The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

Device Description

The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures.
There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.

AI/ML Overview

The provided document, a 510(k) Summary of Safety and Effectiveness for the DigiArc 100AU G-Arm MultiScan System, offers limited information regarding specific acceptance criteria and detailed study results for device performance. It primarily focuses on demonstrating substantial equivalence to predicate devices through compliance with recognized standards and general clinical imaging evaluation.

Here's an attempt to extract and infer the requested information based on the provided text, highlighting what is present and what is not:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative acceptance criteria or detailed device performance metrics in a table format. It states that the device "meets the requirement of intended use and clinical use" and "is as safe and effective as the predicate devices." The primary method of demonstrating compliance is through adherence to relevant IEC standards for X-ray medical electrical equipment and a general assessment of clinical images.

Acceptance Criteria Category	Specific Criteria (Inferred from text)	Reported Device Performance (Inferred from text)
Safety	Compliance with IEC 60601-1:2005	Device passed all tests according to IEC 60601-1:2005.
	Compliance with IEC 60601-1-2:2007 (EMC)	Device passed all tests according to IEC 60601-1-2:2007.
	Compliance with IEC 60601-1-3:2008 (Radiation Protection)	Device passed all tests according to IEC 60601-1-3:2008.
	Compliance with IEC 60601-2-28:2010 (X-ray tube assemblies for medical diagnosis)	Device passed all tests according to IEC 60601-2-28:2010.
	Compliance with IEC 60601-2-54:2009 (X-ray equipment for radiography and radioscopy)	Device passed all tests according to IEC 60601-2-54:2009.
Effectiveness/Functionality	Generation of X-ray fluoroscopic image for real-time positioning and monitoring in surgical applications (trauma, orthopedics, spine, chest).	"Software validation and images assessment for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use."
	Imaging concept and fundamental scientific technology comparability to predicate devices.	"employs the same imaging concepts and fundamental scientific technology with the predicate device."
Image Performance	Unspecified; implied to be adequate for diagnostic exposure of spinal column, chest, abdomen, extremities, and other body parts.	"Clinical images evaluation was performed for each X-Ray generator and image intensifier." Results are stated to be satisfactory for intended use.
Software Performance	Unspecified; implied to support simultaneous imaging function reliably.	"Software validation... for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use."
DICOM Conformance	Compliance with Digital Imaging Communications in Medicine (DICOM) standard.	"the subject device meets the provisions of Digital Imaging communications in Medicine (DICOM)."

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document mentions "Clinical images evaluation was performed," but it does not specify the sample size for this clinical image evaluation (test set). It also does not explicitly state the country of origin of the data or whether the study was retrospective or prospective. Given the manufacturer's location in Beijing, China, it is plausible the data originated from China, but this is not explicitly stated.

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)

The document states "images assessment for simultaneous imaging have been done by the manufacturer" and "Clinical images evaluation was performed." However, it does not specify the number of experts involved in establishing ground truth, nor does it provide any details about their qualifications (e.g., radiologists, years of experience).

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

The document does not describe any adjudication method used for the test set. It simply mentions "images assessment" and "Clinical images evaluation," implying an assessment was made but without detailing the process for resolving discrepancies or establishing a definitive ground truth from multiple readers.

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

The document does not describe an MRMC comparative effectiveness study. The device is an imaging system (fluoroscope), not an AI-assisted diagnostic tool. Therefore, the question of human readers improving with AI assistance is not applicable in this context. The study described focuses on the device's technical performance and image quality compared to predicate devices and standards.

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

This refers to a standalone algorithm performance. Since the device is a medical imaging system (fluoroscope) and not an AI algorithm, a standalone algorithm performance study is not applicable here. The performance evaluated is that of the hardware and integrated software in generating diagnostic images.

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

The document does not explicitly state the type of ground truth used. Given that it involves "Clinical images evaluation," it is most likely that the "ground truth" was established by expert assessment or clinical diagnosis based on a variety of available clinical information, but this is not detailed. There is no mention of pathology or outcomes data being used as ground truth for the imaging system's performance.

8. The sample size for the training set

The document does not mention a training set or its sample size. This is expected as the DigiArc 100AU is a conventional X-ray fluoroscopy system, not a machine learning or AI-driven device that typically requires a training set.

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

As there is no mention of a training set, there is no information on how its ground truth was established.

Summary

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K131423
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WHALE:

510(k) Summary of Safety and Effectiveness

[As required by 21 CFR 807.92]

1. Date Prepared [21 CFR807.92 (a) (1)]

NOV
07 2013

September 30th 2013

2. Submitter's Information [21 CFR807.92 (a) (1)]

Name of Sponsor: Beijing East Whale Imaging Technology Co., Ltd.

Address: No.2 Workshop Building 2,No.9 KeChuang2 Street, Beijing

Economy Technology Exploitation Section

Beijing,China,100023, China

Contact Name: Better Li

Telephone No.: + 86 (10) 67892701- 838

86 (10) 67892580 Fax No.:

Email Address: jqli@whaleimaging.com

Trade Name, Common Name, Classification [21 CFR807.92(a)(2)]

Trade Name: DigiArc 100AU

G-Arm MultiScan System Common Name:

Image-intensified fluoroscopic X-ray system Classification:

Product code: ОХО

Classification Panel: Radiology

510(k) Summary of Safety and Effectiveness

4-1

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Device Class: ll

510(k)Number	K120613	K911739
Applicant	GE Healthcare Surgery	SEEMAC REISON ABCO.
DeviceName	OEC 9900 Elite	SWEMAC REISONBIPLANAR 300

1. Identification of Predicate Device(s) [21 CFR 807.92(a)(3)}

5. Description of the Device [21 CFR 807.92(a)(4)]

There are two sets of X-ray tube assemblies and Image Intensifiers which are perpendicularly distributed on the G-Arm, acting as two sets of vertical X-ray source and receptor systems and providing fluoroscopy image of the patient. The two sets of X-ray tube assemblies and Image Intensifiers can operate simultaneously and separately.

