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The Minhua Disposable Blood Pressure Cuff is an accessory used in conjunction with non-invasive blood pressure monitoring systems for determination of a person's blood pressure. The cuff is non-sterile and for single-patient use. It is available in neonatal, pediatric and adult sizes. The cuff is not designed, sold, or intended for use except as indicated.

The device comprises tubing attached to an inelastic sleeve with an integrated inflatable bladder that is wrapped around the patient's limb, secured by hook and loop closure, and used to measure the patient's blood pressure. The device tubing is connected to a non-invasive blood pressure measurement system.

This document is solely a 510(k) premarket notification summary for a medical device (Minhua Disposable Blood Pressure Cuff). It does not contain information about acceptance criteria and a study proving device performance in the context of an AI/ML powered device.

The provided text describes a traditional medical device (blood pressure cuff) and focuses on demonstrating substantial equivalence to a predicate device through:

• Comparison of Features: Intended use, patient populations, tube configuration, sterility, pressure limits, biocompatibility, cuff and tube port materials, hook & loop fastener, and conformity to AHA bladder sizes.
• Compliance with Standards: ANSI/AAMI SP 10 (sphygmomanometers) and ISO 10993 (biocompatibility).

Therefore, I cannot extract the requested information (acceptance criteria table, sample sizes for test/training, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth types) because it pertains to the evaluation of AI/ML devices, which is not the subject of this document.

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