(132 days)
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. *only applicable to the Reveal XT Patient Assistant Model 9539
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 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 DX Insertable Cardiac Monitors (K103764) does not contain a detailed study with specific acceptance criteria and reported device performance metrics in the format requested.
Instead, it primarily focuses on establishing substantial equivalence to previously cleared predicate devices through general statements about:
- Technological Characteristics: "Intended use, design, materials, performance and technological characteristics are substantially equivalent to the predicate devices referenced."
- Summary of Testing: "Software and system verification testing, system validation testing, electrical design verification testing, human factors testing, and performance validation testing (bench and animal) were performed to demonstrate that the Reveal XT Model 9529 Insertable Cardiac Monitor met established performance criteria and to support equivalency with the reference predicate devices."
- Conclusion: "The results of the testing indicate that the Reveal XT/DX Insertable Cardiac Monitors, Model 9529 and 9528, Reveal XT/DX Patient Assistants Model 9539 and 9538 perform as intended and are safe for their intended use."
The document does not explicitly present:
- A table of acceptance criteria and reported device performance with specific metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
- Details on sample size used for the test set or data provenance (e.g., country, retrospective/prospective).
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was done, or any effect size for human readers' improvement with AI assistance.
- Specific results of a standalone algorithm performance study.
- The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
The document states that "performance validation testing (bench and animal)" was performed and "met established performance criteria," but it does not elaborate on what those criteria were or the specific results. This is common for 510(k) submissions that rely heavily on substantial equivalence to predicate devices, where detailed performance data might have been provided in the predicate device's original submission or is considered confidential manufacturer information not publicly disclosed in the 510(k) summary.
Therefore, I cannot populate the requested sections based on the provided text.
§ 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.