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The Reveal LINQ Insertable Cardiac Monitor is an implantable patient-activated and 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 Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of cardiac event data in the implanted device memory.

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) ventrioular 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 LINO model LNO11 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.

A set of tools are provided with the Reveal LINQ ICM to create the small incision in the skin and to easily form a tight pocket and insert the ICM into the shallow subcutaneous pocket. There are two implant tools: the Incision Tool, used to make a small incision through the patient's skin; and the Insertion Tool, used to insert the device through the incision and into the patient's body at the desired location.

The Reveal Patient Assistant Model 9538 is a hand-held, battery-operated telemetry devices The Patient Assistant activates the data management features in the Reveal LINQ ICM to initiate recording of cardiac event data in the implanted device memory.

Here's a breakdown of the acceptance criteria and supporting study details based on the provided text, focusing on the Reveal LINQ ICM (Model LNQ11) as the primary device mentioned with performance testing.

1. Table of Acceptance Criteria and Reported Device Performance

For the Reveal LINQ ICM, the primary performance criterion explicitly detailed in the document relates to its ability to detect Atrial Fibrillation (AF). The relevant study is the XPECT Trial, which was conducted on a predicate device (Reveal XT), but the results are used to support the new device's capabilities.

Note: The document states "The sensitivity, specificity, positive predictive value, and negative predictive value for identifying patients with any AF were 96.1%, 85.4%, 79.3%, and 97.4%, respectively. Overall accuracy reported for detecting AF was 98.5% for the Reveal XT ICM." These are presented as the performance metrics that presumably satisfied the acceptance criteria for AF detection.

Other performance tests mentioned are at a high level and don't provide specific numerical acceptance criteria or performance figures in this summary:

• Bench Testing: Electromagnetic compatibility (EMC), Electrical safety, Firmware and Hardware verification, Mechanical Verification, Implant Tools Verification, Packaging Design Verification, Sterilization, Biocompatibility, MRI compatibility, Sensing and Detection performance validation, System Validation.
• Animal Testing: Reveal LINQ GLP Study.
• Human Factors Testing: Formative and Validation Testing.

2. Sample Size Used for the Test Set and Data Provenance

• XPECT Trial (AF detection):
  • Sample Size: N = 247
  • Data Provenance: Not explicitly stated (e.g., country of origin). The study type is "Validation," and it utilized a "specialized Holter to record the accuracy of the AF algorithm." It implies a prospective collection of data to validate the algorithm against a reference standard (Holter).
• AIM Study (Insertion Force):
  • Sample Size: N = 41
  • Data Provenance: Not explicitly stated, described as "Prospective, multicenter, feasibility" study.
• MapReveal Study (Signal Amplitude):
  • Sample Size: N = 42
  • Data Provenance: Not explicitly stated, described as "Prospective, multicenter, feasibility" study, with follow-up from 24 hours to > 1 month.
• Subcutaneous Implant Migration (SubQ-IM) Study (Migration Observation/Insertion Force/ECG measurements):
  • Sample Size: N = 40 healthy volunteers (implanted with 1 or 2 nonfunctional device prototypes)
  • Data Provenance: Not explicitly stated, described as "Prospective, multicenter, randomized feasibility" study.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

The document does not explicitly state the number or qualifications of experts used to establish ground truth for any of the studies mentioned. Specifically for the XPECT trial, it mentions a "specialized Holter to record the accuracy of the AF algorithm," which implies a reference standard, but doesn't detail human expert involvement in its interpretation or adjudication.

4. Adjudication Method for the Test Set

The document does not explicitly mention an adjudication method (e.g., 2+1, 3+1, none) for any of the studies.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned in the provided text, nor is there any discussion of an effect size of how much human readers improve with AI vs. without AI assistance. The focus of the clinical performance data (XPECT trial) is on the device's algorithm performance in detecting AF rather than human-in-the-loop performance.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

Yes, a standalone algorithm performance study was done for AF detection. The XPECT Trial was designed "To assess whether the AF detection algorithm reliably detected the presence or absence of AF." This directly evaluates the device's algorithm without explicit human intervention in the detection process quantified by the reported sensitivity, specificity, and accuracy.

7. The Type of Ground Truth Used

• XPECT Trial (AF detection): The ground truth was established by a "specialized Holter to record the accuracy of the AF algorithm." This suggests a reference standard based on another established physiological measurement device and its interpretation.
• AIM Study (Insertion Force): Ground truth was likely direct measurement of insertion force.
• MapReveal Study (Signal Amplitude): Ground truth likely involved direct measurement of R-wave amplitude from ECG and subcutaneous ECG data.
• SubQ-IM Study (Migration): Ground truth for migration was "Using fluoroscopy imaging."

8. The Sample Size for the Training Set

The document does not provide information about the training set size for any algorithms or models used in the device. The XPECT trial is described as a "Validation" study, implying the algorithm was already developed and this study was for its validation using a test set.

9. How the Ground Truth for the Training Set Was Established

The document does not provide information on how the ground truth for any training set was established, as details about a training set are not included.

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