(90 days)
- The TruVue™ System is intended for use by patients who experience transient symptoms that may suggest cardiac arrhythmia.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g. atrial fibrillation)
- Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath)
- Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring
- ECG data recorded by the device can be analyzed by other processing systems, such as the BMS Century Holter system to provide Holter style reports
The TruVue™ system is a continuous ECG monitor and Arrhythmia detector. The system is comprised of a body worn sensor that collects, stores and transmits 2 channels of ECG, a handheld communications device that transmits the ECG to an attended monitoring center and analysis software that continuously analyzes the ECG signal for arrhythmia.
The sensor communicates with the handheld over a Bluetooth link, the handheld communicates with the data center over the cellular telephony network or a land line telephony network. Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician.
The provided 510(k) summary for the TruVue™ System (K100155) does not contain a detailed study with acceptance criteria and reported device performance metrics in the way modern AI/ML device submissions typically do.
This submission from 2010 focuses heavily on substantial equivalence to predicate devices. The "performance validation" mentioned in section 7 ("Conclusions") is likely referring to the device's adherence to relevant performance standards like AAMI EC 38 and ANSVAAMI-EC 57, rather than a specific clinical study with granular performance metrics for arrhythmia detection that would be found in a standalone algorithm study.
Therefore, many of the requested fields cannot be directly extracted from this document. I will fill in what can be inferred or directly stated, and clearly mark what information is not present.
Here's a breakdown based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric/Acceptance Criteria | Reported Device Performance |
|---|---|
| Ambulatory ECG Performance (Compliance to EC 38) | EC 38 compliant (stated as substantial equivalence to predicate devices) |
| Performance of Cardiac Rhythm and ST Segment Measurement Algorithms (Compliance to ANSVAAMI-EC 57) | Implied compliance through referencing the standard, but no specific metrics are reported. |
| Arrhythmia Detection Accuracy (Sensitivity, Specificity, etc.) | Not reported in this document. The document states it has an "analysis algorithm that continuously analyzes the ECG signal for arrhythmia" but provides no performance metrics. |
| Equivalence to predicate devices in function | Stated as "substantially equivalent" for various features (ECG channels, ambulatory performance, acquisition/WAN, transmission technology, user event trigger, algorithm). |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance: Not specified. (The document mentions the device transmits data to a monitoring center, but doesn't detail any specific dataset used for validation beyond adherence to standards).
- Retrospective or Prospective: Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified. The document states "Full disclosure ECG is available at the data center for use by the analysis algorithm or for review and further analysis by a monitoring technician or physician," but doesn't describe expert review for ground truth establishment in a testing context.
4. Adjudication method for the test set
- Adjudication Method: Not specified.
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
- MRMC Study: Not indicated. This type of study is more common for imaging AI devices. The TruVue™ System is an "Arrhythmia Detector and Alarm," and its "analysis algorithm" would likely be evaluated in a standalone performance study rather than a reader study in the context of this 2010 submission.
- Effect Size: Not applicable/Not reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Study: The document implies a standalone algorithm, as it describes "analysis software that continuously analyzes the ECG signal for arrhythmia." However, it does not present specific data from a standalone performance study in terms of metrics like sensitivity, specificity, or PPV/NPV for various arrhythmias. Instead, it relies on compliance with standards (AAMI EC 38, ANSVAAMI-EC 57) for performance validation.
7. The type of ground truth used
- Type of Ground Truth: Not explicitly stated. For a device like this, ground truth would typically be established through expert cardiological review of the full disclosure ECG data (potentially with additional clinical information), but the document does not detail this.
8. The sample size for the training set
- Training Set Sample Size: Not specified. The document describes a "Proprietary / Server side" algorithm but provides no details about its development or training.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not specified.
Summary Limitations:
This 510(k) summary provides very limited information regarding detailed performance studies with acceptance criteria, ground truth, and statistical metrics. This is characteristic of older 510(k) submissions, particularly for devices seeking substantial equivalence where performance is often demonstrated through adherence to recognized standards and comparison to previously cleared devices rather than extensive clinical performance trials with granular data. The focus is on demonstrating that the device is "as safe and effective as its predicates."
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.