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The flat panel detector when used with a radiographic imaging system is intended to generate radiographic images of human anatomy wherever a conventional screen-film, digital radiography (DR) or computed radiography (CR) detector is used for general purposes.

When the dual energy subtraction is enabled, it is intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

This device is not intended for use in mammography applications.

The Reveal 35C Flat Panel Detector is similar to the FDA cleared Yushan X-ray Flat Panel Detector. The detectors consist of amorphous silicon flat panel image sensors with cesium iodide scintillators. The light is captured by an amorphous silicon photodetector and the resulting signal is transferred via amorphous silicon thin film transistor (TFT) switches to external readout electronics to obtain X-ray images. The Reveal 35C Flat Panel Detector is a portable digital detector that can be integrated with a PC workstation and an X-ray source to acquire digital X-Ray images for general radiography. The detector supports wireless and wired data communication and can be used wherever a conventional screen-film, digital radiography, or computed radiography detector is used for general purposes.

The Reveal 35C Flat Panel Detector synchronize their image capture cycle with the X-Ray exposure in either of the two modes:

• 1. Wired Mode
• Wireless Mode 2.

The subject device, Reveal 35C Flat Panel Detector includes an optional Dual-Energy subtraction function. When the Dual-Energy Subtraction function is enabled, it will provide additional dual energy subtracted X-ray images. The images are intended to assist the physician through the visualization of anomalies by reducing the visibility of underlying or overlying anatomical structures.

Here's a summary of the acceptance criteria and study information for the KA Imaging Reveal 35C Flat Panel Detector, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text does not contain a specific table of acceptance criteria or quantitative performance metrics for the Reveal 35C Flat Panel Detector. Instead, it focuses on demonstrating substantial equivalence to predicate devices through technical characteristics, design features, operating principles, functional and performance characteristics, and intended uses.

The text states that:

• Non-clinical bench testing has determined that the device hardware and software requirements conform to its specification. (A general statement of performance.)
• The image quality validation confirmed that the image quality of KA Imaging Reveal 35C Flat Panel Detector is substantially equivalent to that of the predicate device. (A comparative statement.)

Therefore, a table cannot be constructed with specific numerical acceptance criteria and reported device performance directly from this document. The "acceptance criteria" here is implicitly that the device performs equivalently to the listed predicate devices in its general function and image quality.

Study Information:

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

   • The document does not specify the sample size used for any test set or the data provenance (e.g., country of origin, retrospective/prospective). It mentions "non-clinical bench testing" and "image quality validation" but no details on patient data or specific test sets for clinical performance.

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

   • This information is not provided in the document.

3. Adjudication Method for the Test Set:

   • This information is not provided in the document.

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

   • An MRMC comparative effectiveness study is not mentioned in the document. There is no information about human readers improving with or without AI assistance, as the focus is on the device's technical equivalence rather than a clinical reader study of the dual-energy subtraction feature.

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

   • The document implies that the device's dual-energy subtraction function produces images (soft-tissue and bone) that are "equivalent to those of reference predicate devices (K122454 and K013481)." This suggests a standalone comparison of the image output itself, but details of a formal standalone performance study are not explicitly described. The text states the images are "intended to assist the physician," but doesn't quantify this assistance through a standalone algorithm performance metric.

6. Type of Ground Truth Used:

   • The document does not explicitly state the type of ground truth used for any evaluations. Given the focus on image quality equivalence and the absence of clinical outcome studies, it's likely that technical image quality metrics and visual comparison to predicate devices' outputs formed the basis of "validation," but specific ground truth types (e.g., pathology, clinical outcomes) are not mentioned.

7. Sample Size for the Training Set:

   • The document does not provide any information regarding the sample size for a training set. This is not uncommon for 510(k) submissions that focus on device equivalence rather than novel AI/ML algorithm performance where extensive training data details are typically required.

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

   • Since no training set is mentioned, this information is not provided.

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