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.

Device Description

The KMC-950 is a C-arm X-ray mobile systems consisting of a C-arm stand base and monitor trolley. The C-arm mobile stand holds the high-frequency X-Ray generator, X-ray tube assembly, X-ray controls, image intensifier and CCD camera. Monitor trolley supports the image display TV monitors, image processing and recording devices. KMC-950 are providing a dynamic motion images on the TV monitor in such principles of lower dosage, better image quality and digital manipulation, workflow enhancement, operator and patient comfort and versatility. A general radiographic stationary images are able to produce on x-ray film. Therefore a cassette holder is provided with the mobile system.

AI/ML Overview

The provided text describes a 510(k) submission for the KMC-950 C-arm Mobile X-ray Unit. This submission is for a medical device that generates X-ray images, and its acceptance and evaluation are based on conformance to established performance standards for X-ray systems, not on an "AI algorithm" or "device performance" in terms of classification metrics like AUC, sensitivity, or specificity. Therefore, many of the requested categories in your prompt related to AI model evaluation are not applicable to this document.

However, I can extract and present the information that is relevant from the provided text according to your request categories:

1. Table of Acceptance Criteria and Reported Device Performance

For the KMC-950 C-arm Mobile X-ray Unit, "acceptance criteria" and "reported device performance" are defined by compliance with a set of national and international safety and performance standards for medical electrical equipment and diagnostic X-ray systems. The document states that the device conforms to these standards.

Acceptance Criterion (Standard)	Reported Device Performance
21 CFR 1020.30-32: Federal Performance Standard for Diagnostic X-ray Systems	Conformance to all applicable performance standards promulgated by FDA for these systems.
IEC 60601-1-1: Medical Electrical Equipment - Part 1. General Requirements for Safety 1 & 2	Conformance during performance and compliance testing at manufacturing facility and independent test organization.
IEC 60601-1-2: Medical Electrical Equipment Part 1. General Requirements for Safety - 2 (Collateral Standard / Electromagnetic Compatibility - Requirements & Test)	Conformance during performance and compliance testing at manufacturing facility and independent test organization.
IEC 60601-1-3: Medical Electrical Equipment - Part 1 (Collateral Standard / General requirement - For radiation protection in diagnostic x-ray equipment)	Conformance during performance and compliance testing at manufacturing facility and independent test organization.
IEC 60601-2-7: Medical Electrical Equipment - Part 2, Particular Requirements for the safety of high voltage of diagnostic x-ray generators	Conformance during performance and compliance testing at manufacturing facility and independent test organization.
IEC 60601-2-28: Medical Electrical Equipment, X-ray tubes and X-ray Source Assemblies	Conformance during performance and compliance testing at manufacturing facility and independent test organization.
IEC 60601-2-32: Medical Electrical Equipment, Part 2 Particular Requirements for the Safety of associated devices of X-ray equipment	Conformance during performance and compliance testing at manufacturing facility and independent test organization.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable in the context of X-ray system performance standards. The testing is on the device's adherence to regulatory specifications, not on a dataset for diagnostic accuracy.
Data Provenance: Not applicable. The testing described is on the physical device and its operational parameters, not on clinical data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth for these standards is established by the technical specifications and requirements of the standards themselves, not by expert consensus on images.
Qualifications of Experts: Not applicable.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. The testing involves objective measurements against established technical standards.

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, this is an X-ray imaging device. This type of study is not relevant for its regulatory clearance.
Effect Size: Not applicable.

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

Standalone Performance: Not applicable. This document describes an X-ray imaging system, not an AI algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: The ground truth for proving the device meets acceptance criteria is defined by the technical specifications and requirements outlined in the cited national and international performance standards (e.g., 21 CFR 1020.30-32, IEC 60601 series). These standards cover aspects like radiation output, image quality parameters, electrical safety, electromagnetic compatibility, and mechanical integrity, rather than diagnostic accuracy against pathology or outcomes data.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. There is no AI algorithm training described for this device.

9. How the Ground Truth for the Training Set Was Established

Ground Truth for Training Set: Not applicable.

Summary

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Ko32761
Fuje lış

Image /page/0/Picture/1 description: The image shows the logo for United Radiology Systems, Inc. The logo consists of a stylized graphic to the left of the company name. Below the company name is the address "151 South Pfingsten Road, Unit T".

Deerlield, Illinois 60015

Tel: 847-291-0999 Fax: 847-291-1090 ww.united-radiology.com

HAY 1 4 2004

510(k) SUMMARY FOR KMC-950 C-ARM MOBILE X-RAY UNIT

This 510(k) summary of safety and effectiveness information is submitted in accordance with the requirements of 21 CFR Pat 807.87 (a) to (h).

