(60 days)
The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, is intended to provide remote central monitoring and display of information as recorded by multiple Aulisa single-patient monitoring systems, on a central remote screen. The system can be used in a hospital type and clinic environment.
The Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000, operates through an Aulisa-developed software installed on a standard personal computer. The system interlinks multiple Aulisa single-patient monitoring systems to display the information as recorded by each single-patient monitoring system on a central remote screen. The system uses standard off-theshelf communication and IT hardware for data transmission.
The information transmitted from single-patient monitoring systems to the MP1000 system includes the physiological parameters and alarm indications. Adjusting alarm settings can only be performed on the Aulisa Display Unit of the single-patient monitoring system. If configured, the MP1000 screen can also be accessed through remote devices, such as other PCs. In addition, patient history data and report files can be viewed, exported, and/or printed.
The provided document is a 510(k) summary for the Aulisa Multiple Patient Digital Vital Sign Monitoring System, MP1000. It describes the device, its intended use, and a comparison with a predicate device. However, it does not contain detailed information about specific acceptance criteria for a performance study (i.e., quantitative metrics like accuracy, sensitivity, specificity, or error rates) or the study that proves the device meets those criteria.
Instead, the document states:
- "Aulisa Multiple Patient Digital Vital Sign Monitoring System is a medical device stand-alone software; all testing was completed and the software has been verified and validated per FDA's Guidance for Industry and FDA Staff, Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."
- "Further, risk management assessment on the subject device was performed per ISO 14971, Medical Devices- Risk Management to verify that it does not raise any new safety and effectiveness issues in comparison to its predicate device."
- "Test results indicate that the subject device complies with its predetermined specifications and the applicable guidance document and standards."
This indicates that software verification and validation, along with risk management, were performed to demonstrate substantial equivalence, rather than a clinical performance study with defined acceptance criteria for diagnostic performance metrics. The device primarily functions as a remote display system that duplicates data from individual monitoring units, implying that its performance is largely contingent on the accuracy of the connected single-patient monitoring systems, which are not the subject of this 510(k) submission's performance section.
Therefore, for your request, I cannot extract the specific details you've asked for directly from this document, as it does not describe a performance study in the typical manner of an AI/diagnostic device (e.g., measuring sensitivity, specificity against ground truth).
Specifically, the document does NOT include information on:
- A table of acceptance criteria and reported device performance: No quantitative performance metrics or acceptance criteria are listed.
- Sample size for the test set and data provenance: Not applicable as no specific diagnostic performance study is detailed.
- Number of experts used to establish ground truth and qualifications: Not applicable.
- Adjudication method for the test set: Not applicable.
- MRMC comparative effectiveness study or effect size: Not applicable.
- Standalone (algorithm only) performance: Not applicable as it's a data display system, not a diagnostic algorithm.
- Type of ground truth used: Not applicable.
- Sample size for the training set: Not applicable (this is not an AI/ML device in the sense of a trained model).
- How ground truth for the training set was established: Not applicable.
The "Summary of Performance Testing" section (5.8) indicates that software verification and validation were performed according to FDA guidance for software in medical devices, and risk management per ISO 14971. This type of testing ensures the software functions as intended, is reliable, and does not pose undue risks, rather than establishing diagnostic accuracy against a clinical ground truth. The device's primary function is to "display of information as recorded by multiple Aulisa single-patient monitoring systems," not to interpret or derive new diagnostic information.
§ 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).