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Wireless Digital Flat Panel Detector (Model:Mars1717V-VSI, Mano4343W) are indicated for digital imaging solutions designed to provide general radiographic diagnosis for human anatomy including both adult and pediatic patients. They are intended to replace film/screen systems in all general-purpose diagnostic procedures. These two devices are not intended for mammography, dental applications.

Mars1717V-VSI and Mano4343W Wireless Digital Panel Detectors (Hereinafter referred to as Mars1717V-VSI and Mano4343W) are the kind of wireless digital flat panel detectors. They support the single frame mode, with the key component of TFT/PD image sensor flat panel of active area: 427mm x 427mm. Two models Mars1717V-VSI and Mano4343W are totally same except for label and model name. The sensor plate of Mars1717V-VSI and Mano4343W is direct-deposited with CsI scintillator to achieve the conversion from X-ray to visible photon. The visible photons are transformed to electron signals by diode capacitor array within TFT panel, which are composed and processed by connecting to scanning and readout electronics, consequently to form a panel image by transmitting to PC through the user interface. The major function of the Mars1717V-VSI and Mano4343W is to convert the X-ray to digital image, with the application of high-resolution X-ray imaging. Both kinds of detectors are the key component of DR system, enable to complete the digitalization of the medical X-ray imaging with the DR system software.

The provided text is a 510(k) summary for a medical device (Wireless Digital Flat Panel Detector). It describes the device, its intended use, and comparison to a predicate device to demonstrate substantial equivalence. However, it does not contain information about a study proving the device meets specific acceptance criteria based on diagnostic performance (e.g., sensitivity, specificity, accuracy).

The document focuses on demonstrating substantial equivalence primarily through technical characteristics, safety, and non-clinical performance, rather than clinical diagnostic accuracy or reader performance studies.

Therefore, most of the information requested in your prompt regarding acceptance criteria and studies to prove diagnostic performance (points 1-7, and 9 for the test set) cannot be extracted from this document. The document explicitly states: "clinical consideration may not necessary for changes in the pixel size and resolution with the same x-ray detection material and may not necessary for changes in the wireless functionality if non-clinical information is sufficient to support the substantial equivalence." This indicates that a detailed clinical performance study as you've described was not deemed necessary for this 510(k) submission.

Here's what can be extracted based on the provided text:

Preamble: This 510(k) submission for the Wireless Digital Flat Panel Detector (Models: Mars1717V-VSI, Mano4343W) focuses on demonstrating substantial equivalence to a predicate device (Mars1717XF-CSI, K183713) based on technical, electrical, mechanical, and non-clinical performance characteristics, rather than a clinical study evaluating diagnostic accuracy or human reader performance. Therefore, detailed information on diagnostic performance acceptance criteria, sample sizes for such studies, expert involvement for ground truth, or MRMC studies is not present.

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

• Acceptance Criteria (Implicit via comparison to predicate and standards adherence): The device is substantially equivalent to the predicate device and meets applicable electrical safety, EMC, and biological evaluation standards. Specific quantitative diagnostic performance metrics are not provided as acceptance criteria in this document.
• Reported Device Performance (Technical and Safety):

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

• Sample Size: Not applicable/Not specified for diagnostic performance tests. The evaluation was primarily based on technical specifications and non-clinical considerations. The statement "There was no significant difference between the images of the Mars1717V-VSI/Mano4343W and those of the predicate device" implies some form of image comparison, but no formal test set size or study methodology is detailed.
• Data Provenance: Not applicable for diagnostic test set; the document describes a technical and safety comparison.

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

• Not applicable/Not specified. Ground truth in the context of diagnostic performance studies is not mentioned, as such a study was not performed or submitted.

4. Adjudication method for the test set

• Not applicable. No diagnostic test set or ground truth establishment method described.

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, an MRMC comparative effectiveness study was not done. This device is a flat panel detector, not an AI-assisted diagnostic tool.

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

• No, this product is hardware (a flat panel detector), not a standalone algorithm.

7. The type of ground truth used

• Not applicable. No diagnostic ground truth was established as a clinical diagnostic performance study was not performed. The evaluation relied on technical performance metrics, adherence to safety standards, and perceived equivalence of image quality to a predicate device.

8. The sample size for the training set

• Not applicable. This device is a flat panel detector, not an AI/machine learning algorithm requiring a training set.

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

• Not applicable. See point 8.

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