(439 days)
- VectraCor's VectraplexECG System with VectraplexAMI analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of acute myocardial infarction. The device does not provide a diagnosis of acute myocardial infarction, but prompts the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician. Monitoring patients with VectraplexAMI is only indicated for patients presenting with chest pain or other presumed anginal equivalents.
- The VectraplexECG System is intended to derive, display and print a derived 12 lead ECG as well as the X, Y, Z leads from the acquisition of just 3 leads (5 electrodes). The System also has the capability to acquire the standard 12 lead ECG using the standard 10 electrodes. The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
- VectraplexECG is intended to be used by healthcare professionals, i.e. Physicians, Nurses, Technicians, and Physician Assistants, where 12 lead and X, Y, Z leads are indicated for Hospitals and/or Clinics.
- The 12 lead interpretive software is a windows-based program intended to interpret electrocardiograms. The software receives, displays and stores a single, three or standard 12 lead simultaneous ECG recording, which is transmitted either locally or transtelephonically from an ECG monitor using a proprietary digital data transmission protocol. The device contains proprietary software algorithms to receive, store, and interpret the 12 lead ECG signal only.
- Device is for Adult use.
The VectraplexECG System will be able to display and print a 12 lead ECG with 10 electrodes attached. In Addition, VectraplexECG will be able to derive up to a 15 fead ECG from only three measured leads (5 electrodes) and monitor the ECG changes that may be consistent with 12 lead ECG signs of acute myocardial infarction, via a displayed index number, VectraplexAMI.
Here's an analysis of the acceptance criteria and study information for the VectraplexECG System with VectraplexAMI, based on the provided 510(k) summary:
This 510(k) summary provides limited detail on specific acceptance criteria and the comprehensive study methodology. The information primarily focuses on demonstrating substantial equivalence rather than presenting detailed performance measures against predefined acceptance criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Metric | Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Derived 15-lead ECG graphs vs. Measured ECG graphs (for substantial equivalence) | "Substantially equivalent with no difference in clinical outcome" | "The derived 15 lead ECG graphs were compared to measured ECG graphs to determine whether they are substantially equivalent with no difference in clinical outcome." (Implies successful comparison, but no quantitative metric given.) |
| Conformance to design specifications | Implied: Must conform to design specifications | "VectraCor has determined, based on the performance testing, that the VectraplexECG System with VectraplexAMI conforms to the design specifications" |
| Safety and effectiveness vs. predicate devices | Implied: As safe and effective as predicate devices | "The device, as designed, is as safe and effective as the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not explicitly stated. The summary mentions "ECG databases" were used for validation, but the number of cases within these databases for the test set is not provided.
- Data Provenance: Not explicitly stated. The type of ECG databases (e.g., specific clinical trials, publicly available datasets) and their country of origin are not mentioned. It is also not specified whether the data was retrospective or prospective.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- This information is not provided in the 510(k) summary. The summary does not detail how the ground truth for the "ECG databases" was established or if expert review was involved for the comparison of derived vs. measured ECGs.
4. Adjudication Method for the Test Set
- Not applicable/Not described. The summary focuses on comparing derived and measured ECG graphs, not on expert adjudication of diagnostic outcomes.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, a multi-reader multi-case (MRMC) comparative effectiveness study to evaluate human reader improvement with AI assistance was not explicitly described or indicated in the provided summary. The device's primary function is to derive ECGs and monitor for AMI signs, prompting a standard 12-lead for physician interpretation, rather than directly assisting in human reader interpretation of complex findings.
6. Standalone Performance (Algorithm Only without Human-in-the-Loop Performance)
- Yes, a standalone performance evaluation was done. The summary states, "The derived 15 lead ECG graphs were compared to measured ECG graphs to determine whether they are substantially equivalent with no difference in clinical outcome." This indicates that the algorithm's output (derived ECGs) was directly compared to a reference (measured ECGs) without human intervention in the interpretation of the derived output for this comparison.
- For the VectraplexAMI component, it "analyzes data from 3 leads (5 electrodes) and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of acute myocardial infarction." This is a standalone function of the algorithm, though it prompts human action rather than providing a definitive diagnosis.
- For the interpretive software (only available for standard 12-lead ECGs), it "contains proprietary software algorithms to receive, store, and interpret the 12 lead ECG signal only." This is also a standalone algorithmic interpretation.
7. Type of Ground Truth Used
- The ground truth used for the comparison of derived 15-lead ECGs was the measured ECG graphs. This implies that actual 12-lead ECGs (acquired with 10 electrodes) were considered the reference standard against which the algorithm's derived 15-lead ECGs (from 5 electrodes) were validated.
8. Sample Size for the Training Set
- The sample size for the training set is not provided in the summary. The summary only mentions "ECG databases" were used for validation, without distinguishing between training and test data or specifying their sizes.
9. How Ground Truth for the Training Set Was Established
- This information is not provided in the 510(k) summary. The summary does not discuss the establishment of ground truth for any training data.
§ 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).