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The Ziehm Solo FD is intended for use in providing medical imaging for adults and pediatric populations, using pulsed and continuous fluoroscopic imaging.

The device provides contactless fluoroscopic image capture, temporarily storing, and display of digital subtraction, and acquisition of cine loops during diagnostic, interventional and surgical procedures. Examples of clinical application may include pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures.

The visualization of such anatomical structures assists the clinician in the clinical outcome. This device does not support direct radiographic film exposures and is not intended for use in performing mammography. The system is not intended for use near MRI systems.

Ziehm Solo FD uses X-ray imaging to visualize the human anatomy. The X-ray tube in the generator produces X-rays that penetrate the patient and then hit a special detector that converts them into digital images. This is done under the user and at the direction of a physician who determines the specific clinical procedure. This visualization assists the physician in localizing pathological areas or during surgical procedures. The device enables real-time image acquisition of in vivo surgical procedures and post-operative results.

The Ziehm Solo FD consist of one mobile unit, the Mobile Stand. Optionally the device can be ordered with a Viewing Station (Monitor Cart). The Mobile Stand incorporates a small compact design making the C-arm in relation to the patient easier for the operator. The generator with X-ray tube, advanced heat management system, X-ray control and collimators are assembled in one housing in a mono-block generator. The system control is handled via CAN BUS control system.

The mechanical C-Profile supports the flat panel detector and an integrated laser positioning device. The optional available Viewing Station (Monitor Cart) provides a remote touch Solo Center that duplicates the touch Solo Center mounted on the Mobile Stand.

The provided text concerns the FDA 510(k) clearance for the Ziehm Solo FD, an image-intensified fluoroscopic x-ray system. The core of the submission revolves around a software update (Ubuntu 16.04 to Ubuntu 20.04) and asserting substantial equivalence to a predicate device.

However, the provided document DOES NOT contain information about a study that proves the device meets specific acceptance criteria in terms of performance (e.g., diagnostic accuracy, sensitivity, specificity, or human reader improvement with AI assistance). The document primarily focuses on regulatory compliance, technological comparison with a predicate device, and software updates, rather than a detailed performance study with defined acceptance criteria and statistical analysis.

The text explicitly states:

• "No new non-clinical image comparison with sets of images with the modified device and the predicate have been performed, the device equivalent regarding image quality." This indicates that no new image quality performance study was conducted.
• The overall tone suggests a "substantial equivalence" argument primarily based on the software and hardware remaining fundamentally the same as the predicate, not on a new, explicit performance evaluation against novel acceptance criteria.

Therefore, based solely on the provided text, I cannot complete the request to describe the acceptance criteria and the study that proves the device meets them, nor can I fill in a table of acceptance criteria and reported device performance, or provide details on sample sizes, expert involvement, adjudication, or MRMC studies.

The document discusses:

• Device Name: Ziehm Solo FD
• Regulation Number: 21 CFR 892.1650
• Regulation Name: Image-Intensified Fluoroscopic X-Ray System
• Regulatory Class: Class II
• Product Codes: OWB, JAA, OXO
• Intended Use: Providing medical imaging for adults and pediatric populations using pulsed and continuous fluoroscopic imaging, for diagnostic, interventional, and surgical procedures (e.g., pediatric, cholangiography, endoscopic, urologic, lithotripsy, orthopedic, neurologic, vascular, cardiac, angiographic, critical care, and emergency room fluoroscopy procedures).
• Key Modification: Updated software release (Ubuntu 16.04 to Ubuntu 20.04).
• Compliance: States compliance with 21 CFR 1020.30-32 (Federal Performance Standards for X-Ray Fluoroscopic equipment), IEC 60601-1-3, and IEC 60601-2-54.

To reiterate, the information required for the detailed performance study aspects (acceptance criteria table, sample sizes, expert ground truth, MRMC, etc.) is absent from this FDA 510(k) letter and summary.

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