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510(k) Data Aggregation
(177 days)
VITAL SYNC MODEL 5000 SERIES
The Vital Sync™ System is intended for display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. It is not intended for alarm notification, nor is it intended to control any of the independent bedside devices it is connected to.
The Vital Sync™ System is a bedside data management system that receives historic digital data produced by primary external devices through device specific cables, accepts manual data entry, and displays and stores this information for review and archiving by healthcare professionals.
Acceptance Criteria and Device Performance for the SOMANETICS VITAL SYNC SYSTEM
1. Table of Acceptance Criteria and Reported Device Performance
The provided 510(k) summary for the Vital Sync™ System indicates that a comparative study with specific acceptance criteria and performance metrics was not performed in terms of human reader studies or algorithm performance. Instead, the substantial equivalence was demonstrated through bench testing and verification and validation activities.
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Performance, Reliability, and Functionality Bench Testing | Pass/fail criteria established based on the published specifications of both the predicate device (CentraView, ICU DataSystems, K033283) and the current Vital Sync™ System. | Bench testing and verification and validation activities were performed. Testing modes included error handling, system faults, power cycling, consistency, recall, user interface, performance, and maintenance procedures. |
| Automated Data Capture | Compatibility and secure data transfer from supported external devices to the Vital Sync™ System, ensuring accurate acquisition and recording of physiological parameters. | Features tested for automated data capture demonstrated proper function. Additionally, the communication interface for each of the supported devices was stress-tested to ensure safety and compatibility with the Vital Sync™ System. |
| Manual Data Entry | Accurate manual input and storage of physiological data. | Features tested for manual data entry demonstrated proper function. |
| Data Formatting and Report Generation | Proper display, formatting, and generation of reports for review and archiving by healthcare professionals. | Features tested for data formatting and report generation demonstrated proper function. |
| Trending | Accurate representation and storage of trending data for physiological parameters. | Features tested for trending demonstrated proper function. |
| Data Backup and Security | Reliable backup mechanisms and secure handling of patient data. | Features tested for data backup and security demonstrated proper function. |
| Supported Device Communication Interface | Safety and compatibility of the communication interface for each supported device with the Vital Sync™ System under stress conditions. This implies no data corruption or system instability. | The communication interface for each of the supported devices was stress-tested to ensure safety and compatibility with the Vital Sync™ System. The results supported substantial equivalence. |
Conclusion from Testing: The results demonstrate substantial equivalence with the predicate device. The device and its revised indications for use are substantially equivalent to the predicate device and do not raise new questions of safety and effectiveness.
2. Sample Size Used for the Test Set and Data Provenance
The provided document does not mention a clinical test set sample size or data provenance (e.g., country of origin, retrospective/prospective). The submission explicitly states: "Clinical testing was not required to establish substantial equivalence." The evaluation was based entirely on bench testing and verification and validation activities.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
No experts were used to establish ground truth for a clinical test set because, as stated, "Clinical testing was not required." The "ground truth" for the bench testing was based on the "published specifications of both the predicate and the current device."
4. Adjudication Method for the Test Set
No adjudication method was used for a clinical test set, as no clinical testing was performed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done. The submission focuses on the system's ability to display and record physiological parameters, not on interpretation or diagnostic effectiveness involving human readers.
6. Standalone (Algorithm Only) Performance Study
No standalone (algorithm-only) performance study was performed in the context of diagnostic accuracy or interpretation. The device's function is to receive, display, and store data. The "performance data" refers to the system's functionality, reliability, and compatibility with external devices, which was evaluated through bench testing.
7. Type of Ground Truth Used
The "ground truth" for the verification and validation activities was primarily based on the published specifications of both the predicate device and the Vital Sync™ System itself. This means the system's output (e.g., received data, display accuracy, storage integrity) was compared against the expected behavior as defined by the technical specifications.
8. Sample Size for the Training Set
The document does not mention a "training set" or any machine learning/AI components where a training set would typically be used. The system's functionality was evaluated through traditional software and hardware verification and validation, not through a data-driven model training process.
9. How the Ground Truth for the Training Set Was Established
As no training set was utilized, the concept of establishing ground truth for a training set is not applicable to this submission.
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