The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during Diagnostic, Surgical and Interventional procedures.

Examples of Clinical Applications may include Orthopaedic. GI Procedure like Endoscopy and Cholenography. Neurology, Urology Procedures, Vascular, Critical Care and Emergency Room Procedures.

Skan-C is not recommended for Cardiac Applications.

Skan-C Surgical C-Arm is indication in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

Device Description

SKAN-C, is a mobile X-Ray C-Arm fluoroscopic device to assist in quiding medical intervention surgical procedures. The device can also be used for radiographic applications. The device is designed in such a way that it can be moved around and can be positioned for the required anatomical/clinical/procedural position.

SKAN-C, a Mobile Surgical C-Arm consists of two units, namely, Mobile Image Intensified C-Arm unit with generator, and a Work-Station for Image display, store and manipulation. C-Arm unit with generator is capable of movements which are essential for patient positioning, like horizontal travel, orbital movement, wig-wag movement and C rotation. The X-ray generator, X-Ray control system and collimator controls are housed in the C-Arm unit.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Skan C Mobile C-Arm X-Ray system). It outlines the device's indications for use, technological characteristics, and non-clinical/clinical tests performed to demonstrate substantial equivalence to a predicate device, rather than providing specific acceptance criteria and detailed study results typical of a performance evaluation directly tied to an AI algorithm.

Based on the provided text, the device is an X-ray system, not an AI-powered diagnostic device. Therefore, the questions related to AI-specific metrics, ground truth establishment for AI training/testing, and multi-reader multi-case studies for AI assistance are not directly applicable to this document.

However, I can extract information related to the performance evaluation of the X-ray system itself, which serves as its "acceptance criteria" and "study" for regulatory purposes.

Here's an interpretation of the requested information based on the provided document, focusing on the device as an X-ray system:

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

The document doesn't present a direct "acceptance criteria" table in the way one might see for diagnostic performance metrics (e.g., sensitivity, specificity). Instead, it demonstrates compliance with recognized safety and performance standards and compares its technological characteristics to a predicate device. The "acceptance criteria" can be inferred as meeting these standards and showing comparable technical specifications.

Acceptance Criteria (Inferred from Compliance)	Reported Device Performance (Skan C)
Safety & Essential Performance: Compliance with IEC 60601-1	Compliant
Imaging Performance, Accuracy of Loading Factors, Reproducibility of Output: Compliance with IEC 60601-2-54	Compliant
Recovery Management, Patient Data, Last Image Hold, Image Measuring: Compliance with IEC 60601-2-43	Compliant
Radiation Safety (Half Value Layer, Leakage/Stray Radiation): Compliance with IEC 60601-1-3	Compliant
Electromagnetic Compatibility (EMC): Conducted/radiated emission, harmonics, voltage fluctuations, ESD, EFT, RF, surges, power frequency magnetic field, voltage dips as per IEC 60601-1-2	Compliant
Image Quality (DQE, Spatial Resolution, Dynamic Range, Beam Alignment, Recovery/Reuse Rate): As per FDA guidance for solid state X-ray imaging devices	Compliant
FDA Performance Standards: 21 CFR 1020.30-1020.32	Compliant
Traceability to Predicate Device (Technological Characteristics):	"Equivalent in technological and other characteristics to the predicate device. GE OEC Fluorostar."
Usability: User experience with device setup and post-imaging processes	"Did not reveal any discomfort or complex user interfaces."
Image Adequacy for Indicated Use:	"Acquired images were of adequate quality for the indicated use" as per independent radiologists' views.

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 does not specify a numerical sample size for "test sets" in the context of diagnostic image analysis, as it's an X-ray system, not an AI algorithm being tested for diagnostic accuracy on a dataset.

Non-Clinical Tests: These involve testing the physical device against engineering and safety standards. There isn't a "sample size" of images or patients in the typical sense. It refers to testing the device's components and overall system functionality (e.g., radiation output measurements, EMC tests).
Clinical Tests (Usability and Image Quality):
- Usability: "Usability aspects of the device were tested by the users and independent participants." No specific number provided.
- Image Quality: "Independent views of Radiologists were obtained on the imaging performances and the acquired images were of adequate quality for the indicated use." No specific number of images or patients mentioned.
Data Provenance: Not explicitly stated for any "data." The company is based in India (Skanray Technologies Private Limited, Mysore, India). It's common for such tests to be conducted internally or by accredited labs in the manufacturer's region or contracted locations.

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: "Independent views of Radiologists were obtained on the imaging performances." The number of radiologists is not specified, only that "Radiologists" (plural) were involved.
Qualifications: Stated as "Radiologists." No specific experience level (e.g., "10 years of experience") or subspecialty is detailed in the document.

