(25 days)
The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or mufti-parameter vital signs monitor for ECG, noninvasive blood pressure (NIBP) and SpO2. It may be used in the following locations: Hospitals, healthcare facilities, emergency medical applications, during transport, and other healthcare applications. The monitor uses wireless communications to transmit vital signs data to a handheld or PC computer.
The monitor is intended to be used by trained healthcare providers.
The Athena GTX (WVSM) Wireless Vital Signs Monitor is a small, lightweight, rugged, and highly portable patient monitor designed to measure SpO2, NIBP and ECG. Vital signs are displayed directly on the device, and may be transmitted via WiFi 802.11b/g radio frequency communication to a Personal Computer (PC), Personal Digital Assistant (PDA) or Mobile device.
Here's an analysis of the provided text regarding the acceptance criteria and study proving device compliance:
Based on the provided 510(k) summary, the device in question is the "WVSM Wireless Vital Signs Monitor" with an iOS Mobile App Accessory. This submission is for a device modification, and the focus of the testing appears to be on verifying the compliance of this mobile app accessory with established standards.
1. A table of acceptance criteria and the reported device performance
The document explicitly states: "Testing on the WVSM iOS Mobile App has been completed to verify compliance with recognized national and international standards for safety and performance for medical devices, and particular requirements applicable to this device."
However, the provided text does not contain a table detailing specific acceptance criteria and reported device performance metrics (e.g., accuracy, sensitivity, specificity, or specific numerical targets for physiological measurements like ECG, NIBP, SpO2). It only broadly states that testing verified compliance with standards. It also mentions: "the WVSM with iOS Mobile App-accessory is capable of the same ECG, heart rate, systolic and diastolic blood pressure, functional oxygen saturation, and pulse rate measurements as have been provided by the predicate device referenced above." This implies that the performance of the iOS app accessory meets the established performance of the predicate device.
2. Sample size used for the test set and the data provenance
The document does not specify the sample size used for any test set nor does it provide details on data provenance (e.g., country of origin, retrospective or prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The document does not provide any information regarding the number or qualifications of experts used to establish ground truth for testing.
4. Adjudication method for the test set
The document does not describe any adjudication method used for a test set.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. The device is a vital signs monitor, not typically an AI-assisted diagnostic tool that would involve human readers interpreting output in the same way as, for example, an imaging AI.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document describes the device as a "Wireless Vital Signs Monitor" to be used by "trained healthcare providers." The iOS Mobile App Accessory is stated to display vital signs, and the device transmits data. It's not a purely standalone algorithm; it's a device that measures and displays vital signs for human interpretation. The testing performed was to ensure the device (including the app accessory) meets performance and safety standards, implying its standalone measurement capabilities are being assessed. However, the document does not explicitly describe a "standalone" algorithm-only performance assessment in the context of, for instance, an AI diagnostic tool. The compliance testing would inherently evaluate the device's ability to accurately measure vital signs independently.
7. The type of ground truth used
Given that the device measures physiological parameters (ECG, NIBP, SpO2), the ground truth for performance testing would typically be established using calibrated reference standards or other gold-standard medical devices for each parameter. For example, a highly accurate blood pressure cuff for NIBP, a reference SpO2 monitor, or a medical-grade ECG machine. The document does not explicitly state the type of ground truth used.
8. The sample size for the training set
The device is a vital signs monitor, not an AI/machine learning device that typically involves a "training set" in the conventional sense. Therefore, the document does not mention a training set sample size. The development likely involved software engineering, hardware calibration, and verification against known physiological signals or simulated data inputs, rather than training on a separate dataset.
9. How the ground truth for the training set was established
As there is no mention of a "training set" for an AI/ML algorithm, this information is not applicable and not provided in the document.
In summary, the 510(k) Summary emphasizes compliance with recognized national and international standards for safety and performance of medical devices. However, it lacks specific details on the methodologies, sample sizes, expert involvement, and concrete performance metrics that would typically be found in a detailed study report. The acceptance criteria are broadly described as meeting these standards and achieving performance comparable to the predicate device.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).