(32 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. 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 LINQ II Insertable Cardiac Monitor (LNQ22) is intended to monitor subcutaneous ECG and detect cardiac arrhythmias. The provided document, K233320, is a 510(k) premarket notification for a modification to the LINQ II ICM, specifically a new Firmware solution.
Based on the provided text, the document does not contain detailed information about the acceptance criteria and the study that proves the device meets those criteria for the detection of arrhythmias. The submission states that verification and validation testing was performed and met pre-determined acceptance criteria, but it does not describe those criteria or the specifics of the study.
Therefore, many of the requested details cannot be extracted from this document.
Here's what can be inferred or stated based on the provided text:
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1. A table of acceptance criteria and the reported device performance: This information is not provided in the document. The document states that "The results of verification and validation testing met pre-determined acceptance criteria," but it does not list these criteria or the specific performance metrics achieved.
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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 in the document.
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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.
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4. 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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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 as the device is an Insertable Cardiac Monitor, which automatically detects arrhythmias. There is no mention of human reader assistance or AI in the context of improving human performance.
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6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: The device description states it "automatically detects arrhythmias" and "continuously monitors a patient's ECG, and analyze the timing of ventricular events to detect possible episodes of arrhythmia." This implies a standalone algorithm performance is key, but the specifics of how this was evaluated (e.g., in a standalone study) are not detailed. The document focuses on the firmware update and its impact on the existing system.
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7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): This information is not provided in the document.
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8. The sample size for the training set: This information is not provided in the document.
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9. How the ground truth for the training set was established: This information is not provided in the document.
In summary, the provided submission focuses on establishing substantial equivalence for a firmware update to an already cleared device. It asserts that verification and validation testing confirmed the device continues to meet pre-determined acceptance criteria but does not provide the details of those criteria or the studies that established them for the original device's performance regarding arrhythmia detection. To get this specific information, one would need to review the original 510(k) submission (K221962) for the predicate device.
§ 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.