(103 days)
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 II (M302) and LUX-Dx II+ (M312) ICM devices evaluate S-ECG waveform data for indications of cardiac arrhythmias and "marks" the S-ECG signal for clinical presentation and evaluation when the algorithm criteria are met. The ICM device is inserted into the subcutaneous layer of the fourth intercostal space of the left chest wall. The ICM device is powered by an integrated battery. The electrodes used for detecting the S-ECG signal are located on each end of the ICM device, in the header and at the base of the battery. The LUX-Dx system includes the following main components:
- ICM Device - a subcutaneously-implanted cardiac monitor device for cardiac arrhythmia event data collection and transmission. In addition, symptom events are collected and transmitted from the 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 ICM 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 ICM device, an insertion tool and incision tool are provided. In addition, a magnet is provided to initiate ICM/MM app communication.
The provided text describes the LUX-Dx II (M302) and LUX-Dx II+ (M312) Insertable Cardiac Monitors (ICM) and their substantial equivalence to a predicate device. However, the text does not contain detailed acceptance criteria or the specific results of a study demonstrating the device meets those criteria, nor does it provide information about the test set, experts, adjudication, or training set as requested in points 2-9 of your prompt.
The document primarily focuses on establishing substantial equivalence to a predicate device (LUX-Dx ICM M301, K193473) for FDA 510(k) clearance. It mentions "algorithm validation" as part of design validation testing but does not elaborate on the specifics of this validation study to the extent requested.
Here's a breakdown of what can be extracted from the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
What is provided: The document states that the new device models (M302, M312) include "new and enhanced detection algorithms, bring-your-own-device (BYOD) capability, and additional changes for sustaining/maintenance and continuous improvement." Specifically, they feature a PVC detection algorithm and enhancements to the Pause algorithm (M302, M312) and AF algorithm (M312 only) to reduce false positives.
What is missing: The text does not provide specific quantitative acceptance criteria (e.g., sensitivity, specificity, accuracy targets) for these algorithms, nor does it present the reported performance against such criteria. The "Summary of Performance Testing" section broadly mentions "algorithm validation" but gives no results.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Missing. The text mentions "algorithm validation" but does not provide any details about the test set used for this validation, including its size or provenance.
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 information in the document regarding experts or their qualifications for establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Missing. The document does not describe any adjudication methods used for the test set.
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
Missing. The document does not mention an MRMC study or any assessment of human reader improvement with AI assistance. The device is an Insertable Cardiac Monitor, which automatically detects and records arrhythmias, implying less focus on real-time human interpretation with AI assistance in the same way an imaging AI might.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
What is suggested: The mention of "algorithm validation" implies that the standalone performance of the algorithms was tested. The device's nature as an ICM that "marks" S-ECG signal when algorithm criteria are met suggests a primary focus on standalone algorithmic detection.
What is missing: Specific results or details of a standalone performance study.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Missing. The document does not specify how ground truth was established for "algorithm validation."
8. The sample size for the training set
Missing. No information about a training set is provided.
9. How the ground truth for the training set was established
Missing. No information about a training set or its ground truth establishment is provided.
In summary, while the document confirms the device features new and enhanced algorithms for detecting cardiac arrhythmias, it fundamentally lacks the detailed performance study information, acceptance criteria, and ground truth methodologies that your prompt requests. The focus of this FDA 510(k) summary is on demonstrating substantial equivalence rather than providing a detailed performance study report.
§ 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.