OSCAR 15 is a mobile fluoroscopy system is designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care.

The system may be used for other imaging applications at the physician's discretion.

Device Description

OSCAR 15 is consist of X-ray Tube, X-ray tube assembly, x-ray controller, detector and accessories. There is no wireless function in this device.

The OSCAR 15, C-Arm Mobile is the device intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. This device is used for providing fluoroscopic and radiographic images of patient anatomy, especially during the special procedures in a hospital or medical clinics. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.

AI/ML Overview

The provided text is a 510(k) summary for the OSCAR 15 mobile fluoroscopy system. It is a submission to the FDA to demonstrate substantial equivalence to a predicate device, not a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

Therefore, most of the requested information regarding acceptance criteria, reported device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types, and training set details cannot be extracted from this document as it pertains to AI/ML device validation.

Here's what can be extracted and a general explanation for the missing information:

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

The document does not present specific acceptance criteria in terms of numerical performance metrics for an AI/ML component. Instead, it focuses on demonstrating substantial equivalence to a predicate device (ZEN-7000) based on design features, indications for use, and compliance with industry standards for safety and electrical performance.

The reported device performance is primarily in relation to physical and technical specifications, and safety/EMC compliance.

Criterion Category	Acceptance Metric (Implicit from Substantial Equivalence and Standards)	Reported Device Performance (OSCAR 15)	Predicate Device (ZEN-7000)
Indications for Use	Same as predicate device	Mobile fluoroscopy for diagnostic, surgical, interventional procedures (cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care). Physician's discretion for other applications.	Mobile fluoroscopy for diagnostic, surgical, interventional procedures (cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac, critical care, emergency room procedures). Physician's discretion for other applications.
Generator	High Frequency Inverter	High Frequency Inverter	High Frequency Inverter
Max. output power	Similar to predicate (15 kW)	15 kW	5 kW (15 kW Optional)
X-ray Tube	Rotating tube, same focal spots	Rotating tube, Large: 0.6 mm, Small: 0.3 mm	Rotating tube, Large: 0.6 mm, Small: 0.3 mm
Fluoroscopy kV/mA	Similar range to predicate	40-120 kV / 0.2-6.0 mA	40-120 kV / 0.2-6.0 mA
Pulsed Fluoroscopy mA	Similar or improved range to predicate	1 mA to 48 mA	1 mA to 20 mA (5kW), 1 mA to 48 mA (15kW)
Radiography kV/mAs	Similar range to predicate	40-120 kV / 0.4-100 mAs	40-120 kV / 1-100 mAs
Detector Type	Different from predicate, but superior performance shown (DQE, image quality)	Flat panel detector (CMOS)	Image Intensifier
Detector Active Image Area	Specified	260 x 256 mm	9" or 12"
Detector Central Resolution	Specified	4.6 lp/mm	2.2 lp/mm (9"), 1.6 lp/mm (12") - at monitor
Detector Contrast Ratio	Specified	30:1	Not explicitly stated, implied by DQE
Detector Resolution	Specified	2600 x 2560	Not explicitly stated
Detector Pixel Sampling Resolution	Specified	14 bits	Not explicitly stated
Detector Pixel Pitch	Specified	100 µm	Not explicitly stated
Detector MTF	Specified	56%	Not explicitly stated
Detector DQE	Superior to effective DQE of predicate	59%	65% (typical Image Intensifier DQE), but effective DQE of complete predicate device is 51%
Safety, EMC, Performance	Compliance with relevant IEC standards and CFR regulations	Complies with IEC 60601-1 Series, 60601-1-3, 60601-2-28, 60601-2-43, 60601-2-54, 60601-1-2. Meets EPRC standards (21 CFR 1020.30, 31, 32). Followed FDA guidance for SSXI devices, software, and cybersecurity.	Complies with similar standards (implied by K140041 substantial equivalence)
Physical Dimensions (SID, Rotation, Travel)	Similar to predicate	SID: 1000 mm, Panning: ±12.5°, Orbital: 155°, Vert. Travel: 500 mm, Horiz. Travel: 200 mm	SID: 1000 mm, Panning: ±12.5°, Orbital: 135°, Vert. Travel: 500 mm, Horiz. Travel: 200 mm

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

This document describes a medical imaging device (C-arm fluoroscopy system), not an AI/ML algorithm. Therefore, there is no "test set" in the context of an AI/ML model. The evaluation is based on engineering tests, compliance with standards, and comparison of specifications with a predicate device. "Bench and clinical evaluation" is mentioned, suggesting some testing with human interaction, but no details on sample size or data provenance for such evaluations are provided.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable, as this is not an AI/ML device requiring expert-labeled ground truth for model validation.

