The Digital X-ray Detector DFP4343C7 is indicated for digital imaging solution designed for general radiographic system for human anatomy. It is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. Not to be used for mammography.

Device Description

Digital X-ray Detector DFP4343C7 is a medical image processing unit. Especially, advanced digital imaging process allows considerably efficient diagnosis, all kind of information management, real-time sharing of image information on network. DFP4343C7 is a high-resolution digital imaging detector designed for general radiography. It is intended to replace conventional film radiography technique. DFP4343C7 consists of Electro X-ray Unit, Software package(S/P), Power Supply Unit and cables set. DFP 4343C7 is an X-Ray image acquisition device that is based on flatpanel. This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

AI/ML Overview

The provided text describes a 510(k) submission for the Digital X-ray Detector DFP4343C7, asserting its substantial equivalence to a predicate device. However, the document does not contain explicit acceptance criteria tables or detailed information about a study proving the device meets specific performance criteria as typically found in clinical validation reports.

The document states that "Clinical considerations according to FDA 'Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices' was performed. All test results were satisfactory." This is a high-level summary and does not provide the granular details requested in your prompt.

Therefore, I cannot provide a table of acceptance criteria and reported device performance from the given text, nor the detailed information about the study design, sample sizes, ground truth establishment, or expert involvement. The document focuses on demonstrating substantial equivalence through non-clinical and general clinical considerations rather than presenting a standalone performance study with specific endpoints and acceptance criteria.

Based on the provided text, the following information can be extracted partially, but much of the requested detail is missing:

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

Not provided in the document. The text generally states that "All test results were satisfactory" for both non-clinical and clinical considerations without detailing specific criteria or performance metrics.

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

Not provided in the document. The text mentions "Clinical considerations" were performed but does not specify the sample size, type (prospective/retrospective), or origin of any clinical data used.

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 provided in the document. There is no mention of experts, ground truth establishment, or their qualifications for any clinical evaluation.

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

Not provided in the document. There is no information about adjudication methods.

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 provided in the document and not applicable. This device is a digital X-ray detector, not an AI-assisted diagnostic tool. Therefore, an MRMC study comparing human readers with and without AI assistance would not be relevant to its evaluation.

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

Not applicable in the AI sense. The device is a digital X-ray detector. Its "performance" would relate to image quality, dose efficiency, and physical characteristics, rather than an "algorithm only" diagnostic performance in the way AI algorithms are evaluated. The document states "All test results were satisfactory" for non-clinical testing which typically includes various performance measures for detectors.

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

Not provided in the document. Given the nature of a digital X-ray detector (image acquisition hardware), "ground truth" might refer to phantoms or standard reference images for assessing image quality, but this detail is not specified for any clinical or non-clinical evaluation.

8. The sample size for the training set:

Not applicable/Not provided. This device is a hardware detector, not an AI model that requires a training set.

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

Not applicable/Not provided. As above, no training set is relevant for this type of device.

In summary, the provided document is a 510(k) summary focusing on demonstrating substantial equivalence, mainly through compliance with safety, electrical, mechanical, and environmental standards, and general clinical considerations. It does not include the detailed performance study data, acceptance criteria, or methodological specifics typically found in a clinical validation report for a diagnostic device, especially one involving AI or complex performance claims.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the word "ELECTRON" in large, outlined block letters. Below the word "ELECTRON" is the phrase "R&D and Manufacturing Company" in a smaller, sans-serif font. The text appears to be a logo or heading for a company specializing in research and development and manufacturing, likely in the electronics field.

Box 12 Saint-Petershuro Russi (812) 325-02-02. Fax +7 (812) 325ectronxray.com e-mail secretary@electronxray.com

K122589

Section 3: 510(k) Summary

ОСТ 5 2012

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.

Date Summary Prepared: August 20, 2012

1. Submitter's Identification: Applicant: NIPK Electron Co Leningradskaya ul. bldg.52a, lit.A, Pos. Pesochny, Saint-Petersburg, 197758, Russia Telephone - +7 (812) 325 02 02 Fax - +7 (812) 325 02 09 Contact - Julia Nikitina

Submitter:

mdi Consultants, Inc. 55 Northern Blvd Great Neck, NY 11021 Telephone: 516-482-9001 Fax: 516-482-0186 Contact: Jigar Shah, MS, RAC

Name of Device: 2.

