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Planmed Verity is intended to be used for X-ray computed tomography imaging of anatomies within upper and lower extremities.

The use of Planmed Verity X-ray unit is allowed only under supervision of a health care professional.

Planmed Verity utilizes the CBCT (Cone Beam Computed Tomography) technology with a flat panel detector to provide high resolution volumetric images. During image acquisition the detector and X-ray tube perform a single rotation around the target of imaging, during which an amount of snapshot X-ray images are acquired. The X-ray radiation is pulsed so that it is active only when data is collected for the projection images. Before reconstruction, calibration corrections are applied to the image data. The reconstruction is then performed using a dedicated reconstruction engine and algorithm.

The system is designed as a compact, stand-alone unit from which the whole imaging procedure from patient information management to image acquisition, processing and archiving can be performed.

The unit provides a motorized gantry with adjustable height and tilt for the best possible extremity positioning. The construction also enables a weight-bearing option, in which the patient stands inside the gantry during image acquisition. Weight-bearing imaging of the extremity shows the anatomy under natural load.

The provided text does not contain acceptance criteria or a study that proves the device meets specific acceptance criteria.

The document is a 510(k) summary for the Planmed Verity device, seeking clearance based on substantial equivalence to a predicate device (Xoran xCATTM). It describes the device's intended use, technology, and comparison to the predicate device.

Here's a breakdown of why the requested information cannot be extracted from the given text:

• No specific acceptance criteria are listed. The document states that "non-clinical studies were completed to compare the imaging performance... The non-clinical comparison included common image quality measures such as high contrast resolution, image noise and Hounsfield Unit (HU) accuracy." However, it does not provide specific thresholds or targets for these measures.
• The "study" is a comparison to a predicate device, not a study demonstrating achievement of specific performance criteria against predefined benchmarks. The conclusion states that the device was found "both substantially equivalent to the predicate device and sufficient for clinical use," implying the predicate device's performance serves as the de facto "acceptance criteria."

Therefore, I cannot provide the requested table or detailed study information. The current document primarily focuses on establishing substantial equivalence rather than detailing an independent study against predefined acceptance criteria for the Planmed Verity.

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