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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. *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:

1. A table of acceptance criteria and reported device performance with specific metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection).
2. Details on sample size used for the test set or data provenance (e.g., country, retrospective/prospective).
3. Number of experts used to establish ground truth or their qualifications.
4. Adjudication method for the test set.
5. Whether a Multi-Reader, Multi-Case (MRMC) comparative effectiveness study was done, or any effect size for human readers' improvement with AI assistance.
6. Specific results of a standalone algorithm performance study.
7. The type of ground truth used (e.g., expert consensus, pathology, outcomes data).
8. Sample size for the training set.
9. 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.

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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.

Ask a specific question about this device

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.

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