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The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, noninvasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

The Vital Signs Patch (VSP in short) system is designed to monitor selected vital signs of patients in a clinical environment. The VSP system is comprised of the following components: Physical Patch, Brain - VSP Transmitter, Gateway mobile device, Clinical Backend. The Patch is attached to the patient's chest. The Brain plugs into a cradle on the Patch and is connected to the Patch with a 16-pin connector. The Brain receives the power from the Pattery; the data from the sensors are transmitted using the 16-pin connector. The Gateway includes a dedicated, medical SW application (also known as the Gateway application) designed by LifeWatch Technologies. The Brain transmits data to the Gateway application using the RF component. The patient can manually trigger an event by the pressing a button on the Brain. In addition, the Brain contains a 32MB Flash memory chip that can store 6-10 hours of data in case of communication failure with the Gateway. All data received from the Brain is recorded and stored on the Gateway. In addition, the Gateway can be used to view vital sign signals received from the Brain and to transmit the data to a Monitoring Center via the internet by the Wi-Fi network. The VSP is not intended for use on patients with life threatening arrhythmias; hence it is not intended for patients in the ICU. The internal LifeWatch Technologies Ltd. Part Number of the Vital Signs Patch system is CG-1101B; this model serves also as the predicate device (cleared in K132407) for this Special submission.

The provided document is a 510(k) summary for the Vital Signs Patch (VSP) system, which is a modified version of a previously cleared device. It details product information and the modifications made, but it does not contain detailed information about specific acceptance criteria, study methodologies, or performance metrics in a quantitative way.

The document states:
"The 510(k) summarizes the testing that was performed, the acceptance criteria and the results of the testing."
However, this summary itself does NOT provide those details. It explicitly mentions that the full 510(k) contains this information, but this extract does not. Therefore, I cannot construct a table of acceptance criteria and reported device performance from the given text.

Based on the information provided in the extract, here's what can be inferred or stated about the requested points:

1. A table of acceptance criteria and the reported device performance:

   • Not provided in the extract. The document states that the full 510(k) summarizes this, but the extract itself only mentions that testing was performed, acceptance criteria were met, and results did not raise new safety or effectiveness issues.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • Not provided in the extract. The document mentions "design verification and validation testing of the modified device have been performed" but gives no details on sample size, data type, or origin.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not provided in the extract. The nature of the device (vital signs monitor) suggests that ground truth would likely come from standard, calibrated medical equipment rather than expert human interpretation in the same way an AI diagnostic tool might, but this is not explicitly stated.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not provided in the extract.

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/Not provided. This device is a vital signs monitor, not an AI-assisted diagnostic imaging tool for human readers. No mention of human readers or AI assistance in interpretation is present.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

   • Not explicitly stated, but implied. The device is a "continuous, non-invasive monitoring" system for various vital signs. Its primary function is to measure and record these signs. Its performance would inherently be a "standalone" measurement against a gold standard (e.g., how accurately it measures heart rate compared to an ECG machine), rather than an algorithm assisting human interpretation. However, specific details of such standalone performance or the reference standard against which it was compared are not in this excerpt.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • Not explicitly stated. For vital signs, the ground truth would typically be established by established, gold-standard medical measurement devices (e.g., a clinically validated ECG for heart rate, a separate temperature probe for temperature, a hospital-grade oximeter for SpO2). The document mentions "performance specifications," implying comparison to such standards, but doesn't detail them.

8. The sample size for the training set:

   • Not provided in the extract. The document primarily concerns modifications to an existing cleared device ("Special 510(k)"), so extensive new training data might not have been central to this specific submission, but this is speculation.

9. How the ground truth for the training set was established:

   • Not provided in the extract.

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The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia. The device continuously monitors patient ECG, automatically generates an alarm triggered by an arrhythmia detection algorithm, or generates an alarm manually triggered by the patient, and transmits the recorded data transtelephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.

The device has not been tested for and it is not intended for pediatric use.

The ECG Mini System Continuous ECG Monitor and Arrhythmia Detector ("ECG Mini") is a system that records ECG data and detects defined arrhythmias. It is comprised of a disposable 1-lead ECG Patch which includes a processing/transmitting module called a "Brain", and a cellular device (also called "Gateway"). The ECG Patch has 3 electrodes which are used to obtain a 1-lead ECG that is used for arrhythmia detection. The ECG Patch is placed on the upper left side of the chest according to the instructions and guidance in the Patient User Guide (UG-00105).

