The Clear Vision DR7000F product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column,. chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

The Clear Vision DR7000F system is intended to be used in medical clinics and hospitals for emergency, orthopedic, chiropractic, and other medical purposes. This device is not indicated for use in mammography.

Device Description

The Clear Vision DR7000F system is a high-resolution digital imaging system designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.

The detector which is used proposed device is LTX240AA01-A (K090742) and LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd. These detectors are cleared by FDA 510(k).

AI/ML Overview

The provided 510(k) summary for the Clear Vision DR7000F does not contain information about acceptance criteria or a study proving the device meets specific performance criteria related to AI or algorithm-only performance.

The document describes a digital radiography X-ray system, which is a hardware device, not an AI or algorithm-based diagnostic tool. The submission focuses on demonstrating substantial equivalence to predicate hardware devices and compliance with electrical, mechanical, environmental safety, and performance standards for X-ray systems.

Therefore, most of the requested information regarding AI/algorithm performance, ground truth establishment, expert review, and training/test set sizes is not applicable to this document.

Here's a breakdown of what can be extracted or inferred from the provided text, and where information is missing / not applicable:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Electrical, Mechanical, Environmental Safety & Performance: Compliant with EN/IEC 60601-1, 60601-1-1, 60601-1-3, 60601-2-7, 60601-2-28, 60601-2-32.	All test results were satisfactory.
EMC: Compliant with EN/IEC 60601-1-2(2007).	Testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory.
X-ray Detector Performance: Not explicitly stated as a separate criterion, but performance and clinical testing were provided as recommended by FDA guidance for Solid State X-ray Imaging Devices.	Performance and clinical testing for the X-ray detectors were provided. (The document indicates the detectors LTX240AA01-A and LLX240AB01 were previously cleared by FDA 510(k), implying their performance was acceptable.)
Substantial Equivalence: To predicate devices CDX-DR80D (Choongwae Medical Corp.) and LTX240AA01-A, LLX240AB01 (Samsung Mobile Display Co. Ltd.).	The conclusion states the device is substantially equivalent to the predicate devices, implying it meets the necessary performance and safety profiles.

Regarding specific questions related to AI/Algorithm performance:

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

Not applicable / Not provided. This device is an X-ray imaging system, not an AI algorithm. The "clinical testing" mentioned for the X-ray detectors likely refers to performance evaluation under clinical conditions, not an algorithm's diagnostic accuracy on a test set of images.

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 / Not provided. No specific "ground truth" establishment for an algorithm's performance is mentioned. Evaluation of an X-ray system focuses on image quality, radiation dose, safety, and functionality, which are assessed against technical specifications and clinical utility, rather than diagnostic "ground truth" for an AI model.

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

Not applicable / Not provided.

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 / Not provided. This submission is for a medical imaging device, not an AI-assisted diagnostic tool. No MRMC study is mentioned.

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

Not applicable / Not provided. No standalone algorithm performance is discussed.

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

Not applicable / Not provided. For an X-ray device, "ground truth" generally relates to physical measurements (e.g., spatial resolution, contrast-to-noise ratio, MTF, DQE) and clinical image quality (diagnostic acceptability) rather than a pathology reference for an AI diagnosis.

8. The sample size for the training set

Not applicable / Not provided. No AI training set is mentioned.

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

Not applicable / Not provided. No AI training is mentioned.

Summary regarding the device:

The Clear Vision DR7000F is a digital radiography X-ray system. The study proving it meets acceptance criteria primarily involves engineering and performance testing against established international standards (EN/IEC 60601 series) for medical electrical equipment, as well as specific guidance for solid-state X-ray imaging devices. The acceptance criteria relate to electrical, mechanical, environmental safety, electromagnetic compatibility (EMC), and the technical performance and clinical utility of the X-ray detectors. The "study" mentioned is the compilation of these satisfactory test results conducted by the manufacturer, demonstrating compliance and substantial equivalence to existing cleared predicate hardware devices.

