The Combined High Frequency X-ray Source is intended for use by a qualified/trained technician on both adult and pediatric subjects for body extremities and cervical spine exclusively. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position. (Not for mammography)

Device Description

PSM-PD series combined high frequency X-ray source is an advanced high frequency X-ray source, which is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The product is small in size, light in weight and high in power density, which can meet the needs of outdoor portability. At the same time, we provide battery-powered solutions to meet customers' diversified demands for product functions.

AI/ML Overview

This document is a 510(k) summary for a Combined High Frequency X-ray Source (Model: PSM-PD series). It describes the device, its intended use, and a comparison to a predicate device (Sedecal SPL-HF-4.0 and SPL-HF-2.0, K103522) to demonstrate substantial equivalence.

The content focuses on the technical specifications and safety performance of the X-ray source itself, rather than the diagnostic accuracy of an AI-powered medical image analysis device. Therefore, a study demonstrating device performance against specific clinical acceptance criteria, as one would expect for an AI algorithm, is not present in this document.

The "device" in this context is an X-ray generator, a component of an X-ray system. The performance data presented (electrical safety, EMC, software V&V, mechanical/acoustic testing) are engineering validation tests to ensure the hardware and its embedded software function correctly and safely, and meet relevant industry standards. They are not clinical studies for diagnostic accuracy.

Therefore, for aspects relevant to AI-powered medical image analysis (like sample size, ground truth establishment by experts, MRMC studies, standalone performance), the document states "Clinical images are not necessary to demonstrate substantial equivalence, based on the nature of the device (an x-ray generator) and on close similarities to the predicate system. Successful Bench Testing results should be sufficient to show device safety and effectiveness."

Here's a breakdown based on your request, highlighting what is (and isn't) available in this document given the nature of the device:

Acceptance Criteria and Device Performance (as an X-ray Source)

The acceptance criteria are not explicitly listed in a single table but are implied by the performance requirements and standard compliance mentioned. The "reported device performance" is essentially the statement of compliance with these standards and the verification that the device meets its design specifications.

Table of Acceptance Criteria (Implied from Performance Requirements) and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria (Implied)	Reported Device Performance (Compliance Statement)
Electrical Safety	Compliance with IEC 60601-1 and IEC 60601-2-54.	The device complies with IEC 60601-1, IEC 60601-1-3, and IEC 60601-2-54 standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2.	The device complies with IEC 60601-1-2 standard for EMC.
X-ray Tube Voltage	Regulation Range: 40kV~125kV, 1kV step size, tube voltage can be set according to power.	PSM-PD5.6CPL/CPLG, PSM-PD5.6CPE/CPEG, PSM-PD4CPL/CPLG, PSM-PD4CPE/CPEG, PSM-PD3.5CPL/CPLG, PSM-PD3.5CPE/CPEG all have a tube voltage regulation range of 40kV~125kV.
	Deviation: $\pm$(3%+1kV)	Verified by third-party registration testing to meet requirements. (Implicitly within this deviation).
X-ray Tube Current	Regulation Range: (Model-dependent) PSM-PD3.5CPL/CPLG: 5-63mA; PSM-PD4CPL/CPLG: 5-80mA; PSM-PD5.6CPL/CPLG: 5-100mA. Increasing according to R'20 number system (specific data listed).	The stated ranges are the device's performance. The R'20 number system is used.
	Deviation: $\pm$(4%+1mA)	Verified by third-party registration testing to meet requirements. (Implicitly within this deviation).
Loading Time	Regulation Range: 1ms~10000ms, increasing according to R'20 number system (specific data listed).	The stated ranges are the device's performance. The R'20 number system is used.
	Deviation: not greater than $\pm$(2%+0.2ms) @ >5ms; $\pm$(5%+1ms) @ $\le$5ms. "controlled within the scope of the international standard requirements."	Verified by third-party registration testing to meet international standard requirements.
Current Time Product (mAs)	Regulation Range: 0.1-320mAs, increasing according to R'20 number system (specific data listed).	The stated ranges are the device's performance. The R'20 number system is used.
	Deviation: $\pm$(5%+0.1mAs)	Verified by third-party registration testing to meet requirements. (Implicitly within this deviation).
Operating Frequency	Maximum operating frequency: 300kHz $\pm$20kHz.	The device performance is 300kHz $\pm$20kHz.
Functional Requirements	Exposure technology modes (mA/ms, mAs, mAs/ms), Fault diagnosis and prompt (active handbrake release error, oil tank temperature exceed limit error).	Device has mA/ms, mAs, mAs/ms modes. System prompts for handbrake release during exposure and oil tank over-temperature.
Software V&V	Compliance with "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." Software level of concern "Moderate" (failure could indirectly result in minor injury). Software functions: basic data configuration, exposure parameter setting (mode, filament, tube voltage, current, loading time, mAs), information indication and fault prompt.	Software verification and validation testing were conducted, and documentation was provided. Verified by internal tests and third-party registration tests to meet requirements of clinical application.
Cybersecurity	Data interface: RS-232 output for communication. Evaluation for cybersecurity.	Device has an RS-232 interface. "The subject device have been tested and evaluated for cybersecurity."
Mechanical/Acoustic Testing	Acoustic Testing, Elongation of bending cable, Crimp assembly, cable tensile strength, cable flexibility, minimum bending radius, simulated use testing.	These tests were conducted. (Implicitly, the device passed, though specific results are not detailed).
Other Operational Conditions	Temperature: 0~~35°C (AC supply), 0~~40°C (battery discharging). Relative Humidity: 95%, non-condensing. Atmospheric Pressure: 700hPa~1060hPa.	The device is designed to operate within these ranges.

