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The Life Shirt system is intended for use by one adult during daily activities of The Life Shirt System is michaea cerading physiological data for later analysis by a physician. Respiration, ECG, pulse oximetry, blood pressure, and body position a physician. The system is intended to provide analysis of breathing data may be conected. Thic tyot appeas as well as displaying heart rate changes patterns as an all in claboring aparis the wake and sleeping states as well as trom electrocardidographic wavelorms in all was were aceutical studies in which acuvities of daily fiving. Trippiesul indicator, or the general healthcare market respiratory information is a userel manue and the data provided to their physicians as an aid to diagnosis and treatment.

The LifeShirt is a noninvasive ambulatory monitoring device that continuously monitors and stores respiration and ECG onto a CompactFlash™ memory card within a portable battery powered Handspring Visor® worn on a belt or within a pocket. The patient may be located at home or in an alternate care setting. The monitored subject can enter symptoms, activities, and medications into the Handspring Visor® that becomes part of the digital data stream. An optional NONIN pulse oximeter and Critikon noninvasive blood pressure monitor can be connected into the Visor for recordings during sleep or defined activities. The purpose of this system is to collect and store cardiac, respiratory, and blood pressure data as well as body position, various types of activities annotated with symptoms and a medication diary for subsequent analysis and archival at a data center utilizing the VivoLogic 1.0 software program. Data is transferred to the data center generally after the end of a patient data recording session.

I am sorry, but the provided text does not contain the acceptance criteria or a study proving the device meets acceptance criteria. The document is a 510(k) summary for the VivoMetrics LifeShirt System, detailing its components, intended use, and substantial equivalence to predicate devices. It includes a letter from the FDA confirming clearance and the indications for use. However, it does not present any performance data, acceptance criteria, or details of a validation study for the device's accuracy or effectiveness.

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