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The FS IV Mini C-arm system is designed to provide physicians with general fluoroscopic visualization of a patient including, but not limited to, surgical orthopedic and podiatric, critical and emergency care procedures and light anatomy imaging situations.

The FS IV Mini C-arm system is a compact, mobile C-arm specifically designed for X-ray imaging.

The provided text describes the 510(k) summary for the Hologic FS IV Mini C-arm System, which is a fluoroscopic imaging system. It does not contain information about a study with acceptance criteria and device performance in the context of an AI-powered diagnostic device. Instead, it discusses the regulatory submission for a hardware medical device (X-ray system).

Therefore, I cannot provide the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, or MRMC studies, as these details are not present in the provided text.

The "Performance Data" section explicitly states: "Results of bench testing for the FS IV mini C-arm imaging system indicates conformance to all applicable performance standards promulgated by the FDA for fluoroscopic imaging systems." This indicates that the device's performance was evaluated against general FDA performance standards for fluoroscopic imaging systems through bench testing, rather than a clinical study comparing its diagnostic accuracy to specific acceptance criteria.

The "Conclusion" further supports this by stating: "Based on a comparison to other devices determined to be substantially equivalent through the 510(k) premarket notification process and the claim that the FS IV device meets the federal performance standard for fluoroscopic x-ray systems per 21 CFR 1020.30-1020.32, Hologic, Inc. concludes that the FS IV mini C-arm system is as safe, as effective and performs as well as other legally marketed mini C-arm devices." This confirms the assessment was based on substantial equivalence to predicate devices and adherence to federal performance standards for X-ray systems, not specific clinical performance metrics related to diagnostic accuracy typically found in AI/algorithm studies.

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