Regarding the other specific points of your request for AI-powered device studies:

Sample size used for the test set and the data provenance: Not applicable. This is not a study assessing diagnostic performance on a test set of images.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for diagnostic accuracy is not established for this device as it is an X-ray generator.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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: Not applicable. This device does not involve AI assistance for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the context of diagnostic accuracy. The "ground truth" for this device refers to physical and electrical specifications verified by bench testing and compliance with engineering standards.
The sample size for the training set: Not applicable. This device is a hardware component with embedded control software, not a machine learning model that undergoes "training."
How the ground truth for the training set was established: Not applicable.

In summary: This 510(k) submission for an X-ray source focuses on demonstrating substantial equivalence to a predicate device through detailed comparison of technical characteristics, safety standards compliance, and engineering validation (bench testing, software V&V, electrical and mechanical performance). It is not a clinical study assessing the diagnostic performance of an AI-enabled medical image analysis device. Therefore, many of the requested details regarding AI study design are not present in this document.

Summary

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November 1, 2022

Suzhou Powersite Electric Co., Ltd. % Xinyue Lu Regulatory Engineer Building 5, No.188 Fuchunjiang Road, Suzhou New District Suzhou. Jiangsu Province 215151 CHINA

Re: K222258

Trade/Device Name: Combined High Frequency X-ray Source Regulation Number: 21 CFR 892.1720 Regulation Name: Mobile x-ray system Regulatory Class: Class II Product Code: IZL Dated: July 18, 2022 Received: September 6, 2022

Dear Xinyue Lu:

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

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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 (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

Laurel Burk, Ph.D. Assistant Director Diagnostic X-Ray Systems Team DHT8B: Division of Radiological 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) K22258

Device Name Combined High Frequency X-ray Source

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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510(k) Summary

510(k) Submission Number: K222258

I. SUBMITTER

Suzhou Powersite Electric Co., Ltd Building 5, No.188 Fuchunjiang Road, Suzhou New District, Suzhou, Jiangsu Province, PEOPLE'S REPUBLIC OF CHINA

Phone: +86-0512-62913368

Contact Person: Yanyan Cui Phone: +86-13771842733 E-mail: may cui@powersite-group.com

Primary correspondent Name: Xinyue Lu Title: Regulatory Engineer Phone: +86-13722611742 E-mail: xinyue lu@powersite-group.com

