Anyview-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

Device Description

This device is a mobile x-ray fluoroscopic imaging system used by radiation experts. This device is a fluoroscopic imaging system to visualize human body's anatomical structure using a principle that x-ray qenerates hypophonesis difference when penetrating human body depending on tissue's density and thickness. The device is composed of main body, x-ray generating equipment (x-ray controller, high voltage generator, x-ray tube, motortype collimator), image collecting equipment (Image Intensifier, CCD Camera) and digital imaging system (cart including computer and monitor). The product's arm is mobile and rotatable in X, Y and Z axes, which facilitates use of x-ray in every direction.

ANYVIEW imaging software is a Digital Imaging System (DIS) designed for C-arm, Anyview-500R. ANYVIEW imaging software provides useful functions to manage X-ray images obtained from Anyview 500R C-arm.

ANYVIEW imaging software provides various image tools. One of the most noticeable features is that the C-arm images taken during an exam are stored in the database for further review. Image data is integrated with the patient information in DICOM(OPTION) compatible format which allows compatibility with existing DICOM and PACS system. All these features are available in a single application program, ANYVIEW.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Anyview-500R Fluoroscopic Mobile X-ray System," focusing on its substantial equivalence to a predicate device, KMC-950 (K032761). The document primarily addresses the technical specifications and safety standards rather than detailed acceptance criteria for an AI-powered device or a study proving its performance against such criteria.

Therefore, many of the requested details about acceptance criteria, study design for AI evaluation, expert qualifications, and ground truth are not applicable or not provided in the given text.

Here's an attempt to answer the questions based only on the provided text:

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

The document does not explicitly define "acceptance criteria" in the context of a specific performance threshold for an AI-powered device. Instead, it demonstrates substantial equivalence by comparing the technical characteristics and adherence to safety standards of the new device (Anyview-500R) against a predicate device (KMC-950).

The performance comparison is detailed in tables on pages 6, 7, and 8. The provided text highlights differences in specifications such as Resolution, Output Power, Fluoroscopy Pulsed mode, Radiography mAs range, and Image Intensifier Contrast. However, these are technical specifications, not acceptance criteria for an AI device's clinical performance.

Characteristic	Acceptance Criteria (Not explicitly stated as performance threshold, but implied by similarity to predicate)	Reported Device Performance (Anyview-500R)	Predicate Device (KMC-950) Performance
X-ray Generator Type	---	HFG INVERTER TYPE	High frequency Inverter type (POSKOM)
Output power	---	5kW	12.5W
Fluoroscopy - Continuous mode	---	0.5-10mA	0.5-5mA
Fluoroscopy - Pulsed mode	---	0.5-20mA	0.5-5mA
Fluoroscopy - Boost mode	---	30mA	20mA
Radiography - kV range	---	40-125 kV	40-120kV
Radiography - mA range	---	20-100 mA	20-150
Radiography - mAs range	---	0.8~200mAs	0.4~500 mAs
X-ray tube type	---	TOSHIBA XR-2551	Varian RAD-99
Max kV	---	125kV	120kV
Focal spot (S/L)	---	0.3 / 0.6	0.3 / 0.6
Target angle	---	10°	10°
Anode heat capa	---	210 kHU	300 kHU (HU=1.4 x Joule)
Collimator type	---	Open/close motorized	Open/close motorized
Rotation	---	360 °	360 °
Image Intensifier	---	E5830SD-P4A (TOSHIBA)	E5764SD-P4A (TOSHIBA)
Input FOV	---	9inch	9inch
Entrance field size	---	9/6/4.5 in	9/6/4.5 in
Central resolution	---	54/62/70 lp/cm	54 lp/cm
Contrast	---	36:1	25:1
CCD Camera type	---	CCD	CCD
Resolution (CCD Camera)	512 x 512 (Predicate)	1K x 1K	512 x 512
Laser Pointer	---	Included (Class II, 5mW, 655nM)	N/A (Not Applicable)
Performance Standard	---	21CFR 1020.30	21CFR 1020.30
Electrical Safety	---	IEC 60601-1-x series	IEC 60601-1-x series
II Central resolution (Normal)	48 lp/cm	52 lp/cm	48 lp/cm
II Contrast (10% area)	25	30	25

Note: The differences are discussed on page 9, stating that the Anyview-500R has a higher resolution CCD camera (1K x 1K vs 512 x 512) and requires less X-ray source, which leads to lower capacity for the X-ray generator and tube heat storage compared to the predicate device. These differences "do not raise additional risk concerns" and "do not have an effect on safety and effectiveness compared to the predicate device."

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 explicitly states: "No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness." (Page 10, Section 11).

Therefore, there was no clinical test set, and hence no sample size, data provenance, or other details related to a clinical test set are provided. The evaluation was based on non-clinical (bench) testing.

