(56 days)
The CG-2211 SelfCheck ECG Transmitter and LifeWatch Heart Screening Service are intended for self-testing by patients who are concerned about their heart rhythm (i.e. during or after exercise) or who experience the following symptoms that are suggestive of abnormal heart rhythms, and who would like to monitor these symptoms:
- Skipped Beats
- Pounding heart (Palpitations)
- Heart Racing or Irregular Pulse
- Lightheadedness or Faintness
- History of Arrhythmias
The CG-2211 SelfCheck is a personal single lead event ECG transtelephonic transmitter. The device is intended for self-testing by patients and records a limited period of heart activity. The recording is activated by patient, when symptom is experienced. The CG-2211 SelfCheck transmits the recorded data to a receiving station, where data is displayed for analysis and evaluation by physician. The transmission includes the time, when the event recording was activated by patient.
This 510(k) summary does not contain a specific study demonstrating that the device meets acceptance criteria. Instead, it focuses on demonstrating substantial equivalence to predicate devices and lists various validation and environmental tests conducted to verify compliance with design specifications. There is no mention of a clinical study with a test set, ground truth, or expert review for performance evaluation against specific acceptance criteria.
Therefore, many of the requested sections regarding acceptance criteria and a study to prove they are met cannot be filled from the provided document.
Here's a summary of the information that can be extracted or inferred from the document, along with explanations for the missing information:
Acceptance Criteria and Study Information
| Feature | Description from Document |
|---|---|
| 1. Table of Acceptance Criteria & Reported Performance | Not provided in the document. The document states that "laboratory testing was conducted to verify and validate the CG-2211 compliance with all the design specifications." It then lists various types of validation, environmental, and safety tests performed (e.g., High and Low Temperature and Humidity Test, Frequency Response Test, EMC Test, System Noise Test, etc.). However, it does not specify what the acceptance criteria for these tests were (e.g., "Frequency response within X dB from Y Hz to Z Hz") nor does it report the quantitative performance results against these criteria. The conclusion section generally states that "CG-2211 SelfCheck ECG Transmitter constitutes a safe and reliable means for recording and transmitting standard ECG for the purpose of cardiac condition diagnosis," but this is a qualitative summary, not performance data against specific metrics. |
| 2. Sample Size (Test Set) and Data Provenance | Not provided. The document does not describe a clinical test set or any data provenance for performance evaluation. The "validation tests" mentioned appear to be engineering/laboratory tests, not clinical performance studies with patient data. |
| 3. Number & Qualifications of Experts for Ground Truth | Not applicable/provided. Since no clinical test set or ground truth method is described, there's no information on experts or their qualifications. |
| 4. Adjudication Method (Test Set) | Not applicable/provided. No adjudication method is mentioned for a test set. |
| 5. Multi-Reader Multi-Case (MRMC) Study & Effect Size | Not performed/provided. The document does not describe an MRMC study or any assessment of human reader improvement with/without AI assistance. The device is a "SelfCheck ECG Transmitter" that sends data for a physician's analysis, implying human interpretation is always part of the workflow, and the document focuses on the device's ability to transmit data, not on interpretation aid. |
| 6. Standalone Performance (Algorithm Only) | Not performed/provided. The device itself is an ECG transmitter. Its primary function is to record and transmit ECG data for a physician to analyze. There is no mention of an internal algorithm performing interpretation or diagnosis in a standalone capacity. |
| 7. Type of Ground Truth Used | Not applicable/provided. As no clinical performance study involving diagnostic accuracy is described, no ground truth type is mentioned. The "validation tests" refer to engineering and safety verifications. |
| 8. Sample Size for Training Set | Not applicable/provided. This device is an ECG transmitter and does not appear to involve AI or machine learning algorithms that would require a "training set" in the context of diagnostic interpretation. The document describes a hardware device that records and transmits data. |
| 9. How Ground Truth for Training Set was Established | Not applicable/provided. As no training set for an AI/ML algorithm is mentioned, the method for establishing ground truth is not relevant here. |
Key Takeaway:
The provided 510(k) summary for the CG-2211 SelfCheck ECG Transmitter focuses on substantial equivalence to predicate devices and engineering/safety compliance rather than a clinical performance study with defined acceptance criteria for diagnostic accuracy. The device's function is to transmit ECG data for professional analysis, not to provide automated diagnostics itself. Therefore, the details requested about performance studies, data sets, experts, and ground truth, typical for AI-powered diagnostic devices, are not present in this document.
§ 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).