Search Results

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.

Ask a specific question about this device