(244 days)
· The 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 and convert the ECG signal into a digital format.
· 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, analyze and interpret the 12 lead ECG signal only.
· In 5 electrode mode, the System 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 Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI).This mode is not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG (using 10 electrodes) for interpretation by a physician when the Cardian Electrical Biomarker (CEB®) is 95 or greater. Monitoring patients with a CEB® is only indicated for patients presenting with chest pain or other presumed anginal equivalents.
· The interpretation software is only available for the standard 12 lead ECG utilizing the standard 10 electrodes.
· The System is intended to be used by healthcare professionals, or trained personnel where ECG monitoring /acquisition is indicated for hospitals and/or clinics.
· The System can be used within electro-surgical environments.
· Device is for Adult use.
The Universal SmartECG is a device with 10 lead wires attaching to electrodes on a patient's chest and one wire connecting to a computer. The system is able to display, store, and print a 12 lead ECG with 10 electrodes attached to the patient. In addition, The Universal SmartECG incorporates the VectraplexECG software (K102378), to derive up to a 15 lead (standard 12 leads and Frank vector X, Y, and Z leads) ECG from only three measured leads (5 electrodes). The device also monitors, in real-time, ECG changes that may be indicative of acute myocardial ischemic injury, including AMI*, via a displayed index number, the Cardiac Electrical Biomarker (CEB; VectraplexAMI). The system also provides the vector loops. The System's derivation algorithm is able to provide additional information based on geometric principals relating to the placement of electrodes on the body. The Cardiac Electrical Biomarker (CEB) is produced based on an algorithm accounting for the multipolar contributions of the electrical field around the heart, which was FDA cleared via K102378.
The provided text does not contain detailed information about specific acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) summary for the Universal SmartECG, which focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed clinical study report with specific performance metrics against pre-defined acceptance criteria.
However, based on the information provided, here's what can be extracted and inferred, with limitations noted due to the nature of the document:
1. A table of acceptance criteria and the reported device performance
The document states that the new hardware device, the Universal SmartECG, "has been tested to, and passed. 60601-1.-1-2. and 2-25 standards." This implies that the device met the performance requirements of these electrical safety and essential performance standards. However, specific performance metrics (e.g., sensitivity, specificity, accuracy for disease detection) and their acceptance thresholds are not explicitly stated or quantified in this document.
| Acceptance Criteria Category | Acceptance Criteria (Quantified if available, otherwise inferred) | Reported Device Performance |
|---|---|---|
| Electrical Safety | Compliance with IEC 60601-1-1-2 standards | Passed |
| Essential Performance | Compliance with IEC 60601-2-25 standards | Passed |
| CEB® Functionality | The CEB® algorithm functions as previously cleared (K102378) and produces visual/audible alarms for ECG changes consistent with AMII/AMI. Acceptance criteria for its performance (sensitivity, specificity) are not stated in this document but would have been part of the K102378 clearance. | The CEB® algorithm is unchanged from the previously cleared K102378. The system "analyzes data... and produces visual and audible alarms for ECG changes that may be consistent with 12-lead ECG signs of Acute Myocardial Ischemic Injury (AMII), including Acute Myocardial Infarction (AMI)." |
| ECG Acquisition & Display | Ability to derive, display, and print a derived 12-lead ECG from 3 leads (5 electrodes) and acquire/display standard 12-lead ECG using 10 electrodes. | Performs as intended; the "ECGlib.dll which measures ECG waveform components" was updated for compatibility with new hardware. |
| Interpretive Software | Software receives, displays, stores, analyzes, and interprets 12-lead ECG signals. | Functions as intended; "updated to be compatible with a new version of hardware." |
| Electrosurgical Environment Combatibility | Safe and effective operation within electrosurgical environments. | "the device can now be used in electrosurgical environments." |
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 states, "Since this update is not changing the CEB algorithm or the derivation algorithm from the VectraplexECG System it has been determined that no clinical data is necessary to support these functions." This implies that no new clinical test set data was collected for this specific 510(k) submission to demonstrate the performance of the CEB algorithm or the derived ECG. The assessment was based on the fact that existing, previously cleared algorithms and functionalities were not altered in a way that would necessitate new clinical validation for their core performance.
Therefore, sample size, data provenance, retrospective/prospective nature for clinical performance is not applicable to this specific submission. Any previous clinical studies for the predicate device (K102378) would have contained this information.
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)
Not applicable, as no new clinical test set data was collected for this submission. The effectiveness of the CEB® algorithm was previously established during the K102378 submission.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as no new clinical test set data was collected for this submission.
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
Not applicable to this 510(k) submission, as it focuses on demonstrating substantial equivalence of an updated system rather than new clinical effectiveness. The CEB® mode is described as "not intended to be a sole means of diagnosis, but prompts, the user to acquire a standard 12 lead ECG... for interpretation by a physician." This suggests an assistive role, but no MRMC study details are provided in this document.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This document does not specify a standalone performance study. The device's CEB® algorithm is designed to alert users, prompting further physician interpretation. Its performance without human interpretation is integral to its function, but specific standalone metrics are not provided in this summary.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable to this specific submission for new clinical data. For the original clearance of the CEB® algorithm (K102378), the ground truth for Acute Myocardial Ischemic Injury (AMII) and Acute Myocardial Infarction (AMI) would typically involve a combination of:
- Clinical diagnosis: based on patient symptoms, cardiac enzymes (e.g., troponin levels), and serial ECG changes interpreted by cardiologists.
- Outcomes data: confirming a myocardial infarction event.
8. The sample size for the training set
The document does not provide information about the training set size for the algorithms within the Universal SmartECG. This information would have been part of the previous 510(k) for the VectraplexECG System (K102378), which included the CEB® algorithm.
9. How the ground truth for the training set was established
Not provided in this document. Similar to point 7, the ground truth for the training set of the CEB® algorithm (from K102378) would have been established through a combination of clinical diagnosis, cardiac biomarker levels, and expert cardiologist interpretation.
§ 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).