Date Prepared: June 15, 2022

II. DEVICE

Name of Device: Combined High Frequency X-ray Source Model: PSM-PD5.6CPL, PSM-PD5.6CPLG, PSM-PD4CPL, PSM-PD4CPLG, PSM-PD3.5CPL, PSM-PD3.5CPLG, PSM-PD5.6CPE, PSM-PD5.6CPEG, PSM-PD4CPE, PSM-PD4CPEG, PSM-PD3.5CPE, PSM-PD3.5CPEG Common or Usual Name: Combined High Frequency X-ray Source Classification Name: System, X-Ray, Mobile (21 CFR 892.1720) Regulatory Class: II Product Code: IZL Regulation Medical Specialty: Radiology

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III. PREDICATE DEVICE

Device Classification Name: system, x-ray, mobile 510(k) Number: K103522 Device Name: SEDECAL Proprietary-Trade Name: Sedecal SPL-HF-4.0 (and SPL-HF-2.0) Common/Usual Name: Mobile Diagnostic X-Ray System Applicant: SEDECAL S.A. 8870 RAVELLO NAPLES, FL 34114 Regulation Name and Number: 21 CFR 892.1720 Device Class: 2 Classification Product Code: IZL Requlation Medical Specialty: Radiology

This predicate has not been subject to a design-related recall. No reference devices were used in this submission.

IV. DEVICE DESCRIPTION

The working flow of combined high-frequency X-ray source is as follows:

Input single-phase alternating current, through the filter circuit, reduce the influence of 1) harmonics on mains power supply, APFC circuit will change AC into DC, improve the power factor of the product, through the filter circuit to reduce AC ripple.

The DC inverter is converted into high-frequency alternating current by the inverter, and 2) the high-frequency low voltage is boosted into high-frequency high voltage by the boost transformer, and the AC is converted into high-voltage DC by the voltage multiplier, and finally the smooth high voltage is loaded at both ends of the ball tube through filtering.

Set different parameters and working modes through DSP+FPGA control unit.
Provide serial communication and wireless remote control functions.

Provide LCD operation and upper computer software control of two parameters, working 5) mode setting.

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Our company provides Combined High Frequency X-ray Source to the complete machine manufacturer. Then the complete machine manufacturers assemble the complete machine with our product and sell the complete machine to the hospital or others.

The associated consumables include:

. Mains power supply cord
. Hand switch control line
Serial port transfer wiring .
. Fuse(0215016.MXP)
Fuse(8020.0604) .
. Cross countersunk head screw(SUS304, M3*6)
Cross flat head screw(SUS304, M3*8, head diameter 6mm) .
USB flash disk .
Automatic test report .

V. INDICATIONS FOR USE

The Indications for Use statement for the Powersite device is not identical to the predicate device; however, the differences do not alter the intended diagnostic use of the device nor do they affect the safety and effectiveness of the device relative to the predicate. Both the subject and predicate devices have the same intended use for X-ray photography of human limb joints and cervical spine in emergency rescue occasions, by cooperating with X-ray imaging device.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE

PREDICATE DEVICE

At a high level, the subject and predicate devices are based on the following same technological elements:

The working flow of combined high-frequency X-ray source is as follows:

Input single-phase alternating current, through the filter circuit, reduce the influence of 1) harmonics on mains power supply, APFC circuit will change AC into DC, improve the power

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factor of the product, through the filter circuit to reduce AC ripple.

The DC inverter is converted into high-frequency alternating current by the inverter, and the high-frequency low voltage is boosted into high-frequency high voltage by the boost transformer, and the AC is converted into high-voltage DC by the voltage multiplier, and finally the smooth high voltage is loaded at both ends of the ball tube through filtering.
Set different parameters and working modes through DSP+FPGA control unit.
Provide serial communication and wireless remote control functions.

Provide LCD operation and upper computer software control of two parameters, working 5) mode setting.

