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The NetGuard Automated Clinician Alert System is intended for use by licensed clinicians, within a health care facility, to provide notification of life threatening cardiac events in ambulatory adult patients including: . Asystole Ventricular-Fibrillation NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected. The NetGuard System also provides notification for high and low heart rates.

The NetGuard Automated Clinician Alert System is an ambulatory ECG patient monitoring system designed to provide clinicians notification of potentially lethal cardiac events in adult patients, within a healthcare facility. The NetGuard System is a prescription device to be used by licensed clinicians in a healthcare facility.

The provided text is a 510(k) Summary for the NetGuard Automated Clinician Alert System. While it states that the device has undergone performance testing in compliance with FDA guidance and recognized standards, it does not explicitly detail specific acceptance criteria or the results of the study in a quantitative manner that would allow for a table of acceptance criteria and reported device performance.

Here's an analysis of what information is present and what is missing based on your request:

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

• NOT PROVIDED DIRECTLY. The document states: "The NetGuard System has been tested and found to be in compliance with recognized safety, performance and electromagnetic compatibility standards. The FDA guidance Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm (October 28, 2003), was utilized in the planning and conduct of all performance testing." However, specific numerical acceptance criteria (e.g., sensitivity, specificity, accuracy thresholds for arrhythmia detection) and the device's measured performance against those criteria are not listed.

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. The document does not mention the sample size for any test sets or the provenance of any data used for testing.

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. The document does not describe how ground truth was established, nor does it mention the number or qualifications of any experts involved in such a process.

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

• NOT PROVIDED. There is no information regarding any adjudication methodology.

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. The NetGuard System is described as an "Automated Clinician Alert System" and an "Arrhythmia detector and Alarm." It is designed to automatically detect and alert clinicians to "potentially lethal cardiac events" like Asystole and Ventricular-Fibrillation, as well as high and low heart rates. This implies a standalone detection system rather than an AI-assisted human reading system. Therefore, an MRMC study comparing human readers with and without AI assistance is not described or suggested by the device's function as presented.

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

• IMPLIED, BUT NO DETAILS PROVIDED. The description of the device as an "Automated Clinician Alert System" and an "Arrhythmia detector and Alarm" strongly suggests that its primary function is standalone detection. The text states, "NetGuard monitors a patient's ECG and issues an alert whenever these arrhythmias are detected." However, no specific standalone performance metrics (e.g., sensitivity, false positive rate, detection delay) are reported.

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

• NOT PROVIDED. The document does not specify how the ground truth for performance testing was established. Given the nature of cardiac arrhythmias, it would typically involve expert cardiologists confirming events on ECG recordings, but this is not stated.

8. The sample size for the training set

• NOT APPLICABLE / NOT PROVIDED. The document does not describe the device as an AI/ML device that requires a "training set" in the modern sense. It refers to "performance testing" but does not elaborate on a training phase distinct from testing or the data used for such a phase.

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

• NOT APPLICABLE / NOT PROVIDED. Similar to point 8, this is not addressed.

In summary:

The provided 510(k) summary focuses on establishing substantial equivalence to predicate devices and general compliance with regulatory standards. It lacks the detailed performance metrics, study methodologies, and data specifics typically found in a clinical study report for AI/ML-based medical devices or even for more traditional devices that undergo rigorous quantitative performance assessment for specific detection tasks. The document's purpose is a regulatory filing stating compliance, not a detailed technical and clinical performance report.

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The Propaq LT 802 series monitors are highly portable devices intended to be used by clinicians and medically qualified personnel for single or multi-parameter vital signs monitoring of ambulatory and non-ambulatory neonate, pediatric and adult patients. These monitors are indicated for ECG, noninvasive blood pressure (NIBP), respiration and SpO2. The most likely locations for patients to be monitored by this device are hospital general medical, telemetry, and intermediate care floors, hospital emergency departments, transport, emergency medical services and other healthcare applications. The monitors may be used as standalone devices or as devices networked to an Acuity " central station through wireless communication over Welch Allyn's FlexNet™ network.

This device is available for sale only upon the order of a physician or licensed health care professional.

The Propaq LT 802 Series of monitors are small, lightweight patient monitoring devices intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive Interious bo adou by cirite, ECG, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) in ambulatory, non-ambulatory and transport environments

This document is a 510(k) summary for the Welch Allyn Propaq LT 802 Series vital signs monitor. It describes the device, its intended use, and provides a statement of its substantial equivalence to predicate devices. However, it does not contain the detailed performance study results, acceptance criteria, or ground truth information typical for an AI/ML device submission.

Therefore, I cannot fully complete the requested table and sections based on the provided text.

Here's what I can infer and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

Missing Information:

• Specific numerical acceptance criteria for each vital sign parameter (ECG, NIBP, Respiration, SpO2).
• Quantified performance results (e.g., mean absolute difference for NIBP, accuracy percentages for heart rate, SpO2 accuracy over specific ranges).

Study Related Information (Based on what can be inferred/is missing):

• Study That Proves the Device Meets Acceptance Criteria: The document mentions that the device "will be tested in accordance with the [test methods mentioned elsewhere in the submission] using production equivalent units prior to release to market." This indicates that verification and validation testing was planned or executed, but the details of these studies are not present in this summary. The summary focuses on regulatory compliance and substantial equivalence rather than detailed performance study reports.

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

  • Not specified in the document. The document does not provide details on specific test sets, sample sizes, or data provenance.

• 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 applicable/Not specified. For a vital signs monitor, ground truth is typically established by reference devices (e.g., a highly accurate NIBP simulator, a SpO2 simulator, or a known ECG waveform generator) rather than expert consensus on medical images or diagnoses. The document does not mention experts for ground truth establishment.

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

  • Not applicable/Not specified. Adjudication methods are typically used in studies involving subjective interpretation (e.g., image reading). For vital sign measurements, accuracy is usually determined against a validated reference.

• 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:

  • No. This is a vital signs monitor, not an AI-powered diagnostic device. MRMC studies are not relevant in this context.

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

  • Yes, implicitly. The device itself is a standalone vital signs monitor. Its performance would be evaluated as an algorithm/device-only performance against reference standards. This is the primary mode of evaluation for such devices.

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

  • Likely a combination of physical simulators and clinical studies against reference devices. While not explicitly stated, for vital signs monitors, ground truth typically comes from:
    • For NIBP: Cuff inflation measurements against a reference manometer or invasive arterial pressure measurements.
    • For ECG: Standardized ECG waveforms, or simultaneous recordings with a highly accurate reference ECG device.
    • For SpO2: Controlled hypoxia studies against a CO-oximeter, or testing with calibrated SpO2 simulators.
  • The document mentions "production equivalent units," implying testing against established standards.

• 8. The sample size for the training set:

  • Not applicable/Not specified. This is not an AI/ML device that requires a "training set" in the conventional sense. The device's algorithms for processing vital signs are likely based on established physiological principles and signal processing, not statistical learning from a large training dataset.

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

  • Not applicable/Not specified. As it's not an AI/ML device relying on a training set, this question is not relevant.

Summary of Device and Regulatory Context:

This 510(k) summary is for a traditional medical device (vital signs monitor). The regulatory pathway focuses on demonstrating "substantial equivalence" to existing legally marketed predicate devices. This typically involves showing that the new device has the same intended use, similar technological characteristics, and raises no new questions of safety and effectiveness compared to the predicate. The performance data, while crucial for the submission, is usually summarized or referenced rather than detailed in the public 510(k) summary.

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