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

Not applicable, as this is not an AI/ML device.

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. This device is a fluoroscopy system, which provides images directly to the physician. It does not include an AI assistance component whose effectiveness would be measured in an MRMC study.

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

Not applicable, as this is not an AI/ML device with an "algorithm only" performance to evaluate. The device itself is the standalone product.

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

Not applicable, as the evaluation is based on technical specifications, safety standards compliance, and image quality metrics (DQE, resolution, etc.), not the diagnostic accuracy of an AI/ML model against a clinical ground truth.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary

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February 9, 2018

GENORAY Co., Ltd. % Ms. Kaitlynn Min Business Development GENORAY America Inc. 147 E. Bristol Lane ORANGE CA 92865

Re: K172180

Trade/Device Name: Oscar 15 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, JAA Dated: December 28, 2017 Received: January 2, 2018

Dear Ms. Min:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Michael D. O'Hara
For

Robert 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) K172180

Device Name

OSCAR 15

Indications for Use (Describe)

The system may be used for other imaging applications at the physician's discretion.

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

Date of Summary Preparation: July. 04, 2017

1. Submitter and US Official Correspondent
Submitter :	GENORAY Co., Ltd.
Address:	512, 560, Dunchon-daero, Jungwon-gu,
	Seongnam-si, Gyeonggi-Do, Korea
Telephone No.:	+82-31-740-4100
Fax:	+82-31-737-8018

Official Correspondent (U.S): Kaitlynn Min - Business Manager Correspondent: GENORAY America Inc. Address: 147 E. Bristol Lane, Orange, CA 92865 USA Telephone No.: +1-855-436-6729 +1-714-786-8919 Fax: Email: kaitlynn@genorayamerica.com

1. Establishment Registration Number 3005843418

3. Device Information

Trade/Device Name:	OSCAR 15
Regulation Name:	Fluoroscopic X-ray System
Classification Name:	Interventional Fluoroscopic X-Ray System
Product Code:	OWB / Interventional Fluoroscopic X-Ray System
Subsequence product code:	JAA / System, X-Ray, Fluoroscopic, Image-Intensified
Device Class:	Class II per regulation 21 CFR 892.1650

Predicate Device (Equivalent Legally Marketed Device) 4.

Manufacturer:	GENORAY Co., Ltd
Device Name:	ZEN-7000
510(k) Number:	K140041 (Decision Date - November 28, 2014)
Classification:	Interventional Fluoroscopic X-Ray System/OWBImage Intensified Fluoroscopic X-Ray System, Mobile/OXCSystem, X-Ray, Fluoroscopic, Image-Intensified/JAAClass II per regulation 21 CFR 892.1650

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5. Description of the Device

OSCAR 15 is consist of X-ray Tube, X-ray tube assembly, x-ray controller, detector and accessories. There is no wireless function in this device.

6. Indications for use (intended use)

OSCAR 15 is a mobile fluoroscopy system designed to provide fluoroscopic and spot film images of the patient during diagnostic, surgical and interventional procedures. Examples of clinical application may include cholangiography, endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion.