The DigiArc 100AU includes below primary component.

Table 1- Primary components list

510(k) Summary of Safety and Effectiveness

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WHALE"

510(k) Submission

Component	Quantity
Control unit	1
Main monitor	2
Control monitor	1
Control panel	1
G-Arm	1
Image intensifier assembly	2
X-ray tube assembly	2
Foot switch subassembly	1
Printer (optional)	1

6. Intended Use [21 CFR 807.92(a)(5)]

510(k) Summary of Safety and Effectiveness

4-3

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7. Technological Characteristics [21 CFR 807.92(a)(6)]

The DigiArc 100AU employs the same technological characteristics as the predicate devices except items in table 2. However, it employs the same imaging concepts and fundamental scientific technology with the predicate device and the differences do not impact the safety and effectiveness of the device.

Table 2. Major differences between subject device and predicate device

Item	OEC 9900 Elite(K120613)	SWEMAC REISONBIPLANAR 300(K911739)	DigiArc 100AU( K131423 )	Note
G-arm/C-arm	C arm	G arm	G arm	Note 1
Operation of thetwo sets ofimaging systems	--	Operate separatelyonly	Operatesimultaneouslyand separately	Note 2

510(k) Summary of Safety and Effectiveness

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Note1: Image gantry of DigiArc 100AU is referred to as " G-Arm" because of its " G" shaped gantry, compare to the C-arm, there are some mechanical differences, but the differences do not impact the electrical safety and image performance of the device. And the G-arm has passed all the tests in according to IEC 60601-1:2005.

Note 2: There is no international standard special for the function of simultaneous imaging, however, the DigiArc 100AU employs the same imaging concepts and fundamental scientific technology with the predicate devices, standards (IEC 60601-1: 2005 & IEC 60601-1-2:2007 & IEC 60601-1-3:2008 & IEC 60601-2-28:2010 & IEC 60601-2-54:2009 ) that apply to predicate devices also apply to the DigiArc 100AU, the DigiArc 100AU has passed all the tests in according to those standards which ensure that there is no safety and performance issue rasied. Besides, software validation and images assessment for simultaneous imaging have been done by the manufacturer, and the results demonstrate that the subject device meet the requirement of intended use and clinical use.

8. Substantial Equivalence [21 CFR 807.92(b)(1) and 807.92(b)(2)]

Results of performance and compliance testing conducted on DigiArc 100AU indicates conformance to all applicable standards recognized by FDA for this device.

Testing result from non-clinical & clinical demonstrates that the subject device

510(k) Summary of Safety and Effectiveness

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510(k) Submission

K131423
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HALE

DigiArc 100AU is as safe and effective as the predicate devices.

Non-clinical testing

The subject device has been tested to compliance to the following safety and performance standards:

IEC 60601-1: 2005

IEC 60601-1-2:2007

IEC 60601-1-3:2008

IEC 60601-2-28:2010

IEC 60601-2-54:2009

And also the subject device meets the provisions of Digital Imaging communications in Medicine (DICOM)

Clinical testing:

Clinical images evaluation was performed for each X-Ray generator and image intensifier which was considered as a critical component of verification and validation.

9. Conclusion [21 CFR 807.92(b) (3)]

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the non-clinical & clinical testing result and relative information provided in this premarket notification, we concludes that DigiArc 100AU is substantially equivalent to predicate devices with regard to safety and effectiveness.

510(k) Summary of Safety and Effectiveness

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 7, 2013

Beijing East Whale Imaging Technology Co., Ltd. % Better Li No. 2 Workshop Bldg 2, No. 9 KeChuang 2 Street Beijing Economy Technology Exploitation Section Beijing, 100023 CHINA

Re: K131423

Trade/Device Name: G-Arm MultiScan System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OXO Dated: October 14, 2013 Received: October 22, 2013

Dear Better Li:

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. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

Image /page/6/Picture/12 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles an abstract human figure.

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Page 2- Better Li

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resources/orYou/Industry/default.inm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (2) 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

for

Janine M. Morris Director, Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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510(k) submission

WHALE

Indications for Use

510(k) Number (if known): theprocess K131423

Device Name: G-Arm MultiScan System

Indications for Use: The DigiArc 100AU is a mobile digital X-ray G-Arm diagnostic system, which is intended to generate X-ray fluoroscopic image of a patient. The application includes: real-time positioning and monitoring operations in trauma surgery, orthopedics, spine surgery, and chest surgery, it is not intended to be used in interventional procedures. The DigiArc 100AU permits a qualified doctor or technologist to take a range of diagnostic exposures of spinal column, chest, abdomen, extremities, and other body parts on the patients at the age of at least eighteen.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of In Vitro Diagnostic Devices and Radiological Health (OIR)

fm.7)

(Division Sign-Off) Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health

K131423 210(k)

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Indications for Use

ર-1

Regulation Number and Section

N/A