(202 days)
The following Indications for Use are identified for the CardiacLinx device:
- MCT Mode: For use on adult patients who experience transient or non-transient symptoms that may suggest cardiac arrhythmias. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible notification when Ventricular Fibrillation/Flutter, Atrial Fibrillation/Flutter, Pause (Asystole), Bradycardia, or Tachycardia occurs.
- Holter Mode: For use on adult patients experiencing palpitations, syncope, dizziness, arrhythmia, bradycardia, tachycardia, angina, ischemia and paced ECG.
- Multi-Lead (Resting EKG) Mode: For use on adult patients for acquiring, storing and viewing/printing of up to twelve (12) leads of patient ECG waveforms through surface electrodes adhered to the patient's body.
- The intended use locations for CardiacLinx are in a physician's office, hospital or rehabilitation facilities, patient's home, or similar use areas. It is intended to be used by or on the order of a physician or similarly qualified health care professional.
- For general hospital or clinical use by medical professionals whenever an assessment of a patient's ambulatory ECG data is required. Allows for a trained physician or health care professional to download and analyze the data for review and to produce printed reports. This will enable the evaluation of arrhythmias, ischemic attacks, reporting of PQRST intervals, clinical and epidemiological research studies, evaluation of a patient response after resuming occupational or recreational activities (e.g., after myocardial infarction or cardiac surgery), and/or evaluation of patients with pacemakers. CardiacLinx is only available for use upon the order of a physician or other related licensed medical professional.
- For use under the supervision of a qualified physician trained in ECG interpretation to record the electrical activity of the heart for the purpose of correlating resultant waveforms with the health of the heart muscle tissue structures.
The CardiacLinx System is a continuous real-time ECG monitor and arrhythmia detector. It is a multipurpose device designed with the ability to collect ECG data from the patient in order to perform:
- 2-lead Mobile Cardiac Outpatient Telemetry (MCT) for up to 30 days;
- 24 hour or longer 3-lead Holter monitoring; or
- Resting 12-lead ECG with interpretation.
The ambulatory device may be used on an outpatient basis with remote clinician data analysis whenever it is required to assess a patient's ambulatory ECG data (MCT and Holter modes), as well as for use within the physician office setting by the medical professional (resting 12-lead mode).
The product consists of monitoring equipment worn by the patient that transmits all asymptomatic and symptomatic events to a central computer monitoring center in the outpatient setting. The central computer monitoring center is equipped with personal computers running CardiacLinx System software intended for use only by qualified medical professionals and their staff.
CardiacLinx is comprised of three (3) main software components developed by Ross Medical Technology, consisting of:
- The Ross Medical Technology PMD Software that can be run on a Personal Mobile Device ("PMD") with Bluetooth capabilities and a built-in cellular modem. The Personal Mobile Device is configured to process and transmit signals from an FDA cleared patient-worn ECG Monitor (also with Bluetooth capabilities);
- The Ross Medical Technology MCT Server Software that can be run on a central server that receives, interprets (using embedded algorithms), and stores the ECG data from the PMD Software; and
- The Ross Medical Technology MCT Client Software that can be run at a central computer monitoring center attended by trained medical professionals who can view the ECG data and interpretations.
In addition to the three main software components manufactured by Ross Medical Technology. CardiacLinx includes third party components that are necessary to complete the functionality of the device. These third party components are:
- An FDA cleared patient-worn ECG Monitor;
- A Personal Mobile Device with Bluetooth capabilities and built-in cellular modem; and
- Two embedded ECG Interpretation Algorithms found in other FDA cleared ECG analysis devices.
The CardiacLinx device integrates these third party components with RMT's proprietary software.
Here's a breakdown of the acceptance criteria and the study details for the CardiacLinx device, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (What was tested) | Reported Device Performance |
|---|---|
| Ambulatory and Home Environment Interference: To determine if ambulatory and home environments would produce a clinically significant change in ECG interpretation due to electronic sources and motion artifacts. | Device performed as intended. 100 out of 100 samples in each test (1,000 out of 1,000 total samples) showed identical clinical interpretation from two independent board-certified physicians. |
| Data Transmission: Reliability of data transmission from PMD to MCT Server Software. | 97.00% of data packets received by the MCT Server Software between 0 and 5 seconds. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Ambulatory and Home Environment Interference Test: 1,000 total samples (100 samples in each of 10 tests, although the type of "each test" is not specified beyond "electronic sources and motion").
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective for this specific test. It was conducted by Ross Medical Technology itself to "further demonstrate the effectiveness," suggesting it's likely proprietary and possibly prospective within their testing framework, but this is an inference.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Two independent board-certified physicians.
- Qualifications of Experts: Board-certified physicians. (Additional specializations like "radiologist" are not applicable here as it's ECG interpretation).
4. Adjudication Method for the Test Set
- Adjudication Method: The text states, "showed identical clinical interpretation from two independent board certified physicians." This implies consensus (100% agreement) was the adjudication method for determining "identical clinical interpretation." No explicit adjudication method like "2+1" or "3+1" is mentioned, as complete agreement was achieved.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- Was an MRMC study done? No. The performance data presented focuses on standalone device performance and agreement with expert interpretation, not a comparative effectiveness study showing human reader improvement with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- Was a standalone study done? Partially. The "Ambulatory and Home Environment Interference" test evaluates the device's ability to produce "identical clinical interpretation" when compared to human experts. While human experts are involved in verifying the output, the core of this test is assessing whether the device's output (which relies on its embedded algorithms) remains consistent and accurate in challenging environments. The test specifically states, "Device performed as intended. ... showed identical clinical interpretation," implying the device's interpretation was consistent with the experts rather than the experts acting as an "in-the-loop" component to improve the device's performance. The "Data Transmission" test is purely standalone algorithm/system performance.
- The device integrates "Two embedded ECG Interpretation Algorithms found in other FDA cleared ECG analysis devices" and the "MCT Server Software ... interprets the ECG data using the embedded ECG Interpretation Algorithms." This strongly indicates standalone algorithmic interpretation is a core function being evaluated.
7. The Type of Ground Truth Used
- Ground Truth Type: Expert consensus. For the "Ambulatory and Home Environment Interference" test, "identical clinical interpretation from two independent board certified physicians" served as the benchmark against which the device's performance was measured.
8. The Sample Size for the Training Set
- Training Set Sample Size: The document does not provide information about the training set size for the embedded ECG interpretation algorithms. It mentions that the device uses "Two embedded ECG Interpretation Algorithms found in other FDA cleared ECG analysis devices," implying these algorithms were developed and trained independently prior to their integration into CardiacLinx, and their training data is not part of this submission. Ross Medical Technology did not develop these algorithms.
9. How the Ground Truth for the Training Set Was Established
- Training Set Ground Truth Establishment: Similar to the training set size, the document does not specify how the ground truth was established for the training data of the "embedded ECG Interpretation Algorithms" as these are third-party components.
§ 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.