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)

As per the answer to question 2, no clinical test set was used, and therefore, no experts were utilized for establishing ground truth for a clinical test set.

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

Not applicable, as no clinical test set was used.

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

Not applicable. The device is a fluoroscopic mobile x-ray system, not an AI-assisted diagnostic tool.

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

Not applicable. The device is an X-ray imaging system, not a standalone algorithm.

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

Not applicable, as no clinical studies were performed. The "ground truth" for the device's substantial equivalence was based on its technical specifications, conformance to recognized international electrical and safety standards (e.g., IEC 60601 series, NEMA PS 3.1-3.20, 21 CFR 1020.30-32), and software validation and verification testing (page 10).

8. The sample size for the training set

Not applicable, as this is not an AI/machine learning device. The "training" for the device's development would refer to engineering design and testing, not a dataset in the context of AI.

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

Not applicable, as this is not an AI/machine learning device. The "ground truth" during development would be engineering specifications and compliance with established standards.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three overlapping profiles.

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

October 14, 2016

ECOTRON Co., Ltd % Mr. Dave Kim Medical Device Regulatory Affairs Mtech Group 8310 Buffalo Speedway HOUSTON TX 77025

Re: K160279

Trade/Device Name: Anyview-500R Fluoroscopic Mobile X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA, OXO Dated: September 30, 2016 Received: October 05, 2016

Dear Mr. Kim:

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 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.

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

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 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 Industry and Consumer Education 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,

Michael O'Hara

For

Robert 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) K160279

Device Name

Anyview-500R Fluoroscopic Mobile X-ray System

Indications for Use (Describe)

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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Image /page/3/Picture/0 description: The image contains a logo for a company called "ecoTRON eco & electronics". The logo consists of a series of blue squares on the left, followed by the word "ecoTRON" in a bold, sans-serif font. Above the word "ecoTRON", there is smaller text that reads "eco & electronics". The overall design is clean and modern, suggesting a company that is involved in technology and environmental sustainability.

SECTION 04

510(k) SUMMARY

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Image /page/4/Picture/0 description: The image is a logo for "eco & electronics eddotRON". The logo has a blue square design on the left side, followed by the text "eco & electronics" in a smaller font. Below the blue square design, the text "eddotRON" is written in a larger font. The logo is simple and modern, with a focus on the company's name and its association with electronics.

1. Traditional 510(k) SUMMARY

This summary of 510(k) is being submitted in accordance with requirements of SMDA 1990 and 21 CFR Part 807.92.

Date 510K summary prepared : September 30, 2016

Submitter's Name, address, telephone number, a contact person:

Submitter's Name :	ECOTRON Co, Ltd.
Submitter's Address:	Rm 504, Hanshin IT Tower II, 47, Digital-ro 9-gil,Geumcheon-gu, Seoul, Korea
Submitter's Telephone:	Tel:+82-2-2025-3760 / Fax:+82-2-2025-3764
Contact person:	Mr. Sang Bong Lee / RA Assist Mgr
Official Correspondent:	Dave Kim (davekim@mtech-inc.net)
Address:	8310 Buffalo Speedway, Houston, TX 77025
Telephone:	+713-467-2607
Fax:	+713-583-8988

Name of the device, including the trade or proprietary name if applicable, the common or usual name and the classification name, if known:

510K Number:	K160279
Trade/proprietary name:	ANYVIEW-500R Fluoroscopic Mobile X-ray System
Regulation Name:	Image-intensified Fluoroscopic X-ray System
Regulation Number:	21 CFR 892. 1650
Regulatory Class:	II
Product Code:	OWB, JAA, OXO
Predicate Device Trade Name	KMC-950
510(k) Clearance #	K032761
Clearance date	05/14/2004
Classification Name	Image Intensified Fluoroscopic X-ray System
Classification Panel	Radiology
CFR Section	21CFR 892.1650 (Produce Code; JAA, OWB, OXO)
Device Class	Class II

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2. Device Description

3. Indications for Use

Anvyiew-500R fluoroscopic mobile x-ray system is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.

This system can be applied in emergency room, operation room, cast room or etc. of hospital.

4. Summary of Design Control Risk management

Anyview-500R Fluoroscopic Mobile X-ray System has been developed to provide the mobility of X-ray users for convenient access to patients while meeting the critical functional requirements and international safety standards. The risks and the hazardous impact of the device design were analyzed with FMEA method. The specific risk control and protective measures to mitigate the risks from the device design and production phase were reviewed and implemented in the new product design phase. The overall assessment concluded that all risks and hazardous conditions identified arising from the design and production were successfully mitigated and accepted.

