(120 days)
The SmartCardia 7L Platform is a prescribed device used for the purpose of identifying non-lethal arrhythmias. The SmartCardia 7L Platform is intended for:
- Patients who experience transient symptoms that may suggest cardiac arrhythmia.
- Patients who require monitoring of effect of drugs to control ventricular rate in various atrial arrhythmias (e.g., atrial fibrillation).
- Patients with symptoms that may be due to cardiac arrhythmias. These may include but are not limited to symptoms such as: a) dizziness or lightheadedness; b) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded; and c) dyspnea (shortness of breath).
- Patients recovering from cardiac surgery or interventional procedures who are indicated for outpatient arrhythmia monitoring.
- ECG data recorded by the device can be analyzed by other processing systems to provide Holter style reports. Measurements include: electrocardiogram (ECG signal), R-R interval, Heart Rate. Notification alerts can be set for one or more of these measures.
The SmartCardia 7L Platform is indicated for use on patients who are 18 years of age or older to provide monitoring of physiological information. It is intended for use in a physician office, outpatient facility, or in the patient's home.
SmartCardia 7L Platform contraindications: - The SmartCardia 7L Platform is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required.
- The SmartCardia 7L Platform is contraindicated for use during external defibrillation.
The SmartCardia 7L Platform is a body worn Holter monitoring product that is designed with a disposable adhesive 7L Patch and reusable 7L Sensor. It is designed to be worn by the patient for up to 14 days. If longer monitoring is necessary, the 7L Patch is removed from the body, the 7L Sensor is removed from the worn 7L Patch which is discarded. The 7L Sensor is inserted into a new 7L Patch and the new assembly is placed on the patient for monitoring to continue.
The 7L Sensor/7L Patch assembly communicates to the SmartCardia Phone via Bluetooth technology and shows the patient's heart rate and ECG on its display and allows the patient to input symptoms (Mark Event) which are shown in the patient record. The SmartCardia Phone has a medical grade mains powered charger and uses its cellular technology to act as a gateway to the SmartCardia Cloud Service provided by Amazon Web Services. The SmartCardia Phone is pre-configured by SmartCardia and placed in a kiosk mode. Data stored in the SmartCardia cloud can be viewed in the SmartCardia Web Browser application by a clinician or healthcare provider. The SmartCardia 7L Platform incorporates two modes of Holter monitoring:
- Holter Monitoring (up to 48 hours) and Extended Holter Monitoring (>48 hours and up to 14 days),
- Event Monitoring (up to 48 hours, and >48 hours up to 14 days)
During any of the selected modes of Holter monitoring, a clinician or healthcare provider can use the SmartCardia Web Browser and continuously monitor the patient.
The SmartCardia 7L Platform provides alarm notifications for heart rate and atrial fibrillation. As stated in the Intended Use statement, the system is contraindicated for use in a critical care setting where an immediate response to life threatening conditions such as lethal arrhythmias is required. There are no alarm signals presented to the clinician for conditions other than heart rate and atrial fibrillation.
The SmartCardia 7L Platform, like most Holter monitoring systems performs retrospective analysis and identifies events which it shows the clinician when they are reviewing historical data. The clinician must then review these events and determine if they are indeed valid and should be included in a physician's report. These events are things like 'Ventricular Bigeminy', 'Supraventricular Couplet', etc. A full list is included in the Clinician Instructions for Use.
This document describes the device's technical characteristics and bench testing summary but does not provide complete details on a clinical study that proves the device meets the acceptance criteria, particularly for AI/algorithm performance. The information provided is primarily focused on hardware and basic signal acquisition validation against regulatory standards.
Here's an attempt to answer your questions based on the provided text, with explicit notes where information is missing or unclear for a comprehensive AI/algorithm study:
1. Table of Acceptance Criteria and Reported Device Performance
The document mentions "Pass criteria is compliance with the claimed range and precision provided in the labeling for the SmartCardia 7L Platform" and that the device "met the pass/fail criteria established by the appropriate standards." However, it does not explicitly list specific numerical acceptance criteria or performance metrics for arrhythmia detection beyond stating that "the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Compliance with claimed ranges and precision provided in labeling for heart rate, R-R interval, and ECG signal performance (no specific values given). | Device met these pass/fail criteria. |
| ECG detection algorithm performance for "stated output arrhythmia" meeting "industry norms" per ANSI/AAMI EC57 (excluding ST-segment analysis). | Algorithm detection and reported results were satisfactory and met industry norms. |
| Wireless Coexistence testing per FDA Guidance and ANSI C63.27: 2017. | Testing showed compliance. |
| Basic Safety and Essential Performance per IEC 60601-1. | Testing showed compliance. |
| Electromagnetic Compatibility per IEC 60601-2. | Testing showed compliance. |
| Life Cycle testing per IEC 60601-11 Home Healthcare. | Testing showed compliance. |
| ECG electrode testing per ANSI/AAMI EC12. | Testing showed compliance. |
| Cleaning and disinfection methods as defined by SmartCardia SA. | N/A (protocol defined, performance not explicitly stated). |
| ECG Waveform Quality and Wearability. | Verification testing performed, included in DVR-67-01 report. Results stated as satisfactory regarding morphology and ECG characteristics. |
| Effects of Sensor Positioning on ECG Performance. | N/A (protocol defined, performance not explicitly stated). |
| Defibrillator protection. | Testing performed to ensure no excessive energy shunted. Device contraindicated during defibrillation and labeled accordingly. |
2. Sample Size Used for the Test Set and Data Provenance
The document states, "SmartCardia developed a protocol and database for evaluating the analysis algorithm" for the EC57 testing. However, it does not specify the sample size of this database (test set). It also does not mention the country of origin of the data or whether it was retrospective or prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For an algorithm evaluation, expert review is crucial for establishing ground truth, but no details are given.
4. Adjudication Method for the Test Set
This information is not provided in the document.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not indicate that a MRMC comparative effectiveness study was done. The testing described is primarily focused on the device's technical performance and algorithm's standalone detection capabilities, not the improvement in human reader performance with AI assistance.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
Yes, a standalone performance evaluation of the algorithm was conducted. The document states: "The ECG detection algorithm was tested per ANSI/AAMI EC57 standard for testing and reporting performance results of cardiac rhythm... SmartCardia developed a protocol and database for evaluating the analysis algorithm. The results show that the SmartCardia 7L Platform algorithm detection and reported results for the stated output arrhythmia were satisfactory and met industry norms."
7. Type of Ground Truth Used
The document mentions "SmartCardia developed a protocol and database for evaluating the analysis algorithm" per the ANSI/AAMI EC57 standard. This standard provides guidelines for performance reporting of cardiac rhythm algorithms, which typically implies comparison against known, validated arrhythmia events within the ECG recordings. The source of this ground truth (e.g., expert consensus, independent adjudication, or a pre-validated dataset) is not explicitly stated, but for EC57, it's generally based on highly accurate reference annotations.
8. Sample Size for the Training Set
The document does not mention any details about a training set or its sample size. The focus of this submission is on the testing and validation of the device, not its development or algorithm training.
9. How the Ground Truth for the Training Set Was Established
Since no training set details are provided, information on how its ground truth was established is not available in this document.
§ 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.