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The following technological differences exist between the subject and predicate devices:

Table 1 Comparison Table

Comparisonitem	The subject product	The predicate device(K103522)	Difference	Overview ofsupportingmaterials
Common/UsualName of Device	Combined High Frequency X-ray Source	Mobile Diagnostic X-ray System	SE	User manual
ModelSpecification	PSM-PD5.6CPL、PSM-PD5.6CPLG、PSM-PD4CPL、PSM-PD4CPLG、PSM-PD3.5CPL、PSM-PD3.5CPLG、PSM-PD5.6CPE、PSM-PD5.6CPEG、PSM-PD4CPE、PSM-PD4CPEG、PSM-PD3.5CPE、PSM-PD3.5CPEG	Sedecal SPL-HF-4.0 (and SPL-HF-2.0)	SE	User manual
Indications foruse	The Combined High Frequency X-raySource is intended for use by aqualified/trained technician on both adultand pediatric subjects for body extremitiesand cervical spine exclusively. Applicationscan be performed with the patient sitting,standing, or lying in the prone or supineposition. (Not for mammography)	Intended for use by a qualified/traineddoctor or technician on both adult andpediatric subjects for taking diagnosticradiographic exposures of the skull,spinal column, chest, abdomen,extremities, and other body parts.Applications can be performed with thepatient sitting, standing, or lying in theprone or supine position. (Not formammography)	SE	User manual
Basic principle(Working	The working flow of combined high-frequency X-ray source is as follows:	The working flow of combined high-frequency X-ray source is as follows:	SE	User manual
principle / Action mechanism)
1. Input single-phase alternating current,through the filter circuit, reduce theinfluence of harmonics on mains powersupply, APFC circuit will change AC intoDC, improve the power factor of theproduct, through the filter circuit to reduceAC ripple.2. The DC inverter is converted into high-frequency alternating current by theinverter, and the high-frequency low voltageis boosted into high-frequency high voltageby the boost transformer, and the AC isconverted into high-voltage DC by thevoltage multiplier, and finally the smoothhigh voltage is loaded at both ends of theball tube through filtering.3. Set different parameters and workingmodes through DSP+FPGA control unit.4. Provide serial communication andwireless remote control functions.5. Provide LCD operation and uppercomputer software control of twoparameters, working mode setting.	1. Input single-phase alternating current,through the filter circuit, reduce theinfluence of harmonics on mains powersupply, APFC circuit will change AC intoDC, improve the power factor of theproduct, through the filter circuit toreduce AC ripple.2. The DC inverter is converted intohigh-frequency alternating current by theinverter, and the high-frequency lowvoltage is boosted into high-frequencyhigh voltage by the boost transformer,and the AC is converted into high-voltage DC by the voltage multiplier, andfinally the smooth high voltage is loadedat both ends of the ball tube throughfiltering.3. Set different parameters and workingmodes through DSP+FPGA control unit.4. Provide serial communication andwireless remote control functions.5. Provide LCD operation and uppercomputer software control of twoparameters, working mode setting.	Difference:1) The structure	User manual
Structural composition	Combined High Frequency X-ray Source	The predicate device consists of the
	product consists of the control software(Release version: V1.0) and the host ofCombined High Frequency X-ray Source.The host of Combined High Frequency X-ray Source is mainly composed of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery.	control software and the host ofCombined High Frequency X-ray Source.The host of the predicate device is composed of a control panel with a display, a power module, a high voltage tank (TANK), a collimator, a handswitch, and a mobile column with an articulated arm and a cassette basket.	composition isdifferent. Thepredicate device isaccompanied with amobile column witharticulated arm andcassette basket,which the subjectdevice does nothave.
Basic parameter	1. AC power input100V~240VAC, ±10%50Hz/60Hz±1Hz	1. AC power input100~240VAC, ±10% VAC,50/60Hz		User manual
	2. DC power input48VDC/2A	2. DC power input48VDC/2A

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3. Maximum nominal electrical powerPSM-PD3.5CPL/CPLGPSM-PD3.5CPE/CPEGPSM-PD4CPL/CPLGPSM-PD4CPE/CPEGPSM-PD5.6 CPL/CPLGPSM-PD5.6CPE/CPEG	3.2kW4.0kW5.6kW	3. Maximum nominal electrical powerSPL-HF4: 4kW
4. Maximum output electric powerPSM-PD3.5CPL/CPLGPSM-PD3.5CPE/CPEGPSM-PD4CPL/CPLGPSM-PD4CPE/CPEGPSM-PD5.6 CPL/CPLGPSM-PD5.6CPE/CPEG	3.6kW4.0kW5.6kW	4. Output power:SPL-HF4: 4kW
		Difference:2) The maximum nominal electric power and the maximum output electric power are different. The maximum nominal electric power and the maximum output electric power in the model declared by the subject device are 5.6kW. While the maximum nominal electric power and the maximum output electric power in the model declared by the predicate device are 4kW.

