uDR 380i Pro is a mobile digital radiography device intended to acquire X-ray images of the human anatomy for medical diagnosis. uDR 380i Pro can be used on both adult and pediatric patient by a qualified and trained operator. This device is not intended for mammography.

Device Description

uDR 380i Pro is a diagnostic mobile x-ray system utilizing digital radiography (DR) technology. It can be moved to different environments for an examination, like emergency room. ICU and ward. It mainly consists of a lifting column - telescopic cantilever frame system, system motion assembly, X-ray System (high voltage generator, x-ray tube, collimator and wireless flat panel detectors which have been cleared in K170332 and K192632), power supply system and software for acquiring and processing the clinical images.

uDR 380i Pro is intended to acquire X-ray images for both adult and pediatric, especially for person who may not be able to be moved to a traditional RAD room. The system offers:

A 14"×17" or 14"×14" flat panel detector
. A high-power, 32 kW or 50kW generator
A maneuverable drive system
X-ray tube-collimator assembly with flexible movement
Storage for detectors and supplies
Image Acquisition Workstation with touchscreen user interface

AI/ML Overview

I am sorry, but the provided text does not contain detailed information about the acceptance criteria or a study that proves the device meets specific acceptance criteria in the way you've outlined with performance metrics, sample sizes, expert qualifications, and adjudication methods.

The document is a 510(k) premarket notification for a medical device (uDR 380i Pro) and focuses on demonstrating substantial equivalence to a predicate device (Carestream DRX-Revolution). While it lists some technical specifications and claims that these differences do not raise new safety and effectiveness concerns, it does not present a formal study with acceptance criteria and reported device performance in the format you requested.

Here's a breakdown of what is available in the provided text in relation to your request:

1. A table of acceptance criteria and the reported device performance:

The document provides a "Comparison of Technological Characteristics with the Predicate Devices" table (pages 4-7) which lists various specifications for both the proposed device (uDR 380i Pro) and the predicate device (DRX-Revolution).
Instead of acceptance criteria, it provides the specifications of both devices and uses "Remark" notes (Note 1 to Note 13) to discuss any differences and justify why these differences do not raise new safety and effectiveness concerns.
For example, for "Maximum Output Power," the proposed device lists "32kW/ 50kW" compared to the predicate's "32kW." The remark states that the larger output power represents better capability and does not raise new safety and effectiveness concerns.
For "DQE" (Detective Quantum Efficiency), it states "Typical: 58% @3uGy,0.5lp/mm" for the proposed device and "Typical: 63% @2.5uGy,0.5lp/mm" for the predicate, noting that "Performance is similar" and "it did not raise new safety and effectiveness concerns."
This is a comparison for substantial equivalence, not a standalone performance study against pre-defined acceptance criteria.

2. Sample size used for the test set and the data provenance:

The document mentions a "Clinical Image Evaluation" on page 10. It states: "Sample image of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission."
However, it does not specify the sample size (number of images or cases) used for this evaluation.
The data provenance is not explicitly stated (e.g., country of origin, retrospective or prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

It states that "a board certified radiologist" was used.
It refers to "a board certified radiologist" (singular), implying one expert.
No specific experience level (e.g., 10 years of experience) is mentioned beyond "board certified."

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

The document states that "Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis."
This description points to a subjective review rather than a formal adjudication process (like 2+1 or 3+1 consensus). It sounds like a single radiologist's assessment.

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 MRMC comparative effectiveness study is mentioned. The device is a mobile X-ray system, not an AI-based diagnostic tool that assists human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

The device is a hardware system (mobile X-ray) with accompanying software for image acquisition and processing. It is not an algorithm for standalone diagnostic performance. Therefore, this question is not directly applicable in the context of this device. The "Clinical Image Evaluation" was about the image quality produced by the system for visual assessment by a radiologist.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

For the "Clinical Image Evaluation," the "ground truth" was the assessment of image quality by "a board certified radiologist" who determined if the images were "sufficient for clinical diagnosis." This falls under expert opinion/assessment of image quality rather than a definitive diagnosis established by other means like pathology or outcomes data.

8. The sample size for the training set:

The document does not mention any training set size because the submission is for a medical imaging device (hardware and software for image acquisition), not a machine learning or AI algorithm that requires a training set for its core function of interpretation or diagnosis.

9. How the ground truth for the training set was established:

As no training set is discussed or implied for the device's primary function, this information is not available.