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

The document states "Independent views of Radiologists were obtained." This implies individual assessments. There is no mention of an adjudication method (like 2+1 or 3+1 consensus) being used for combining expert opinions or resolving discrepancies.

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

There was no MRMC comparative effectiveness study done comparing human readers with AI assistance versus without AI assistance. This device is an X-ray imaging system, not an AI diagnostic tool. Its performance evaluation focuses on the safety, technical specifications, and image quality of the X-ray system itself.

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

This question is not applicable. The device is a C-Arm X-Ray system, not an AI algorithm. Therefore, there is no "standalone algorithm" performance to report.

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

For the "clinical tests" part of the evaluation:

Usability: The "ground truth" was user feedback and observational assessment by "users and independent participants."
Image Quality: The "ground truth" was "Independent views of Radiologists" regarding image adequacy. This is a form of expert opinion/consensus (though the consensus method isn't detailed). There's no mention of pathology or outcomes data for this specific evaluation in the provided summary.

8. The sample size for the training set

This question is not applicable. The device is a C-Arm X-Ray system, not an AI algorithm that requires a "training set" in the machine learning sense. The X-ray system is developed and validated through engineering standards and clinical evaluations demonstrating its functionality and safety, not through machine learning training.

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

This question is not applicable, as there is no "training set" for an AI algorithm in the context of this device.

Summary

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November 24, 2017

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health and 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.

Skanray Technologies Private Limited % Parul Chansoria Regulatory Consultant Elexes Medical Consulting Pvt Ltd. #6494. Tralee Village Dr. Dr Dublin, California 94568

Re: K170946

Trade/Device Name: Skan C Mobile C-Arm X-Ray system - 230V Variant (303-000187-1), Skan C Mobile C-Arm X-Ray system - 110V Variant (303-000187-2) Regulation Number: 21 CFR 892.1650 Regulation Name: Image-Intensified Fluoroscopic X-Ray System Regulatory Class: Class II Product Code: OXO, OWB Dated: October 17, 2017 Received: November 9, 2017

Dear Parul Chansoria:

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 (QS) regulation (21 CFR Part 820);

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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 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 mediation-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,

Robert Oals

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) K170946

Device Name

Skan C Mobile C-Arm X-Ray system - 230V Variant (303-000187-1), Skan C Mobile C-Arm X-Ray system - 110V (303000187-2)

Indications for Use (Describe)

The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during Diagnostic, Surgical and Interventional procedures.

Examples of Clinical Applications may include Orthopaedic. GI Procedure like Endoscopy and Cholenography. Neurology, Urology Procedures, Vascular, Critical Care and Emergency Room Procedures.

Skan-C is not recommended for Cardiac Applications.

Skan-C Surgical C-Arm is indication in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

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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Section.5- 510K Summary 1

5.1. Sponsor

Date:	September 28, 2017
Applicant:	Skanray Technologies Private Limited,Plot # 15-17, Hebbal Industrial AreaMysore-570016, India
Contact Person:	Parul Chansoria, Regulatory Consultant, Elexes
Email Id:	parul@elexes.com
Phone:	650-528-2445

5.2. Establishment Registration Number

FDA	3009001657
establishment
registrationnumber:

5.3. Device Name

Trade Name:	Skan C
Variants:	Skan C Mobile C-Arm X-Ray system-230V Variant(303-000187-1)
	Skan C Mobile C-Arm X-Ray system-110V Variant(303-000187-2)
Regulation Name:	lmage-Intensified Fluoroscopic X-Ray System
Regulation Number:	892.1650
Product Code:	OXO -Primary & OWB-Secondary

5.4. Predicate Device

GE	OEC Fluorostar - K043076
Regulation Name:	Image-intensified fluoroscopic x-ray system
Regulation number:	892.1650
Product Code:	OWB
Subsequent Product Codes:	JAA, OXO

5.5. Reference Device

Genoray	ZEN-2090 Pro - K091918
Regulation Name:	Image-intensified fluoroscopic x-ray system

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Regulation number:	892.1650
Product Code:	OWB
Subsequent Product Codes:	JAA, OXO

5.6. Product Description

5.7. Indications for Use

The Skan-C, a Mobile Surgical C-Arm X-Ray System, is intended to provide Fluoroscopic and Radiographic images of the patient during diagnostic, surgical and interventional procedures.

Examples of clinical applications may include orthopaedic, GI procedures like endoscopy and cholenography, neurology, urology, vascular, critical care and emergency room procedures.

Skan-C is not recommended for cardiac applications.

Skan-C Surgical C-Arm is indicated for visualization in real time and/or recording of surgical region of interest and anatomy, using X-ray imaging technique.

5.8. Technology Characteristics

Major similarities between subject and predicate device.

