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The Micropaq monitor is intended to be used by clinicians for single or multiparameter vital signs montoring of ambulatory and non-ambulatory pediatric and adult patients in health care facilities. It is also intended for patient transport. Micropaq is intended to operate with an Acuity® central station through wireless communication over Welch Allyn Protocol's FlexNet™ network. FlexNet connects multiple devices through hardwired Ethernet networks and Wireless Local Area Networks (WLANs) to an Acuity® central station. If the Micropaq is moved out of range or loses communication with the FlexNet network, it continues to monitor the patient, display patient data, and generate local patient alarms or alert messages.
The ECG channel is intended for five-lead ECG monitoring.
The Pulse Oximetry channel is intended for continuous noninvasive monitoring of functional oxygen saturation of arteriolar hemoglobin (SpO2) and pulse rate (measured by an SpO2 sensor).
The most likely locations for patients monitored by this device are step-down units, telemetry departments, general med/surg floors, emergency departments, and in-hospital transport. This device is available for sale only upon the order of a physician or licensed health care professional.

The Micropaq is a patient wearable device that provides real time monitoring and display of ECG and SpO2. The Micropaq is powered by a rechargeable battery and has a liquid crystal display (LCD) that displays both waveforms and numerics. The Micropag communicates with Welch Allyn Protocol's Acuity® central station through a wireless local area network (WLAN) operating in the ISM 2.4 GHz band. The communication link is bi-directional, providing monitoring at the Acuity central station and remote control of the Micropaq from the Acuity central station.

The provided 510(k) summary for the Welch Allyn Micropaq vital signs monitor (K021681) does not contain the detailed information requested regarding specific acceptance criteria, device performance metrics, and the study methodology for proving those criteria.

Instead, the summary focuses on establishing substantial equivalence to predicate devices and adherence to general medical device standards. It mentions:

• Substantial Equivalence: The Micropaq 400 series monitors are considered substantially equivalent to the Micropaq 400 series monitors cleared under K002725. The SpO2 channel in model 404 is substantially equivalent to the SpO2 channel in the Nellcor Puritan Bennett, Inc. N-595 Pulse Oximeter cleared under K019821.
• Compliance with Standards: The device and accessories "have been tested and found to comply with the recognized, national and international, performance, safety, and electromagnetic compatibility standards for medical devices and product specifications listed in the Micropaq labeling."
• Risk Analysis: A risk analysis was developed, verified, and validated.
• Quality System: The manufacturer's Quality System conforms to 21CFR820 and is certified to ISO 9001 and EN46001.

Without access to the full submission or specific test reports referenced, it's impossible to provide the detailed table of acceptance criteria and associated performance metrics, sample sizes, ground truth establishment, or multi-reader study information.

Here's a breakdown of what cannot be extracted from the provided text and why:

1. Table of Acceptance Criteria and Reported Device Performance: No specific performance metrics (e.g., accuracy, precision, sensitivity, specificity for ECG or SpO2) are listed, nor are the thresholds for acceptance defined. The document only states compliance with "recognized... performance... standards."
2. Sample Size and Data Provenance for Test Set: No information is given about the number of patients or recordings used in any performance testing, nor their origin (country, retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth: The document does not describe any human expert review process for establishing ground truth for performance testing. Medical devices like vital signs monitors often rely on established reference devices or physical simulators for validation, rather than expert human interpretation in the same way an AI diagnostic tool might.
4. Adjudication Method: Not applicable as no expert review for ground truth is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: This is explicitly not mentioned. MRMC studies are typically for AI-assisted diagnostic tools where human reader performance is a key metric. This device is a vital signs monitor, not typically subject to this type of study for its primary function.
6. Standalone (Algorithm Only) Performance: While the device monitors and displays, the "performance testing" described is likely for the accuracy of parameters (ECG, SpO2) compared to a reference, not necessarily an "algorithm-only" performance in the sense of a diagnostic AI. The document doesn't provide such details.
7. Type of Ground Truth Used: Given the nature of a vital signs monitor, ground truth would typically come from:
   • Reference Devices: Highly accurate, calibrated medical instruments used simultaneously with the device under test (e.g., a laboratory oximeter or a 12-lead ECG system).
   • Simulators: Bio-simulators that accurately reproduce physiological signals.
   • Clinical Data (Comparative): Comparing readings to established clinical methods, often in a controlled environment.
     However, the document does not specify which type was used.
8. Sample Size for Training Set: This device is not described as an AI/ML device that requires a "training set" in the modern sense. It's an electronic monitoring device.
9. How Ground Truth for Training Set was Established: Not applicable, as there's no mention of a "training set."

In summary, the provided 510(k) summary is typical for a medical device seeking substantial equivalence based on engineering and safety standards, rather than the detailed performance and ground truth studies often available for AI/ML-driven diagnostic devices. The document confirms that performance testing was done in accordance with applicable standards, but it does not disclose the specific criteria or the results of those tests.

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