(70 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 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 of respiration rate, non-invasive blood pressure and weight in adults.
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 arrhythmas 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 specific devices for monitoring of blood pressure 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) and weight (WEIGHT).
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.q. an office or within the hospital or could be with the patient in their own home.
The provided document is a 510(k) summary for the Current Wearable Health Monitoring System. It details the device's intended use, classification, and comparison to predicate devices, along with non-clinical and software testing. However, it explicitly states:
- No animal studies were conducted.
- No clinical studies were conducted.
Therefore, there is no study described in this document that proves the device meets specific acceptance criteria based on clinical performance. The document primarily focuses on non-clinical performance (bench testing) and software verification/validation to demonstrate substantial equivalence to previously cleared predicate devices.
Given this, I cannot provide acceptance criteria and reported device performance from a clinical study, nor details on sample sizes, ground truth establishment, or expert adjudication as these elements are typically part of clinical studies, which were not performed for this submission according to the document.
The document does, however, list several non-clinical tests performed and their results, which all "Passed." These implicitly serve as the acceptance criteria for those specific tests.
Here is a table summarizing the acceptance criteria (implied by the test description) and reported performance from the non-clinical tests:
1. Table of Non-Clinical Acceptance Criteria and Reported Device Performance
| Test Name | Implied Acceptance Criteria (from Test Description) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Meet applicable standards for electrical safety (IEC 60601-1). | Passed |
| EMC | Meet applicable standards for electromagnetic compatibility (EMC) (IEC 60601-1-2). | Passed |
| QI Charger Testing | Device can be charged using the QI Charger. | Passed |
| Environment Testing | Operate within and withstand specified storage and operating temperature ranges. | Passed |
| Alarm Testing | Meet applicable standards for basic safety and essential performance for alarm systems (IEC 60601-1-8); Alarm Function Verification Tests for each parameter function are successful. | Passed |
| Pulse Rate Testing Validation of accuracy | Accuracy of pulse rate monitoring in accordance with ISO 80601-2-61 and FDA Pulse Oximeters - Premarket Notification Submissions: Guidance for Industry and FDA Staff. | Passed |
| Battery Testing | Demonstrate specified battery life in various operating modes and time to full charge. | Passed |
| PDU Buffering Time Testing | Observe a maximum PDU buffering time consistent with or better than theoretical maximum. | Passed |
| Usability Testing | Compliance with IEC 62366 - Medical devices - Application of usability engineering to medical devices and IEC 60601-1-11. | Passed |
| Device Ship/Transport Testing | Device, enclosed in selected shipping container, meets ASTM D4169 specifications. | Passed |
| Biocompatibility Testing | Compliance to ISO 10993-1: Biological evaluation of medical devices – Guidance. | Passed |
| SpO2 Testing Validation of accuracy | Accuracy and communication of SpO2 functions within the Current Health system as per ISO80601-2-61 and the FDA SpO2 guidance; Pulse Oximeters-Premarket Notification Submissions Guidance for Industry and Food and Drug Staff. | Passed |
| Respiratory Rate Testing | Accuracy of measurement of respiration rate in comparison to respiration rate measured via end-tidal CO2 in a variety of postures. | Passed |
| Temperature Measurement Accuracy | Accuracy of the temperature measurement in compliance with ISO 80601-2-56. | Passed |
| Wireless Radio Communication (Wireless Coexistence Testing) | Device can communicate via wireless radio in its intended environment. | Passed |
| System Verification and Validation Testing | Software and firmware of the Current Health System are verified; integration and interoperability of peripheral devices for blood pressure and weight are tested. | Passed |
Since no clinical studies were performed, the following information is not available from the provided document:
- Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
- Adjudication method for the test set: Not applicable.
- 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, as this is a monitoring device and not an AI-assisted diagnostic tool for human readers, and no comparative effectiveness studies were conducted.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The non-clinical tests assess the device's technical performance, which can be seen as "standalone" algorithm/device performance. However, human interpretation of the displayed data is inherent to the intended use.
- The type of ground truth used: For the non-clinical tests, the "ground truth" was typically established by recognized standards, reference devices, or defined test protocols. For example, for pulse rate and SpO2, the ground truth would be from a reference oximeter or validated physiological simulator. For temperature, it would be a reference thermometer.
- The sample size for the training set: Not applicable, as no machine learning training data is mentioned.
- How the ground truth for the training set was established: Not applicable.
§ 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).