(29 days)
The LINQ II ICM is an insertable automatically-activated and patient-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 LINQ II Insertable Cardiac Monitor (ICM) Model LNQ22 is a programmable device that continuously monitors a patient's ECG and other physiological parameters. The device records cardiac information in response to automatically detected arrhythmias and patient-initiated activation or markings. The device is designed to automatically record the occurrence of an episode of arrhythmia in a patient. Note: Arrhythmias are classified as tachyarrhythmia, bradyarrhythmia, pause, atrial tachyarrhythmia, or atrial fibrillation. Patients may also manually record symptoms. In order to manually record symptoms, the patient will also need either the MyCareLink Heart App (patient app on mobile device) or the Patient Assistant Model PA97000. The patient can use the MyCareLink Heart App or the Patient to manually record his or her cardiac rhythm while experiencing or immediately after a symptomatic event.
The provided text is a 510(k) Summary for the Medtronic LINQ II Insertable Cardiac Monitor. This document focuses on demonstrating substantial equivalence to a predicate device after a software update (RAMware). It does not contain a comprehensive study detailing the initial performance of the device against specific acceptance criteria for arrhythmia detection, but rather confirms that the software update did not negatively impact the previously established performance.
Therefore, much of the requested information regarding acceptance criteria and a study proving the device meets these criteria for the core functionality of arrhythmia detection is not present in this specific document. The document only states that "The results of the above verification and validation testing met the specified acceptance criteria and did not raise new safety or performance issues." after a RAMware update.
However, I can extract what is implied and what minimal information is available about the impact of the RAMware update:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the acceptance criteria and performance reported relate specifically to the RAMware update and its impact on battery reporting and rejection parameters, not the overall arrhythmia detection performance of the LINQ II ICM.
| Acceptance Criteria (Implied for RAMware update) | Reported Device Performance (for RAMware update) |
|---|---|
| Adequate mitigation of incorrect battery reporting parameter settings | Met via design verification and validation testing, confirming no adverse impact. |
| Adequate mitigation of incorrect rejection parameter settings | Met via design verification and validation testing, confirming no adverse impact. |
| No adverse impact to the functioning of the modified LINQ II ICM device | Confirmed through successful design verification and validation activities. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document refers to "device verification and system validation testing" but does not specify 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)
This information is not provided in the document.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
An MRMC study is not mentioned in this document. This document is focused on a software update for an existing device, not an AI-assisted interpretation system. The LINQ II is an "automatically-activated and patient-activated monitoring system that records subcutaneous ECG" and is an "arrhythmia detector and alarm," implying automated detection rather than human reader improvement with AI.
6. If a standalone (i.e. algorithm only, without human-in-the-loop performance) was done
The LINQ II ICM is inherently a standalone device in its primary detection function ("automatically-activated"). The document does not describe a separate standalone performance study in the context of this software update, but rather confirms the continued proper functioning of the device as a standalone detector after the update.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
This information is not provided in the document. For an arrhythmia detector, ground truth would typically involve expert-reviewed ECGs or confirmed clinical diagnoses. However, for this submission, the "ground truth" for the RAMware update likely refers to engineering specifications and expected behavior for battery reporting and rejection parameters.
8. The sample size for the training set
This information is not applicable/provided. The document describes a "RAMware update" to existing firmware, implying a software modification rather than a new machine learning model requiring a dedicated training set.
9. How the ground truth for the training set was established
This information is not applicable/provided for the reasons stated in point 8.
§ 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.