The FLAATZ 500 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 mammography applications).

Device Description

The FLAATZ 500 is a radiographic Image acquisition 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 500 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 Detector 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 for image data capture and correction of defects on the image data.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the FLAATZ 500, based on the provided text:

Acceptance Criteria and Device Performance:

The provided 510(k) summary for the FLAATZ 500 states that the device has been evaluated as per FDA's "Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises" and has shown good performance, substantially equivalent to the predicate device.

However, specific numerical acceptance criteria (e.g., minimum MTF, DQE values, contrast resolution) and corresponding reported device performance metrics are not explicitly provided in the text. The summary relies on the general statement of "good performance" and "substantially equivalent" to the predicate without detailing the quantitative measures.

Study Information:

Since specific performance metrics are not listed, many of the requested details about the study (sample size, ground truth, experts, etc.) are not available in the provided 510(k) summary. The document focuses on declaring substantial equivalence to a predicate device based on general performance.

Here's what can be inferred or is explicitly stated:

Feature	Information from Document
1. Acceptance Criteria & Reported Device Performance	Acceptance Criteria: Not explicitly listed as quantitative values. The overarching criterion appears to be "substantially equivalent to the predicate device" and meeting the "FDA's Guidance for the Submission of 510(k)s for Solid State X-ray Imaging Devises." Reported Device Performance: "Has shown good performance, substantially equivalent to the predicate device." No specific numerical values (e.g., DQE, MTF, resolution) are provided in the summary.
2. Sample size used for the test set and data provenance	Not specified. The document does not describe a specific clinical test set or its sample size. The equivalence claim is based on general performance evaluation rather than a detailed comparative study with a human-read test set.
3. Number of experts and their qualifications for ground truth	Not applicable/Not specified. Since no specific clinical test set for human review against a ground truth is mentioned, the number and qualifications of experts are not provided. The evaluation appears to be technical performance-based, or against a predicate's known technical performance.
4. Adjudication method for the test set	Not applicable/Not specified. No such method is mentioned as a specific clinical test set is not detailed.
5. Multi-reader multi-case (MRMC) comparative effectiveness study	No. The document does not describe an MRMC study comparing human readers with and without AI assistance. The FLAATZ 500 is an image acquisition device, not an AI-powered diagnostic aid. The "AI" in the prompt relates to AI-powered algorithms, which this device is not. It's a digital X-ray detector system.
6. Standalone (algorithm only without human-in-the-loop) performance	Yes (implicitly, for its function as an imaging device). The FLAATZ 500 is a radiographic image acquisition device. Its performance is inherent in its ability to capture images. The "algorithm" in this context refers to the device's internal image processing and API for data capture/correction, which operates standalone to produce the image data. Its performance is evaluated independently of human interpretation in terms of technical specifications.
7. Type of ground truth used	Not explicitly stated for a clinical ground truth. Given the nature of a digital X-ray detector, the ground truth for its performance would typically involve physical phantoms for evaluating technical image quality parameters (e.g., spatial resolution, contrast-to-noise ratio, detective quantum efficiency) rather than a clinical ground truth like pathology or outcomes data. The document states it was evaluated as per FDA's guidance, which would involve these types of technical performance assessments.
8. Sample size for the training set	Not applicable/Not specified. This device is an image acquisition hardware component, not an AI model that requires a training set of images.
9. How the ground truth for the training set was established	Not applicable. As the device is not an AI model requiring a training set, this question is not relevant.

Summary and Caveats:

The 510(k) summary for the FLAATZ 500, K091747, is typical for an image acquisition device seeking substantial equivalence to a predicate. It emphasizes meeting FDA guidance for such devices and demonstrating "good performance" that is "substantially equivalent" to an already cleared device (FLAATZ 750, K080064). It does not contain the detailed clinical study information often associated with AI/CADe devices, which require extensive reader studies and ground truth establishment against clinical outcomes or expert consensus. The evaluation is focused on the technical performance of the imaging hardware itself.

Summary

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K091747

510(k) Summary

JUL - 1 2009

Submitter

DRTECH Corporation 333-1 Sangdaewon1 Dong, Seongnam City Gyeonggi-do, Korea (462-807) www.drtech.co.kr

Contact Person

...

Date Prepared ::

Device Name

Reason for Submission
Classification
Product Code
Predicate Device

New Device

May 25, 2009

FLAATZ 500

Baom Jin Moon Vice President bimgon@drtech.co.kr + 82-31-730-6800

21 CFR 6892 1680

FLAATZ 750 DRTECH Corporation

510(k) No :: K080064

Device Description

The FLAATZ 500 is a radiographic Image acquisition device. It is a fully integrated limage capture and routing system under human operator control. This system may be usable by a technician in a typical radiology environment.

The ELAATZ: 500 system Includes a Detector Panel, Control Box, Switch Box, Unterconnecting Cables, and API. The Detector Panel is a direct conversion device in the form of a square plate in wrich the input x-ray photons are absorbed in an a-Sellayer: The Control Box functions as a buffer between the Detector Panel and Operating PC while also supplying power.to the Detector-Panel. The Switch Box transfers: signals between the Control Box and X-ray Generator and also indicates the status of the panel using LED tights. Finally, the API contains for image data capture and correction of defects on the image data.

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Prematket Notification: FLAATZ-500

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10. Intended Use

The FLAATZ 500 is indicated for use in generating radiographic images of human analomy. It is intended to replace radiographic film/screen systems in all general purpose diagnostic procedures (excluding fluoroscopic, anglographic, and mammographic applications).

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Premarket Notification: FLAATZ 500

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1. Functional and Safety Testing

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12, Conclusion

The FLAATZ 500 is substantially equivalent to the Predicate Device in design and performance

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. 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 human figure embracing or protecting another figure, represented by three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DRTECH Corporation % Mr. Marc M. Mouser CAS Manager II/Office Coordinator Underwriters Laboratories. Inc. 2600 NW Lake Road CAMAS WA 98607

Re: K091747

Trade/Device Name: FLAATZ 500 Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR Dated: June 1, 2009 Received: June 16, 2009

Dear Mr. Mouser:

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 either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. 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 Part 801); medical device reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance: Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

510(k) Number (if known):

K091747

Device Name: FLAATZ 500

Indications for Use

The FLAATZ 500 is indicated for use in generating radiographic 100 a 0 le s anatomy. It is intended to replace radiographic film/screen systems in all purpose diagnostic procedures (excluding fluoroscopic, anglograph mammographic applications).

Preseription Use GVer- The AND/OH (Part 21 CFR-801 Subpart D) 21 6 8 8 8 8 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6 6

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Concurrence of CDRH, Office of Device Evaluation (ODE)

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Premarket Notification:

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.