In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on technical specifications and a general assessment of clinical image quality by a radiologist, rather than a detailed performance study against specific acceptance criteria for an AI-enabled diagnostic device.

Summary

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September 30, 2022

Shanghai United Imaging Healthcare Co., Ltd. % Xin Gao Regulatory Affairs Manager No. 2258 Chengbei Rd., Jiading Industrial District Shanghai, Shanghai 201807 CHINA

Re: K222339

Trade/Device Name: uDR 380i Pro Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile X-Ray System Regulatory Class: Class II Product Code: IZL Dated: July 30, 2022 Received: August 3, 2022

Dear Xin Gao:

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

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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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) 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,

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Imaging Devices and Electronic Products OHT8: Office of 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) K222339

Device Name uDR 380i Pro

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/1 description: The image contains the logo for United Imaging. The logo consists of the words "UNITED IMAGING" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized symbol that resembles a "U" shape with a vertical line running through the center. The color of the logo is a dark teal or blue-green.

510 (k) SUMMARY

Date of Preparation: 1. July 30, 2022
K222339

2. Sponsor Identification

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

Establishment Registration Number: 3011015597

Contact Person: Xin GAO Position: Regulatory Affairs Manager Tel: +86-021-67076888-5386 Fax: +86-021-67076889 Email: xin.gao@united-imaging.com

3. Identification of Proposed Device

Trade Name: uDR 380i Pro Common Name: Mobile Digital Medical X-ray Imaging System Model(s): uDR 380i Pro

Regulatory Information Classification Name: Mobile X-Ray System Classification: II Product Code: IZL Regulation Number: 21 CFR 892.1720 Review Panel: Radiology

4. Identification of Predicate Device(s)

Predicate Device

510(k) Number: K191025 Device Name: DRX-Revolution Mobile X-ray System Manufacturer: Carestream Health, Inc.

Regulatory Information

Classification Name: Mobile X-Ray System Classification: II Product Code: IZL Regulation Number: 21 CFR 892.1720 Review Panel: Radiology

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Image /page/4/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, dark teal font. To the right of the text is a stylized "U" shape, also in dark teal. The logo is simple and modern.

5. Device Description

uDR 380i Pro is intended to acquire X-ray images for both adult and pediatric, especially for person who may not be able to be moved to a traditional RAD room. The system offers:

A 14"×17" or 14"×14" flat panel detector
. A high-power, 32 kW or 50kW generator
A maneuverable drive system
X-ray tube-collimator assembly with flexible movement
Storage for detectors and supplies
Image Acquisition Workstation with touchscreen user interface

6. Indications for use

7. Comparison of Technological Characteristics with the Predicate Devices

A comparison between the technological characteristics of proposed and predicate devices is provided as below.

ITEM	Predicate Device:DRX-Revolution	Proposed Device:uDR 380i Pro	Remark
Product Code	IZL	IZL	Same
Regulation No.	21 CFR 892.1720	21 CFR 892.1720	Same
Class	II	II	Same
Indicationsfor Use	The device is designed toperform radiographic x-rayexaminations on allpediatric and adult patients,in all patient treatmentareas.	uDR 380i Pro is a mobiledigital radiography deviceintended to acquire X-rayimages of the humananatomy for medicaldiagnosis. uDR 380i Procan be used on both adult	Same
		and pediatric patient by aqualified and trainedoperator. This device is not
		intended formammography.
Specifications
	High Voltage Generator
MaximumOutput Power	32kW	32kw/ 50kW	Note 1
kV Range	40~150kV	40~150kV	Same
mA Range	25~400 mA	10~~400mA/ 10~~560mA	Note 2
mAs Range	0.1-320 mAs	0.1-630 mAs	Note 3
	X-ray Tube
Anode HeatContent	300kHU	300kHU	Same
Focus Size	0.6mm/ 1.2mm	0.6mm/ 1.2mm	Same
Anode TargetAngle	14°	14°	Same
	Collimator
MaximumLight Field	43cm × 43cm	43cm × 43cm	Same
AdjustmentMethod	Manual	Manual	Same
	Flat Panel Detector
Detector Size	17" × 17"/ 14" × 17"/ 10" ×12"	14" × 17"/ 11" × 14"	Note 4
ScintillatorMaterial	Cesium Iodide	Cesium Iodide	Same
Semiconductor Material	Amorphous Silicon	Amorphous Silicon	Same
Pixel Size	139µm	125µm	Note 5
DQE	Typical:63% @2.5uGy,0.5lp/mm	Typical:58% @3uGy,0.5lp/mm	Note 6
MTF	Typical: 61% @ 1lp/mmTypical: 32% @2lp/mm	Typical: 63% @ 1lp/mmTypical: 35% @2lp/mm	Note 7
Anti-scatter Grid
Grid size	350mm × 430mm	356mm × 445mm	Note 8
Grid ratio	8:1	8:1	Same
Telescoping Column
X-ray TubeAssemblyRVA	-180°~+180°	-315°~+315°	Note 9
X-Ray TubeAssemblyTilting Range	-20°~+90°	-30°~+90°	Note 10
Max.DistanceBetweenTube Focusand Ground	2058mm	2000mm	Note 11
Min. DistanceBetweenTube Focusand Ground	724mm	680mm	Note 12
Battery
BatteryCapacity	2.88kWh	2.40kWh	Note 13
Image Acquisition Workstation
Display Size	19"	19"	Same
Disk Size	500GB	500GB	Same
Software function
ImageExport/Import	Yes	Yes	Same
ImageViewing	Yes	Yes	Same
ImageMeasurement	Yes	Yes	Same
ImageAnnotation	Yes	Yes	Same
Image Post-processing	Yes	Yes	Same
Virtual grid	Yes	Yes	Same
Accessory	Badge Reader	Yes	Yes	Same
Safety
ElectricalSafety	Comply with AAMIES60601-1:2005 +C1;A2:2012	Comply with AAMIES60601-1:2005 +C1:A2:2012	Same
EMC	Comply with IEC60601-1-2:2014	Comply with IEC60601-1-2:2014	Same

