(36 days)
The Wireless Vital Signs Monitor (WVSM) is intended to be used as an adult patient monitor. It is indicated as a single or multi-parameter vital signs monitor far 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) or Personal Digital Assistant (PDA).
Here's an analysis of the acceptance criteria and study information for the Athena GTX Wireless Vital Signs Monitor (WVSM), based on the provided text:
Summary of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table of acceptance criteria with numerical targets. Instead, it broadly states that testing 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." The conclusion is that the WVSM is "safe and effective, and is substantially equivalent to the above listed predicate devices."
Therefore, the implicit acceptance criteria are that the device performs comparably to the predicate devices and meets relevant safety and performance standards for its intended physiological measurements (ECG, NIBP, SpO2), and wireless communication.
A placeholder table is provided below, reflecting the performance claims made in relation to the predicate devices.
| Metric / Parameter | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| ECG Measurement | Performance comparable to the Welch Allyn Propaq LT (K033378) | The WVSM is capable of the same ECG measurements as the combination of predicate devices. |
| Heart Rate | Performance comparable to the Welch Allyn Propaq LT (K033378) | The WVSM is capable of the same heart rate measurements as the combination of predicate devices. |
| Systolic BP | Performance comparable to the Welch Allyn Propaq LT (K033378) | The WVSM is capable of the same systolic blood pressure measurements as the combination of predicate devices. |
| Diastolic BP | Performance comparable to the Welch Allyn Propaq LT (K033378) | The WVSM is capable of the same diastolic blood pressure measurements as the combination of predicate devices. |
| SpO2 (Functional) | Performance comparable to the Nonin Medical, Inc. Model # 7500 (K071285) and Welch Allyn Propaq LT (K033378) | The WVSM is capable of the same functional oxygen saturation measurements as the combination of predicate devices. |
| Pulse Rate | Performance comparable to the Nonin Medical, Inc. Model # 7500 (K071285) and Welch Allyn Propaq LT (K033378) | The WVSM is capable of the same pulse rate measurements as the combination of predicate devices. |
| Wireless Comm. | Reliable wireless transmission of vital signs data to a handheld or PC computer. | The monitor uses wireless communications (WiFi 802.11b/g) to transmit vital signs data to a handheld or PC computer. Testing confirmed compliance with recognized national and international standards for performance applicable to this device, which would include wireless communication functionality. |
| Safety | Compliance with recognized national and international safety standards for medical devices and relevant regulations | Testing confirmed compliance with recognized national and international standards for safety for medical devices. The device is determined to be "safe and effective." |
| Effectiveness | Performance comparable to predicate devices for intended use case. | "Based on the results for all safety and compliance testing performed, it is the opinion of Athena GTX the WVSM Wireless Vital Signs Monitor is safe and effective, and is substantially equivalent to the above listed predicate devices." The WVSM is designed for the same application and intended use as the combination of listed predicate devices and is capable of the same measurements. |
Study Details from the Provided Text:
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Sample size used for the test set and the data provenance:
- Sample Size: Not specified in the provided text. The document states "Testing On the WVSM 5.0 has been completed," but does not provide details on the number of subjects, cases, or data points used in the testing.
- Data Provenance: Not specified. It's unclear if the testing involved human subjects, simulated data, or a combination, and if location data was collected.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not specified. The document describes technical testing against recognized standards and comparison to predicate devices, rather than a clinical study requiring expert ground truth establishment in a diagnostic context.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable/Not specified. This type of adjudication is relevant for studies where human interpretation or diagnosis is being evaluated against expert consensus. The provided text outlines technical and performance testing against standards.
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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:
- Not applicable. This device is a vital signs monitor, not an AI-assisted diagnostic tool for human readers. No MRMC study was conducted or mentioned.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, implicitly. The testing described is of the device's performance itself, measuring vital signs and transmitting data, which represents its standalone functionality. However, the exact methodology and results of this "standalone" testing are not detailed beyond "compliance with recognized national and international standards for safety and performance."
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The ground truth would have been established by reference standards or highly accurate clinical measurement devices/calibrated equipment used during the "testing... to verify compliance with recognized national and international standards for safety and performance." For example, for NIBP, a reference invasive blood pressure measurement system or a highly accurate non-invasive system would be used as ground truth. For SpO2, a co-oximeter or other reference method would be used. The document does not specify these reference standards.
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The sample size for the training set:
- Not applicable/Not specified. This device is described as a monitor that directly measures physiological parameters, not a machine learning model that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. The device does not explicitly mention using a training set as it would be understood in the context of AI/ML.
§ 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).