(15 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.
This document describes post-market changes rather than initial device approval, meaning that the full clinical study details are not provided in the typical format for proving initial efficacy or safety against a specific set of acceptance criteria. Instead, the focus is on demonstrating that a modification to an already approved device does not negatively impact its performance or safety, maintaining substantial equivalence to its predicate.
Therefore, the information regarding acceptance criteria and study details for device performance is limited to information on the modifications and the verification/validation activities assessing those modifications.
Here's a breakdown of the available information based on your requested categories:
1. A table of acceptance criteria and the reported device performance
Based on the provided text, the device itself (LINQ II ICM) is already cleared. The current submission (K240693) describes a modification to the LINQ II ICM. The acceptance criteria and "reported device performance" here refer to the evaluation of this modification.
| Acceptance Criteria (for the modification) | Reported Device Performance (for the modification) |
|---|---|
| No adverse impact to the function of the modified LINQ II ICM. | All verification and validation activities were completed successfully and demonstrated there was no adverse impact to the function of the modified LINQ II ICM. |
| The results of verification and validation activities met pre-determined acceptance criteria. | The results of verification and validation activities met pre-determined acceptance criteria. |
| The modification introduces a new design output requiring a minimum bond strength at the feedthrough via interface. | Implicitly met, as the conclusion states no new safety or performance issues were raised and the device is substantially equivalent. Specific bond strength values are not provided in this summary. |
2. Sample size used for the test set and the data provenance
The document does not specify a "test set" sample size in the context of a new clinical study. Instead, it refers to "design verification and validation activities" for the modification. These are typically laboratory-based tests or engineering evaluations, not patient studies with specific sample sizes. Therefore, information on data provenance (country of origin, retrospective/prospective) for a clinical test set is not applicable here.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided as the submission focuses on design verification and validation of a modification, not a new clinical trial requiring expert consensus for ground truth establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided as the submission focuses on design verification and validation of a modification, not a new clinical trial that typically employs adjudication.
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 type of study is not mentioned as the LINQ II ICM is an insertable cardiac monitor that automatically detects arrhythmias and allows patient-initiated recordings. It's a monitoring device, not an AI-assisted diagnostic tool for human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device is inherently "standalone" in its automatic detection function, as it continuously monitors and records without constant human intervention. The submission focuses on ensuring this existing functionality is maintained after the modification. No specific "standalone performance study" in the context of a new algorithm is detailed. The device's primary function is automatic arrhythmia detection, which is essentially an algorithm-only function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For the original LINQ II ICM, ground truth would likely have been established through clinical correlation with electrophysiologist interpretations or other diagnostic methods. However, for this modification, the "ground truth" for the verification and validation activities would be engineering specifications, established performance standards, and comparison to the predicate device's known characteristics.
8. The sample size for the training set
This information is not provided. The document describes a modification to an existing device, not the development of a new algorithm with a training set.
9. How the ground truth for the training set was established
This information is not provided, as a training set for a new algorithm is not discussed in this submission.
§ 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.