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ZEN-2090 Turbo, C-Arm mobile is used for providing fluoroscopic images of patient anatomy in a hospital or medical clinics.

ZEN-2090 Turbo, C-arm mobile is used for providing fluoroscopic image of patient anatomy, especially during diagnostic, surgical and interventional procedures. The fluoroscopic mode of operation is very useful to the attending physician to see the images on real time without the need to develop individual films.

ZEN-2090 Turbo is consisting of the X-ray tube, X-ray tube assembly, X-ray controller, XTV Camera and some accessories.

The provided text is a 510(k) summary for the ZEN-2090 Turbo device, which is an Image-Intensified Fluoroscopic X-Ray System. This submission focuses on demonstrating substantial equivalence to a predicate device (ZEN-2090 Pro), rather than presenting a standalone study proving a new device's performance against specific acceptance criteria for an AI/algorithm-based diagnostic tool.

The document primarily discusses the technical specifications of theZEN-2090 Turbo and compares them to the predicate device to argue for substantial equivalence. It does not contain the kind of detailed study design, data, and acceptance criteria normally provided for AI-driven diagnostic systems where performance metrics like sensitivity, specificity, or AUC are critical.

Therefore, I cannot extract the information requested regarding acceptance criteria, study details, sample sizes, expert ground truth establishment, or MRMC studies, as these aspects are not present in the provided 510(k) summary for this type of device (a C-arm mobile fluoroscopic X-ray system).

The document states:

• Device Type: Image-Intensified Fluoroscopic X-Ray System (ZEN-2090 Turbo)
• Purpose: Provides fluoroscopic images of patient anatomy.
• Mode of Action: Traditional X-ray imaging, not an AI/algorithm-driven diagnostic aid.
• Basis for Clearance: Substantial equivalence to a predicate device (ZEN-2090 Pro, K091918).
• Performance Claim: "ZEN-2090 Turbo has better image quality than predicate device, ZEN-2090 Pro (K091918)" due to higher power output in fluoroscopy modes.
• Testing: Verification and validation testing per quality system, engineering bench testing, and compliance with IEC and 21 CFR standards. Software verification for functional requirements, performance, safety, risk management, privacy, and security was also performed.

In summary, the provided text does not describe an AI/algorithm-driven diagnostic device study with the requested metrics and methodologies. The device is a traditional medical imaging hardware system.

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