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The EVS 2430W and EVS 2430GW 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 EVS 2430(G)W is a wired/wireless 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. EVS 2430(G)W 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 EVS 2430(G)W 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.

This document describes the regulatory submission for the DRTECH Corporation's EVS 2430W and EVS 2430GW Digital X-ray detectors. The submission aims to demonstrate substantial equivalence to a predicate device (EVS 3643, EVS 3643G, K162552).

Here's an analysis of the provided information regarding acceptance criteria and the supporting study:

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining explicit acceptance criteria with specific thresholds for each parameter. Instead, it compares the performance of the modified device (EVS 2430W, EVS 2430GW) to the predicate device (EVS 3643, EVS 3643G). The acceptance is implicitly based on the new devices showing "basically equal or higher" physical values for key X-ray device comparison metrics.

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

• Sample Size: Not explicitly stated as a number of cases or images. The document mentions "Clinical images were provided" and "study confirmed that the x-ray detectors EVS 2430(G)W provide images of equivalent diagnostic capability." The specific number of images or patients in the clinical image test set is not provided.
• Data Provenance: Not explicitly stated. The study was a "single-blinded concurrence study according to CDRH's Guidance for the Submission of 510(k)'s for Solid State X-ray Imaging Devices." This typically implies a controlled setting, but the origin (e.g., country, type of clinic) of the raw images or data used is not mentioned. It is a clinical test to demonstrate clinical effectiveness. Whether it's retrospective or prospective is also not stated clearly for this "clinical image evaluation."

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

• Number of Experts: Not specified. The document states it was a "single-blinded concurrence study." This implies that expert readers (e.g., radiologists) were involved in evaluating the images, but their number is not provided.
• Qualifications of Experts: Not specified. While the context (radiographic diagnosis) implies radiologists would be the experts, their specific qualifications (e.g., years of experience, subspecialty) are not mentioned.

4. Adjudication Method for the Test Set:

• Adjudication Method: Not explicitly stated. The term "concurrence study" implies that multiple readings were compared for agreement, but the specific adjudication method (e.g., 2+1, 3+1, majority vote, etc.) is not detailed. The "single-blinded" aspect means the readers were unaware which images came from the test device versus the predicate.

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

• Was an MRMC study done? A "single-blinded concurrence study" was conducted to confirm "equivalent diagnostic capability" to the predicate. This is a type of comparative effectiveness study. However, it's not explicitly framed as an "MRMC study" in the sense of a statistical design aimed at measuring observer performance gains. It's more of a qualitative assessment of equivalence.
• Effect size of human readers with AI vs. without AI assistance: Not applicable. This device is a digital X-ray detector, not an AI-assisted diagnostic tool. The comparison is between the new detector and a predicate detector, not about AI assistance for human readers.

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

• Was standalone performance done? Not applicable. The device is a hardware component (X-ray detector). Its "performance" is measured by physical metrics (DQE, MTF, Resolution) and its ability to produce diagnostically equivalent images for human interpretation, not by an autonomous algorithm making diagnoses.

7. The Type of Ground Truth Used:

• Type of Ground Truth: The document states that the "clinical image evaluation proved the clinical effectiveness of the subject device" and that the study confirmed "equivalent diagnostic capability." This strongly suggests that the ground truth was established by expert consensus (i.e., expert readers determining the diagnostic quality and clinical equivalence of images produced by the test device compared to the predicate). It does not mention pathology, outcomes data, or other definitive ground truths.

8. The Sample Size for the Training Set:

• Sample Size for Training Set: Not applicable. This document is for a hardware device (X-ray detector), not a machine learning algorithm that requires a "training set." The tests described are for objective performance metrics and clinical image evaluation for equivalence.

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

• How Ground Truth for Training Set was Established: Not applicable, as this is not an AI/ML device requiring a training set.

In summary, the document details a comparison of a new X-ray detector to a predicate device, focusing on technical specifications and demonstrating "equivalent diagnostic capability" through a clinical image evaluation. While it confirms the device meets acceptance criteria (primarily by demonstrating equivalence to a previously cleared device), many specific details about the clinical study's methodology, particularly regarding reader numbers, qualifications, and exact sample sizes, are not provided in this specific excerpt.

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