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The EXPD 4343P / EXPD 3643P 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 4343P / EXPD 3643P 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 4343P differs from traditional Xray 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 4343P / EXPD 3643P Detector is an indirect conversion device in the form of a square plate in which converts the incoming X-rays into 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.

This document describes a 510(k) submission for the EXPD 4343P / EXPD 3643P Digital X-ray detector, which is intended to replace film or screen-based radiographic systems in general diagnostic procedures. The key aspect of the submission is to demonstrate substantial equivalence to a legally marketed predicate device (EVS 4343A / EVS 4343AG / EVS 3643A / EVS 3643AG, K192400).

The primary difference and focus of the study is the change in the TFT panel technology from amorphous silicon to IGZO. The manufacturer claims that IGZO offers improved performance characteristics such as lower resistance and leakage current, which can reduce signal delay and line noise.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for performance are implicitly tied to demonstrating that the new device (EXPD 4343P/3643P) is equal to or better than the predicate device (EVS series) in terms of established X-ray device performance metrics: Detective Quantum Efficiency (DQE) and Modulation Transfer Function (MTF). Resolution is also a key parameter.

Analysis of Performance vs. Criteria:

• DQE: For the EXPD 4343P (50.0%), it is slightly lower than the EVS 4343A (52.9%) but significantly higher than the EVS 4343AG (27.2%). For the EXPD 3643P (52.3%), it is slightly higher than the EVS 3643A (50.5%) and significantly higher than the EVS 3643AG (26.3%). The statement "basically equal or worth than the predicate device" needs to be interpreted in the context of the range of predicate devices. The claim states that the subject device's performance is "equal or worth than the predicate device," which suggests that being comparable or slightly below the predicate in some aspects (like EXPD 4343P DQE vs EVS 4343A) is acceptable, especially when other aspects (like EXPD 3643P DQE vs EVS 3643AG or EXPD 4343P MTF vs EVS 4343A) are superior. The overall conclusion is that the new device meets the criteria of being "equal or worth than" the predicate, especially considering the performance improvements over the "AG" models of the predicate.
• MTF: For the EXPD 4343P (52.3%), it is higher than both comparing EVS 4343A (44.1%) and EVS 4343AG (49.2%). For the EXPD 3643P (46.8%), it is higher than EVS 3643A (44.5%) and slightly higher than EVS 3643AG (46.3%). In all primary MTF comparisons, the subject device shows equal or better performance.
• Resolution: Matches the predicate at 3.5 lp/mm.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states that the data comes from a "bench test report" and "non-clinical performance testing."

• Sample Size: The document does not specify a sample size for the testing of DQE, MTF, or resolution. These are typically measured on a single device following standardized procedures (e.g., IEC 62220-1). It implies testing on representative units of the EXPD 4343P and EXPD 3643P.
• Data Provenance: The testing is "non-clinical," meaning it does not involve human subjects or retrospective/prospective medical data. It is laboratory performance testing. The manufacturer is DRTECH Corporation, based in the Republic of Korea.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This submission is for a digital X-ray detector, not an AI/CAD device. Therefore, there is no concept of "ground truth" established by human experts in the traditional sense for image interpretation. The ground truth for performance metrics like DQE, MTF, and resolution is established through standardized physical measurements and calculations as per recognized consensus standards (e.g., IEC 62220-1).

4. Adjudication Method for the Test Set

• Not applicable, as this is objective engineering performance measurement, not subjective clinical interpretation of images requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

• No MRMC study was done or reported. This device is a hardware component (digital X-ray detector) and not an AI-powered diagnostic tool intended for human reader assistance. The study focuses purely on the physical performance characteristics of the detector itself.

6. Standalone Performance (Algorithm Only without Human-in-the-Loop)

• This is not an algorithm, but a hardware device. The reported performance metrics (DQE, MTF, Resolution) are the "standalone" or intrinsic performance of the detector itself, independent of interpretation by a human or an AI. So, in concept, the reported performance is standalone.

7. Type of Ground Truth Used

• The "ground truth" for the device's performance is based on objective physical measurements conducted according to international standards (specifically, IEC 62220-1 for DQE) and general engineering principles for X-ray detector characterization. It is not based on expert consensus, pathology, or outcomes data, as those would be relevant for diagnostic accuracy studies of interpreted images.

8. Sample Size for the Training Set

• Not applicable. This is a hardware device. There is no "training set" in the machine learning sense for the device itself.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. (See #8)

Summary of the Study:

The study proving the device meets the acceptance criteria is a non-clinical bench test comparing the objective physical performance parameters (DQE, MTF, Resolution) of the new EXPD 4343P/3643P digital X-ray detectors against their predicate devices (EVS 4343A/AG / EVS 3643A/AG). The ground truth for these parameters is established through standardized measurement methodologies defined by international consensus standards, such as IEC 62220-1 for DQE. The study found that the new devices' performance was "equal or worth than" the predicate devices, thereby demonstrating substantial equivalence, particularly highlighting improvements in MTF over the predicate. No human readers, clinical data, or AI algorithms were involved in this specific performance assessment.

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