5. Summary of the technological characteristics of the device compared to the predicate device:

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Image /page/6/Picture/0 description: The image shows the logo for "eco & electronics eddotron". The logo is in blue and gray. The word "eddotron" is in gray, with the "eco & electronics" in smaller blue font above it.

Anyview-500R Fluoroscopic Mobile X-ray System described in this 510(k) has the similar indications for use and technical characteristics as the predicate device, KMC-950 (K032761) manufactured by COMED Medical Systems, Inc.

6. Substantial Equivalence

Anyview-500R Fluoroscopic Mobile X-ray System conforms to the FDA recognized standards as like the predicate device. Based on the recognized standard conformity evidences related to electro-, mechanical-, software-, clinical-, and risk management, it's the sponsor's opinion that the Anyview-500R Fluoroscopic Mobile X-ray System is a safe and effective device.

Characteristics	Anyview-500R FluoroscopicMobile X-ray System(K160279)	KMC-950 (K032761)	SE-#
Intended Use	Anyview-500R mobile C-arm, fluoroscopic x-ray system, is radiation medical equipment only used by professional radiologists. This product is designed to provide fluoroscopic and spot film images of the patient during diagnostic and interventional procedures.This system can be applied in emergency room, operation room, cast room or etc. of hospital.	The KMC-950 is intended to provided fluoroscopic and radiographic imaging of the patient during diagnostic, surgical and interventional procedures. Clinical applications may include but are not limited to digital subtraction angiography, orthopedic, neurological, abdominal, vascular, cardiac, critical care and emergency room procedures.The system may be used for other RF imaging application at physician's discretion.	Similar
Energy Source	220V~230V, Single 50/60 Hz	100V-120V or 200V-230VSingle 50/60 Hz	Similar

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X-rayGeneratorType	HFG INVERTER TYPE	High frequency Invertertype(POSKOM)	Same
Output power	5kW	12.5W	#1
Fluoroscopy
-Continuousmode	0.5-10mA	0.5-5mA	Similar
-Pulsed mode	0.5-20mA	0.5-5mA	#2
-Boost mode	30mA	20mA	Similar
Radiographymode
-kV range	40-125 kV	40-120kV	Similar
-mA range	20-100 mA	20-150	Similar
-mAs range	0.8~200mAs	0.4~500 mAs	#3
X-ray tubetype	TOSHIBA XR-2551	Varian RAD-99
Max kV	125kV	120kV	Similar
Focal spot (S/L)	0.3 / 0.6	0.3 / 0.6	Same
Target angle	10°	10°	Same
Anode heatсара	210 kHU	300 kHU (HU=1.4 xJoule)	Similar
Collimatortype	Open/close motorized	Open/close motorized	Same
Rotation	360 °	360 °	Same
ImageIntensifier	E5830SD-P4A (TOSHIBA)	E5764SD-P4A (TOSHIBA)
Input FOV	9inch	9inch	Same
Entrance fieldsize	9/6/4.5 in	9/6/4.5 in	Same
Centralresolution	54/62/70 lp/cm	54 lp/cm	Same
Contrast	36:1	25:1	#4
CCD Cameratype	CCD	CCD	Same
Resolution	1K x 1K	512 x 512	Different
Laser Pointer	Included	N/A
(1) Laser Class	Class II	N/A
(2) Max Power	5mW	N/A
(3) Wavelength	655nM	N/A

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Image /page/8/Picture/0 description: The image shows the logo for "eco & electronics edotron". The logo has a blue square design on the left side of the logo. The text "eco & electronics" is in a smaller font above the word "edotron". The word "edotron" is in a larger, gray font.

PerformanceStandard	21CFR 1020.30	21CFR 1020.30	Same
Electrical SafetyIEC 60601-1:	IEC 60601-1:IEC 60601-1-2IEC 60601-1-3IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54	IEC 60601-1:IEC 60601-1-2IEC 60601-1-3IEC 60601-2-28IEC 60601-2-43IEC 60601-2-54	Same

Image intensifier Performance Comparison Data – TOSHIBA

			Predicate device (KMC-950) (K032761)			Subject device (Anyview-500R)
Model Name			E5764SD-P4A (previously cleared under K032761)			E5830SD-P4A (previously cleared under K160065)
Manufacturer			TOSHIBA			TOSHIBA
Overall Length			338±5 mm			338±5 mm
Maximum Diameter			304±2 mm			304±2 mm
Parameters				Normal	Magn.1	Magn.2		Normal	Magn.1	Magn.2
Output image size			20.0 ± 0.5 mm			25.2 ± 0.2 mm
Nominal entrance field size			230	160	120	230	160	125
DQE			65	-	-	65	-	-
Conversion factor(cd.m2/μGy.s-1)			28	-	-	26	-	-
Central resolution			48	56	66	52	58	68
Contrast	10% area		25	-	-	30	-	-
ratio	10mm dia.		16	-	-	19	-	-
Weight(approx.)			18 kg			20 kg
Power	Input voltage		24±1 Vdc			24±1 Vdc
supply	Output	Anode	30	30	30	30	30	30
	voltage	G3 Electrode(kV)	3 to 4	5 to 8	9 to 12	3 to 4	5 to 8	9 to 12
		G2 Electrode	400 to	400 to	500 to	400 to	400 to	500 to
		(V)	800	800	1200	800	900	1200
		G1 Electrode	100 to	100 to	100 to	150 to	150 to	100 to
		(V)	250	250	250	300	300	250
		Photocathode(V)	0	0	0	0	0	0
Relevant standard			IEC 1262-1 to 7			IEC 1262-1 to 7

