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The Reveal XT/DX Insertable Cardiac Monitor is an implantable patientactivated 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 Reveal XT/DX Patient Assistant is intended for unsupervised patient use away from a hospital or clinic. The Patient Assistant activates one or more of the data management features in the Reveal Insertable Cardiac Monitor:

• . To verify whether the implanted device has detected a suspected arrhythmia or device related event. *
• To initiate recording of cardiac event data in the implanted device . memory.

The Reveal XT Model 9529 and Reveal DX Model 9528 Insertable Cardiac Monitors (ICM) are designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, asystole, or (fast) ventricular tachyarrhythmia. The Reveal XT 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 XT ICM Model 9529 and Reveal DX Model 9528 are small, leadless devices that are typically implanted under the skin, in the chest. Two electrodes on the body of the device continuously monitor the patient's subcutaneous ECG.

The Reveal XT Patient Assistant Model 9539 and the Reveal DX Patient Assistant Model 9538 are hand-held, battery-operated telemetry devices that enable the patient to start recording cardiac information in the Reveal XT and DX ICMs, respectively after experiencing symptoms of a possible cardiac event. The Reveal XT Patient Assistant query function enables the patient to check the status of physician-programmed parameters. A query function enables the patient to check his or her device and receive notification when an arrhythmia has occurred or when the device status has changed.

The provided 510(k) summary for the Medtronic Reveal XT and Reveal DX Insertable Cardiac Monitors (ICM) does not contain specific acceptance criteria or a detailed study description with performance metrics for software or algorithm performance. Instead, it relies on substantial equivalence to previously cleared devices.

Here's an analysis of the information that is available and what is explicitly missing:

1. Table of Acceptance Criteria and Reported Device Performance

Not available. The submission states: "Software and system verification testing, system validation testing, functional testing and performance validation testing (bench) was performed to demonstrate the Reveal XT Model 9529 Insertable Cardiac Monitor meets established performance criteria and to support equivalency to the reference predicate devices." However, these "established performance criteria" are not detailed, nor are the specific results of the validation testing provided in a measurable format in this summary.

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

Not available. The summary refers to "performance validation testing (bench)" but provides no information on the sample size of data used for this testing or its provenance.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not available. Since specific performance testing results and the methodologies for evaluating them are not described, there is no information about expert involvement in establishing ground truth.

4. Adjudication Method

Not available. No information about adjudication methods is provided, as specific performance studies are not detailed.

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

Not available. There is no mention of an MRMC study or any comparison of human reader performance with or without AI assistance. The device is an insertable cardiac monitor that automatically detects arrhythmias, not an AI-assisted diagnostic tool that human readers would use in interpretation.

6. Standalone (Algorithm Only) Performance Study

Partially addressed, but no specific metrics. The device's primary function is automatic arrhythmia detection, implying standalone algorithm performance is key. The summary states: "The Reveal XT Model 9529 and Reveal DX Model 9528 Insertable Cardiac Monitors (ICM) are designed to automatically record the occurrence of arrhythmias... Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM." It also mentions "performance validation testing (bench) was performed to demonstrate the Reveal XT Model 9529 Insertable Cardiac Monitor meets established performance criteria." However, the actual performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection) from such testing are not included in this summary.

7. Type of Ground Truth Used

Not available. Without details on the performance validation testing, the type of ground truth used (e.g., expert consensus, independent diagnostic methods) cannot be determined from this document.

8. Sample Size for the Training Set

Not available. There is no information regarding a training set, as the focus is on a device for arrhythmia detection rather than a machine learning model requiring explicit training data.

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

Not available. Given no mention of a training set, this information is also absent.

In summary, this 510(k) summary primarily focuses on demonstrating substantial equivalence by stating that the device's design, materials, and intended use are similar to previously cleared predicate devices. It confirms that software and system verification/validation testing was done to ensure the device "meets established performance criteria" and is "safe for its intended use," but it does not provide the quantitative details of those criteria or the study results that would typically be presented for novel algorithm performance. This is common for devices seeking 510(k) clearance based on substantial equivalence, especially if the underlying technology or algorithms are not significantly changed from the predicate.

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