(302 days)
• 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
| Acceptance Criteria / Performance Aspect | Reported Device Performance | Comments / Context |
|---|---|---|
| Functionality | ||
| Transfer information between networked devices (VectraplexECG Systems) | Verified through testing procedures. | The system allows a central monitoring system to view multiple VectraplexECG Systems via intranet or internet. Consists of Monitor Agent (remote display/control), Device Agent (on bedside device), and Proxy Agent (integrates systems). |
| Remote monitor management, printing, viewing, processing, remote control | Verified through testing procedures. | The Central Monitoring System can be used for these purposes. |
| Audibly and visually alarm based on VectraplexECG System's CEB® | The Vectraplex CMS will audibly and visually alarm if the VectraplexECG System's CEB® (VectraplexAMI), Cardiac Electrical Biomarker, reaches an alarm condition. | This is a stated core functionality. While stated as an "alarm condition," specific thresholds or accuracy metrics for triggering the alarm are not detailed in this summary. |
| Connectivity & Load | ||
| Maximum Capacity | A total of 16 devices. | Each Proxy Agent can withstand a maximum load of 16 devices displayed on 3 different monitors, displaying duplicates of the same 16 devices. |
| Latency with maximum load | Between 6 and 7 seconds. | This average latency was observed during the maximum load test (16 devices, 3 monitors, single proxy agent). |
| Usability | Verified (successful with no critical errors). | Usability testing was performed as outlined in the "Vectraplex CMS Usability Test Plan document." |
| Safety and Effectiveness | Conforms to design specifications, safe and effective as predicate devices. | Based on performance testing, VectraCor determined that the device is substantially equivalent to predicate devices. |
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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).