(146 days)
The PMP4 SelfCheck™ ECG and Card Guard Heart Screening Service are intended for self-testing by patients and by health care professionals at home and at medical settings. This 12- lead and 1-lead electrocardiogram(ECG), allows remote patients to display and transmit their ECG data to medical professionals via a communication device to a remote server.
Specifically, the PMP4 SelfCheck™ ECG is intended for patients who are concerned about their heart rhythm and have experienced the following symptoms that are suggestive of abnormal heart rhythms:
- Skipped Beats
- Pounding heart (Palpitations) ●
- Heart Racing or Irregular Pulse ●
- Lightheadedness or Faintness ●
- History of Arrhythmias ●
PMP4 SelfCheck™ ECG allows transmitting multiple ECG recordings of 1 or 12-lead to a device (PMP+ or compatible generic PDA or mobile telephone with Bluetooth support) allowing physician to monitor the device output remotely.
Multi-functional Patient Monitor:
- Built-in 1-lead ECG monitor ●
- 12-lead ECG monitor using an'extemal patient cable ●
The provided text does not contain detailed information about specific acceptance criteria, a study proving device performance against those criteria, or the specific metrics typically associated with AI/algorithm performance (like sensitivity, specificity, or F1 score). The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a comprehensive clinical study report with detailed performance metrics.
However, based on the information available, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state quantitative acceptance criteria or report specific performance metrics like accuracy, sensitivity, or specificity. Instead, it refers to:
| Acceptance Criteria (Implied) | Reported Device Performance (Implied) |
|---|---|
| Safety | "PMP4 SelfCheck™ ECG constitutes a safe and reliable means for transmitting ECG data. Its material composition and operation present no adverse health effect or safety risks to patients when used as intended." |
| Reliability | "PMP4 SelfCheck™ ECG constitutes a safe and reliable means for transmitting ECG data." |
| Biocompatibility | "The device biocompatibility was evaluated and found to be satisfactory." |
| Compliance with Design Specifications | "laboratory testing were conducted to verify and validate the PMP4 SelfCheck™ ECG compliance with all design specifications." |
| Risk Analysis | "The system safety and risk analysis conducted for PMP4 SelfCheck™ ECG provided rigorous design and structural evaluation aimed at revealing potential failures or possible system flaws which could directly or indirectly affect the patient." |
| Level of Concern | Characterized as a "moderate level of concern system." |
| Intended Use | Device allows transmission of 1-lead or 12-lead ECG data for display and transmission to medical professionals via communication devices to a remote server. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a sample size for a test set or discuss data provenance related to performance evaluation. It only mentions "laboratory testing" for design compliance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided in the document. The document refers to the device allowing transmission of ECG data to "medical professionals," but it doesn't detail how ground truth was established for any performance validation studies using expert review.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided in the document.
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
The document does not mention an MRMC comparative effectiveness study or any analysis of human reader improvement with or without AI assistance. The PMP4 SelfCheck™ ECG is described as a device for transmitting ECG data, not for providing AI-powered interpretation or direct assistance to human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document does not describe a standalone algorithm performance study. The device's function is data acquisition and transmission, with the interpretation seemingly intended for medical professionals. The warning "This non- standard 12- lead and 1- lead electrocardiogram (ECG), which is measured using the SelfCheck™ ECG. should not be used for diagnostics in comparison to the standard 12 lead ECG obtained with standard electrode placement" further indicates that the device itself is not performing diagnostic interpretation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document does not specify the type of ground truth used as it does not detail performance studies against a clinical "truth." The focus is on the device's ability to safely and reliably transmit ECG data.
8. The sample size for the training set
The document does not mention a training set sample size, as it doesn't describe the development or validation of an algorithm requiring such a set.
9. How the ground truth for the training set was established
Not applicable, as no training set for an algorithm is discussed.
§ 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).