(24 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 Reveal LINQ Model LNQ11 Insertable Cardiac Monitors (ICM) is designed to automatically 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 LINO ICM Model LNO11 is a small. leadless device that is typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.
This document describes modifications to the Reveal LINQ Insertable Cardiac Monitor (ICM). While it mentions verification and validation activities were completed successfully and demonstrated no adverse impact, it does not provide detailed acceptance criteria and a study proving the device meets those criteria in a format that lends itself to the requested table.
Here's a breakdown of what can be extracted and what is missing based on your request:
1. A table of acceptance criteria and the reported device performance:
This information is not explicitly provided in the document. The document states: "The results of the above verification and validation testing met the specified acceptance criteria and did not raise new safety or performance issues." However, it does not detail what those acceptance criteria were or present specific performance metrics against them. The modification was related to "RAMware to ensure the detection parameters are appropriately configured after a partial electrical reset," implying the acceptance criteria would be related to the correct configuration of these detection parameters.
2. Sample size 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. The document mentions "device verification and system validation testing" and "design verification and validation activities" but gives no details about the sample sizes of devices or patient data used, nor its provenance or whether it was retrospective or prospective.
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. The document describes a technical modification related to device configuration, not an algorithm that interprets medical data requiring expert ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
This information is not provided. The nature of the modification (RAMware for detection parameter configuration) does not suggest a need for a human adjudication process as would be typical for clinical diagnostic algorithms.
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:
This is not applicable/not provided. The device is an Insertable Cardiac Monitor (ICM) that automatically records arrhythmias, and the specific modification discussed is a technical fix related to internal device configuration. There is no mention of an "AI" component or a "human-in-the-loop" study in this context.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This is not applicable/not provided in the context of an "algorithm only" performance study. The modification is a technical change to the device's internal software/firmware to ensure correct parameter configuration. The document implies device-level testing of this configuration.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of the modification (RAMware to ensure detection parameters are appropriately configured after a partial electrical reset), the "ground truth" would likely be the expected correct configuration of the detection parameters as defined by the device's design specifications. This would be established through engineering and software validation processes, not clinical expert consensus or pathology.
8. The sample size for the training set:
There is no mention of a training set. The modification is a specific technical fix to ensure proper configuration, not a machine learning model that would require a training set.
9. How the ground truth for the training set was established:
There is no mention of a training set, so this information is not applicable.
§ 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.