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The Reveal DX 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 that may suggest a cardiac arrhythmia

The Reveal 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 DX Model 9528 Insertable Cardiac Monitor (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as bradyarrhythmia, asystole, or (fast) ventricular tachyarrhythmia. The Reveal DX ICM provides storage of ECG and marker channels during patientactivated 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 DX ICM Model 9528 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.

The Reveal Patient Assistant Model 9538 is a hand-held, battery-operated telemetry device that enables the patient to start recording cardiac information in the Reveal DX ICM after experiencing symptoms of a possible cardiac event.

The provided 510(k) summary for the Medtronic Reveal DX Insertable Cardiac Monitor (Model 9528) and Reveal Patient Assistant (Model 9538) does not contain specific acceptance criteria or a detailed study proving the device meets particular quantitative performance metrics for arrhythmia detection (e.g., sensitivity, specificity for bradyarrhythmia, asystole, or fast ventricular tachyarrhythmia).

Instead, the summary focuses on demonstrating substantial equivalence to predicate devices. The "Summary of Testing" section broadly states that "Device verification testing was performed to demonstrate the Reveal DX Model 9528 Insertable Cardiac Monitor and Reveal Patient Assistant Model 9538 meet established performance criteria and to support equivalency to the reference predicate devices." It lists various types of testing completed (EMC, electrical safety, firmware, MRI compatibility, sensing and detection performance validation testing, etc.) but does not provide results for these tests or specific acceptance criteria met.

Therefore, many of the requested details about a study proving specific acceptance criteria cannot be extracted from this document, as it primarily serves to establish substantial equivalence through general verification and validation, rather than a detailed performance study with quantitative acceptance criteria.

However, based on the information provided, here's what can be answered:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not explicitly stated in the provided 510(k) summary. The document focuses on demonstrating substantial equivalence to predicate devices rather than reporting specific quantitative acceptance criteria or performance metrics for arrhythmia detection (e.g., sensitivity, specificity, accuracy). It generally states that "sensing and detection performance validation testing" was completed and that the device performs "as intended."

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

This information is not provided in the summary. No details about a specific test set, its size, or the origin of the data are mentioned.

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

This information is not provided. The summary does not detail any expert review process for a test set.

4. Adjudication Method for the Test Set

This information is not provided.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

An MRMC comparative effectiveness study is not mentioned in the summary. The device's primary function is automatic arrhythmia detection, not as an AI assistant for human readers.

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

The summary indicates that standalone performance testing was done for the automated detection capabilities. It states: "The Reveal DX Model 9528 Insertable Cardiac Monitor (ICM) is designed to automatically record the occurrence of arrhythmias in a patient. ... Auto activation may help to detect abnormal heart rhythms in patients who may not activate/trigger the ICM." The "sensing and detection performance validation testing" mentioned under "Summary of Testing" would pertain to this standalone performance. No specific quantitative results are provided, but the statement "the results of the testing indicate that the Reveal DX Insertable Cardiac Monitor Model 9528 ... perform as intended" suggests the standalone algorithm's performance was evaluated.

7. The Type of Ground Truth Used

The type of ground truth used for "sensing and detection performance validation testing" is not explicitly stated. However, for arrhythmia detection devices, the ground truth is typically established by expert review of ECG signals, sometimes correlated with clinical outcomes or invasive EP studies, but the document does not specify.

8. The Sample Size for the Training Set

This information is not provided. The summary does not mention a training set, which is typical for devices cleared under substantial equivalence based on established predicate technology rather than novel AI/ML development requiring explicit training data.

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

This information is not provided, as no training set is mentioned.

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