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The LUX-Dx Insertable Cardiac Monitor (ICM) is intended to monitor and record subcutaneous electrocardiogram (S-ECG). The recorded S-ECG is used for the clinical evaluation and diagnosis of cardiac arrhythmias. The LUX-Dx is indicated for use in patients that have a known heart condition and are at risk of developing an abnormal heart rhythm, or have symptoms that may suggest a cardiac arrhythmia 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-ECG 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 base of 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 Clarity™ 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 510(k) clearance for the LUX-Dx Insertable Cardiac Monitor (ICM) but does not include detailed acceptance criteria or a specific study proving device performance against those criteria.

Instead of a detailed study on device performance and acceptance criteria, the document states:

• "Boston Scientific performed safety risk management activities and design verification and validation testing to demonstrate that the LUX-Dx sensor device software is substantially equivalent to the predicate device software. The system conforms to user needs and intended use and software requirements and design specifications."

It lists the following categories of "Performance Testing - Bench":

• Software Verification
• System Verification
• Confirmatory Validation

Therefore, I cannot fulfill the request for a table of acceptance criteria and reported device performance, sample sizes, expert details, adjudication methods, or MRMC study results because this information is not present in the provided text.

The document focuses on demonstrating substantial equivalence to a predicate device (also a LUX-Dx Insertable Cardiac Monitor, K193473) based on general performance testing and software verification, rather than presenting a detailed clinical or standalone performance study with specific metrics and acceptance thresholds.

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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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