OSCAR 15 & OSCAR 15i are 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, neurologic, vascular, cardiac and critical care. The system may be used for other imaging applications at the physician's discretion. OSCAR 15i are indicated only for adult patients.

Device Description

The OSCAR 15 & OSCAR 15i, C-Arm Mobile are used for providing fluoroscopic and radiographic images of patient anatomy, especially during 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. These devices are intended to visualize anatomical structures by converting a pattern of x-radiation into a visible image through electronic amplification. The OSCAR 15 & OSCAR 15i consist of the X-ray tube assembly, X-ray controller, Image receptor and some accessories with no wireless function. The difference between OSCAR 15 and OSCAR 15i is only image acquisition parts. (An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i.)

AI/ML Overview

The provided text is a 510(k) Pre-Market Notification for the OSCAR 15 & OSCAR 15i mobile fluoroscopy systems. It asserts substantial equivalence to a predicate device (OSCAR 15, K172180) and describes non-clinical performance and safety testing. However, it does not include specific acceptance criteria or a study that directly quantifies device performance against those criteria in a format applicable to AI/CADe devices (e.g., sensitivity, specificity, FROC analysis).

The document is concerned with demonstrating that the devices (OSCAR 15 and the newly added OSCAR 15i) function safely and effectively as fluoroscopic X-ray systems, primarily through comparison to a previously cleared predicate device and compliance with relevant IEC and CFR standards. It describes physical and technical specifications and differences, particularly in the image acquisition parts (Flat Panel Detector vs. Image Intensifier).

Therefore, based on the provided text, I cannot complete the requested tables and information for acceptance criteria and a study proving the device meets those criteria in the way typically expected for AI/CADe devices, as this information is not present. The document focuses on regulatory compliance and substantial equivalence for an imaging hardware device, not an AI/CADe algorithm.

Here's what can be extracted and what is missing based on your request:

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

Acceptance Criteria: Not explicitly stated in terms of specific performance metrics (like sensitivity, specificity, accuracy) that would be common for AI/CADe devices. The acceptance criteria for this type of device are primarily compliance with safety and performance standards (e.g., IEC 60601 series, 21 CFR 1020.30, 1020.31, 1020.32) and demonstrating "substantial equivalence" to a predicate device.
Reported Device Performance: The document states that "the performance related to image quality was also different" due to the detector change, and "The image performance was evaluated according to the IEC standard through performance bench testing demonstrated that these differences do not matter and effectiveness in comparison with the predicate device." It also mentions "clinical images have been evaluated by a licensed radiologist confirmed the sufficient diagnostic quality to provide accurate information." However, no quantified performance metrics are provided.

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

Test Set Sample Size: Not specified. The document mentions "performance bench testing" and evaluation of "clinical images" but does not give a number for images or cases used in these evaluations.
Data Provenance: Not specified.

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)

Number of Experts: One ("a licensed radiologist") is mentioned for evaluating clinical images.
Qualifications of Experts: Only "a licensed radiologist" is mentioned; no specific experience level or sub-specialty is provided.

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

Adjudication Method: Not specified. Only one radiologist is mentioned for evaluation, implying no consensus/adjudication process was detailed.

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

MRMC Study: No, an MRMC study targeting human reader improvement with AI assistance was not mentioned. The device is a fluoroscopy system, not an AI/CADe tool for interpreting images.

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

Standalone Performance: No, this does not apply. The device is a fluoroscopy system, a hardware imaging device, not an algorithm being evaluated in a standalone capacity.

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

Type of Ground Truth: For the "clinical images," the "sufficient diagnostic quality" was confirmed by a "licensed radiologist." This implies a form of expert opinion/judgment, but it's not explicitly framed as establishing a ground truth for a diagnostic algorithm. For the hardware performance, ground truth would be adherence to physical and electrical specifications verified through bench testing.

