Search Results

· 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.

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.

Ask a specific question about this device

• Vectraplex® CMS in a Central Monitoring System intended to transfer information between networked devices (only VectraplexECG Systems), which include hard-wired or wireless devices
• The Central Monitoring System can be used for remote monitor management, printing, viewing or otherwise processing of information from VectraplexECG Systems including remote control
• The device is intended to be used by qualified medical professionals
• The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition.
• The Vectraplex CMS' intended use population consists of those patients with certain medical conditions in whom continuous cardiac monitoring is considered to be a medical necessity in the judgment of the ordering healthcare provider.
• The Vectraplex CMS is intended for centralized monitoring of patients through a network in hospitals, Emergency Departments and Surgical Centers, doctor's offices, and urgent care facilities.
• Not for home use

The Vectraplex CMS is a program that can allow a central monitoring system to view multiple VectraplexECG Systems through either an intranet or internet connection. There are three programs to the central monitoring system: the Monitor Agent, the Device Agent, and the Proxy Agent. The programs require Java version 1.7 or higher prior to installation. The Monitor Agent will remotely display and control another device's screen. The Device Agent (installed on the bedside monitoring device) will allow the Monitor Agent (remote central monitoring system) to access the Device Agent's system and control it on demand. The Proxy Agent is a "behind the scenes" program installed on a computer or server, running Windows 7 operating system, which integrates multiple systems (central monitoring system, bedside monitors) and allows them to communicate. The Monitor and Device Agents connect through the use of the Proxy Agent by utilizing a singular IP address, either through the internet or the intranet. Due to the separation of the Proxy Agent from the other systems, communication may occur over both intranet as well as internet connections. The maximum capacity of the Vectraplex CMS is a total of 16 devices. Each Proxy Agent can withstand a maximum load of 16 devices displayed on 3 different monitors. These 3 monitors are duplicates of the same 16 devices.

Below is the information regarding the acceptance criteria and the study that proves the device meets those criteria, as extracted from the provided text.

Note: The provided text is a 510(k) summary for a medical device. This type of document focuses on demonstrating substantial equivalence to a predicate device rather than providing detailed study results with specific acceptance criteria and performance metrics typically found in a clinical study report. Therefore, some of the requested information, particularly quantitative performance metrics against specific acceptance criteria, detailed sample sizes, expert qualifications, and specific ground truth methods beyond general "testing procedures," is not explicitly present in the document.

Acceptance Criteria and Device Performance Study for Vectraplex CMS

The Vectraplex CMS is a Central Monitoring System intended to transfer information between networked devices (VectraplexECG Systems), and provides remote monitoring management, printing, viewing, processing information, and remote control of these systems. It also audibly and visually alarms if the VectraplexECG System’s CEB® (Cardiac Electrical Biomarker) reaches an alarm condition.

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size for Test Set: The document explicitly states: "The maximum load test was done using 16 devices and 3 monitors over a single proxy agent." This refers to the number of monitored devices. No specific "patient" sample size or study size for performance evaluation is mentioned, as the testing focuses on the system's technical function and connectivity with other devices.
• Data Provenance: Not explicitly stated as retrospective or prospective patient data. The testing appears to be primarily system-level verification and validation using simulated or lab environments with connected VectraplexECG Systems, rather than a clinical trial with patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• This information is not provided in the document. The document describes "verification, validation and testing procedures" and "usability testing," but does not mention experts establishing ground truth for a test set in a diagnostic or interpretive context. The device is a central monitoring system, not a diagnostic algorithm that interprets medical images or signals requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

• Not applicable/Not provided. Since this is a central monitoring system, and the testing described is primarily technical (connectivity, latency, alarming functionality), an adjudication method for establishing ground truth (like 2+1 or 3+1 for diagnostic interpretations) is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study was not done or described in this 510(k) summary. The device is a central monitoring system, not a diagnostic aid that would typically involve human readers interpreting cases with and without AI assistance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The device itself is a "system, network and communication" component, and its primary function is to transfer and display information from other devices (VectraplexECG Systems). While it does have an alarming function based on the CEB from the VectraplexECG System, the 510(k) summary describes functional testing of the system rather than a standalone algorithm's performance in a diagnostic capacity. Therefore, the concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not explicitly addressed for this central monitoring system. The latency test with max load could be considered a form of standalone system performance.

7. The Type of Ground Truth Used

• The ground truth for the functional and performance testing appears to be based on design specifications and expected system behavior. For example, the ground truth for alarming would be whether the system correctly alarms when a connected VectraplexECG System's CEB passes an alarm threshold, as defined by the VectraplexECG. For latency, the ground truth is the actual measured time for data transfer. It's not based on expert consensus, pathology, or outcomes data in the usual clinical diagnostic sense, as the device is for monitoring and communication, not generating a diagnosis.

8. The Sample Size for the Training Set

• This information is not provided as the device is not described as involving a machine learning or AI algorithm that requires a "training set" in the conventional sense for diagnostic prediction. The "programs" described (Monitor Agent, Device Agent, Proxy Agent) appear to be traditional software components, not machine learning models trained on data.

9. How the Ground Truth for the Training Set Was Established

• Not applicable/Not provided, as there is no mention of a training set or machine learning algorithm within this 510(k) summary.

Ask a specific question about this device

• 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

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.

Ask a specific question about this device