(121 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 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 LINQ ICM Model LNQ11 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.
Reveal LINQ ICM includes the following accessories: LINQ Tool Kit Model LNQTOOL, Patient Assistant PA96000, Reveal LINQ™ Mobile Manager Model MSW002 used with Patient Connector Model 24967, CareLink Programmer Model 2090, Encore Programmer Model 29901, Reveal LINO Application Software Model SW026, MyCareLink Patient Monitor Models 24950 and 24955, CareLink Express Monitor Model 2020B, Device Data Management Application Model 2491, Device Command Library Model 2692 and Instrument Command Library Model 2691, CareLink Express Mobile Application Models 31302, and CareLink Network. New to the Reveal LINO ICM system is the AccuRhythm AI ECG Classification System Models ZA400, ZA410, ZA420, included in this submission.
The provided text describes the regulatory clearance of the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM) with AccuRhythm AI ECG Classification System. While it states that "Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts," and "All results met or exceeded the criteria in the Validation Plan," the document does not explicitly detail the specific acceptance criteria or the numerical results of the device's performance against those criteria. It refers to the testing done for the predicate device (LINQ II ICM with AccuRhythm AI ECG Classification System K210484) and states that no new changes were made to the Reveal LINQ ICM itself.
Therefore,Based on the provided text, I can infer some aspects of the study and its criteria, but much of the specific numerical data requested (like actual performance results, sizes for test set, and detailed information about ground truth establishment for this specific submission) is not present. The document focuses on showing substantial equivalence to a previously cleared device (K210484), rather than providing a full detailed clinical study report for the AccuRhythm AI component.
Here's an attempt to answer your questions based on the available information:
Acceptance Criteria and Reported Device Performance
The document states that "All results met or exceeded the criteria in the Validation Plan." However, the specific numerical acceptance criteria and the reported device performance values are not provided in this document. The focus is on the function of the AI system: to "reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts."
| Acceptance Criteria (Inferred from text) | Reported Device Performance |
|---|---|
| Reduction of false alerts for AF and Pause episodes | Met or exceeded criteria (Specific metrics not provided) |
| Retention of true alerts for AF and Pause episodes | Met or exceeded criteria (Specific metrics not provided) |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for the validation testing of the AccuRhythm AI ECG Classification System in this document. The document refers to "Performance validation testing and analysis."
- Data Provenance: Not specified in this document (e.g., country of origin, retrospective or prospective).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided in the document.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- This information is not provided in the document.
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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:
- The document does not mention an MRMC comparative effectiveness study where human readers' performance with and without AI assistance was evaluated. The testing described is focused on the algorithm's ability to reduce false alerts and retain true alerts, implying a standalone performance evaluation or an evaluation within the device's existing automatic detection framework.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, the description of "Performance validation testing and analysis were completed to ensure the algorithms were able to reduce false alerts from ICM detected AF and Pause episodes while retaining true alerts" strongly suggests a standalone (algorithm-only) performance evaluation was conducted for the AccuRhythm AI component. The specific metrics, however, are not provided.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The type of ground truth used is not explicitly stated. However, given the context of ECG classification for arrhythmias (AF and Pause), it is highly probable that the ground truth was established through expert adjudication of ECG recordings, possibly referring back to established clinical diagnoses or reference standards.
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The sample size for the training set:
- The sample size for the training set is not provided in this document.
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How the ground truth for the training set was established:
- This information is not provided in this document.
In summary, this FDA clearance letter emphasizes the substantial equivalence to a previously cleared device that includes the AccuRhythm AI system (K210484). While it states that performance validation was done and met criteria for reducing false alerts and retaining true alerts, the detailed specifics of the study design, sample sizes, expert involvement, and numerical performance metrics for the AI component itself are not included in this high-level summary. These details would typically be found in the full 510(k) submission and associated scientific documentation, not necessarily in the publicly available clearance letter.
§ 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.