8. The sample size for the training set

Training Set Sample Size: Not applicable/not mentioned. This device is a hardware fluoroscopy system, not an AI model requiring a training set.

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

Ground Truth for Training Set: Not applicable/not mentioned, as there is no AI model or training set described.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

July 20, 2023

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

Re: K230787

Trade/Device Name: Oscar 15 & Oscar 15i Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OWB, JAA Dated: May 22, 2023 Received: July 3, 2023

Dear Kaitlynn 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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Lu Jiang

Lu Jiang, Ph.D. Assistant Director Diagnostic X-ray Systems Team DHT8B: Division of Radialogical 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K230787

Device Name OSCAR 15 & OSCAR 15i

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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Exhibit 5 510(k) Summary

K230787

This 510(k) summary information is prepared in accordance with 21 CFR 807.92

Date of Summary Preparation [21 CFR 807.92(a) (1)] 1.
: Mar. 08, 2023

2. Administrative Information [21 CFR 807.92(a) (1)]

510(k) Submitter	GENORAY Co.,LtdAddress: 512, 560, Dunchon-daero, Jungwon-gu,Seongnam-si, Gyeonggi-Do, KoreaTelephone No.: +82-31-5178-5771Fax: +82-31-5178-5599Contact Person: JiYeon Choi(jychoi@genoray.com)
Official Correspondent	GENORAY America Inc.Address: 147 E. Bristol Lane, Orange, CA 92865 USATelephone No.: +1-855-436-6729Fax: +1-714-786-8919Contact Person: Kaitlynn Min (kaitlynn@genorayamerica.com)

3. Device Information [21 CRF 807.92(a) (2)]

Trade / Device Name:	OSCAR 15 & OSACR 15i
Common or Usual Name:	Fluoroscopic X-ray System
Classification Name:	Interventional Fluoroscopic X-ray System
Classification Regulation:	21 CFR 892.1650
Class of Device:	Class II
Panel:	Radiology
Product Code:	OWB / Interventional Fluoroscopic X-Ray System
Subsequence product code:	JAA / System, X-Ray, Fluoroscopic, Image-Intensified

Predicate Device Information [21 CRF 807.92(a) (3)] 4.

Manufacturer:	GENORAY Co., Ltd
Name of Device:	OSCAR 15 (K172180)
Common or Usual Name:	Fluoroscopic X-ray System
Classification Name:	Interventional Fluoroscopic X-ray System
Classification Regulation:	21 CFR 892.1650
Class of Device:	Class II
Panel:	Radiology
Product Code:	OWB / Interventional Fluoroscopic X-Ray System

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Subsequence product code: JAA / System, X-Ray, Fluoroscopic, Image-Intensified

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

The OSCAR 15 & OSCAR 15i consist of the X-ray tube assembly, X-ray controller, Image receptor and some accessories with no wireless function. The difference between OSCAR 15 and OSCAR 15i is only image acquisition parts. (An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i.)

Indications for use (intended use) [21 CRF 807.92(a) (5)] 6.

OSCAR 15 & OSCAR 15i are 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. OSCAR 15 and OSCAR 15i are indicated only for adult patients.

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7. Substantial equivalence chart [21 CRF 807.92(a) (6)]