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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" stacked on top of each other in a bold, sans-serif font. To the right of the text is a stylized "U" symbol, which is also in a bold, sans-serif font. The logo is simple and modern, and the use of bold fonts gives it a strong and confident look.

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Image /page/6/Picture/1 description: The image contains the logo for United Imaging. The text "UNITED IMAGING" is in bold, sans-serif font, stacked on top of each other. To the right of the text is a stylized "U" symbol, which is dark gray and has a white horizontal line through the middle.

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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" symbol, which is dark teal in color and has a white vertical line running through the center.

Biocompatibility	Comply with ISO10993-5:2009 and ISO10993-10:2010	Comply with ISO10993-5:2009 and ISO10993-10:2010	Same
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	Justification
Note 1	The proposed device has two kinds of maximum output. One is same withthe predict device, one is larger than the predict device. Larger maximumoutput power represents better capability at generating higher mA or kVlevel in X-ray. When operated under the intended use, increasing mA or kVcan achieve the same dose/signal level with shorter exposure time. Thedifference did not raise new safety and effectiveness concerns.
Note 2	The proposed device has two kinds of mA range. One is larger than thepredict device. Larger mA range (10~~560mA compare to 25~~400mA)represents better capability at generating higher mA level in X-ray. Whenoperated under the intended use, increasing mA can achieve the samedose/signal level with shorter exposure time. The difference did not raisenew safety and effectiveness concerns.
Note 3	The proposed device has a larger mAs Range than the predict device. LargermAs Range can meet the clinical demand for high dose exposure of peoplewith larger body thickness. The different range of mAs did not raise newsafety and effectiveness concerns.
Note 4	The proposed device does not have a 17" x 17" detector. However, the14*17 board can cover any parts that need to be inspected, and it is also asize commonly used in clinical practice. The 11" x 14" detector size islarger than 10" x 12", which allows it to better cover all detection needs ofthe infant. In addition, the 11" x 14" detector can meet the size of the crib.The different size of detector did not raise new safety and effectivenessconcerns.
Note 5	The pixel size of the proposed device is smaller than that of the predictdevice. Smaller pixel size, better capability at generating higher spatialresolution X-ray images. The different pixel size of detector did not raisenew safety and effectiveness concerns.
Note 6	DQE of the proposed device and predict device was test under differentcondition. Performance is similar. When operated under the intended use, itdid not raise new safety and effectiveness concerns.
Note 7	MTF of the proposed device is better than that of the predict device. When operated under the intended use, it did not raise new safety and effectiveness concerns.
Note 8	The grid size of the proposed device is larger than that of the predict device and can fully cover its detector. When operated under the intended use, it did not raise new safety and effectiveness concerns.
Note 9	The X-ray tube assembly RVA range of the proposed device is larger than that of the predict device. Larger range, better X-ray tube assembly positioning capability. When operated under the intended use, it did not raise new safety and effectiveness concerns.
Note 10	The X-ray tube assembly tilting range of the proposed device is larger than that of the predict device. Larger range, better X-ray tube assembly positioning capability. When operated under the intended use, it did not raise new safety and effectiveness concerns.
Note 11	The maximum distance between the tube focus and ground of the proposed device is shorter than that of the predict device, however the height can satisfy its intended use. So it did not raise new safety and effectiveness concerns.
Note 12	The minimum distance between the tube focus and ground of the proposed device is shorter than that of the predict device. Shorter distance, better X-ray tube assembly positioning capability. When operated under the intended use, it did not raise new safety and effectiveness concerns.
Note 13	The battery capacity of the proposed device is lower than that of the predict device. However, it can satisfy the requirement of clinical use, thus it did not raise new safety and effectiveness concerns.

