(30 days)
The LINQ II ICM is an insertable automatically-activated and patient activated monitoring system that records subcutaneous ECG and is indicated in adult patients, and in pediatric patients who are at least 2 years old, 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 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. LINO II ICM includes the following accessories: LINQ II Tool Kit Model LNQ22TK, Reveal LINQ™ Mobile Manager Model MSW002, Device Command Library Model 2692, Instrument Command Library Model 2691, and AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420 and CareLink SmartSync LINQ II ICM Application Model D00U024. New to the LINQ II ICM system is the CareLink SmartSync LINQ II Platform Application Model D00U027.
I am sorry, but based on the provided text, I cannot extract any information about the acceptance criteria for device performance, a study proving the device meets acceptance criteria, sample sizes used, data provenance, number of experts, adjudication methods, MRMC comparative effectiveness studies, standalone performance, type of ground truth, or training set details.
The document discusses the substantial equivalence of the LINQ II Insertable Cardiac Monitor (ICM) when used with the CareLink SmartSync LINQ II Platform Application to a predicate device. It states that design verification and validation were performed to ensure the application met design requirements and established performance criteria, and that "all test executions resulted in a status of Passed" and "All results met the criteria in the Validation Plan." However, it does not specify what those performance criteria or validation plan criteria were, nor does it provide details about any specific studies conducted to establish device performance in terms of diagnostic accuracy or clinical effectiveness.
The document focuses on regulatory approval based on substantial equivalence to a predicate device, and the testing mentioned appears to be primarily related to software and system design verification and validation, rather than a clinical performance study with specific acceptance criteria that would include the metrics you've asked for (e.g., sensitivity, specificity, accuracy against a ground truth from experts).
§ 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.