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The EXPD 86P, EXPD 86PG, EXPD 129PG Digital X-ray detector is indicated for digital imaging solution designed for providing general radiographic diagnosis of human anatomy. This device is intended to replace film or screen based radiographic systems in all general purpose diagnostic procedures. This device is not intended for mammography applications.

The EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG is a 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 86P, EXPD 129P, EXPD 129PG 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 86P, EXPD 86PG, EXPD 129P, EXPD 129PG Detector is an indirect conversion device 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 spatial distribution 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 text describes the 510(k) summary for the EXPD 86P, EXPD 86PG, EXPD 129P, EXPD 129PG digital X-ray detectors. This document focuses on demonstrating substantial equivalence to a predicate device (EVS 4343A/AG and EVS 3643A/AG, K192400) rather than presenting a detailed clinical study for novel AI/ML-driven diagnostic aids.

Therefore, many of the requested criteria related to clinical studies, ground truth establishment, expert adjudication, and MRMC studies are not applicable to this type of submission. The performance assessment here is primarily based on technical benchmarks and non-clinical data demonstrating that the new device performs at least as well as the predicate device in fundamental radiographic characteristics.

Here's a breakdown of the requested information based on the provided text:

1. Table of acceptance criteria and the reported device performance

The acceptance criteria are implicitly defined by demonstrating that the subject devices (EXPD 86P/PG and EXPD 129P/PG) perform "equal or worth" (meaning equal to or better) than the predicate devices (EVS 4343A/AG and EVS 3643A/AG) across key performance metrics. 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."

Note: The DQE and MTF values are reported at different spatial frequencies for the subject and predicate devices (0.5 lp/mm vs 1.0 lp/mm for DQE, and both at 2.0 lp/mm for MTF). The document states the "bench test report... proved that the DQE and MTF... are basically equal or worth than the predicate device," suggesting that despite the different measurement points for DQE, the overall performance comparison satisfied the criteria.

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

Not applicable in the context of a clinical test set for AI/ML performance. This submission is for a digital X-ray detector, and the performance assessment is based on non-clinical, technical measurements (e.g., DQE, MTF) rather than a patient image test set for diagnostic accuracy. The testing performed would be lab-based measurements on the physical detectors.

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

Not applicable. Ground truth in this context refers to physical characteristics measured on the device itself, not clinical diagnoses or interpretations of images by experts.

4. Adjudication method for the test set

Not applicable. No adjudication process is described as the evaluation is based on technical specifications rather than human interpretation.

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

No. This is not an AI-assisted diagnostic device. It is a digital X-ray detector, which is hardware for acquiring images. No MRMC study was conducted or is relevant for this type of device submission.

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

Not applicable. This is a hardware device (X-ray detector), not a standalone algorithm. Its performance is measured directly through physical parameters.

7. The type of ground truth used

The "ground truth" for this device's performance evaluation is based on physical and engineering measurements of objective image quality parameters such as DQE (Detective Quantum Efficiency), MTF (Modulation Transfer Function), and spatial resolution (lp/mm). These are standard metrics for evaluating X-ray detectors.

8. The sample size for the training set

Not applicable. This is a hardware device; there is no "training set" in the machine learning sense. Its design and performance are based on engineering principles and fabrication, not learned from data.

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

Not applicable. As there is no training set for a machine learning model, there is no corresponding ground truth to establish for it.

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