	Proposed device		Predicate device
	OSCAR 15	OSCAR 15i	OSCAR 15
Manufacturer	GENORAY Co., Ltd.	GENORAY Co., Ltd.	GENORAY Co., Ltd.
510(k) No.	-	-	K172180
ClassificationName	Interventional Fluoroscopic X-Ray System		Interventional FluoroscopicX-Ray System
	Image: OSCAR 15	Image: OSCAR 15i	Image: OSCAR 15
	Proposed device		Predicate device
	OSCAR 15	OSCAR 15i	OSCAR 15
Indicationsfor use	OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to providefluoroscopic and spot film images of the patient during diagnostic, surgical andinterventional procedures. Examples of clinical application may include cholangiography,endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The systemmay be used for other imaging applications at the physician's discretion. OSCAR 15 andOSCAR 15i are indicated only for adult patients.	OSCAR 15 & OSCAR 15i are a mobile fluoroscopy system designed to providefluoroscopic and spot film images of the patient during diagnostic, surgical andinterventional procedures. Examples of clinical application may include cholangiography,endoscopy, urologic, orthopedic, neurologic, vascular, cardiac and critical care. The systemmay be used for other imaging applications at the physician's discretion. OSCAR 15 andOSCAR 15i are indicated only for adult patients.	OSCAR 15 is a mobile fluoroscopy systemdesigned to provide fluoroscopic and spotfilm images of the patient duringdiagnostic, surgical and interventionalprocedures. Examples of clinicalapplication may include cholangiography,endoscopy, urologic, orthopedic,neurologic, vascular, cardiac and criticalcare. The system may be used for otherimaging applications at the physician'sdiscretion..
Max. outputpower	15 kW	15 kW	15 kW
X-ray Tube	Rotating tube	Rotating tube	Rotating tube
	Large : 0.6 mmSmall : 0.3 mm	Large : 0.6 mmSmall : 0.3 mm	Large : 0.6 mmSmall : 0.3 mm
	High Frequency Inverter	High Frequency Inverter	High Frequency Inverter
	Proposed device		Predicate device
	OSCAR 15	OSCAR 15i	OSCAR 15
	[Radiography]	[Radiography]	[Radiography]
	• Output kV, mAs: 120kV @ 100mAs (max.)	• Output kV, mAs: 120kV @ 100mAs (max.)	• Output kV, mAs: 120kV @ 100mAs (max.)
	• kV range: 40kV ~ 120kV, Step: 1kV	• kV range: 40kV ~ 120kV, Step: 1kV	• kV range: 40kV ~ 120kV, Step: 1kV
	• mAs range: 0.4mAs ~ 100mAs, 24 Steps(Snapshot: 1.0mA ~ 50.0mA)	• mAs range: 0.4mAs ~ 100mAs, 24 Steps(Snapshot: 1.0mA ~ 50.0mA)	• mAs range: 0.4mAs ~ 100mAs, 24 Steps
Generator	[Fluoroscopy]	[Fluoroscopy]	[Fluoroscopy]
	• Output kV, mA: 120kV, 4mA (max.)	• Output kV, mA: 120kV, 4mA (max.)	• Output kV, mA: 120kV, 4mA (max.)
	• kV range: 40kV ~ 120kV, step: 1kV	• kV range: 40kV ~ 120kV, step: 1kV	• kV range: 40kV ~ 120kV, step: 1kV
	• mA range- Small focus :0.2mA ~ 6.0mA, Continuous mode2.0mA ~ 10.0mA, Pulsed mode- Large focus :1.0mA ~ 20.0mA, Continuous mode3.0mA ~ 50.0mA, Pulsed mode	• mA range- Small focus :0.2mA ~ 6.0mA, Continuous mode2.0mA ~ 10.0mA, Pulsed mode- Large focus:1.0mA ~ 20.0mA, Continuous mode3.0mA ~ 50.0mA, Pulsed mode	• mA range- Small focus :0.2mA ~ 6.0mA, Continuous mode1.0mA ~ 10.0mA, Pulsed mode- Large focus :1.0mA ~ 20.0mA, Continuous mode1.0mA ~ 48.0mA, Pulsed mode
	Proposed device		Predicate device
	OSCAR 15	OSCAR 15i	OSCAR 15
	FXDD-1212GA (Flat Panel Detector)	E5830SD-P4A (Image Intensifier)	DualRay-Q (Flat Panel Detector)
Detector	• Active image area : 296.96 x 296.96 mm	• Size of incident surface : 230 mm (9")	• Active image area : 260 x 256 mm
	• Maximum resolution: 3.4 lp/mm	• Conversion factor29 (cd/m2)/(uGy/s)250 (cd/m2)/(uGy/s)	• Central Resolution: 4.6 lp/mm
	• Type : TFT	• Rated of contrast30:1 (10% Area Contrast)19:1(10mm Dia. Contrast)	• Type : CMOS
	• Pixel sampling resolution : 16 bits	• DQE: 65%	• Pixel sampling resolution : 14 bits
	• Pixel pitch : 145 μm	• Resolution9" - 52 (Lp/cm typ.)6" - 58 (Lp/cm typ.)4.5" - 68 (Lp/cm typ.)	• Pixel pitch: 100 μm
	• MTF: 78% (0.5 lp/mm)	• Out image diameter : 25 ±0.5 mm	• MTF: 56%
	• DQE: 60% (0.5 lp/mm)	Previously cleared under K211780.	• DQE: 59%
	• Scintillator : CsI		• Scintillator: CsI





