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The Current Wearable Health Monitoring System is intended for reusable bedside, mobile and central multi-parameter, physiologic monitoring of patients aged 14 years old and above 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:

• · Pulse rate
• · Oxygen saturation
• · Temperature
• Movement

The Current Wearable Health Monitoring System is intended for intermittent or spot-check monitoring 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 System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by 14 years old and above patients, a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.

The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.

I am sorry, but the provided text does not contain the specific information required to complete your request. The document is a 510(k) summary for the Current Health System, focusing on an age range extension. While it mentions the device's intended use and compares it to a predicate device, it explicitly states that "no animal or clinical performance data is included" (Page 11) and that "The performance of the modification is identical to the predicate and previously cleared device in terms of technical specification and safety." (Page 11).

Therefore, there is no study described that proves the device meets specific acceptance criteria through performance data, sample sizes, expert involvement, or ground truth establishment. The submission relies on the existing clearance of the predicate device for its performance claims.

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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 System is a remote patient monitoring system that consists of a monitoring device (the wearable) worn on the upper arm by adult patients (aged 18 years old and over), a software platform (containing the alarming system) and a user interface to allow presentation of vital signs data both on mobile devices and web-based dashboard. The Current Wearable System is also integrated with third-party devices for displaying and monitoring physiological signs.

The Wearable is intended to continuously monitors physiological vital sign data from the person being monitored and securely transmit the encrypted data via the secure server. The wearable is intended for use in professional healthcare facilities, such as hospitals or skilled nursing facilities, or the home by trained healthcare professionals.

The healthcare professional can securely access the patient physiological signs remotely via a mobile application or a web-interface which is also intended to provide visual and audible physiologic multi-parameter alarms.

This FDA 510(k) submission describes a Special 510(k) for a modification to the alarm functionality of the Current Wearable Health Monitoring System. The submission argues for substantial equivalence to a previously cleared device (K191272) of the same name.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide a table with specific acceptance criteria (e.g., sensitivity, specificity, accuracy targets) and corresponding reported performance metrics for the alarm system modification. Instead, it states that "the performance of the alarm system modification is identical to the previously cleared device in terms of technical specification and safety." The rationale for this is that the modification primarily focuses on how data is utilized to generate alarms, not on the fundamental accuracy or reliability of the individual physiological measurements or the alarm presentation itself.

The key claim is that the modified system "allows a wider range of patient observation data to generate alarms and it enhances the reliability, and scalability of the alarm system." However, no quantifiable performance improvements or acceptance criteria for these enhancements are detailed.

Therefore, a table of acceptance criteria and reported device performance specific to the alarm system modification cannot be extracted from this document in the traditional sense, as the claim is one of equivalence in performance to the predicate and improved functionality/reliability of the underlying alarm generation logic, rather than a new performance metric.

2. Sample Size Used for the Test Set and Data Provenance

The document explicitly states: "Substantial equivalence is based on an assessment of non-clinical performance data and no animal or clinical performance data is included."

This indicates that there was no test set of patient data used for clinical performance evaluation of the alarm system modification. The "performance data" referred to are non-clinical (likely software and system testing, as per "All changes were verified and validated according to Current Health's internal design control process").

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

Since there was no clinical test set with patient data for assessing the alarm system's performance against a ground truth, there were no experts used to establish ground truth for such a test set.

4. Adjudication Method for the Test Set

As there was no test set for clinical performance evaluation, there was no adjudication method applied.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states "no animal or clinical performance data is included."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

The focus of this Special 510(k) is the software platform's alarm functionality. The document states, "The modification enables it to fully utilise a broader range of patient observation data to generate appropriate alarms, notifications, and quantified notes for the clinical care team. It also enhances the reliability, auditability, and scalability of the independent alarm system." This describes an algorithm-only modification (the alarm generation logic).

However, the document does not detail specific "standalone performance" metrics for this algorithm (e.g., how accurately it identifies the need for an alarm based on data inputs, independent of human interpretation). It instead relies on the assertion that this modification is consistent with the cleared performance of the predicate device and has been verified through software testing.

7. The Type of Ground Truth Used

Given the absence of clinical performance data, there was no ground truth based on expert consensus, pathology, or outcomes data for evaluating the alarm system modification's performance. The "ground truth" for the non-clinical testing would have been defined by the expected behavior of the software components based on the design specifications.

8. The Sample Size for the Training Set

The document does not mention a training set for the alarm system modification. This is a modification to existing alarm logic, not typically a machine learning model that would require a separate training set.

9. How the Ground Truth for the Training Set Was Established

As no training set is mentioned, this question is not applicable.

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