(60 days)
The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic patient monitoring of adult patients in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals.
The Current Wearable Health Monitoring System is intended to provide visual and audible physiologic multi-parameter alarms. The Current Wearable Health Monitoring System is intended for temperature monitoring where monitoring temperature at the upper arm is clinically indicated.
The Current Wearable Health Monitoring System is intended for continuous monitoring of the following parameters in adults:
- · Pulse rate
- · Oxygen saturation
- · Temperature
- · Movement
The Current Wearable Health Monitoring System is intermittent or spot-check monitoring, in adults, of.
- · Respiration rate
- · Non-invasive blood pressure
- · Lung function & spirometry
- · Weight
The Current Wearable Health Monitoring System is not intended for use in high-acuity environments, such as ICU or operating rooms.
The Current Wearable Health Monitoring System is not intended for use on acutely ill cardiac patients with the potential to develop life threatening arrhythmias e.g. very fast atrial fibrillation. For these patients, they should be monitored using a device with continuous ECG. The Current Wearable Health Monitoring System is not a substitute for an ECG monitor.
The Current Wearable Health Monitoring System is not intended for SpO2 monitoring in conditions of high motion or low perfusion.
The Current Wearable Health Monitoring System consists of a single monitoring device worn on the upper arm, a software platform (containing an alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and a central station. The Current Wearable Health Monitoring System is also integrated with devices for monitoring of blood pressure, spirometry & lung function, and weight.
The system is intended to continuously monitor adult patient vital signs in professional healthcare facilities, such as hospitals or skilled nursing facilities, or their own home. It is intended for monitoring of patients by trained healthcare professionals. It is intended to continuously monitor pulse rate (PR), oxygen saturation (SpO2), temperature (TEMP) and movement (MOVEMENT). Current is intended for intermittent or spot-checking monitoring of respiration rate (RESP), blood pressure (BP), spirometry & lung function, and weight (WEIGHT).
While the wearable device monitors skin temperature, an additional adhesive axillary sensor can be used to monitor axillary temperature.
In the home environment, the patient will have responsibility for applying the device to their arm, charging the device and plugging in the Homehub to mains power. However, the data will still be made directly available to healthcare professionals. These healthcare professionals will be at a remote location e.g. an office or within the hospital or could be with the patient in their own home.
The provided document does not contain detailed acceptance criteria or the specific study details for validating the device's performance against such criteria. Instead, it lists various "Test Names" and "Test Descriptions" which broadly indicate areas of testing (e.g., electrical safety, EMC, pulse rate testing, SpO2 testing, respiration rate testing, temperature measurement accuracy). However, it does not specify quantitative acceptance thresholds for these performance metrics, nor does it provide the reported device performance in those quantitative terms.
For example, for "Pulse Rate Testing," the description mentions "Validation of the accuracy of pulse rate monitoring of the system in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. 2007." While this indicates the standards followed, it doesn't state what specific accuracy (e.g., within X beats per minute) was achieved or was the acceptance criterion. The "Results" column consistently states "Passed," but without the specific acceptance criteria, it's impossible to determine the benchmark used for passing.
Therefore, most of the requested information cannot be extracted from the provided text.
Here's an attempt to answer based on the absence of the requested information:
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A table of acceptance criteria and the reported device performance:
Performance Metric Acceptance Criteria Reported Device Performance Electrical Safety Unspecified; adherence to IEC 60601-1 "Passed" EMC Unspecified; adherence to IEC 60601-1-2 "Passed" Alarm Testing Unspecified; adherence to IEC 60601-1-8 "Passed" Pulse Rate Accuracy Unspecified; adherence to ISO 80601-2-61 and FDA Guidance 2007 "Passed" SpO2 Accuracy Unspecified; adherence to ISO80601-2-61 and FDA Guidance 2013 "Passed" Respiration Rate Accuracy Unspecified; comparison to end-tidal CO2 "Passed" Temperature Measurement Accuracy Unspecified; adherence to ISO 80601-2-56 "Passed" Battery Life Unspecified "Passed" PDU Buffering Time Unspecified "Passed" Usability Unspecified; adherence to IEC 62366 and IEC 60601-1-11 "Passed" Device Ship/Transport Unspecified; adherence to ASTM D4169 "Passed" Biocompatibility Unspecified; adherence to ISO 10993-1 "Passed" Wireless Coexistence Unspecified "Passed" System V&V Unspecified "Passed" Software V&V Unspecified "Passed" -
Sample size used for the test set and the data provenance: This information is not provided in the document. The document states "No clinical studies were conducted as part of submission to prove substantial equivalence." The non-clinical tests mention "the system was tested," but do not specify sample sizes for these tests (e.g., how many subjects for pulse rate and SpO2 accuracy, or how many devices for other tests).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.
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Adjudication method for the test set: This information is not provided.
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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: This information is not provided. The device is a "Wearable Health Monitoring System" and the testing described is primarily about the accuracy of its vital sign measurements and compliance with various standards, rather than evaluating AI assistance for human readers in a diagnostic capacity.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The document describes various "non-clinical tests" and "software verification and validation testing" which would fall under standalone performance. However, specific performance metrics quantifying the algorithm's output (e.g., sensitivity, specificity, accuracy %) against a ground truth are not provided. The results are merely "Passed" for general compliance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For physiological parameters, the ground truth would typically be established by a reference method. The document mentions "in accordance with ISO 80601-2-61 and the FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff" for pulse rate and SpO2, and "comparison to respiration rate measured via end-tidal CO2" for respiration rate. These represent established reference methods for ground truth, but the details of their application in the study (e.g., specific devices used for reference, blinded measurements) are not given. For other tests like electrical safety or EMC, the ground truth is adherence to the specified standard.
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The sample size for the training set: This information is not provided. The document does not discuss a training set, as it mainly focuses on verification and validation testing rather than the development of AI/ML models that would require training data.
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How the ground truth for the training set was established: This information is not provided, as a training set is not discussed.
§ 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).