Summary

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K102327 APR 1 3 2012

510 (k) Summary

April 11, 2012

1. Company and Correspondant Making the Submission:

Name: JPI Healthcare Co., LTD Address: Woolim e-BIZ center #608 170-5, Kuro-3-dong, Kuro-gu Seoul, 152-769 Telephone: +82-2-2108 - 2580 (Ext. 500-504) Fax: +82-2-2108-1180 Contact: John Lim Website: http://www.jpi.co.kr/

1. Identification of Device

Classification Name:	Stationary X-ray System
Common Name:	Digital Radiography X-ray System
Trade/Proprietary Name:	Clear Vision DR7000F

1. Predicate Device

Manufacturer:	Choongwae Medical Corporation
Device:	CXD-DR80D
510(k) Number:	K083640 (Decision Date Jul 29, 2009)
Manufacturer:	Samsung Mobile Display Co., Ltd
Device:	LTX240AA01-A
510(k) Number:	K090742 (Decision Date Sep 18, 2009)
Manufacturer:	Samsung Mobile Display Co., Ltd
Device:	LLX240AB01
510(k) Number:	K102587 (Decision Date Dec 01, 2010)

Product Classification Names and Citations 4.
Regulatory Number: 21 CFR 892.1680 Regulatory Class: II 90 MQB Product Code:
Description: న.
The Clear Vision DR7000F system is a high-resolution digital imaging system

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designed for digital radiography. It is designed to replace conventional film radiography techniques. This system consists of a tube head/collimator assembly mounted on a U-Arm, along with a generator, generator control, and a detector, operating software.

The detector which is used proposed device is LTX240AA01-A (K090742) and LLX240AB01 (K102587) of Samsung Mobile Display Co., Ltd. These detectors are cleared by FDA 510(k).

1. Indication for use
  The Clear Vision DR7000F product is intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

1. Comparison with Predicate Device:
  JPI Healthcare Co., Ltd, believes that the Clear Vision DR7000F is substantially equivalent to the CDX-DR80D of Choongwae Medical Corporation and the LTX240AA01-A, LLX240AB01 of Samsung Mobile Display Co. Ltd.
1. Safety, EMC and Performance Data
  Electrical, mechanical, environmental safety and performance testing according to standard EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-3, EN/IEC 60601-2-7, EN/IEC 60601-2-28 and EN/IEC 60601-2-32 was performed, and EMC testing was conducted in accordance with standard EN/IEC 60601-1-2(2007). All test results were satisfactory.

We have also provided performance and clinical testing for the X-ray detectors, as recommended by the FDA guidance document "Guidance for Industry and/or for FDA Reviewers/Staff and/or Compliance: Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices"

1. Conclusions:
  In accordance with the Federal Food. Drug and Cosmetic Act, 21 CFR Part 807 and based on the information provided in this premarket notification JPI Healthcare Co., Ltd. concludes that Clear Vision DR7000F is safe and effective and substantially equivalent to predicate devices as described herein.
1. JPI Healthcare Co. Ltd. will update and include in this summary any other information deemed seasonably necessary by the FDA.

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, a traditional symbol of medicine, but with a more abstract and modern design.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

JPI Healthcare Co., Ltd. % Mr. William Little Product Manager JPI Healthcare Solutions, Inc. 52 Newtown Plaza PLAINVIEW NY 11803

APR 1 3 2012

Re: K102327

Trade/Device Name: Clear Vision DR7000F/Digital Radiography X-ray System Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: MQB and KPR Dated: February 7, 2012 Received: February 7, 2012

Dear Mr. Little:

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 or uny 1 carated and 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 (OS) 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/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 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/cdrb/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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Indications for Use

510(k) Number (if known): K102327

Device Name: Clear Vision DR7000F / Digital Radiography X-ray System

Indications for Use:

Prescription Use X Prescription Use _____________________________________________________________________________________________________________________________________________________________

Over-The-Counter Use N/A (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sigh-Off)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety
K107327

રીકાર

Page I of 1

Regulation Number and Section

§ 892.1680 Stationary x-ray system.

(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. 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). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary 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.