(159 days)
The Reveal XT 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 XT 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 Insertable Cardiac Monitor (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. asystole, or (fast) ventricular tachyarrhythmia. The Reveal XT ICM provides storage of ECG and marker channels during patient-activated and automaticallydetected (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 is a small, leadless device that is typically implanted under the skin, in the chest. Two clectrodes on the body of the device continuously monitor the patient`s subcutaneous ECG.
The Reveal XT Patient Assistant Model 9539 is a hand-held, battery-operated telemetry device that enables the patient to start recording cardiac information in the Reveal XT ICM after experiencing symptoms of a possible cardiac event. 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 Reveal XT Patient Assistant query function enables the patient to check the status of physician-programmed parameters.
The provided text describes a 510(k) submission for the Medtronic Reveal XT Insertable Cardiac Monitor and Patient Assistant. However, it does not include specific acceptance criteria or the details of a study demonstrating the device meets such criteria to the level of detail requested in the prompt.
The document primarily focuses on establishing substantial equivalence to predicate devices and lists various types of testing performed without providing quantitative results or acceptance thresholds.
Therefore, I cannot fulfill your request for the specific acceptance criteria and the study details as they are not present in the provided text.
Here's an analysis of what is and is not in the provided text relative to your request:
1. A table of acceptance criteria and the reported device performance
- Missing: The document states that "Device verification testing was performed to demonstrate the Reveal XT Model 9529 Insertable Cardiac Monitor and Reveal XT Patient Assistant Model 9539 meet established performance criteria..." but it does not list these established performance criteria (i.e., acceptance criteria) nor does it provide quantitative "reported device performance" against those criteria. It states that "The results of the testing indicate that the Reveal XT Insertable Cardiac Monitor Model 9529 and Reveal XT Patient Assistant Model 9539 perform as intended and are safe for their intended use," but this is a high-level conclusion, not specific performance data.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Missing: The document mentions "sensing and detection performance validation testing" was completed, but it does not specify the sample size used, the nature of the test set (e.g., patient ECGs, simulated data), or the data provenance (country, retrospective/prospective).
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)
- Missing: There is no mention of experts or how ground truth was established for any performance testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Missing: No information on adjudication methods is provided.
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 / Missing: This device is an Insertable Cardiac Monitor, which automatically records arrhythmias. It's not a diagnostic aid for human readers in the way an AI for image analysis would be. Therefore, an MRMC comparative effectiveness study comparing human readers with and without AI assistance is not relevant to this type of device. The document does not discuss any human-in-the-loop performance studies or associated effect sizes.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Implied (but details missing): The device is described as automatically detecting arrhythmias. The "sensing and detection performance validation testing" mentioned would constitute standalone performance testing. However, the document does not provide the results, metrics, or detailed methodology of this testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Missing: This information is not provided in the document.
8. The sample size for the training set
- Not Applicable / Missing: This document describes a 510(k) for a medical device that predates the common usage of "training set" in the context of deep learning AI as understood today (the document is from 2007). While the device involves algorithms for arrhythmia detection, the development process likely involved traditional signal processing and rule-based algorithms rather than machine learning models requiring training data in the modern sense. Even if there were some form of algorithm development data, the document does not mention a "training set" size.
9. How the ground truth for the training set was established
- Not Applicable / Missing: Same as point 8; no information is provided.
Conclusion:
The provided 510(k) summary focuses on establishing substantial equivalence and general device testing without detailing specific acceptance criteria, quantitative performance results, or the methodologies (like ground truth establishment, sample sizes for specific performance studies, or expert involvement) that would be expected to fully address your request. This level of detail is often found in more comprehensive testing reports, which are typically not part of the public 510(k) summary.
§ 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.