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Image /page/9/Picture/0 description: The image is a logo for "eco & electronics eddotRON". The logo features a blue square design on the left, followed by the text "eco & electronics" in a smaller font size. Below this text is the word "eddotRON" in a larger, bolder font, with the "o" in "eddotRON" being a different color than the rest of the letters. The overall design is clean and modern.

7. Difference Discussion

SE-#	SE discussion
SE-#1, #2, #3, #4	Anyview-500R Fluoroscopic Mobile X-ray System is equipped withhigh resolution CCD camera in comparison with the predicate device;1K x 1K vs 512 x 512.Anyview-500R Fluoroscopic Mobile X-ray System requires less X-raysource and therefore less capacity for the X-ray generator and tubeheat storage compared to the predicate device. Such differences inperformance do not raise additional risk concerns.

8. Summary of the technological characteristics of the device compared to the predicate device:

The indications for use, mechanical components, performances and safety characteristics of Anyview-500R Fluoroscopic Mobile X-ray System described in this 510(k) are similar to those of the predicate device.

The primary differences are the specifications of X-ray tube, and X-ray generator of the subject device. The performance specifications of the subject device are lower than those of the predicate device such as the X-ray generator and X-ray tube anode heat content (Heating Unit). However Anyview-500R Fluoroscopic Mobile X-ray System is equipped with high resolution CCD camera in comparison with the predicate device: 1K x 1K vs 512 x 512. Anyview-500R Fluoroscopic Mobile X-ray System requires less X-ray source and therefore less capacity for the X-ray generator and tube heat storage compared to the predicate device.

These differences do not have an effect on safety and effectiveness compared to the predicate device.

9. Performance Testing/Data

Testing for verification and validation of the device was found acceptable to support the claims of substantial equivalence. Safety compliance checking (including EMC, and so on) was evaluated according to the IEC Standards. ECOTRON Co., Ltd certifies conformance to Voluntary Standards covering electrical and Mechanical safety. In conclusion, the identified risk of electrical hazards was mitigated and it is the sponsor's opinion that Ayview 500-R appears to be as safety and effective as the predicate device.

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10. Description of non-clinical tests.

Anyview-500R Fluoroscopic Mobile X-ray System has been tested for electrical safety and electromagnetic compatibility. The device also complies with FDA EPRC Performance Standard: 21 CFR 1020.30-32. The software validation and verification testing was also performed. The results of nonclinical testing indicate that the Anyview-500R Fluoroscopic Mobile X-ray System is as safe and effective as the predicate device.

Compliance evidences were submitted for the following standards:

IEC60601-1:2005 + A1 (2012)
IEC60601-1-2:2007
IEC60601-1-3:2008
IEC60601-2-28:2010
IEC60601-2-43:2010
IEC60601-2-54:2009
NEMA PS 3.1-3.20

11. Description of clinical tests.

No clinical data is necessary to evaluate safety or effectiveness for purposes of determining substantial equivalence of the proposed modification. Bench testing was performed to assess the device safety and effectiveness.

12. Conclusion as to Substantial Equivalence

Anyview-500R Fluoroscopic Mobile X-ray System is substantially equivalent to the predicate device KMC-950 (K032761). Both devices are very similar in the intended use, the design principle, the performance and the applicable standards. Some characteristics, for example, their appearance, the user interfaces and the capacity of Xray generator and X-ray tube are different. However, the compliance reports, performance demonstrations and description of non-clinical review result in this submission STED provide demonstration that these differences do not raise any new questions of safety and effectiveness. Therefore, it is the sponsor's opinion that Anyview-500R Fluoroscopic Mobile X-ray System appears to be as safe and effective as the predicate device.

Regulation Number and Section

§ 892.1650 Image-intensified fluoroscopic x-ray system.

(a)
Identification. An image-intensified fluoroscopic x-ray system is a device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). An anthrogram tray or radiology dental tray intended for use with an image-intensified fluoroscopic x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9. In addition, when intended as an accessory to the device described in paragraph (a) of this section, the fluoroscopic compression device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.