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YI XIN Sterile Syringe for Single Use is a sterile, single-use, disposable and nonreusable syringe intended for injection of fluids into or withdraw fluids from the body.

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The provided text is a 510(k) clearance letter from the FDA for a medical device. It does not contain information about the acceptance criteria, device performance, study design, or specific results of a study as requested in the prompt. The letter confirms that the device, "YI XIN Sterile Syringe For Single Use," is substantially equivalent to predicate devices and can be marketed.

Therefore, I cannot provide the requested information based on the given input.

To answer your request, I would need a scientific report, clinical trial results, or a summary of performance testing for the device.

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YI XIN Safety Syringe is a sterile, single-use, disposable and nonreusable, manual retractable safety syringe intended for injection of fluids into or withdraw fluids from the body, while reducing the risk of sharps injuries and the potential for syringe reuse. The safety syringes are for IV and IM use.

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The provided text is an FDA 510(k) clearance letter for the YI XIN Safety Syringe. It confirms the device's substantial equivalence to a predicate device and its classification. However, this document does not contain information on acceptance criteria for device performance or any study details that would typically prove a device meets such criteria.

The letter focuses on regulatory approval based on substantial equivalence, not on a detailed analysis of performance data. Therefore, I cannot provide the requested information from the given input.

To clarify, the type of information you're asking for (acceptance criteria, study design, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, training data) would typically be found in a device's 510(k) summary, clinical study reports, or design validation documentation, not in the clearance letter itself.

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