(170 days)
The FLAATZ 760 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).
The FLAATZ 760 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 760 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 rectangular 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 functions for image data capture and correction of defects on the image data.
The provided text describes the 510(k) submission for the FLAATZ 760, a radiographic image acquisition device. The study presented is a non-clinical and clinical comparison to a predicate device, FLAATZ 750, to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the FLAATZ 760 are primarily based on demonstrating substantial equivalence to the predicate device, FLAATZ 750, across various performance metrics. The reported device performance is directly compared to the predicate.
| Metric (Acceptance Criteria relative to FLAATZ 750) | FLAATZ 760 Reported Performance | FLAATZ 750 (Predicate) Performance |
|---|---|---|
| DQE @ 0.5lp/mm | 45.1% | 40% |
| MTF @ 3lp/mm | 78% | 77.7% |
| Resolution | 3.0 lp/mm | 3.0 lp/mm |
| Ghosting @ RQA5 Condition | <1% | <1% |
| Defect Compensation | By Calibration | By Calibration |
| Dynamic Range | 14bit | 14bit |
| DICOM Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant |
| Electrical Safety | Acceptable | Acceptable |
| Thermal Safety | Acceptable | Acceptable |
| EMI/EMS | Suitable | Suitable |
| Diagnostic Image Quality (Clinical Study) | Equivalent to FLAATZ 750 | N/A (predicate for comparison) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The text mentions a "clinical study" where "Various parts of FLAATZ 760 images were shown to 5 experts." It doesn't specify the exact number of images in the test set.
- Data Provenance: The country of origin for the data is not explicitly stated. However, the submitting company is DRTECH Corporation in South Korea. The study appears to be prospective in the sense that the FLAATZ 760 images were specifically generated for this evaluation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
- Number of Experts: 5 experts.
- Qualifications of Experts: The text states "5 experts" but does not specify their qualifications (e.g., "radiologist with 10 years of experience").
4. Adjudication Method for the Test Set
The text states that in the clinical study, "Various parts of FLAATZ 760 images were shown to 5 experts and clinical study: concludes FLAATZ 760 diagnostic images of equivalent quality as FLAATZ 750." This implies a form of expert consensus or qualitative assessment, but the specific adjudication method (e.g., 2+1, 3+1, majority vote, independent review with a final decision by a super-reader) is not detailed. It simply states they "conclude equivalent quality."
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The provided text does not describe an MRMC comparative effectiveness study in the typical sense of measuring human reader improvement with or without AI assistance. The study described is a comparison of image quality, with experts evaluating the diagnostic images of the FLAATZ 760 against the FLAATZ 750. This is a device performance comparison, not an evaluation of human reader performance with AI assistance. The FLAATZ 760 is an image acquisition device, not an AI-powered diagnostic tool.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, partially, in the form of non-clinical technical performance tests. The "Performance test (MTF, DQE, Line Resolution)" were conducted for the FLAATZ 760. These are objective measures of the device's image formation capabilities and do not involve human interpretation in the loop to determine the metric itself. The clinical study, while involving human experts, focuses on the diagnostic quality of images produced by the device, not an algorithm's standalone diagnostic performance.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For the clinical study, the ground truth was established by expert consensus or qualitative assessment of "diagnostic images of equivalent quality." This is based on the subjective assessment of the 5 experts. For non-clinical tests (MTF, DQE, Resolution), the "ground truth" is derived from established measurement methodologies for those physical properties.
8. Sample Size for the Training Set
The document does not mention a training set, as the FLAATZ 760 is a radiographic image acquisition device, not an AI algorithm that requires training. The validation is against a predicate device and technical specifications.
9. How the Ground Truth for the Training Set Was Established
As there is no training set for this type of device, this question is not applicable.
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NOV 3 0 2011
510(k) Summary
| 1. Submitter | DRTECH Corporation333-1 Sangdaewon1-Dong, Seongnam CityGyeonggi-do, Korea [462-807]http://drtech.co.kr |
|---|---|
| 2. Contact Personcwshin@drtech.co.kr | Choul-Woo ShinVice President+ 82-31-730-6823 |
| 3. Date Prepared | March 31, 2011 |
| 4. Device Name | FLAATZ 760 |
| 5. Reason for Submission | New Device |
| 6. Classification | 21 CFR §892.1650 |
| 7. Product Code | KPR |
| 8. Predicate Device | FLAATZ 750DRTECH Corp. South Korea510(k) No.: K080064 |
9. Device Description
The FLAATZ 760 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 760 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 rectangular 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 functions for image data capture and correction of defects on the image data.
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10. Intended Use
The FLAATZ 760 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).
-
- Substantial Equivalence
The FLAATZ 760 is substantially equivalent to the FLAATZ 750 cleared on Jan 28 2008 via 510k K080064.
