(193 days)
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:
- A table of acceptance criteria and reported device performance.
- Sample sizes used for the test set.
- Data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method.
- Information on MRMC comparative effectiveness studies or effect sizes.
- Information on standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- 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.
§ 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.