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The EXPD 4343D and EXPD 3643D Digital X-ray detector are indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This devices are intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This devices are not intended for mammography applications.

The EXPD 4343D, EXPD 3643D are flat-panel type digital X-ray detector that captures projection radiographic images in digital format within seconds, eliminating the need for an entire x-ray film or an image plate as an image capture medium. EXPD 4343D, EXPD 3643D differs from traditional X-ray systems in that, instead of exposing a film and chemically processing it to create a hard copy image, a device called a Detector is used to capture the image in electronic form.

The EXPD 4343D, EXPD 3643D Detector are indirect conversion devices in the form of a square plate in which converts the incoming X-rays into visible light. This visible light is then collected by an optical sensor, which generates an electric charges representation of the incoming X-ray quanta.

The charges are converted to a modulated electrical signal thin film transistors. The amplified signal is converted to a voltage signal and is then converted from an analog to digital signal which can be transmitted to a viewed image print out, transmitted to remote viewing or stored as an electronic data file for later viewing.

The provided FDA 510(k) summary for the DRTECH EXPD 4343D and EXPD 3643D digital X-ray detectors focuses on demonstrating substantial equivalence to a predicate device (K192400), rather than a clinical study establishing new acceptance criteria for diagnostic performance.

Therefore, many of the requested items related to clinical studies, expert-established ground truth, and human reader performance are not applicable in this context.

Here's the information that can be extracted or deduced from the document:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria here are based on equivalence to the predicate device's measured physical performance parameters (DQE and MTF) and compliance with recognized standards. The "study" proving this is a bench test report.

The document states: "According to bench test report, it is proved that the DQE and MTF of predicated device and subject device are basically equal or worth than the predicate device. As a result, subject devices performance is equal or worth than the predicate device."
This indicates that the acceptance criteria for DQE was for the subject device to be at least equal to or better than the predicate, and for MTF, it was to be at least equal to or better than the predicate.

2. Sample size used for the test set and the data provenance

• Sample Size: Not applicable. This was a bench test on the physical performance of the X-ray detectors, not a study involving patient data or a test set of images.
• Data Provenance: Not applicable, as it's a bench test. The manufacturer (DRTECH Corporation) is located in South Korea.

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

• Not applicable. The "ground truth" here is objective physical measurements (DQE, MTF, Resolution) taken from the devices themselves, not expert interpretation of diagnostic images.

4. Adjudication method for the test set

• Not applicable. No diagnostic images or expert reviews were involved in establishing the performance parameters for this submission.

5. 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

• Not applicable. This submission does not describe a comparative effectiveness study involving human readers or AI. It's for a digital X-ray detector (hardware).

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

• Not applicable. This is a hardware device (digital X-ray detector), not an algorithm or AI software for image analysis.

7. The type of ground truth used

• Physical measurements/Instrumental data: DQE, MTF, and Resolution measurements are determined through standardized test procedures defined by documents like IEC 62220-1-1.

8. The sample size for the training set

• Not applicable. This submission does not involve a training set as it is not an AI/ML device.

9. How the ground truth for the training set was established

• Not applicable. This submission does not involve a training set.

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