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These Digital Radiographic Systems are intended for use by a qualified/trained doctor or technician on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skall, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patient sitting, standing, or lying in the prone or supine position.

These digital diagnostic x-ray systems consist of a tubehead and collimator assembly mounted on a U-Arm, along with a generator, generator control, and an xray table. Power ratings for the available generators are in the rage of 50 kw to 80 kW. Exposure voltage range varies from 40 - 125 KV or 40 - 150 kV with current of 300 - 100 mA. Exposure time is 1 ms - 10 s. This device represents a new combination of already cleared Sedecal and Canon products.

The provided document is a 510(k) summary for the Sedecal Millennium Plus Digital Diagnostic X-Ray System. It states that the new device is substantially equivalent to legally marketed predicate devices. However, this document does not contain information about specific acceptance criteria, a study that proves the device meets those criteria, or details regarding performance metrics, sample sizes, ground truth establishment, or expert involvement in a study as requested.

The document primarily focuses on establishing substantial equivalence by comparing the new device's characteristics and intended use to those of its predicate devices (Sedecal Millennium Digital K042876 and Sedecal X Plus LP Plus K062335) and by stating that it passes bench and test laboratory evaluations to applicable standards (21 CFR 1020.30 and IEC 60601).

Therefore, I cannot provide the requested table and detailed information based on the content of this document. The document explicitly states:

"The results of bench and test laboratory indicates that the new device is as safe and effective as the predicate devices."
and
"After analyzing bench and external laboratory testing to applicable standards, it is the conclusion of Sedecal Inc that the Scdecal Millennium Plus Digital Diagnostic X-Ray Systems are as safe and effective as the predicate device, have few technological differences, and has no new indications for use, thus rendering them substantially equivalent to the predicate devices."

This indicates that general safety and effectiveness testing was conducted, but the specific details of the acceptance criteria, study design, performance metrics, sample sizes, ground truth, or expert involvement are not disclosed in this 510(k) summary.

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