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The TRIMLINE Large Face Aneroid Sphygmomanometer: is a non-automated, mechanical blood pressure sphygmomanometer that is used for the non-invasive indication of blood pressure. may be used with neonatal, pediatric and adult patients

non-automated, mechanical blood pressure sphygmomanometer

I am sorry, but after reviewing the provided documents, I could not find information regarding the acceptance criteria or a study proving the device meets acceptance criteria for the TRIMELINE™ Large Face Aneroid Sphygmomanometer.

The documents primarily consist of:

• An FDA 510(k) clearance letter confirming substantial equivalence to a predicate device.
• Information regarding regulatory compliance and contact details for further inquiries.
• The "Indications for Use" statement for the device.

There is no mention of specific acceptance criteria (e.g., accuracy thresholds, precision values), performance metrics, study design, sample sizes, ground truth establishment, or expert involvement as requested. This type of detailed performance data is typically found in design validation reports or specific performance characteristic sections of a 510(k) submission, which are not present in the provided text.

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The TRIMLINE Tempa-Kuff Blood Pressure Cuff:

• is an accessory used in conjunction with non-invasive blood pressure measuring systems
• is non-sterile and may be used on a limited basis :
• . may be used with neonatal, pediatric and adult patients

Not Found

This document is a 510(k) premarket notification decision letter from the FDA for the TRIMLINE™ Tempa-Kuff® Blood Pressure Cuff. It confirms that the device is substantially equivalent to legally marketed predicate devices.

The provided text does not contain any information about acceptance criteria, performance studies, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or ground truth establishment. Therefore, I cannot fulfill your request based on the given input.

The document is purely a regulatory approval letter and does not describe the technical details of the device's validation.

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