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Normaloperatingcondition	1. Temperature:0~~35°C (AC supply )0~~40°C (only for battery discharging)2. Relative humidity:95%, non-condensing;3. Atmospheric pressure:700hPa~1060hPa.	1. Temperature:0~~40°C2. Relative humidity:95%, non-condensing;3. Atmospheric pressure:700hPa~~1060hPa.	SE	User manual
Performancerequirements	1. X-ray tube voltagea) Tube voltage regulation range:40kV~~125kV, 1kV step size, tube voltagecan be set according to power.Model Tube voltageregulationrange PSM-PD5.6CPL/CPLGPSM-PD5.6CPE/CPEGPSM-PD4CPL/CPLGPSM-PD4CPE/CPEGPSM-PD3.5CPL/CPLG 40kV~~125kV					1. X-ray tube voltagea) Tube voltage regulation range:40~~125kV, 1kV step size.Model Tube voltageregulation range SPL-HF4 40~~125kVb) Tube voltage deviation: ±(3%+1kV)						User manual

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PSM-PD3.5CPE/CPEG
b) Tube voltage deviation:$\pm$ (3%+1kV)
2. X-ray tube currenta) Tube current regulation range		2. X-ray tube currenta) Tube current regulation range	Difference:
Model	Tube currentregulationrange	Model	Tube currentregulation range	3) The number systemsof tube current,loading time andcurrent time productare different. Thesubject device isdistributed accordingto the R'20 numbersystem, and thepredicate device isdistributed accordingto the R'10 numbersystem and the user-defined numbersystem.
PSM-PD3.5CPL/CPLG	5-63mA	SPL-HF4	5~100mA
PSM-PD3.5CPE/CPEG		16 steps, the specific data are: 5, 6.4, 8,10, 12.5, 16, 20, 25, 32, 40, 50, 64, 80,100 mA
PSM-PD4CPL/CPLG	5-80mA
PSM-PD4CPE/CPEG
PSM-PD5.6CPL/CPLG	5-100mA	b) Tube current deviation:

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PSM-PD5.6CPE	$\pm(4% + 1 mA)$
Increasing according to the number systemR'20, the specific data are 5、5.6、6.3、7.1、8、9、10、11、12.5、14、16、18、20、22、25、28、32、36、40、45、50、56、63、71、80、90、100。b) Tube current deviation:$\pm(4% + 1 mA)$

3. Loading timea) Loading time regulation range:1ms~10000ms,Increasing according to the number systemR'20, the specific data are 1、1.1、1.25、1.4、1.6、1.8、2、2.2、2.5、2.8、3.2、	3. Loading timea) Loading time regulation range:1 ms~10000ms,Increase according to the numbersystem R'10 (in 25% steps), for a total of41 steps	Difference:4) The loading timedeviation is different.The loading timedeviation of thesubject device islarger than that of thepredicate device. The
3.6、4、4.5、5、5.6、6.3、7.1、8、9、10、11、12.5、14、16、18、20、22、25、28、32、36、40、45、50、56、63、71、80、90、100、110、125、140、160、180、200、220、250、280、320、360、400、450、500、630、710、800、900、1000、1100、1250、1400、1600、1800、2000、2200、2500、2800、3200、3600、4000、4500、5000、6300、7100、8000、900、10000;	b) Loading time deviation:$\pm$ (2% + 0.1ms)	deviation of thesubject device iscontrolled within thescope of theinternationalstandardrequirements.
b) Loading time deviation:not greater than$\pm$ (2%+0.2ms) @ >5ms$\pm$ (5%+1ms) @ ≤5ms

