(285 days)
The device is intended for use by individuals who are at risk of having cardiac disease and those that have intermittent symptoms indicative of cardiac disease and demonstrated a need to be monitored on a continuing basis. The ECG recordings can be uploaded to monitoring center in a variety of ways - transmitted via Cellular RF Modem, via RF, via TTL, or flash card to an FTP storage location or software package to be read by a healthcare professional.
Patients include, but at are not limited to, those requiring monitoring for a) non-life threatening arrhythmias such as supraventricular tachycardias (e.g. atrial fibrillation, atrial flutter, PACS, PSVT) and ventricular ectopy, b) evaluation of bradyarrhthmias and intermittent bundle branch block including after cardiovascular surgery and myocardial infarction, and c) arrhythmias associated with co-morbid conditions such as hyperthyroidism or chronic lung disease.
Patients with symptoms that may be due to cardiac arrhythmias. These may include, but are not limited to, symptoms such as a) syncope of unknown etiology in which arrhythmias are suspected or need to be excluded, c) dyspnea (shortness of breath). Patients with palpitations with or without known arrhythmias to obtain correlation or arrhythmias with symptoms.
Patients who requiring monitoring of the effects of drugs to control ventricular rate in atrial arrhythmias (e.g. atrial fibrillation).
Patients recovery from cardiac surgery who are indicated for outpatient arrhythmia monitoring.
Patients with diagnosed sleep disordered breathing including sleep apnea (obstructive central) to evaluate possible nocturnal arrhythmias.
Patients requiring arrhythmia evaluation of etiology of stroke or transient cerebral ischemia, possibly secondary to atrial fibrillation or flutter.
Data from this device may be used by another device to analyze , measure or report QT interval . The device is not intended to sound any alarms for QT interval changes.
The Aera CT is an ECG Device with auto trigger capability using MCOT compliant wireless technology for monitoring ambulatory patients with non-life threatening conditions.
The device is composed of patient (ECG) leads, monitor, and charging wall board adapter.
A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm or when the event processing event key is depressed, the data is transmitted by RF to a data storage location monitored by receiving center. The transmission may occur via Cellular RF modem, RF, or TTL via a landline telephone. The data is received and reviewed by the appropriately trained healthcare professionals or technicians. Request for additional data can be sent to MCT device via SMS text formatted message that will originate from the receiving software.
The provided document for the Aera CT device does not contain a detailed study proving the device meets specific acceptance criteria with performance metrics. Instead, it focuses on demonstrating substantial equivalence to predicate devices based on shared characteristics, intended use, operating principles, and technological characteristics. The submission states that:
"The TZ Medical has developed tests using the same requirements that CardioNet (K072558) and (K100155) have used and stated that their devices comply with in their respective 510k submission. The TZ Medical device and the two predicated devices are tested to and comply with all applicable tests and requirements in the relevant standards as stated in this submission."
And, "TZ Medical will compile and analyze clinical test data at a trial site prior to use. Results of data will be used as part of the validation and verification data submitted with the design file. Clinical test will be conducted at facilities that are familiar with predicate devices and will submit reports verifying substantial equivalence to competitive products and on performance to specifications."
However, the specific performance data, acceptance criteria, or a detailed study report are not included in this 510(k) summary. The submission asserts compliance with standards like AAMI EC 38:2007 (Ambulatory Electrocardiographs) and ANSI/AAMI EC 57:1998 (Testing & reporting performance results of cardiac and ST-segment measurement algorithms), which would inherently imply certain performance thresholds, but these thresholds and the device's measured performance against them are not explicitly listed in the document.
Therefore, many of the requested details about acceptance criteria and a specific study cannot be extracted directly from this submission.
Here's a breakdown of what can be inferred or explicitly stated based on the provided text, and what is missing:
1. A table of acceptance criteria and the reported device performance
A specific table of acceptance criteria and reported device performance is not explicitly provided in the document. The submission implies that the device meets the performance requirements outlined in referenced standards (EC 38 compliant, and tested to all applicable tests in relevant standards). However, the quantitative acceptance criteria for parameters like accuracy, sensitivity, specificity for arrhythmia detection, and the device's measured performance against those criteria are not detailed.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "clinical test data at a trial site" to be compiled and analyzed, but does not specify the sample size, whether the data is retrospective or prospective, or its country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. The document states that "Interpretation and diagnosis is the responsibility of a trained healthcare professional or physician," implying that expert review would establish ground truth for clinical data, but specifics regarding the number and qualifications of experts for a test set are absent.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
This information is not provided.
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
This information is not applicable/provided. The Aera CT is an "Arrhythmia Detector and Alarm" system that analyzes ECG signals with "automated arrhythmia analysis algorithms" and "does not provide interpretive or diagnostic statements." Its function as described is not primarily for AI-assisted human reading to improve diagnostic accuracy, but rather for automated detection and transmission of data to be read by professionals. Therefore, an MRMC study on human reader improvement with AI assistance is not described or implied for this device.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done
The submission implies extensive standalone testing of the algorithm against relevant performance standards. It states, "A sensor captures the ECG signal from the patient's body and transmits the signal to the small (hand sized) monitor where data is stored and analyzed by automated arrhythmia analysis algorithms. When events are detected by the arrhythmia analysis algorithm... the data is transmitted..." This describes a standalone algorithmic function. The claim of "EC 38 compliant" and compliance with "all applicable tests and requirements in the relevant standards" (which includes ANSI/AAMI EC 57:1998 for testing performance of cardiac algorithms) suggests that standalone algorithm performance testing was central to the submission, although the specific results are not provided.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Since no specific study results are provided in this summary, the type of ground truth used is not explicitly stated. However, for arrhythmia detection algorithms, ground truth is typically established by expert review (e.g., experienced cardiologists or electrophysiologists) of the ECG tracings.
8. The sample size for the training set
This information is not provided. The document does not discuss the development or training of its proprietary algorithm.
9. How the ground truth for the training set was established
This information is not provided.
§ 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.