The FLAATZ 750 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 750 is a radiographic image acquisition device. It is a fully integrated image capture and rouling system under human operator control. This system may be useble by a technician in a typical radiology environment. The FLAATZ 750 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 buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell 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 describes a 510(k) submission for a new device, the FLAATZ 750, which is a radiographic image acquisition device. However, the document is a regulatory submission summary and an FDA letter, not a detailed study report. Therefore, it does not contain the specific information requested about acceptance criteria, detailed study design, sample sizes, expert qualifications, or ground truth establishment.

Here's a breakdown of what can be extracted and what is missing:

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

Acceptance Criteria: Not explicitly stated in a quantifiable manner in this document. The document says, "The FLAATZ 750 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 implies the acceptance criteria were met by demonstrating substantial equivalence, but the specific metrics are not detailed here.
Reported Device Performance: The document only states that the device "has shown good performance, substantially equivalent to the predicate device" (Saturn 9000, K063710). No specific performance metrics (e.g., DQE, MTF, SNR, contrast detectability) are provided in this summary.

Acceptance Criteria (Implicit)	Reported Device Performance
Conformance to FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devices" and substantial equivalence to predicate.	"Good performance, substantially equivalent to the predicate device [Saturn 9000 (K063710)]" and "met applicable ElectroMagnetic Compatibility (EMC) requirements."

Missing Information (2-9):

The provided 510(k) summary and FDA letter do not contain the following information:

Sample sizes used for the test set and the data provenance: Not mentioned.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
Adjudication method for the test set: Not mentioned.
If a multi reader multi case (MRMC) comparative effectiveness study was done, and the effect size: Not mentioned. The focus is on demonstrating "substantial equivalence" of the device (FLAATZ 750) to a predicate device, not on human reader performance with or without AI assistance. This is a hardware device, not an AI diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a digital radiography detector, not an algorithm.
The type of ground truth used: Not applicable in the context of diagnostic accuracy studies for AI. For a hardware device, "ground truth" often refers to quantitative imaging performance metrics compared against industry standards or predicate device specifications.
The sample size for the training set: Not applicable. This is a hardware device, not a machine learning model.
How the ground truth for the training set was established: Not applicable. This is a hardware device, not a machine learning model.

Summary of available information:

Device Name: FLAATZ 750
Intended Use: Generating radiographic images of human anatomy, replacing film/screen systems in general-purpose diagnostic procedures (excluding fluoroscopic, angiographic, and mammographic applications).
Predicate Device: Saturn 9000 (New Medical Co., LTD., 510(k) No.: K063710)
Study described: A functional and safety testing to demonstrate substantial equivalence to the predicate device, following FDA guidance for solid-state X-ray imaging devices, and meeting EMC requirements.
Conclusion: The FLAATZ 750 is substantially equivalent to the Predicate Device in design and performance.
Date Prepared: December 5, 2007 (FDA response AUG 23 2013, correcting a previous letter from Jan 23, 2008).

To obtain the detailed information requested (acceptance criteria, specific performance metrics, sample sizes, expert qualifications, etc.), one would need to review the full 510(k) submission, specifically the sections pertaining to "Performance Data" or "Clinical Data" which are not included in this summary.

Summary

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

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 Presidentbjmoon@drtech.co.kr+ 82-31-730-6804
3. Date Prepared	December 5, 2007
4. Device Name	FLAATZ 750
5. Reason for Submission	New Device
6. Classification	21 CFR §892.1650
7. Product Code	MQB
8. Predicate Device	Saturn 9000New Medical Co., LTD.510(k) No.: K063710

9. Device Description

The FLAATZ 750 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 buffen believe a the Detector Panel and Operating PC while also supplying power to the Detector Panell 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.

CONFIDENTIAL

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

10. Intended Use

11. Functional and Safety Testing

The FLAATZ 750 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.

The FLAATZ 750 has also met applicable ElectroMagnetic Compatibility (EMC) requirements.

12. Conclusion

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

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

Image /page/2/Picture/0 description: The image shows the Department of Health & Human Services USA logo. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird-like figure. The symbol is composed of several curved lines and shapes, creating a stylized representation of a bird in flight.

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

DRTECH Corporation % Mr. Ned Devine Senior Staff Engineer/Program Reviewer Underwriters Laboratories. Inc. 333 Pfingsten Road NORTHBROOK IL 60062

AUG 2 3 2013

Re: K080064

Trade/Device Name: FLAATZ 750 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: December 20, 2007 Received: January 10, 2008

Dear Mr. Devine:

This letter corrects our substantially equivalent letter of January 23, 2008.

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surve in the encreations of 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, devices mat have boon require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, and 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 that I Drims made a actives and regulations administered by other Federal agencies. You must or any I cacial statutes and regarations, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Parts 801 and 809); medical device reporting (reporting of

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

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 11 you dostro openio an 100 co 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 I va may other valle guits guiners, 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

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

Indications for Use Statement

510(k) Number (if known): Ko80064

Device Name: FLAATZ 750

Indications for Use:

The FLAATZ 750 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 × (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 Device Evaluation (ODE)

Lust Het Witz

(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number

DRTECH

CONFIDENTIAL

Premarket Notification000063

. ••

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.