The ECG Mini system consists of following three components:

• . Patch: Disposable 1-lead Patch with ECG electrodes
• Brain: Reusable processing and transmitter device
• . Gateway Cellular Device: Communicates data to the Monitoring Center

The provided document describes the LifeWatch ECG Mini System Continuous ECG Monitor and Arrhythmia Detector. Here's an analysis of the acceptance criteria and study data based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with specific numerical targets. However, it lists performance tests and the standards they comply with, which implies that compliance with these standards serves as the acceptance criteria.

Specific performance metrics for arrhythmia detection (e.g., sensitivity, specificity for specific arrhythmias) are not provided in this summary, only that testing was done to the standard.

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

The document does not specify the sample sizes used for the test sets in any of its performance studies.

Regarding data provenance:

• The overall device is for "patients who experience transient symptoms that may suggest cardiac arrhythmia."
• There's no mention of country of origin for any data, nor if studies were retrospective or prospective.

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

The document does not provide information on the number of experts or their qualifications used to establish ground truth for any of the performance studies.

4. Adjudication Method for the Test Set

The document does not describe any adjudication method (e.g., 2+1, 3+1, none) used for the test sets.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

The document does not mention or suggest that a multi-reader multi-case (MRMC) comparative effectiveness study was conducted, nor does it provide an effect size for human readers with and without AI assistance. The device is an "algorithm only" type of detection system, and its output (recorded data and alarms) is provided to medical practitioners for evaluation, implying it's not designed for human-in-the-loop assistance in real-time interpretation against an initial human read.

6. Standalone (Algorithm Only) Performance Study

Yes, a standalone performance study was conducted. The "Arrhythmia Detection" testing, compliant with ANSI/AAMI EC57: 2012, is an assessment of the algorithm's performance in detecting various arrhythmias. While specific metrics are not provided in this summary, the standard itself pertains to "Testing and reporting performance results of cardiac rhythm and ST-segment measurement algorithms," indicating an algorithm-only evaluation.

7. Type of Ground Truth Used

The document does not explicitly state the type of ground truth used for any of its studies. For arrhythmia detection studies (per ANSI/AAMI EC57), it is typically a meticulously adjudicated ECG dataset by multiple cardiologists or experts, but this is not confirmed in the text.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size for the training set of the arrhythmia detection algorithm.

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

The document does not provide any information on how the ground truth for the training set was established.

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The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended for use by patients who experience transient symptoms that may suggest cardiac arthythmia. The device continuously monitors patient ECG, automatically generates an alert triggered by an arrhythmia detection algorithm, or generates an alert manually triggered by the patient, and transmits the recorded data trans-telephonically to a monitoring center provides the ECG data to the medical practitioner for evaluation.

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is intended to be prescribed for patients who have demonstrated a need for cardiac monitoring and are at low risk of developing life-threatening arrhythmias. Conditions where the system should not be used include patients likely to experience primary Ventricular Fibrillation or Ventricular Tachycardia and patients who have other co-morbid cardiovascular conditions where an arrhythmia could be potentially life threatening.

This device has not been tested for and it is not intended for pediatric use.

The CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector is designed for self-testing by patients at home and for analysis by medical professionals at a remote Monitoring Center.

The chest-worn sensor is used for the acquisition, recording, and transmission of the ECG signal. The device is equipped with 4 electrodes on a harness and it houses a 3.6V AA battery, a Bluetooth transceiver and a patient alert buzzer.

The ECG signals are transmitted via Bluetooth to a handheld device with a proprietary interactive application, configured to process and transmit the ECG recordings. The handheld device is a mobile computing device with a display and a touch input such as a cell phone. It has sufficient memory and processing capability to run the proprietary application.

When an arrhythmia event is detected, the handheld device transmits the recorded ECG information automatically via cellular link, to the Monitoring Center for professional analysis. When cellular service is unavailable the patient has an option to transmit via a landline telephone.

The modification that led to this submission was the change from a mobile platform with a Windows-based OS to one with an Android-based OS.

The provided document is a 510(k) premarket notification for the LifeWatch Technologies CG-6108 ACT-3L Continuous ECG Monitor and Arrhythmia Detector with Software Version 6.1.17. While it asserts substantial equivalence to a predicate device, it does not contain a detailed study report with specific acceptance criteria and performance data for the device's arrhythmia detection capabilities. Instead, it refers to internal validation reports and conformance to standards.

Therefore, the following information is based on what can be extracted from the document, with many fields indicated as "Not provided" because the detailed study information is not present in this summary.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance
The document does not provide a sample size for the test set used to evaluate the arrhythmia detection algorithm, nor does it specify the data provenance (e.g., country of origin, retrospective/prospective). It refers to an internal report "Testing of the ACT-3L algorithm, LifeWatch Technologies, VATR-0164" but does not detail its contents.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not provided in the 510(k) summary.

