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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.

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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