The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures. (excluding fluoroscopic, angiographic, and mammographic applications).

Device Description

The FLAATZ 750E is a radlographic image ecquisition device. It is a fully integrated image capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The FLAATZ 750E system includes a Detector Panel, Control Box, Switch Box, interconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in which the input x-ray photons are absorbed in an a-Se layer. The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power to the Delector Panel. The Switch Box transfers signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED lights. Finally, the API contains functions for Image data capture and correction of defects on the image data.

AI/ML Overview

The provided text is a 510(k) summary for the FLAATZ 750E device. It details the device's description, intended use, and substantial equivalence to a predicate device, but it does not contain any information about acceptance criteria or a specific study proving the device meets those criteria, especially not in the context of AI/ML performance.

The document states: "The FLAATZ 750E has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device." This indicates that the evaluation was likely focused on demonstrating performance comparable to an existing device for general radiography, rather than establishing specific acceptance criteria for AI/ML performance or conducting a comparative effectiveness study with human readers.

Therefore, I cannot provide the requested information. The text does not include:

A table of acceptance criteria and reported device performance related to AI/ML.
Sample sizes or data provenance for a test set for AI/ML evaluation.
Number or qualifications of experts for ground truth establishment for AI/ML.
Adjudication method for an AI/ML test set.
Information about a multi-reader multi-case (MRMC) comparative effectiveness study or related effect sizes.
Results of a standalone AI algorithm performance study.
The type of ground truth used for AI/ML (as no AI/ML performance study is mentioned).
Sample size for a training set for AI/ML.
How ground truth for a training set for AI/ML was established.

This document is a standard 510(k) Pre-Market Notification for a radiographic image acquisition device, which essentially describes a digital X-ray detector system. It is not about an AI/ML-driven diagnostic device.

Summary

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MAR - 4 2011

510(k) Summary

1. Submitter	DRTECH Corporation333-1 Sangdaewon1-Dong, Seongnam CityGyeonggi-do, Korea (462-807)www.drtech.co.kr
2. Contact Person	Beom-Jin MoonVice Presidentbimoon@drtech.co.kr+ 82-31-788-7653
3. Date Prepared	June 25, 2010
4. Device Name	FLAATZ 750E
5. Reason for Submission	New Device
6. Classification	21 CFR §892.1650
7. Product Code	KPR
8. Predicate Device	FLAATZ 750DRTECH Corporation510(k) No.: K080064

9. Device Description

DRTECH

CONFIDENTIAL

Premarket Notification: FLAATZ 750

નિર

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10. Intended Use

The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all general-purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammographic applications).

11. Functional and Safety Testing

The FLAATZ 750E has been evaluated as per FDA's "Guldance for the Submission of 510(k)s for Solld State X-ray Imaging Devices" and has shown good performance, substantially equivalent to the predicate device.

The FLAATZ 750E has also met applicable Electro Magnetic Compatibility (EMC) requirements.

1. Conclusion
  The FLAATZ 750E is substantially equivalent to the Predicate Device in design and performance.

DRTECH

CONFIDENTIAL

Premarket Notification: FLAATZ 750

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Image /page/2/Picture/0 description: The image shows the logo of the Department of Health & Human Services. The logo consists of a stylized graphic of human figures in blue, along with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in blue font. The text is positioned to the right of the graphic.

Public Health Service

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

DRTECH Corporation % Mr. Charlie Mack Principal Engineer IRC 77325 Joyce Way ECHO OR 97826

Re: K102474

Trade/Device Name: FLAATZ 750E Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: February 18, 2011 Received: February 25, 2011

AUG 2 3 2013

Dear Mr. Mack:

This letter corrects our substantially equivalent letter of March 4, 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/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,

Janine M. Morris

Janine M. Morri 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 Statement

510(k) Number (if known):

Device Name: FLAATZ 750E

Indications for Use:

The FLAATZ 750E is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generalpurpose diagnostic procedures. (excluding fluoroscopic, angiographic, and mammographic applications).

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Bewine Evaluation (ODE) CCVI

Mary Scott

Division of Radio Offica of in Vitro Diagno

510K K102474

DRTECH

Confidential

Premarket Notification: FLAATZ: 750E

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.