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PERSONA C HR is a mobile X-ray device used for radiological guidance and visualization during diagnostic, interventional and surgical procedures.

PERSONA C HR device can be used on all patients, except pediatric patients, within the limits of the device.

Examples of clinical applications could be Orthopedic surgery, General surgery, Cardiac procedures, Thoracic surgery, Vascular procedures, Pain therapy and Urological procedures.

PERSONA C HR is a C-arm mobile unit with flat panel detector.

It allows imaging under the following modes:

• Low Dose Fluoroscopy,
• High Quality Fluoroscopy,
• High Quality + Fluoroscopy
• Digital radiography (Snapshot),
• Fluoroscopy in Road Mapping mode (optional),
• Fluoroscopy in DSA mode (optional).

It is provided with a 30x30 cm Flat Panel detector and a 25 kW X-ray generator.

The unit is composed of: Monitor unit, Stand with c-arm, X-ray commands, Printer (optional).

The device acquires images employing X-rays emitted by an X-ray source which can produce up to 25kW.

The unit, which is powered by a single-phase electrical supply, generates ionizing radiations (X-rays) which, as they pass through the patient, reach a flat panel detector that produces radiological images.

An x-ray collimator, placed on the monobloc, is responsible for limiting the emission beam of ionizing radiation.

The images collected by the detector are sent to a video processor, which, after processing the information received, allows radiological images to be displayed on the display monitor.

I am sorry, but the provided text does not contain the detailed information necessary to fully address all aspects of your request regarding acceptance criteria and a study proving device performance. The document is an FDA 510(k) clearance letter and summary, which confirms substantial equivalence to a predicate device but does not typically include the granular details of performance studies you are looking for, such as specific acceptance criteria thresholds, detailed test set data, expert adjudication methods, or MRMC study results with effect sizes.

Specifically, the document states: "Substantial equivalence was supported by engineering-based performance testing, including evaluation of image quality using test phantoms and cadaver images by an 'American Board of Radiology' radiologist." However, it does not provide the specifics of this evaluation in the way you've outlined in your request.

Therefore, I cannot generate the table of acceptance criteria with reported device performance or the detailed study breakdown that you've requested beyond what is implicitly stated about image quality evaluation.

If you have a different document that contains this information (e.g., a detailed clinical study report or a more extensive validation report), I would be happy to analyze it for you.

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