagnostic imagingsystem that combines twoexisting imagingmodalities - PET and CT.The quantitativedistribution informationof PETradiopharmaceuticalswithin the patient bodymeasured by PET canassist healthcareproviders in assessing themetabolic andphysiological functions.CT provides diagnostictomographic anatomicalinformation as well asphoton attenuationinformation for thescanned region. Theaccurate registration andfusion of PET and CTimages providesanatomical reference forthe findings in the PETimages.	The uMI 780 PET/CT isa diagnostic imagingsystem that combinestwo existing imagingmodalities - PET andCT. The quantitativedistribution informationof PETradiopharmaceuticalswithin the patient bodymeasured by PET canassist healthcareproviders in assessingthe metabolic andphysiological functions.CT provides diagnostictomographic anatomicalinformation as well asphoton attenuationinformation for thescanned region. Theaccurate registration andfusion of PET and CTimages providesanatomical reference forthe findings in the PETimages.
	This system is intendedto be operated byqualified healthcareprofessionals to assist inthe detection,localization, diagnosis,staging, restaging,treatment planning andtreatment responseevaluation for diseasesand disorders in, but notlimit to, oncology,cardiology andneurology.	This system is intendedto be operated byqualified healthcareprofessionals to assist inthe detection,localization, diagnosis,staging, restaging,treatment planning andtreatment responseevaluation for diseasesand disorders in, but notlimit to, oncology,cardiology andneurology.
PET Specification
Sensitivity	>/=10cps/kBq	>/=15cps/kBq
NECR PeakValue	>/=90 kcps@13kBq/cc	>/=165kcps@16kBq/cc
Peak True CountRate	>/=300kcps@27kBq/cc	>/=500kcps@30kBq/cc
PET ScatterFraction	=0.44</td =0.44</td
Count Rate Bias	=±5%</td =±5%</td
AxialFWHM@1cm	=3.5mm</td =3.5mm</td
TransaxialFWHM@1cm	=3.5mm</td =3.5mm</td
AxialFWHM@10cm	=4.0mm</td =4.0mm</td
TransaxialFWHM@10cm	=4.0mm</td =4.0mm</td
CT Specification
Scan Regime	Continuous Rotation	Continuous Rotation
Scan Modes	TopoAxial ScanHelical Scan	TopoAxial ScanHelical Scan
Z-plane coverage	22mm	40mm
Number ofdetector row	40	80
Minimum slicethickness	0.55mm	0.5mm
Rotation speed	Up to 0.5 sec per 360°rotation	Up to 0.3 sec for 360°rotation
Table Maximumtable load	250kg	250kg
Safety
Biocompatibility	Comply with ISO 10993-5,ISO 10993-10	Comply with ISO 10993-5,ISO 10993-10
Electrical Safety	Comply with ANSI AAMI ES60601-1	Comply with ANSI AAMI ES60601-1
EMC	Comply with IEC 60601-1-2	Comply with IEC 60601-1-2

Table 1 Comparison of Technological Characteristics

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Image /page/7/Picture/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" shape, which is dark gray. Inside the "U" shape is a horizontal white line.

8. Performance Data

The following performance data were provided in support of the substantial equivalence determination.

Non-Clinical Testing

Non-clinical testing including dosimetry and image performance tests were conducted for the uMI 550 during the product development.

UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Electrical Safety and Electromagnetic Compatibility (EMC)

Electrical Safety and Electromagnetic Compatibility (EMC) testing were conducted on the uMI 550 in accordance with the following standards:

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005, MOD)
A IEC 60601-1-2 Edition 4.0 2014-02 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
IEC 60601-2-44 Edition 3.2: 2016 Medical electrical equipment - Part 2-44: Particular requirements for the basic safety and essential performance of x-ray equipment for computed tomography
IEC 60825-1 Edition 2.0 2007-03 Safety of laser products - Part 1: Equipment classification, and requirements [Including: Technical Corrigendum 1 (2008), Interpretation Sheet 1 (2007), Interpretation Sheet 2 (2007)]

Product Particular Standards

IEC 60601-1-3 Edition 2.1 2013-04 Medical electrical equipment Part 1-3: General A requirements for basic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
A IEC 61223-3-5 First edition 2004-08 Evaluation and routine testing in medical imaging departments - Part 3-5: Acceptance tests -Imaging performance of computed tomography X-ray equipment [Including: Technical Corrigendum 1 (2006)]
A NEMA XR 25-2010: Computed Tomography Dose Check

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A NEMA XR 28-2013 Supplemental Requirements for User Information and System Function Related to Dose in CT
A NEMA XR 29-2013: Standard Attributes on CT Equipment Related to Dose Optimization and Management

Performance Verification

NEMA NU 2-2012 Performance Measurements of Positron Emission Tomographs A
Clinical Evaluation for sample clinical images evaluation; A
A AEC Test Report for AEC performance study.

Software

NEMA PS 3.1-3.20(2011): Digital Imaging and Communications in Medicine A (DICOM)
A IEC 62304: Medical Device Software - software life cycle process
A Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Biocompatibility

ISO 10993-10 Third Edition 2010-08-01 Biological evaluation of medical devices -A Part 10: Tests for irritation and skin sensitization
ISO 10993-5 Third edition 2009-06-01 Biological evaluation of medical devices -Part 5: Tests for in vitro cytotoxicity

Other Standards and Guidances

ISO 14971: Medical Devices Application of risk management to medical devices A
A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
A Code of Federal Regulations, Title 21, Subchapter J - Radiological Health
A Laser Products - Conformance with IEC 60825-1 and IEC 60601-2-22; Guidance for Industry and FDA Staff (Laser Notice No. 50)
Provision for Alternate Measure of the Computed Tomography Dose Index (CTDI) to Assure Compliance with the Dose Information Requirements of the Federal Performance Standard for Computed Tomography

Software Verification and Validation

Software documentation for a Moderate Level of Concern software per FDA' Guidance Document "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" is included as a part of this submission.

The risk analysis was completed and risk control was implemented to mitigate identified hazards. The testing results show that all the software specifications have met the acceptance criteria. Verification and validation testing of the proposed device was found acceptable to support the claim of substantial equivalence.

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UNITED IMAGING HEALTHCARE conforms to the Cybersecurity requirements by implementing a process of preventing unauthorized access, modification, misuse or denial of use, or unauthorized use of information that is stored, accessed, or transferred from a medical device to an external recipient. Cybersecurity information in accordance with guidance document "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices" is included in this submission.

Clinical Testing

No Clinical Study is included in this submission.

Summary

The features described in this premarket submission are supported with the results of the testing mentioned above, the uMI 550 was found to have a safety and effectiveness profile that is similar to the predicate device.

9. Conclusions

Based on the comparison and analysis above, the proposed device has same intended

use, similar performance, equivalence safety and effeteness as the predicate device.

The differences above between the proposed device and predicate device do not

affect the intended use, technology characteristics, safety and effectiveness. And no

issues are raised regarding to safety and effectiveness. The proposed device is

determined to be Substantially Equivalent (SE) to the predicate device.

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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.