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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™ Insertable Cardiac Monitor (ICM) Model LNQ11 is designed to 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 Model LNQ11 is a small, leadless implantable device that is typically implanted under the skin, in the chest. Two electrodes on the body of the implantable device continuously monitor the patient's subcutaneous ECG.

The provided document is a 510(k) premarket notification for the Medtronic Reveal LINQ Insertable Cardiac Monitor (ICM), Model LNQ11. However, the submission does not contain specific acceptance criteria or an explicit study describing device performance against those criteria.

The focus of this 510(k) is to demonstrate substantial equivalence of the Reveal LINQ ICM (Model LNQ11) when used with a new mobile application (Reveal LINQ Mobile Manager App Model MSW002 for iOS) compared to its use with an existing mobile application (Reveal LINQ Mobile Manager App Model MSW001 for Android).

The document explicitly states:
"The Reveal LINQ Mobile Manager App Model MSW002 and patient connector Model 24965 have no impact on the physical characteristics, materials, mechanical, electrical, hardware, components, firmware, operation, performance, and telemetry protocol of the Reveal LINQ ICM."
And, "There are no differences in the performance, features, materials, hardware, intended use or programmer-to-implantable device interface between the Reveal LINQ ICM used with the Reveal LINQ Mobile Manager App Model MSW002 and patient connector Model 24965 versus the existing Reveal LINQ Mobile Manager App Model MSW001 and patient connector Model 24965."

Therefore, the provided document does not include detailed acceptance criteria or a study proving the device (the ICM itself) meets specific performance metrics in the way a de novo or more comprehensive submission might. It relies on the assertion that the core device (ICM Model LNQ11) and its performance remain unchanged from its previous clearance (K150614) and that the new mobile app does not alter this performance.

Given this, I cannot directly extract the specific information requested in the prompt based on the provided text for acceptance criteria and a study demonstrating performance. The document focuses on demonstrating that the addition of a new mobile app platform does not negatively impact the already-cleared device.

However, I can provide a summary of what the document does include regarding testing and equivalence:

1. A table of acceptance criteria and the reported device performance:

• Acceptance Criteria: Not explicitly stated as pass/fail thresholds for specific performance metrics of the ICM. The acceptance hinges on demonstrating that the new mobile app (MSW002) does not alter the performance or intended use of the already-cleared ICM (LNQ11).
• Reported Device Performance: The document asserts that the performance, features, materials, hardware, intended use, and programmer-to-implantable device interface are the same when using the new iOS app (MSW002) as with the existing Android app (MSW001). The inherent performance of the LNQ11 ICM for "recording the occurrence of arrhythmias" is considered equivalent to its predicate.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

• Sample Size: Not specified for any particular test set. The document refers to "system verification and system validation" for the ICM model LNQ11 itself, and for the new mobile app and patient connector. These are typically internal engineering and software tests rather than clinical studies with patient data.
• Data Provenance: Not applicable in the context of this submission, as it focuses on software and system equivalence rather than clinical data from patients.

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):

• Not applicable. Ground truth as typically defined in clinical performance studies (e.g., expert consensus on diagnostic accuracy) is not a component of this submission, which focuses on device and software functional equivalence.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

• Not applicable. Adjudication methods are relevant for clinical studies involving human interpretation or challenging diagnoses, which is not the subject of this 510(k).

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:

• Not applicable. This device is an Insertable Cardiac Monitor, which automatically detects arrhythmias. It is not an AI-assisted diagnostic imaging device that involves human readers interpreting output.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• The Reveal LINQ ICM is described as an "automatically-activated monitoring system that records subcutaneous ECG." This indicates its primary function is standalone detection and recording of arrhythmias. The 510(k) implies that the core detection algorithms of the ICM (e.g., "Full View + P-wave presence filter") remain unchanged from the predicate device. However, the document does not detail a standalone performance study in this specific submission. It relies on the fact that the ICM Model LNQ11 already had standalone performance established in its prior clearance (K150614).

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• Not applicable to this specific 510(k) submission for mobile app equivalence. For the original ICM clearance (K150614), the ground truth for arrhythmia detection would typically involve a comparison of the device's automatic detections against expert-annotated ECGs or other clinical evidence. This detail, however, is not in the provided text.

8. The sample size for the training set:

• Not applicable. This submission is for a device and an associated app, not a new algorithm developed via machine learning requiring an explicit training set described within this document. The detection algorithms are stated to be "Same" as the predicate device.

9. How the ground truth for the training set was established:

• Not applicable for the same reasons as #8.

In summary: The provided document is a 510(k) submission focused on demonstrating substantial equivalence for a software update (new mobile app) for an already cleared device. It asserts that the performance of the core device remains unchanged, rather than providing new performance criteria or studies for the device itself. Therefore, the specific details regarding acceptance criteria and performance studies for the ICM are not contained within this particular document. They would have been part of the original K150614 submission for the Reveal LINQ ICM (Model LNQ11).

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