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Image /page/8/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" symbol, which is also in a bold, sans-serif font. The color of the text and the "U" symbol is a dark teal.

8. Performance Date

Non-Clinical Testing

Non clinical tests were conducted to verify that the proposed device met all design specifications as it is Substantially Equivalent (SE) to the predicate device. UNITED IMAGING HEALTHCARE claims conformance to the following standards and guidance:

Electrical Safety and Electromagnetic Compatibility (EMC)

ANSI AAMI ES60601-1:2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A A2:2010/(R)2012, Medical electric for basic safety and essential performance

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Image /page/9/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. The logo is simple and modern in design.

(IEC 60601-1:2005, MOD).

IEC 60601-1-2: 2014, Edition 4.0, Medical electrical equipment Part 1-2: A General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests.
A IEC 60601-1-3: 2008+AMD1:2013, Edition 2.1, Medical electrical equipment -Part 1-3: General requirements for basic safety and essential performance -Collateral Standard: Radiation protection in diagnostic X-ray equipment.
A IEC 60601-2-54: 2009 +A1:2015+A2:2018, Edition 1.2, Medical electrical equipment - Part 2-54: Particular requirements for the basic safety and essential performance of X-ray equipment for radiography and radioscopy.
IEC 60825-1: 2007+COR1:2008, Edition 2.0, Safety of laser products - Part 1: Equipment classification and requirements.IEC 60601-1-6:2010+A1:2013, Edition 3.1, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability.
IEC 62366-1:2015/COR1:2016 Medical devices - Part 1: Application of usability engineering to medical devices
A IEC 62304: 2006+A1:2015, Edition 1.1, Medical device software - Software life cycle processes.

Biocompatibility

A ISO 10993-5: 2009, Edition 3.0, Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity.
ISO 10993-10: 2010, Edition 3.0, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization.

Software

NEMA PS 3.1-3.20(2016): Digital Imaging and Communications in Medicine (DICOM)
Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices
Content of Premarket Submissions for Management of Cybersecurity in Medical Devices

Other Standards and Guidance

A ISO 14971: Medical Devices - Application of risk management to medical devices
A Code of Federal Regulations, Title 21, Part 820 - Quality System Regulation
A FDA guidance, Pediatric Information for X-ray Imaging Device Premarket Notifications.

Performance Verification

Code of Federal Regulations, Title 21, Part 1020 Performance standards for A

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Image /page/10/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 letter "U" with a vertical line running through the center, creating a negative space "I" shape. The color of the text and symbol is a dark teal or blue-gray.

ionizing radiation emitting products

Clinical Image Evaluation

The clinical image evaluation was performed under the proposed device. Sample image of Head, chest, abdomen, spine, pelvis, upper extremity and lower extremity were provided with a board certified radiologist to evaluate the image quality in this submission. Each image was reviewed with a statement indicating that image quality are sufficient for clinical diagnosis.

9. Conclusions

Based on the comparison and analysis above, the proposed device uDR 380i Pro has the equivalent intended use, safety and effectiveness as the predicate device Carestream DRX-Revolution. The differences in technical specifications between the proposed device and the predicate devices do not negatively affect the system's safety and effectiveness. The proposed device uDR 380i Pro is determined to be Substantially Equivalent (SE) to the predicate device Carestream DRX-Revolution.

Regulation Number and Section

§ 892.1720 Mobile x-ray system.

(a)
Identification. A mobile x-ray system is a transportable device system intended to be used to generate and control x-ray for diagnostic procedures. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.