Search Results

The EXPD 4357, EXPD 4357P 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 4357, EXPD 4357P 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 4357P 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 4357, EXPD 4357P 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 text focuses on demonstrating substantial equivalence to a predicate device, rather than outlining specific clinical acceptance criteria and related studies for the EXPD 4357 and EXPD 4357P. The document primarily discusses non-clinical performance (DQE, MTF, Resolution) and compliance with regulatory standards.

Therefore, many of the requested details about acceptance criteria, study design, and clinical performance cannot be extracted from this document.

Here's an analysis based on the information available:

1. A table of acceptance criteria and the reported device performance

The document provides performance data for non-clinical parameters and compares them to the predicate device. It does not state explicit clinical acceptance criteria in the sense of accuracy, sensitivity, or specificity for diagnosis. Instead, it compares the technical performance to show equivalence or superiority.

Note: The document states that "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 phrasing suggests the "acceptance criteria" are simply to perform comparably or better than the predicate for these technical specifications.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document primarily describes non-clinical bench testing. There is no mention of a test set comprising patient data or clinical images. The performance data (DQE, MTF, resolution) are derived from technical measurements, not clinical studies.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This was a non-clinical/technical performance evaluation, not a clinical study involving expert interpretation of images or establishment of ground truth.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, for the same reasons as above.

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. The EXPD 4357/4357P is a digital X-ray detector, which is a hardware device for capturing images. It is not an AI-assisted diagnostic tool for which an MRMC study would be conducted to evaluate reader performance with and without AI.

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

Not applicable. This is a hardware device. Its "performance" is in image capture quality, not diagnostic interpretation by an algorithm.

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

For the non-clinical performance characteristics (DQE, MTF, Resolution), the "ground truth" is established through standardized physical measurement methods as outlined in IEC 62220-1-1. This is not a clinical ground truth.

8. The sample size for the training set

The document describes a hardware device, not an AI or software algorithm that requires a training set of data.

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

Not applicable, as there is no training set for this hardware device.

Ask a specific question about this device