(149 days)
The PRIME ECG System is intended for the recording of electrocardiographic signals from the body surface.
The PRIME ECG System uses an 80-lead disposable electrode array referred to as a vest. The electrodes are screen-printed onto a clear plastic substrate. 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 PRIME software also contains a diagnostic algorithm that may be used as an aid in diagnosing AMI. The algorithm provides an explanation of the measurements that were interpreted to reach the suggested diagnosis.
Acceptance Criteria and Study Details for PRIME ECG System with Diagnostic Algorithm
The provided 510(k) summary for the PRIME ECG System with Diagnostic Algorithm (K030104) offers limited details on specific acceptance criteria and the comprehensive study that proves the device meets them. However, it does state that a clinical study was performed to demonstrate the algorithm's utility in diagnosing AMI. Based on the available information, here's a breakdown:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Safety: Device 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. |
| Biocompatibility: Patient contact material shown to be safe for use. | Biocompatibility testing of the patient contact material showed that the material is safe for use. |
| Performance Equivalence: Performance to EC 11 standard demonstrates equivalence to marketed ECG systems. | Performance testing to EC 11 standard demonstrates performance equivalent to marketed ECG systems. |
| Clinical Utility (Diagnostic Algorithm): Algorithm provides information that may assist in the diagnosis of acute myocardial infarction (AMI). | "a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction." |
Note: The 510(k) summary does not specify quantitative metrics for the "assistance in diagnosis of AMI" nor does it provide a specific performance target or range for this criterion. It merely states that the study "demonstrated" this capability.
2. Sample Size Used for the Test Set and Data Provenance
The 510(k) summary does not provide details on the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective nature) for the clinical study validating the diagnostic algorithm.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The 510(k) summary does not provide details on the number of experts used to establish ground truth or their qualifications for the clinical study.
4. Adjudication Method for the Test Set
The 510(k) summary does not provide details on the adjudication method used for the test set in the clinical study.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The 510(k) summary does not mention a multi-reader multi-case (MRMC) comparative effectiveness study or any effect size of human readers improving with AI vs. without AI assistance. The study described appears to focus solely on the algorithm's ability to "provide information that may assist in the diagnosis of AMI," rather than a comparative study with human readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone study appears to have been conducted. The description "a clinical study was performed that demonstrated that the PRIME ECG System diagnostic algorithm provides information that may assist in the diagnosis of acute myocardial infarction" suggests that the algorithm's performance in providing diagnostic information was evaluated. There is no mention of human-in-the-loop performance in the context of this specific clinical study for the diagnostic algorithm.
7. Type of Ground Truth Used
The 510(k) summary does not explicitly state the type of ground truth used for the clinical study demonstrating the diagnostic algorithm's utility for AMI. Given the nature of AMI diagnosis, it is highly probable that a combination of clinical assessment (symptoms, physical exam), biomarkers (cardiac enzymes), follow-up outcomes, and potentially expert consensus on other diagnostic tests (e.g., echocardiography, coronary angiography) would have been used to establish the ground truth for AMI. However, this is an inference and not explicitly stated in the document.
8. Sample Size for the Training Set
The 510(k) summary does not provide details on the sample size for the training set used for the diagnostic algorithm.
9. How Ground Truth for the Training Set Was Established
The 510(k) summary does not provide details on how the ground truth for the training set was established for the diagnostic algorithm.
§ 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).