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The FLAATZ 560 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 mammography applications).

The FLAATZ 560 is a radiographic image acquisition device. It is a fully integrated image capture and routing system under human operator control. TThis system may be usable by a technician in a typical radiology environment. The FLAATZ 560 system includes a Detector Panel, Case, Grid, 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.

Here's a summary of the acceptance criteria and the study that proves the FLAATZ 560 device meets those criteria, based on the provided text:

Acceptance Criteria and Reported Device Performance

The acceptance criteria for the FLAATZ 560 are based on demonstrating substantial equivalence to its predicate device, the KRYSTALRAD 560 (FLAATZ 560) SYSTEM. The performance metrics are compared directly to the predicate device.

Study Details

The provided document describes both non-clinical and clinical studies to demonstrate the substantial equivalence of the FLAATZ 560 to its predicate device.

1. Sample Size used for the test set and the data provenance:

   • Test Set Sample Size: Not explicitly stated for either non-clinical or clinical tests. For the clinical study, it mentions "Various parts of FLAATZ 560 images were shown to 5 experts," implying multiple images, but the exact number isn't quantified.
   • Data Provenance: Not explicitly stated, but the submitter is DRTECH Corporation from Gyeonggi-do, Korea, which suggests the studies were conducted by or for them, likely using data generated in Korea or a similar setting. The studies are prospective in the sense that they are specifically conducted to evaluate the FLAATZ 560 for regulatory submission.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • Number of Experts: 5 experts were used for the clinical study.
   • Qualifications of Experts: Not specified. It only states "5 experts."

3. Adjudication method for the test set:

   • Not explicitly described. It states that "clinical study concludes FLAATZ 560 diagnostic images of equivalent quality as KRYSTALRAD 560 (FLAATZ 560)" based on images shown to 5 experts. This implies a consensus or comparative evaluation by the experts, but the specific adjudication rules (e.g., majority vote, independent review with arbitration) are not detailed.

4. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

   • No. This is not an AI-powered device. It is a radiographic image acquisition device intended to replace film/screen systems. The clinical study was a comparative effectiveness study between two imaging devices (FLAATZ 560 vs. KRYSTALRAD 560), not a study evaluating human reader improvement with AI assistance.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • No. As explained above, this is an image acquisition device, not an AI algorithm. The performance tests (DQE, MTF, Resolution, Ghosting) are intrinsic technical performance measures of the device itself and can be considered "standalone" in the sense that they measure the device's physical output quality.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • For the non-clinical tests (DQE, MTF, Resolution, Ghosting), the "ground truth" is established by direct measurement of physical properties of the imaging system against established industry or regulatory standards for image quality.
   • For the clinical test, the "ground truth" for equivalence was based on expert consensus regarding the diagnostic quality of images produced by the FLAATZ 560 compared to the predicate device.

7. The sample size for the training set:

   • This is not an AI/machine learning device, so there is no concept of a "training set" in the traditional sense. The device's performance is driven by its physical design and manufacturing, not by algorithms trained on data.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no training set for this type of device.

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