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4. Current time producta) Current time product regulation range:	4. Current time producta) Current time product regulation range:	Difference:5) The regulation range of current time product is different. The regulation range of current time product of the subject device is larger than that of the predicate device.
Model Current time product regulation range PSM-PD3.5CPL/CPLGPSM-PD3.5CPE/CPEGPSM-PD4CPL/CPLGPSM-PD4CPE/CPEGPSM-PD5.6CPL/CPLGPSM-PD5.6CPE/CPEG 0.1-320mAs					Model Current time product regulation range SPL-HF4 0.1 mAs ~ 250 mAs Increase according to the numbersystem R'10 (in 25% steps), a total of 34 stepsb) Current time product deviation:$\pm$ (5% + 0.1 mAs)

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Increasing according to the number system
R'20, the specific data are 0.1、0.11、
0.12、0.14、0.16、0.18、0.2、0.22、
0.25、0.28、0.32、0.4、0.45、0.5、
0.56、0.63、0.71、0.8、0.9、1、1.1、
1.25、1.4、1.6、1.8、2、2.2、2.5、2.8、
3.2、3.6、4、4.5、5、5.6、6.3、7.1、8、
9、10、11、12.5、14、16、18、20、22、
25、28、32、36、40、45、50、56、63、
71、80、90、100、110、125、140、
160、180、200、220、250、280、320。
b) Current time product deviation:
± (5% + 0.1 mAs)

5. Operating frequency:	5. Operating frequency:
Maximum operating frequency	Maximum operating frequency
300kHz±20kHz	300kHz

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Functionalrequirements	1. Exposure technology modeThe device should have mA/ms, mAs,mAs/ms modes.2. Fault diagnosis and prompt1) During the exposure process, release thehandbrake actively, and an error should beprompted.2) If the internal temperature of the oil tankof the combined head exceeds the limit, anerror should be prompted.	1. Exposure technology modeThe device should have mA/ms, mAsmodes.2. Fault diagnosis and promptAll filament currents display values.When the range is exceeded, theexposure is not allowed, a continuousalarm will sound and the value on thedisplay will flash.	SE	User manual
	Electrical safety	Shall comply with the requirements of IEC60601-1 and IEC 60601-2-54.	Shall comply with the requirements ofIEC 60601-1 and IEC 60601-2-54.	SE	User manual
	EMC	Shall comply with the requirements of IEC60601-1-2.	Shall comply with the requirements ofIEC 60601-1-2.	SE	User manual
	Softwarerequirements	1. Basic data configuration2. Exposure parameter setting	1. Basic data configuration2. Exposure parameter setting	SE	User manual

	It should be able to operate the software toset the exposure mode, filament, tubevoltage, tube current, loading time andcurrent time product.3. Information indication and fault prompt	It should be able to operate the softwareto set the exposure mode, filament, tubevoltage, tube current, loading time andcurrent time product.3. Information indication and faultprompt
Cybersecurityrequirements	Data interface:There is an RS-232 output interface, andthe RS-232 interface is used for thecommunication between the CombinedHigh Frequency X-ray Source and thecontrol software of the client X-ray imagingdevice to meet the interactive information.	None	Difference:6) Cybersecurityrequirements aredifferent. The subjectdevice have beentested and evaluatedfor cybersecurity. Wehave not foundinformation related tocybersecurity aboutthe predicate device.
				User manual





Sterilization /disinfectionmethod	Not applicable	Not applicable	Neithersterilization/disinfection isrequired.	/

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There are 6 differences in comparison items between the subject device and the predicate device of the same type of medical devices:

