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The Dash 2500 Patient Monitor is intended for use under the direct supervision of a licensed healthcare practitioner. The intended use of this device is a portable (intrahospital) multiparameter unit designed for monitoring adult, pediatric, and neonate patient vital signs in a hospital subacute care environments, such as same-day surgery, emergency rooms, recovery/PACU, progressive care, interventional radiology, special care units, and GI/endoscopy.

The Dash 2500 Patient Monitors and displays oscillometric non-invasive blood pressure (systolic, diastolic and mean arterial pressure), heart/pulse rate, respiration rate, ECG, temperature with an reusable electronic thermometer (predictive mode for oral and rectal temperature measurement, monitor mode for axillary temperature measurement), and functional oxygen saturation (SpO2) and pulse rate via spot checking and continuous monitoring, including monitoring during conditions of clinical patient motion or low perfusion.

The Dash 2500 also detects alarm limit conditions and is capable of recording up to two waveforms. Using this monitor a clinician can view, record and recall clinical data derived from each parameter.

The Dash 2500 Patient Monitor is a portable (intra-hospital) multi-parameter monitor designed for monitoring adult, pediatric, and neonate patient vital signs.
The Dash 2500 Patient Monitor is self-contained and can be powered by batteries or AC. The Monitor has a carrying handle and can be operated on a shelf or table. It can also be mounted in a variety of ways (e.g., wall, pole, bed rail, or head/foot board) using a mounting plate located on the bottom of the Monitor. The Monitor can be used as a stand-alone monitor with the capability to interface to a central station, a server or any other device capable of receiving data using the host communications protocol.

The provided text does not contain specific acceptance criteria or a study detailing device performance against those criteria. Instead, it is a 510(k) summary for the GE Dash 2500 Patient Monitor, which focuses on demonstrating substantial equivalence to a predicate device rather than presenting detailed performance metrics from a specific study with defined acceptance criteria.

The document mentions:

• Voluntary standards compliance: "The Dash 2500 complies with the voluntary standards as detailed in Section 9 of this submission." However, Section 9 is not provided in the input, so the specific standards and their associated performance criteria are unknown.
• Quality assurance measures: A list of measures applied during development (Risk Analysis, Requirements Reviews, Design Reviews, Testing on unit level, Integration testing, Final acceptance testing, Performance testing, Safety testing, Environmental testing).
• Conclusion: "The results of these measurements demonstrated that the Dash 2500 is as safe, as effective, and performs as well as the predicate device." This is a general statement of equivalence, not a report of specific numerical performance against acceptance criteria.

Therefore, I cannot provide a table of acceptance criteria and reported device performance, nor details about sample sizes, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set information, as this data is not present in the provided submission. The submission confirms a 510(k) clearance based on substantial equivalence, not a detailed performance study against explicit acceptance criteria.

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