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The Opera Swing is indicated for performing general radiography, fluoroscopy and angiography procedures/applications. The device is intended for use in:

• Skeleton
• Chest and lungs
• Pediatrics
• Emergency/traumatology
• Gastroenterology
• Urology and gynecology
• Linear tomography
• Digital angiography
• Stitching

Not Found

The provided document K140380 is a 510(k) clearance letter for the GENERAL MEDICAL MERATE S.P.A. "Opera Swing" device, an image-intensified fluoroscopic x-ray system.

This document does not contain any information regarding acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications typically associated with AI/ML device evaluations. The letter is solely an FDA clearance stating substantial equivalence to a predicate device based on the indications for use.

Therefore, I cannot provide the requested information from this document. The sections you asked for, such as acceptance criteria, study details, sample sizes, and ground truth, are not present in this type of FDA clearance letter, which focuses on regulatory approval rather than technical performance data from a clinical study.

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The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

The PRECISION RXi System was originally cleared by the FDA under 510(k) K041605. This submission describes design changes including modifications to the positioner tilting/elevating movement and the compressor.

This document does not contain the specific information required to answer your request. The provided text is a 510(k) premarket notification for an X-ray system, focusing on its classification, indications for use, and design changes. It does not include details about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert involvement in evaluation.

Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria and the study proving the device meets them based on the provided input.

Ask a specific question about this device

The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are intended for performing general R&F, radiography, fluoroscopy, interventional and angiography procedures/applications.

Not Found

The provided text is a 510(k) Premarket Notification from the FDA, specifically for the "PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System".

This document does not contain any information about acceptance criteria or a study proving that the device meets acceptance criteria.

The 510(k) document is a regulatory approval letter based on establishing substantial equivalence to a predicate device. It confirms that the FDA has reviewed the manufacturer's submission and found the device to be substantially equivalent for the stated indications for use.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Name: PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System
• Regulation Number & Name: 21 CFR 892.1650, Image-intensified fluoroscopic x-ray system
• Regulatory Class: II
• Product Code: OWB and JAA
• Indications for Use: The PRECISION RXi Analog X-ray System and PRECISION RXi Digital X-ray System are indicated for performing general R&F, radiography, fluoroscopy, interventional, and angiography procedures/applications.
• Substantial Equivalence: A declaration that the device is substantially equivalent to legally marketed predicate devices.

To answer your detailed request about acceptance criteria and study data, clinical trial reports or performance testing documentation would be required, which are not part of this 510(k) FDA letter.

Ask a specific question about this device