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The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous ECG (S-ECG) for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition, are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a heart condition such as dizziness, palpitations, syncope, chest pain, and/or shortness of breath.

The LUX-Dx has not been tested specifically for pediatric use.

The LUX-Dx ICM sensor device (Model M301) evaluates S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-EG signal for clinical presentation when the algorithm criteria are met. The device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The sensor device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the sensor device, in the header and at the battery. The LUX-Dx system includes the following main components:

• LUX-Dx™ sensor device a subcutaneously-implanted sensor device for cardiac arrhythmia event ● data collection and transmission. In addition, symptom events are collected and transmitted from the sensor device.
• Mobile Monitor (MM) mobile applications (myLUX™ Patient app and LUX-Dx™ Clinic Assistant . app) running on an OTS mobile device that communicates with the LUX-Dx sensor device (using Bluetooth Low Energy (BLE)) and the LATITUDE server (using cellular/Wi-Fi) for collection and transmission of event, patient, and device data.
• . LATITUDE Clarity™ server - a server that communicates with the Mobile Monitor for bidirectional data transmission and provides web access for clinicians to perform remote monitoring activities and manage general patient and system parameters and workflow activities.
• . System Accessories- for insertion of the sensor device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate sensor/MM app communication.

The provided text describes the LUX-Dx Insertable Cardiac Monitor (ICM) and its substantial equivalence to a predicate device, but it does not contain specific acceptance criteria, detailed study designs, or performance metrics to fill out a table as requested.

The document is a 510(k) summary filed with the FDA, primarily addressing regulatory compliance and substantial equivalence to a predicate device (Medtronic Reveal LINQ LNQII). It lists various types of performance testing, such as "Algorithm Validation" and "LUX-Dx GLP and non-GLP studies," but it does not provide the results, acceptance criteria for these results, or the methodologies (e.g., sample sizes, ground truth establishment, expert qualifications, adjudication methods).

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and reported device performance.
2. Sample sizes used for the test set.
3. Data provenance.
4. Number of experts used to establish ground truth and their qualifications.
5. Adjudication method.
6. Information on MRMC comparative effectiveness studies or effect sizes.
7. Information on standalone algorithm performance.
8. Type of ground truth used.
9. Sample size for the training set.
10. How ground truth for the training set was established.

The document states that "Boston Scientific performed safety risk management activities, design verification, design validation, and usability testing to demonstrate that the LUX-Dx system is substantially equivalent to the predicate device." It also lists "Algorithm Validation" as a type of performance testing. However, the details of this algorithm validation, including specific acceptance criteria and performance metrics, are not present in this public 510(k) summary. These details would typically be found in direct study reports, which are not included here.

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The Reveal LINQ ICM is an insertable 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 device has not been tested specifically for pediatric use.

The Reveal® LINQ™ Insertable Cardiac Monitor (ICM) Model LNQ11 is designed to record the occurrence of arrhythmias in a patient. Arrhythmia may be classified as atrial tachyarrhythmia/atrial fibrillation (AT/AF), bradyarrhythmia, pause, or (fast) ventricular tachyarrhythmia. The Reveal LINQ 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 LINQ Model LNQ11 is a small, leadless implantable device that is typically implanted under the skin, in the chest. Two electrodes on the body of the implantable device continuously monitor the patient's subcutaneous ECG.

The provided document is a 510(k) premarket notification for the Medtronic Reveal LINQ Insertable Cardiac Monitor (Model LNQ11) when used with an alternative LINQ Programmer Application (Model MSW001) and patient connector (Model 24965). The submission aims to demonstrate substantial equivalence to the previously cleared Reveal LINQ ICM (Model LNQ11) with existing programmer software and hardware.

The document discusses various tests performed to establish this equivalence, but it does not contain specific acceptance criteria or detailed study results for device performance related to diagnostic accuracy (e.g., sensitivity, specificity for arrhythmia detection). Instead, the focus is on showing that the new programmer system does not alter the performance or safety of the previously cleared implantable device. The "Summary of Testing" section primarily lists types of verification and validation activities conducted, rather than specific performance metrics against an acceptance threshold.

Therefore, many of the requested details, especially those pertaining to diagnostic performance, ground truth, expert adjudication, and comparative effectiveness studies, cannot be extracted from this document.

Here's a breakdown of what can and cannot be answered based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not list specific acceptance criteria or reported device performance metrics such as sensitivity, specificity, or accuracy for arrhythmia detection. The testing described focuses on demonstrating that the new programming system does not negatively impact the existing device's performance, rather than establishing new performance benchmarks.

The table in the "Device Description" section lists technical parameters of the Reveal LINQ ICM (e.g., Longevity, Electrode Spacing, Volume, Mass, Episode Storage, MRI Compatibility, Detection Algorithms). For all these parameters, the "Reported Device Performance" is simply "Same" when comparing the device with the existing programmer vs. the alternative LINQ Programmer Application and patient connector. This indicates that the new component introduces no change to these specifications.

2. Sample Size for Test Set and Data Provenance

The document does not provide a sample size for a test set in the context of diagnostic performance. The "Summary of Testing" mentions "System verification and system validation" for the Reveal LINQ ICM and the LINQ Programmer Application, and various tests (EMC, RF compliance, electrical safety, mechanical, packaging, biocompatibility, performance verification, firmware verification, system verification, system validation) for the patient connector. However, these refer to engineering and regulatory compliance testing rather than clinical diagnostic performance studies involving patient data.

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

This information is not available in the provided text. The document does not describe a study involving human experts establishing ground truth for a diagnostic performance test set.

4. Adjudication Method for the Test Set

This information is not available in the provided text, as no diagnostic performance test set involving adjudication is described.

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

A MRMC comparative effectiveness study is not described in this document. The submission focuses on demonstrating substantial equivalence of a new programming interface to an existing one, not on the improvement of human reader performance with AI assistance.

6. Standalone (Algorithm Only) Performance Study

A standalone performance study focused on algorithmic diagnostic accuracy and reported as such is not explicitly described. The device (Reveal LINQ ICM) itself has "Detection Algorithms" listed (Full View + P-wave presence filter), which implies automated detection. However, the document does not provide details on the performance metrics of these algorithms alone. The testing described is verification and validation of the system and its components.

7. Type of Ground Truth Used

The document does not specify the type of ground truth used for diagnostic performance evaluation, as detailed diagnostic performance studies are not the primary focus of this 510(k) submission for the new programmer. Given the nature of a cardiac monitor, ground truth for arrhythmia detection would typically come from expert cardiologists reviewing raw ECG data, possibly correlated with clinical outcomes. However, this is speculative outside the provided text.

8. Sample Size for the Training Set

The document does not provide any information regarding a training set sample size or the development of the detection algorithms. The submission is about a component change for an already cleared device, not the initial development of the detection algorithms themselves.

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

This information is not available in the provided text.

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