(17 days)
Heartrak ECAT is a hand-held, portable, externally applied, cardiac event recorder; electrocardiograph transmitter.
Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. Heartrak Smart ECAT registers symptomatic and asymptomatic cardiac events triggered by a patient manually or auto-triggered by embedded arrhythmia detection algorithms. Using wireless technology, Heartrak Smart ECAT, when placed within range of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
Heartrak Smart ECAT does not deliver any energy, administer any drugs, make any diagnosis, or control a patient's life. Heartrak Smart ECAT is for prescription use only.
Heartrak Smart ECAT is a cardiac event recorder that is used to continuously scan and capture ECG signals. Patients can use Heartrak Smart ECAT to capture ECG data both before and after they experience a cardiac symptom. Heartrak Smart ECAT can capture and automatically record asymptomatic, infrequent, or illusive arrhythmia events such as Bradycardia, and Atrial Fibrillation.
Heartrak Smart ECAT can store up to 30 days of ECG data in its memory. The physician can use a compatible wireless device to set event recording times and autotriggering parameters and then upload them to a patient's monitor.
Using wireless technology, Heartrak Smart ECAT, when placed within range (less than 10 meters) of an RF compatible receiver, uploads recorded ECG waveform and ECG parameter data to the receiver. When data upload is complete, data can be reviewed and analyzed at a physician's office, clinic, or monitoring center.
The physician is to instruct the patient on the proper use and care of the Heartrak Smart ECAT monitor. Patients should be told to contact their physician if they have any further questions.
This document describes a 510(k) premarket notification for the "Heartrak Smart ECAT" cardiac event recorder. The primary purpose of this submission is to demonstrate substantial equivalence to legally marketed predicate devices, not to present a de novo clinical study with specific acceptance criteria and performance results in the format requested.
Therefore, the information required to fully answer the request (acceptance criteria, specific study results for the device, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth details, and training set information) is not explicitly provided in this 510(k) summary.
510(k) submissions typically focus on demonstrating that a new device is "substantially equivalent" to an existing legally marketed device (predicate device) in terms of intended use, indications for use, technological characteristics, and safety and effectiveness. They often rely on bench testing, comparison to predicate devices, and sometimes non-clinical performance data rather than extensive human clinical trials with predefined acceptance criteria for AI algorithms.
However, based on the provided text, I can extract information related to the device and its intended function, and highlight what is not present:
Device Description and Intended Use:
The Heartrak Smart ECAT is a wireless ambulatory, multi-channel, continuous ECG event recorder with embedded arrhythmia detection algorithms. It registers symptomatic and asymptomatic cardiac events (manual or auto-triggered) and uploads recorded ECG data to a receiver for review and analysis by a physician.
The document indicates that the device has "embedded arrhythmia detection algorithms" capable of auto-triggering for events like Bradycardia, Tachycardia, and Atrial Fibrillation. This suggests an AI-like component or automated analysis, but details on its performance are not given as "acceptance criteria" and "reported performance" in the requested tabular format.
Here's an attempt to answer the request based only on the provided text, with clear indications of what information is missing:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (e.g., Sensitivity, Specificity for arrhythmia detection) | Reported Device Performance (e.g., Sensitivity, Specificity) |
|---|---|
| NOT PROVIDED IN DOCUMENT | NOT PROVIDED IN DOCUMENT |
| The document focuses on substantial equivalence to predicate devices based on technological characteristics and intended use, not explicit performance metrics for arrhythmia detection algorithms. | See above. No specific performance metrics (e.g., sensitivity, specificity, accuracy) for the embedded arrhythmia detection algorithms are quantified or reported in this 510(k) summary. |
2. Sample size used for the test set and the data provenance
- Sample Size (Test Set): Not specified.
- Data Provenance (e.g., country of origin, retrospective/prospective): Not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not specified.
- Qualifications of Experts: Not specified.
- The document mentions data can be "reviewed and analyzed at a physician's office, clinic, or monitoring center," implying expert review as part of the intended use, but not for establishing ground truth in a clinical study context for the device's algorithms.
4. Adjudication method for the test set (e.g., 2+1, 3+1, none)
- Adjudication Method: Not specified.
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
- MRMC Study: Not mentioned or indicated.
- This type of study is not typically a requirement for 510(k) clearance based on substantial equivalence.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: Not explicitly described.
- While the device has "embedded arrhythmia detection algorithms," the document does not detail a standalone performance study of these algorithms with metrics like sensitivity and specificity.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: Not specified for any internal validation of the "embedded arrhythmia detection algorithms."
- The device's output (recorded ECG waveform and ECG parameter data) is intended for "review and analysis at a physician's office, clinic, or monitoring center," which implies human expert interpretation as part of the clinical workflow, but not as the ground truth for evaluating the device's internal algorithms in a study.
8. The sample size for the training set
- Sample Size (Training Set): Not specified.
- Information on a "training set" would typically be relevant if the device involved a machine learning algorithm explicitly described as such, and if a detailed performance study was conducted. This 510(k) summary is for a device with "embedded arrhythmia detection algorithms" but does not delve into the specifics of their development or internal validation datasets.
9. How the ground truth for the training set was established
- Ground Truth Establishment (Training Set): Not specified.
Summary of Missing Information:
This 510(k) submission primarily focuses on demonstrating substantial equivalence of the Heartrak Smart ECAT to predicate devices (Heartrak Smart AF and CG-6108 Arrhythmia ECG Event Recorder) based on functional and technological characteristics (e.g., 3-lead patient cable, continuous monitoring, RF data transmission, auto-triggering for Bradycardia, Tachycardia, Atrial Fibrillation). It does not provide the detailed performance metrics, study designs, sample sizes, or specifics regarding ground truth and expert adjudication that would be expected for a comprehensive evaluation of an AI/algorithm's acceptance criteria and performance as requested.
§ 870.2920 Telephone electrocardiograph transmitter and receiver.
(a)
Identification. A telephone electrocardiograph transmitter and receiver is a device used to condition an electrocardiograph signal so that it can be transmitted via a telephone line to another location. This device also includes a receiver that reconditions the received signal into its original format so that it can be displayed. The device includes devices used to transmit and receive pacemaker signals.(b)
Classification. Class II (performance standards).