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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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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:

1. 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"

2. 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).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This information is not provided.

4. Adjudication method for the test set: This information is not provided.

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: 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.

6. 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.

7. 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.

8. 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.

9. How the ground truth for the training set was established: This information is not provided, as a training set is not discussed.

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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 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

Since no clinical studies were performed, the following information is not available from the provided document:

2. Sample size used for the test set and the data provenance: Not applicable as no clinical test set was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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: 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.
6. 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.
7. 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.
8. The sample size for the training set: Not applicable, as no machine learning training data is mentioned.
9. How the ground truth for the training set was established: Not applicable.

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