Name	Proposed deviceOSCAR 15	Predicate deviceZEN-7000
Manufacturer	GENORAY Co., Ltd.	GENORAY Co., Ltd.
510(k) No.	-	K140041
Indicationsfor use	OSCAR 15 is a mobile fluoroscopysystem designed to providefluoroscopic and spot film images ofthe patient during diagnostic, surgicaland interventional procedures.Examples of clinical application mayinclude cholangiography, endoscopy,urologic, orthopedic, neurologic,vascular, cardiac and critical care.The system may be used for otherimaging applications at thephysician's discretion.	ZEN-7000 is a mobile fluoroscopysystem designed to providefluoroscopic and spot film images ofthe patient during diagnostic, surgicaland interventional procedures.Examples of clinical application mayinclude cholangiography, endoscopy,urologic, orthopedic, neurologic,vascular, cardiac, critical care andemergency room procedures. Thesystem may be used for otherimaging applications at thephysician's discretion.
Name	Proposed device	Predicate device
	OSCAR 15	ZEN-7000
Manufacturer	GENORAY Co., Ltd.	GENORAY Co., Ltd.
510(k) No.	-	K140041
Generator	High Frequency Inverter	High Frequency Inverter
Max. output power	15 kW	5 kW
		15 kW (Optional)
X-ray Tube	Rotating tube	Rotating tube
	Large : 0.6 mm	Large : 0.6 mm
	Small : 0.3 mm	Small : 0.3 mm
Fluoroscopy	40-120 kV / 0.2-6.0 mA	40-120 kV/ 0.2-6.0 mA
Pulsed Fluoroscopy	1 mA to 48 mA	1 mA to 20 mA(5kW)
		1 mA to 48 mA(15kW)
Radiography	40-120 kV / 0.4-100 mAs	40-120 kV / 1-100 mAs
Detector	Active image area : 260 x 256 mmCentral Resolution 4.6 lp/mmContrast Ratio (10%) : 30:1Type : CMOSResolution : 2600 x 2560Pixel sampling resolution : 14 bitsPixel pitch : 100 μmMTF: 56%DQE: 59%Scintillator : CsI	9" (9"/6"/4.5")● Minimum central resolution(at the monitor):-9" (23cm): 2.2 lp/mm-6" (15cm): 2.8 lp/mm-4.5" (11cm): 3.0 lp/mm● DQE: 65% (typical)12" (12"/9"/6")● Minimum central resolution(at the monitor):-12" (31cm): 1.6 lp/mm-9" (23cm): 2.0 lp/mm-6" (15cm): 2.5 lp/mm● DQE: 65% (typical)
Dimensions	SID : 1000 mmPanning Rotation: ±12.5°Orbital Rotation: 155°Vert. Travel: 500 mmHoriz. Travel: 200 mm	SID : 1000 mmPanning Rotation: ±12.5°Orbital Rotation: 135°Vert. Travel: 500mmHoriz. Travel: 200mm

Substantial equivalence chart 7.

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The proposed OSCAR 15 is based on the predicate device, ZEN-7000(K140041). The generator is similar to predicate device with output power, 15 kW. Also X-ray tube of OSCAR 15 is same with predicate device.

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The difference between OSCAR 15 and predicate device is the options of Image acquisition parts. OSCAR 15 is Flat panel detector and predicate device is Image Intensifier. As mentioned in the comparison table, predicate device DQE is higher than OSCAR 15. However, predicate device DQE is the DQE of the image intensifier itself. In general, when image intensifier is combined with CCD camera the DQE decreases. In conclusion, the DQE of the complete predicate device is 51%. So the DQE of the OSCAR 15 is more effective and safety than predicate device. Also flat panel detector type has excellent image uniformity, no geometric distortion, no veiling glare or vignetting, small and thin physical size as compared to the Image Intensifier type.

The OSCAR 15 is substantially equivalent to the predicate device, ZEN-7000(K140041).

1. Safety, EMC and Performance data comparison to Predicate
  OSCAR 15 complies with industry standards such as IEC 60601-1 Series and 21 CFR 1020.30, 21 CFR 1020.31 and 21 CFR 1020.32 to minimize electrical, mechanical and radiation hazards.
Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1, IEC 60601-1-3, IEC 60601-2-28, IEC 60601-2-43 and IEC 60601-2-54 were performed.
EMC testing was conducted in accordance with standard IEC 60601-1-2.
OSCAR 15 meets the EPRC standards (21 CFR 1020.30, 31, 32).
FDA guidance "guidance for SSXI devices". "guidance for the Content of Premarket Submissions for Software Contained in Medical devices", and "content of premarket submissions for management of cyber security" was performed for OSCAR 15.

All test results were satisfactory and the result of bench and clinical evaluation indicates that the new device is as safe and effective as the predicate device.

1. Conclusion
  In reference to the comparison information provided in substantial equivalence chart, and the most of functions and electronic features are similar with predicate device. We believe that the OSCAR 15 is safe and effective as predicate device, and has no new indication for use. Therefore, OSCAR 15 is substantially equivalent to 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.