1.0. Identification of submitter

United Radiology Systems, Inc 151 S. Pfingsten Road, Unit T Deerfleid, IL 60015

Establishment Registration No. : # 1424287 Corresponding official : John W. Lee / President

2.0. Identification of Product

Trade / Model Name : KMC-950, C-arm Mobile Panel : X-Ray System Classification : Class II

Product Code : Fluoroscopic, Image Intensified ( 90 JAA)

Regulation No. : 21 CFR 892. 1650/ Product code : 90 JAA ر/WB, OXO

Manufacturer : COMED Medical Systems, Inc. 58 Hak-Dong, Chowol-Myun, Kwangju-Shi, Kyunggi- Do South Korea

3.0. Reason for 510 (k) PMN Submission

KMC-950, C-arm mobile is new X-ray mobile systems.

4.0. Product Description

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K03276d

page 3

Monitor trolley supports the image display TV monitors, image processing and recording devices.

KMC-950 are providing a dynamic motion images on the TV monitor in such principles of lower dosage, better image quality and digital manipulation, workflow enhancement, operator and patient comfort and versatility.

A general radiographic stationary images are able to produce on x-ray film. Therefore a cassette holder is provided with the mobile system.

6.0. Intended Use :

The KMC-950 C-arm X-ray mobile system is used to meet the radiographic and fluoroscopic image & visualization required in surgical, orthopedic and emergency room operation.

The fluoroscopic mode of operation allows the attending physician to see the image directly on the TV monitor in real time without the need to develop individual lilms.

6.0. Equivalent Devices :

The KMC-950 C-arm X-ray mobile systems are substantially equivalent to a legally marketed predicate devices and 510(k) numbers with regard to safely and effectiveness as following list :

◆ GE OEC 9800 PLUS : K 021049
- Siemens, Siremobile ISO-C : K 973598
◆ Medison Acoma, MCA-6100 : K993896 -
- ELMSTech. IMPERIUM : K022114

7.0. Performance Standards :

The KMC-950 is designed in accordance with the national and intemational product safety and performance requirements established in the following standards :

- 21 CFR 1020.30-32 : Federal Performance Standard for Diagnostic X-rav Systems.
- IEC 60601-1-1 : Medical Electrical Equipment- Part 1. General Requirements for Safety 1 & 2
- IEC 60601-1-2 : Medical Electrical Equipment Part 1.
  - . General Requirements for Safety- 2
  - Collateral Standard / Electromagnetic ー
    - Compatibility- Requirements & Test

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Kosztoi
page 3 of 3

◆ IEC 60601-1-3 : Medical Electrical Equipment- Part 1
- General Requirement for safety -3 "
- Collateral Standard / General requirement -For radiation protection in diagnostic x-ray equipment.
- IEC 60601-2-7 : Medical Electrical Equipment- Part 2, Particular Requirements for the safely of high voltage of diagnostic x-ray generators
IEC 60601-2-28 Medical Electrical Equipment, X-ray tubes and � X-ray Source Assemblies
IEC 60601-2-32 Medical Electrical Equipment, Part 2 Particular � Requirements for the Safely of associated devices of X-ray equipment .

Results of performance and compliance testing conducted at manufacturing facility and independent test organization on KMC-950 C-arm mobile systems, indicates conformance to all applicable performance standards promulgated by FDA for these systems.

8.0. Component & Material

Certifiable Component List

General Description	Component / Model Designation
X-ray Controller	KMC-950-HFG-C
High Tension Transformer	KMC-950-HTT
Image Intensifier Tube	TH-9466
X-ray Tube	KMC-950-RAD-99
Collimator	KMC-950-CM-4MR

Appendix & Attachment : 9.0.
- A. Product Comparison List
- Product Identification & Labels B.
- PMN Truthful & Accurate Statement C.
- D. Premarket Notification 510(k) Statement
- E. Software Validation & Verification

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of a human figure in profile, repeated three times to create a sense of depth and connection. The figures are rendered in blue. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the figure.

Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993

MAY 22 2012

Mr. John W. Lee President United Radiology Systems. Inc. 151 South Pfingsten Road, unit T DEERFIELD IL 60015

Re: K032761

Trade/Device Name: KMC-950 C-Arm Mobile System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: OWB, OXO, and JAA Dated: April 23. 2004 Received: April 27, 2004

Dear Mr. Lee:

This letter corrects our substantially equivalent letter of November 14, 2011.

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.

If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of

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medical device-related adverse events) (21 CFR 803); and good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and 809), please contact the Office of In Vitro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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/ReportalProblem/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/cdrh/industry/support/index.html.

Sincerely Yours,

Janine M. Morris

Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health

Enclosure

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STATEMENT OF INTENDED USE

510 (k) Number ( If known) : - Notknown K-03276 I Device Name : KMC-950 C-arm Mobile System

INDICATIONS OF USE :

The system may be used for other RF imaging application at physician's discretion.

( Please do not write below this line – continue on the another page if needed )

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use __ Use

Over- The - Counter -OR

( Per 21 CFR 801.109 )

Daniel A. Lyman

Division Sien-Off 510(k) Number

( Optional Format 1-2-9)

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.