	Previously cleared under K180473.
Dimensions	SID : 1000 mm	SID : 1000 mm	SID : 1000 mm
	C-arc Panning : ±12.5°	C-arc Panning : ±12.5°	C-arc Panning : ±12.5°
	C-arc Orbital angle : 150°	C-arc Orbital angle : 135°	C-arc Orbital angle : 155°
	C-arc up/down range : 500 mm	C-arc up/down range : 500 mm	C-arc up/down range : 500 mm
	C-arc back/forward range : 200 mm	C-arc back/forward range : 200 mm	C-arc back/forward range : 200 mm

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When compared to the predicate device (K172180), the proposed devices presented in this submission has the identical

Indications for use
Maximum output power
X-ray source

The differences between proposed device and predicate device (K172180) are change of detector, addition of New model OSCAR 15i.

A new model, OSCAR 15i has been added to the predicate device (K172180).

The difference between OSCAR 15i and predicate device (K172180) is image acquisition parts. An Flat Panel Detector (FPD) is applied to OSCAR 15, and an Image instensifier is applied to OSCAR 15i. Brief description of technology and conversion principle of whole detector chain through an Inage intensifier is below. Total conversion is that x-ray signal irradiated to the surface of the IIT is converted into a pixel value of a digital image in proportion to its anount. That of conversion method described by several steps by the IT' and the CCD camera attached o IT output window. FPDs designed specifically for thoroscopic use and dose efficiency generally superior to the II systems that they replace, except at the lowest fluoro dose levels. Advantages include excellent image uniformity, no veiling glar or vigneting, and small, thin physical size for improved patient accessibility. Since a detective is applied to the proposed device, the performance related to image quality is also different. The image performance was evaluated according to the IEC standard through performance bench testing denonstrated that these differences do not railer and effectiveness in companson with the predicate device. Furthermore, clinical images have been evaluated by a licensed radits confirmed the sufficient diagnostic quality to provide accurate information.

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8. Safety, EMC and Performance data comparison to Predicate [21 CRF 807.92(b)]

OSCAR 15 & OSCAR 15i have been successfully completed verification and validation testing per GENORAY quality system as well engineering bench testing in support of this submission. The system has been tested and is compliant with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-3, IEC 60601-1-6, IEC 60601-2-28, IEC 60601-2-43, IEC 60601-2-54, IEC 62366. Also, OSCAR 15 & OSACR 15i comply with all applicable 21 CFR performance standards (21 CFR 1020.30, CFR 1020.31, 1020,32)

And Software was validated according to the FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical devices", FDA Guidance "Guidance for the content of premarket submissions for management of cyber security". Results demonstrated that all executed verification tests were passed.

Non-clinical validation testing has been performed to validate that OSCAR 15 & OSACR 15i conform to the intended use, claims, user needs, effectiveness of safety measures and instructions for use.

As a results, 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.

9. 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 & OSCAR 15i are safe and effective as predicate device, and have no new indication for use. Therefore, OSCAR 15 & OSCAR 15i are 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.