		SkanraySkan-C	GE OECFluorostar	SERemark/Comment
X-Ray Tube	Type	Stationary	Stationary	Same
	Focal Spot	0.6/1.8	0.5/1.5	Similar, slightly higher focal spot is to improve the thermal performance of the generator.
	Anode Heat capacity	45KHU	46KHU	Similar, Is the characteristic of X-Ray Tube. Meets the criteria of 10min continuous
		SkanraySkan-C	GE OECFluorostar	SERemark/Comment
				exposure
ImageIntensifier	Make	Thales	Thales/Thomson
	Modes	Triple Mode,9", 6" & 4.5"	Triple Mode, 9",6" & 4.5"	Same
	DQE (%)	65	65	Same
Camera	Technology	CCD	CCD	Same
	Resolution	1k x 1k	1k x 1k	Same
MaxRadiographic Power		2.2 kW	2.2 kW	Same
LoadingFactors	RadiographyKV Range	40-110 kV	36-110 kV	Better Stability within therange specified.
	mAs Range	200 mAs	52 mAs	Better mAs range fordense anatomy due tohigher Focal Spot size.
	Fluoroscopy kVRange	40-110 kV	36-110 kV	Better Stability within therange specified
	FluoroscopymA Range(Normal andboost Mode)	0.2-8 mA	0.2-8 mA	Same
PhysicalParameters	Free SpaceAvailablebetweenSource andDetector	75 Cm	76 Cm	The minor difference inthe physical parametersin terms of dimensionsdoes not have any impacton the claimed indicationsfor use.
	SID	95 Cm	98 Cm
	C-Arm Depth	65 Cm	66 Cm
	HorizontalTravel	20 Cm	20 Cm
	VerticalMovement	40 Cm	43 Cm
	Orbital Rotation	(125°)90°/-	(120°)90°/-
		SkanraySkan-C	GE OECFluorostar	SERemark/Comment
		35°	30°
	Angulation	$180° (+/- 180°)$	$450° (+225°/- 225°)$
	Wig-Wag	+-12,5°	+-10°
OperatingEnvironment	Input EnergySource	100-110 VAC,50/60 Hz	100-110 VAC,50/60 Hz	Same
	OperatingTemperatureRange	10deg C to40deg C	10deg C to40deg C	Same
	OperatingHumidityRange	20- 80 % Non-Condensing	20- 80 % Non-Condensing	Same

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Table 1: Technological characteristics

With the above comparison, the subject device, Skan C, is equivalent in technological and other characteristics to the predicate device. GE OEC Fluorostar.

5.9. FDA Guidance Documents

The following guidance documents were referred during development of the subject device:

1. Content of Premarket Submissions for Management of Cybersecurity in Medical Devices.
1. Off-The-Shelf Software Use in Medical Devices.
1. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices.
1. Draft Guidance for Industry and Food and Drug Administration Staff -Paediatric Information for X-ray Imaging Device Premarket Notifications
1. Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices - Guidance for Industry and Food and Drug Administration Staff.

5.10. Non-Clinical Tests:

The subject device has been evaluated and found to be compliant to safety and essential performance as per IEC 60601-1, accuracy of loading factors, reproducibility

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of radiation output and imaging performance as per IEC 60601-2-54, recovery management, patient data, last image hold, image measuring functions as per IEC 60601-2-43, half value layer, leakage radiation in loading and normal state and strav radiation as per IEC 60601-1-3, conducted emission, radiated emission, harmonics, voltage fluctuations, electrostatic discharge (ESD), electrical fast transients (EFT), radiated RF electromagnetic field, continuous conducted RF, surges, power frequency magnetic field, voltage dips and short interruption as per IEC 60601-1-2, detective quantum Efficiency (DQE), spatial resolution, dynamic range, beam alignment, recovery time, dose requirements, stability of device characteristics with time, frame rate, reuse rate as per FDA guidance document for solid state X-ray imaging devices. The device also complies with FDA performance standards 21CFR 1020.30-1020.32. The verification and validation testing performed demonstrated compliance to the design requirements and intended use of SKAN C.

5.11. Clinical Tests:

Usability aspects of the device were tested by the users and independent participants including the setting up device and the post imaging processes. The results of the study did not reveal any discomfort or complex user interfaces for the intended purpose of the device.

Independent views of Radiologists were obtained on the imaging performances and the acquired images were of adequate quality for the indicated use. The results of the validation activities confirmed that the device is safe and effective for its intended application.

5.12. Conclusion

In accordance with the Federal Food, Drug and Cosmetic Act, 21 CFR Part 807 and based on the non-clinical tests, clinical tests and relative information provided in this premarket notification, we conclude that SKAN C Mobile C-arm X-ray system is substantially equivalent to predicate device with regard to safety and performance.

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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.