Device trade name: DFP4343C7 Common name: Digital X-ray Detector Classification: Solid State X-ray Imager (Flat Panel/Digital Imager) Class II MQB 21 CFR 892.1650

Predicate Device Information: 3.

Manufacturer: Samsung Mobile Display Co., Ltd.

{1}------------------------------------------------

Image /page/1/Picture/0 description: The image shows the word "ELECTRON" in large, outlined block letters. Below the word "ELECTRON" is the text "R&D and Manufacturing Company" in a smaller font. The text appears to be the name of a company.

Trade/proprietary name: LTX240AA01-A Common Name: Digital Flat Panel X-Ray Detector 510(k) Number: K090742

4. Device Description:

4.1 General

DFP4343C7 is a high-resolution digital imaging detector designed for general radiography. It is intended to replace conventional film radiography technique .

DFP4343C7 consists of Electro X-ray Unit, Software package(S/P), Power Supply Unit and cables set.

4.2 Features

DFP 4343C7 is an X-Ray image acquisition device that is based on flatpanel. This device should be integrated with an operating PC and an X-Ray generator. It can do to utilize as digitalizing X-ray images and transfer for radiography diagnostic.

Indication for Use: 5.

6. Substantial Equivalence:

NIPK Electron Co believes that Digital X-ray Detector DFP4343C7 is substantially equivalent to LTX240AA01-A Digital Flat Panel X-Ray Detector of Samsung Mobile Display Co., Ltd.

7. Discussion of Non-Clinical Tests Performed for Determination of

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the word "ELECTRON" in large, outlined letters. Below the word, in a smaller font, is the text "R&D and Manufacturing Company". The text is black and appears to be a company logo.

Substantial Equivalence are as follows:

Electrical, mechanical, environmental safety and performance testing according to standard IEC 60601-1 was performed and EMC testing was conducted in accordance with standard IEC-60601-1-2.

Biocompatibility testing was conducted in accordance with Standard ISO 10993-1.

Safety of Programmable medical systems in accordance with IEC 60601-1-4 was performed.

A product risk management is executed according to ISO 14971 and all risks are reduced to an acceptable level by implementation and verification of appropriate measures.

Non-clinical considerations according to FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

7. Discussion of Clinical Tests Performed:

Clinical considerations according to FDA "Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices" was performed. All test results were satisfactory.

8. 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 NIPK Electron Co concludes that the Digital X-ray Detector DFP4343C7 is substantially equivalent to the predicate in intended use, operation, safety, function, and is safe and effective for its' intended use.

{3}------------------------------------------------

Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized human figure with three arms reaching upwards, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular pattern around the figure. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

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

OCT 5 2012

NIPK Electron Co. % Mr. Jigar Shah, M.S., RAC Official Correspondent mdi Consultants, Inc. 55 Northern Boulevard, Suite 200 GREAT NECK NY 11021

Re: K122589

Trade/Device Name: Digital X-ray Detector DFP4343C7 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, MQB Dated: August 20, 2012 Received: August 24, 2012

Dear Mr. Shah:

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

{4}------------------------------------------------

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/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/cdrh/industry/support/index.html.

Sincerely Yours,

uch D. O'hern for

Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

{5}------------------------------------------------

Image /page/5/Picture/0 description: The image shows the word "ELECTRON" in large, bold, sans-serif font. Below the word "ELECTRON" is the phrase "R&D and Manufacturing Company" in a smaller, serif font. The text is black and the background is white.

NIPK Electron Co P.O. Box 12, Saint-Petersburg, Russia 198188 Tel. +7 (812) 325-02-02, Fax +7 (812) 325-04-44 www.electronxray.com e-mail secretary@electronxray.com

Section 2: Indications for Use

of 1 Page 1

510(k) Number (if known): K122589

Device Name: Digital X-ray Detector DFP4343C7

Indications For Use:

Prescription Use X (Per 21 CFR 801 Subpart D)

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sion.Off

(Division Sign-OH)
Division of Radiological Devices
Office of In Vitro Diagnostic Device Evaluation and Safety

510K K 122589

2-1

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.