(219 days)
The PRIME ECG is indicated for the recording of electrocardiographic signals on the body surface.
The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest or harness. The electrodes are screen-printed onto a clear plastic substrate. The section of the vest applied to the anterior side of the patient (anterior harness, applied to chest area) contains channels 1 to 55 and 59 to 64. The section applied to the posterior side of the patient (posterior harness, applied to the patient's back) contains channels 65 to 80. Channels 56, 57 and 58 are applied to the right arm, left arm and left leg, respectively. Signals are conducted along pathways that are also printed, eliminating the need for conventional lead wires. The electrode array or " vest" features pre-applied gel to assure good conductivity and secure attachment. Anatomical markers provide for consistent location on different size patients. The vest can be applied in less than 5 minutes. An 80 channel recording device is attached to the vest by means of two spring clips that interface with the printed lead lines. This means that 80 separate electrical signals are collected and stored. The system measures the ECG recordings simultaneously for all 80 channels. For practical reasons only eight channels are displayed at one time, so the operator may scroll through 10 screens to visualize all active channels. The system contains an algorithm that identifies (with color, words and symbols) any individual electrode that may be suspect, allowing the operator to make adjustments before recording. Once satisfied, the operator activates the recording and the system retains 10.0 seconds of data. If the recording contains any poor signals, the algorithm alerts the operator who must determine whether to accept the recording. The number of poor quality leads may not exceed 6 on the anterior harness. If the signals from any 2 adjacent electrodes, or any posterior electrode, are bad, the maps are not accepted. It is possible for the operator to accept a recording which contains channels that have low quality, but resulting maps contain the legend "Unacceptable Quality" and each poor quality channel is marked in red. Because the electrode vest covers most of the torso, electrode locations include those for a standard 12-lead ECG. This means that among the 80 leads individual locations are consistent with required placement necessary to result in a conventional 12-lead recording and display. There is a user-selected option for displaying these leads, (e.g., the channels are automatically selected and displayed which correspond to a Lead II ECG), although the operator may designate specific electrodes to reflect preferred locations for display. Once the 80-lead recording is accepted, the system creates a series of isopotential and isointegral images (maps) for specific segments of a single beat. Measuring signal strength at a specific time interval of the beat creates Isopotential maps. The resulting strengths and locations of these signals are plotted against an "unwrapped" image of the torso. For example, the unwrapped torso image can be oriented with an x and y axis. At a given point in time, an voltage measurement in millivolts is collected at each location (x,y). This voltage can be plotted along the z axis. If lines are drawn on this plot to connect points with the same voltage z, isopotential contour maps are created. Isopotential maps can be created at any point in time during the cardiac cycle to reflect the cyclic polarization and repolarization of the heart. Isointegral maps are an attempt to provide a look at what is happening over the cycle, as a body surface distribution of the ventricular gradient. At each location (x,y) the potential z changes over the time of the cardiac cycle. Integrating the areas under the QRST of each lead gives the gradient at each point. The gradient at each point is then mapped. Joining points on the plot with the same calculated gradient produces the isointegral contour map. The isointegral map allows evaluation of repolarization properties.
This document describes the PRIME ECG™ System, an 80-lead electrocardiograph, and its FDA 510(k) submission. However, the provided text does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and the comprehensive study that proves the device meets those criteria.
Specifically, the document states: "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems." However, it does not provide the results, metrics, acceptance criteria, study design details (like sample size, ground truth, expert qualifications), or specific effect sizes from this clinical study.
Therefore, the following response will reflect the information that is present in the provided text.
Acceptance Criteria and Study for PRIME ECG™ System
Based on the provided 510(k) summary, the PRIME ECG™ System's acceptance criteria primarily revolve around its equivalence to a predicate device and its compliance with relevant industry standards. While a clinical study is mentioned for improved AMI diagnosis, the details of its acceptance criteria and results are not included.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria (from document) | Reported Device Performance (from document) |
|---|---|---|
| Substantial Equivalence | Equivalence to Hewlett Packard M1700A (K911139) for intended use. | "The PRIME ECG System is substantially equivalent to the Hewlett Packard M1700A cleared under K911139. Both systems have the same intended use, which is to record electrocardiographic signals." |
| Safety Standards | Compliance with IEC-601-1 (including subparagraphs) Electro-Medical Equipment Safety Standard. | "The entire system has been tested to demonstrate compliance with IEC-601-1 (including its subparagraphs) Electro-Medical Equipment Safety Standard." |
| Biocompatibility | Patient contact material is safe for use. | "Biocompatibility testing of the patient contact material is safe for use." |
| Performance Standards | Compliance with EC 11 standard for diagnostic ECG systems. | "Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems." |
| Clinical Efficacy | Provide information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems. (Note: Specific quantitative acceptance criteria and results for this are not detailed in the provided text.) | "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems." (No specific results or metrics are given in this document.) |
| Signal Quality (Internal) | Algorithm identifies suspect electrodes; operator decides to accept. If poor signals, algorithm alerts. Max 6 poor quality leads on anterior harness. No more than 2 adjacent poor electrodes, or any posterior electrode, can be bad for maps to be accepted. | If operator accepts recording with low quality channels, resulting maps display "Unacceptable Quality" and poor quality channels are marked red. (This is a system feature/rule, not a performance metric for the clinical study.) |
2. Sample Size for Test Set and Data Provenance
- Test Set Sample Size: The document mentions that "a clinical study was performed," but it does not specify the sample size for this study or any test set.
- Data Provenance: Not specified. (e.g., country of origin, retrospective/prospective).
3. Number of Experts and Qualifications for Ground Truth for the Test Set
- The document does not specify the number of experts used or their qualifications for establishing ground truth in the "clinical study."
4. Adjudication Method for the Test Set
- The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- The document mentions "a clinical study was performed that demonstrated that the PRIME ECG System provides information enabling improved diagnosis of AMI upon presentation to the ER compared to standard 12 lead ECG systems."
- However, it does not provide details on whether this was an MRMC study, nor does it specify an "effect size of how much human readers improve with AI vs. without AI assistance." The PRIME ECG is described as an ECG system itself, not necessarily an AI-assisted interpretation tool in the context of human reader improvement. It provides more data (80-leads) to aid diagnosis.
6. Standalone Performance Study (Algorithm Only)
- The document does not explicitly state if a standalone (algorithm only without human-in-the-loop performance) study was done for the "improved diagnosis of AMI" claim. The nature of an ECG system typically involves a clinician interpreting the output.
7. Type of Ground Truth Used
- The document does not specify the type of ground truth used (e.g., expert consensus, pathology, outcomes data) for the "clinical study" related to AMI diagnosis.
8. Sample Size for the Training Set
- The document does not mention any training set or its sample size. This suggests the primary demonstration of equivalence was based on predicate device comparison and standard compliance, with the clinical study serving as supportive evidence for improved diagnostic capabilities, rather than a deep learning model requiring a distinct training and test set in the modern sense.
9. How Ground Truth for the Training Set Was Established
- As no training set is mentioned (see point 8), the method for establishing its ground truth is not applicable based on the provided text.
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).