No.	Different item	Difference description	Detailed description
1	Structuralcomposition	The predicate deviceis accompanied with amobile column witharticulated arm andcassette basket, whichthe subject devicedoes not have.	The subject device is an X-ray source which is acomponent of the X-ray system and does notrequire a mobile column with an articulated arm anda cassette basket. We sell the subject device to thecomplete machine manufacturers, and they mightprovide a mobile column with an articulated armand a cassette basket, or other accessoriesaccording to their own needs.
2	Basicparameter	The maximum nominalelectric power and themaximum outputelectric power in themodel declared by thesubject device are5.6kW. While themaximum nominalelectric power and themaximum outputelectric power in themodel declared by thepredicate device are4kW.	The subject device has more models and variouspowers. There is only one model of the predicatefor comparison, and the power data is single. Therange of the subject device applied for is wider andapplicable to more places and body parts.
3	Performancerequirements	The number systemsof tube current, loadingtime and current timeproduct are different.	The distribution of the subject device is more thanthat of the predicate device, and the radiation dosereceived by patients is more accurate, so as toavoid the adverse impact of useless dose on
	The subject device isdistributed accordingto the R'20 numbersystem, and thepredicate device isdistributed accordingto the R'10 numbersystem and the user-defined numbersystem.	patients.
	The loading timedeviation of the subject	The irradiation time of the subject device is 0.1mslonger than that of the predicate device during one
	device is larger thanthat of the predicatedevice. The deviationof the subject device is	exposure, which has no effect on the radiation dose
		received by the human body. The performance
		indicators of the subject device have been verified
		by third-party registration testing and meet the
	4	controlled within the
		scope of the
		international standardrequirements.

5		The current time product range of the subject
		device is larger than that of the predicate device,
	The regulation range	and is applicable to a wider range of patient groups,
	of current time product	body parts and places. The performance indicators
	of the subject device is	of the subject device have been verified by third-
	larger than that of the	party registration testing and meet the requirements
	predicate device.	of IEC 60601-1 and IEC 60601-2-54. This
		difference does not adversely affect the safety andefficacy of the product.
			The control software of the subject device is
6	Cybersecurityrequirements	The subject devicehave been tested andevaluated forcybersecurity. Wehave not foundinformation related tocybersecurity aboutthe predicate device.	installed on the general computer platform andconfigured by the user. The user manual providesinstructions for the installation, operation,uninstallation and other use of the control software.The software functions and cybersecurityrequirements have been verified by internal testsand third-party registration tests to meet therequirements of clinical application of the product,which will not adversely affect the safety andeffectiveness of the product.

Table 2 Comparative Analysis

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Through the above comparative analysis, the differences between Combined High Frequency X-ray Source of our company and the predicate device will not affect the safety and effectiveness of the product.

VII. PERFORMANCE DATA

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

Biocompatibility testing

N/A.

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Powersite device, consisting of shell case, control panel mounting assembly, DCDC riser mounting assembly, power panel mounting assembly, ESU energy storage capacitor mounting assembly, high voltage TANK, collimator, Lithium battery. The device complies with the IEC 60601-1, IEC 60601-1-3 and IEC 60601-2-54 standards for safety and the IEC 60601-1-2 standard for EMC.

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Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices." The software for this device was considered as a "Moderate" level of concern, since a failure or latent flaw in the software could indirectly result in minor injury to the patient or operator through incorrect or delayed information or through the action of a care provider.

Mechanical and acoustic testing

· Acoustic Testing
· Elongation of the bending cable

· Crimp assembly, cable tensile strength, cable flexibility, minimum bending radius of the cables

· Simulated use testing

Animal Study

N/A.

Clinical Studies

Clinical images are not necessary to demonstrate substantial equivalence, based on the nature of the device (an x-ray generator) and on close similarities to the predicate system. Successful Bench Testing results should be sufficient to show device safety and effectiveness.

Summarv

Based on the basic principle, intended use, performance parameters, operating environment, etc, Powersite Combined High Frequency X-ray Source was found to have a safety and effectiveness profile that is similar to the predicate device.

VIII. CONCLUSIONS

Since the subject device is an integral part of the X-ray imaging system, and similar products are mature and clinical-free products, substantial equivalence can be supported by comparing the basic principles, intended use, performance parameters, operating environment, etc. The

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safety of the device is supported by non-clinical data, hardware and software verification and validation indicate that Powersite Combined High Frequency X-ray Source should perform as intended under the specified conditions of use. The performance of Powersite Combined High Frequency X-ray Source is equivalent to that of similar devices for the same intended use sold on the market at present.

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.