(149 days)
The Reveal LINQ ICM is an insertable automatically-activated monitoring system that records subcutaneous ECG and is indicated in the following cases:
· patients with clinical syndromes or situations at increased risk of cardiac arrhythmias
· patients who experience transient symptoms such as dizziness, palpitation, syncope, and chest pain that may suggest a cardiac arrhythmia
The device has not been tested specifically for pediatric use.
The Reveal® LINQ™ Insertable Cardiac Monitor (ICM) Model LNQ11 is designed to record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINQ ICM provides storage of ECG and Marker Channel during patient-activated and automatically-detected (auto-activated) events. Auto-activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM. The Reveal LINQ Model LNQ11 is a small, leadless implantable device that is typically implanted under the skin, in the chest. Two electrodes on the body of the implantable device continuously monitor the patient's subcutaneous ECG.
The provided document is a 510(k) premarket notification for the Medtronic Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) when used with an alternative LINQ Programmer Application (Model MSW001) and patient connector (Model 24965). The submission aims to demonstrate substantial equivalence to the previously cleared Reveal LINQ ICM (Model LNQ11) with existing programmer software and hardware.
The document discusses various tests performed to establish this equivalence, but it does not contain specific acceptance criteria or detailed study results for device performance related to diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection). Instead, the focus is on showing that the new programmer system does not alter the performance or safety of the previously cleared implantable device. The "Summary of Testing" section primarily lists types of verification and validation activities conducted, rather than specific performance metrics against an acceptance threshold.
Therefore, many of the requested details, especially those pertaining to diagnostic performance, ground truth, expert adjudication, and comparative effectiveness studies, cannot be extracted from this document.
Here's a breakdown of what can and cannot be answered based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
This document does not list specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, or accuracy for arrhythmia detection. The testing described focuses on demonstrating that the new programming system does not negatively impact the existing device's performance, rather than establishing new performance benchmarks.
The table in the "Device Description" section lists technical parameters of the Reveal LINQ ICM (e.g., Longevity, Electrode Spacing, Volume, Mass, Episode Storage, MRI Compatibility, Detection Algorithms). For all these parameters, the "Reported Device Performance" is simply "Same" when comparing the device with the existing programmer vs. the alternative LINQ Programmer Application and patient connector. This indicates that the new component introduces no change to these specifications.
2. Sample Size for Test Set and Data Provenance
The document does not provide a sample size for a test set in the context of diagnostic performance. The "Summary of Testing" mentions "System verification and system validation" for the Reveal LINQ ICM and the LINQ Programmer Application, and various tests (EMC, RF compliance, electrical safety, mechanical, packaging, biocompatibility, performance verification, firmware verification, system verification, system validation) for the patient connector. However, these refer to engineering and regulatory compliance testing rather than clinical diagnostic performance studies involving patient data.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not available in the provided text. The document does not describe a study involving human experts establishing ground truth for a diagnostic performance test set.
4. Adjudication Method for the Test Set
This information is not available in the provided text, as no diagnostic performance test set involving adjudication is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A MRMC comparative effectiveness study is not described in this document. The submission focuses on demonstrating substantial equivalence of a new programming interface to an existing one, not on the improvement of human reader performance with AI assistance.
6. Standalone (Algorithm Only) Performance Study
A standalone performance study focused on algorithmic diagnostic accuracy and reported as such is not explicitly described. The device (Reveal LINQ ICM) itself has "Detection Algorithms" listed (Full View + P-wave presence filter), which implies automated detection. However, the document does not provide details on the performance metrics of these algorithms alone. The testing described is verification and validation of the system and its components.
7. Type of Ground Truth Used
The document does not specify the type of ground truth used for diagnostic performance evaluation, as detailed diagnostic performance studies are not the primary focus of this 510(k) submission for the new programmer. Given the nature of a cardiac monitor, ground truth for arrhythmia detection would typically come from expert cardiologists reviewing raw ECG data, possibly correlated with clinical outcomes. However, this is speculative outside the provided text.
8. Sample Size for the Training Set
The document does not provide any information regarding a training set sample size or the development of the detection algorithms. The submission is about a component change for an already cleared device, not the initial development of the detection algorithms themselves.
9. How the Ground Truth for the Training Set Was Established
This information is not available in the provided text.
§ 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.