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to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals.

This device, the Fluoroview "" Series Fluoroscopic Tables (Model 9680) and the Time Table C-Arm Stretcher. Model 9670 is designed for clinical applications such as: to support a patient and facilitate a diagnostic procedure employing some imaging technique or to position a patient for various treatments in clinics or hospitals. This device is used by a physician or a health care professional: this device is not operated by a patient. This is a Class II device has a Classification name as: Mobile Fluoroscopic Tilting Table, as described in 21 CFR Part 892.11980. U.S. Imaging Tables, Incorporated has determined this device is substantially equivalent to a predicate medical device which is currently in commerce and is identified as: Deluxe "C" Arm Stretcher, Model 056-004. and is manufactured by Biodex Medical Systems. Inc. of Shirley New York.

This document is a 510(k) summary for a Class II medical device, specifically fluoroscopic tables and a C-arm stretcher designed for patient positioning during diagnostic imaging or treatment. It aims to demonstrate substantial equivalence to a predicate device.

Based on the provided text, it's explicitly stated that the device's substantial equivalence is based on its mechanical support, conventional design and materials, adherence to Good Manufacturing Procedures, performance characteristics, and safety and effectiveness for its intended application.

However, the provided text does not contain any information regarding specific acceptance criteria, study methodologies, sample sizes, expert qualifications, ground truth establishment, or any of the detailed metrics typically associated with proving a device meets acceptance criteria through a formal study.

The document primarily focuses on establishing substantial equivalence to a predicate device by asserting:

• The device offers mechanical support and adjustment.
• It uses conventional design, construction, and materials.
• It conforms to Good Manufacturing Procedures.
• It has performance characteristics substantially equivalent to its predicate.
• It is safe and effective for its intended use.

Therefore, I cannot populate the requested table or sections because the necessary detailed information is not present in the provided text. The document describes the basis for regulatory clearance (substantial equivalence), but not a rigorous study proving specific performance metrics against pre-defined acceptance criteria.

Missing Information:

• Specific quantitative acceptance criteria are not mentioned. The document states "performance characteristics substantially equivalent to its predicate device," but doesn't define what those characteristics are or what thresholds must be met.
• No study details are provided. There's no mention of a particular study, its design, endpoints, or results. The statement "This device has been tested to confirm its safety and effectiveness" is a general claim, not a description of a specific study.
• Sample sizes, data provenance, expert details, adjudication methods, MRMC studies, standalone performance, or training set information are entirely absent.

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