4. Adjudication Method for the Test Set
This information is not provided in the 510(k) summary.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention an MRMC comparative effectiveness study or any effect size of human readers improving with or without AI assistance. The focus is on the device's automatic detection capabilities and transmission to a monitoring center for professional analysis.

6. Standalone Performance
Yes, a standalone performance assessment of the algorithm was conducted. The document states:

"Testing of the ACT-3L algorithm, LifeWatch Technologies, VATR-0164" was performed and passed. This indicates that the algorithm's performance in detecting arrhythmias (Atrial Fibrillation, Tachycardia, Bradycardia, and Pause) was evaluated independent of human intervention.

7. Type of Ground Truth Used
The specific type of ground truth used for validating the arrhythmia detection algorithm is not explicitly stated in the summary. For ECG arrhythmia detection, common ground truths include expert consensus (manual review by cardiologists) on annotated ECG recordings or reference annotations from established databases. Given the nature of cardiac monitoring, it is highly likely that expert consensus on ECG segments served as the ground truth, but this is an inference, not a direct statement from the document.

8. Sample Size for the Training Set
The document does not provide information on the sample size for the training set used to develop or train the arrhythmia detection algorithm.

9. How the Ground Truth for the Training Set Was Established
This information is not provided in the 510(k) summary.

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The Vital Signs Patch (VSP) system is intended to be used on patients in a clinical environment for the continuous, non-invasive monitoring of ECG, Heart Rate (HR), respiration rate, surface temperature, and arterial blood oxygen saturation (intended use group adults 21 and above), when prescribed by a physician or other qualified healthcare professional.

The Vital Signs Patch (VSP) system is designed to monitor vital signs of patients. The internal LifeWatch Technologies Ltd. (LWT in short) Part Number of the VSP is CG-1101B. The VSP system consists of the following components: Vital Signs Patch, VSP transmitter ("Brain"), Gateway, Clinical Backend.

Here's a breakdown of the acceptance criteria and study information for the Vital Signs Patch system, based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of acceptance criteria with corresponding performance metrics. Instead, it states that the device was subjected to extensive verification/validation testing to ensure it meets all functional and performance requirements and is fit for its intended use. The performance details are primarily linked to the adherence to voluntary performance standards and a specific clinical trial for SpO2.

Here's an attempt to infer and summarize based on the provided text, linking performance to the mentioned standards:

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

• Sample Size for Test Set: The document explicitly mentions a "Clinical trial of the SPO2 function." However, it does not specify the sample size for this clinical trial or for any other performance test.
• Data Provenance: The document does not specify the country of origin of the data. It also does not specify if the studies were retrospective or prospective, although "Clinical trial of the SpO2 function" typically implies a prospective study.

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

The document does not provide information on the number of experts used or their qualifications for establishing ground truth for any of the tests, including the SpO2 clinical trial.

4. Adjudication Method

The document does not specify any adjudication methods (e.g., 2+1, 3+1, none) used for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

There is no mention of a Multi-Reader Multi-Case (MRMC) comparative effectiveness study being performed, nor any effect size of human readers improving with or without AI assistance. The device is for monitoring vital signs, not for assisting human interpretation of complex medical images or data that would typically involve a MRMC study.

6. Standalone Performance Study

The document indicates that studies were performed on the device's functional and performance requirements. The Arrhythmia Detection Algorithm Performance Validation and the Clinical trial of the SPO2 function suggest standalone performance evaluations of these specific features, focusing on the algorithm's accuracy in detecting arrhythmias and the SpO2 sensor's performance against a reference. While not explicitly termed "standalone performance study," the objective of these tests, especially against recognized standards, inherently assesses the algorithm/device performance without constant human intervention in data collection during the measurement phase. The device then presents data to a human for diagnosis.

7. Type of Ground Truth Used

• For SpO2: A "Clinical trial" was conducted. In such trials for pulse oximetry, the ground truth is typically established by comparing the device's readings against arterial blood gas (ABG) measurements from a co-oximeter, which is considered the gold standard for SpO2. This is implied by the nature of such a clinical trial conforming to ISO 80601-2-61.
• For ECG/Arrhythmia Detection: The ground truth for algorithm performance validation against standards like ANSI/AAMI/ISO EC57 often involves using truth-labeled ECG databases (e.g., MIT-BIH Arrhythmia Database) or synchronously recorded and extensively reviewed ECGs by expert cardiologists.
• For other vital signs (HR, Respiration, Temperature): Ground truth would typically be established by comparing the device's readings against established reference methods or calibrated medical devices known for their accuracy.

8. Sample Size for the Training Set

The document does not provide any information regarding the sample size used for the training set for any of the algorithms or features.

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

The document does not provide any information on how the ground truth for the training set was established.

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