- Substantial Equivalence
| FLAATZ 760 | FLAATZ 750 | ||
|---|---|---|---|
| 510(k) Number | Pending | K080064 | |
| Indication for Use | The FLAATZ 760 is indicatedfor use in general radiographicimages of human anatomy. Itis intended to replaceradiographic film/screensystems in all general-purposediagnostic procedures(excluding fluoroscopic,angiographic, andmammographic applications) | The FLAATZ 750 systemgenerates digital X-ray imagesthat can be used for general X-ray system. The FLAATZ 750system can interface totraditional X-ray generator andget digital X-ray image. TheFLAATZ 750 is intended to beused in same clinical applicationas traditional film-screen basedgeneral radiography system. | |
| Panel Shape | Square Panel | Square Panel | |
| Detector Size | 43 x 43 (cm) | 43 x 43 (cm) | |
| Dimensions (W/L/H) | 460 x 460 x 15 (mm) | 482 x 482 x 35 (mm) | |
| Design | Pixel Pitch | 168 x 168 (µm) | 168 x 168 (μm) |
| Image Size | 2,560 x 2,560 (pixels) | 2,560 x 2,560 (pixels) | |
| Weight (Detector) | 4.6 (kg) | 6.2 (kg) | |
| Fill Factor | 83% | 83% | |
| Materials | Amorphous Selenium(a-Se) Detector | Amorphous Selenium(a-Se) Detector | |
| DQE | 45.1% @ 0.5lp/mm | 40% @ 0.5 lp/mm | |
| MTF | 78% @ 3lp/mm | 77.7% @ 3lp/mm | |
| Resolution | 3.0 lp/mm | 3.0 lp/mm | |
| Performance | Ghosting | <1% @ RQA5 Condition | <1% @ RQA5 Condition |
| DefectCompensation | By Calibration | By Calibration | |
| Dynamic Range | 14bit | 14bit | |
| DICOM Compatibility | DICOM 3.0 Compliant | DICOM 3.0 Compliant | |
| Anatomical Sites | General Radiography | General Radiography | |
| Energy Used and/or Delivered | The Control Box has thefollowing Power Requirement:100 | The Control Box has thefollowing Power Requirement:100 |
Image /page/1/Picture/6 description: The image is a black and white photograph with a high contrast. The image is mostly white with some black spots and lines. The black spots and lines are scattered throughout the image, and they do not seem to form any recognizable pattern or shape. The image is blurry and out of focus.
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| FLAATZ 760 | FLAATZ 750 | ||
|---|---|---|---|
| CompatibilitywithEnvironmentand otherDevices | EMC | Suitable for EMI and EMS test. | Suitable for EMI and EMS test. |
| OperatingTemperature | +5 to +35 °C | +5 to +35 °C | |
| StorageTemperature | +0 to +40 °C | +0 to +40 °C | |
| Electrical Safety | Acceptable electrical safety level. | This is suitable for electrical safety. | |
| Thermal Safety | Acceptable thermal safety level. | This is suitable for thermal safety. | |
| Standards Met | IEC 60601-1Medical electrical equipment - Part 1General Requirements for safety.IEC 60601-1-2Medical electrical equipment - Part 1-2General requirements for safetyCollateral standard:Electromagnetic compatibility - Requirements and tests | IEC 60601-1Medical electrical equipment - Part 1: General Requirements for safety.IEC 60601-1-2Medical electrical equipment - Part 1-2: General requirements for safetyCollateral standard:Electromagnetic compatibility - Requirements and tests | |
| Non-clinical test report | Performance test (MTF, DQE,Line Resolution) were done forFLAATZ 760 and the resultconcludes FLAATZ 760 candisplay similar images asFLAATZ 750. | Performance test (MTF, DQE,Line Resolution) were done forFLAATZ 750 and the resultconcludes FLAATZ 760 candisplay similar images asFLAATZ 750. | |
| Clinical test report | Various parts of FLAATZ 760images were shown to 5experts and clinical study:concludes FLAATZ 760diagnostic images ofequivalent quality as FLAATZ750 | Various parts of FLAATZ 750images were shown to 5experts and clinical studyconcludes FLAATZ 760diagnostic images ofequivalent quality as FLAATZ750 |
12. General Safety and Effectiveness Concerns
The FLAATZ 760 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 760 has also met applicable Electro Magnetic Compatibility (EMC) requirements.
-
- Conclusion
The FLAATZ 760 is substantially equivalent to the Predicate Device in design and Performance.
- Conclusion
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Image /page/3/Picture/0 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three lines forming the shape of a bird or abstract human figure. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the central emblem.
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
NOV 3 0 2011
Mr. Choul-woo Shin Vice President DRTECH Corporation 333-1 Sangdaewon1-Dong 462-807 SEONGNAM-CITY GYEONGGI-DO KOREA
Re: K111655
Trade/Device Name: FLAATZ 760 Regulation Number: 21 CFR 892.1650 Regulation Name: Image-intensified fluoroscopic x-ray system Regulatory Class: II Product Code: KPR Dated: October 28, 2011 Received: November 4, 2011
Dear Mr. Shin:
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/ReportalProblem/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,
Mary Pastel
Mary S. Pastel, Sc.D. 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 760
Indications for Use:
The FLAATZ 760 is indicated for use in generating radiographic images of human anatomy. It is intended to replace radiographic film/screen systems in all generaldiagnostic procedures (excluding purpose 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 Device Evaluation (ODE)
.
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510K K111 655
DRTECH
CONFIDENTIAL
Premarket Notification: FLAATZ 760
§ 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.