(55 days)
DataEngine is indicated for use in data collection and clinical information management either directly or through networks with independent bedside devices. DataEngine is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices ( independent bedside devices / information systems ) it is connected to.
DataEngine is a comprehensive solution to integrate medical device data into HIS. It is also designed to be compatible with XML and HL7. All data collected from medical device is able to transfer to readable format of XML and HL7. Caregiver or nurses will be beneficial from DataEngine, device connectivity software to collect data in real time and receive a complete electronic data for patient's record. Medical staffs do not have to spend much time on manual script. Every patient's real time data will be stored in database server for future research projects, education, and clinical study.
The provided text describes a 510(k) summary for the POISE DataEngine, a Patient Physiological Monitor. The document focuses on establishing substantial equivalence to a predicate device and does not contain information about specific acceptance criteria, a study proving device performance against such criteria, or the details typically found in a clinical validation study for an AI/ML device.
Therefore, I cannot fulfill the request for information regarding performance tables, sample sizes, expert ground truth establishment, MRMC studies, standalone performance, or training set details as that information is not present in the provided text.
Based on the information provided, here's what can be extracted:
- Device Name: POISE DataEngine
- Classification: Class II, Product Code MWI
- Intended Use: Data collection and clinical information management, either directly or through networks with independent bedside devices. Not intended for monitoring purposes or to control clinical devices.
- Predicate Device: CAPSULE TECHNOLOGIE Datacaptor, K032142
- Similarities to Predicate: Same intended use, same output mode, same technological characteristics (software server application, no contact with patients, not controlling life-sustaining devices).
- Differences from Predicate (Performance Differences): Can output formats other than just text files, supports waveform information for some devices, supports HL7 & Database, can output in Database format, easier to organize, easy to learn.
Key takeaway regarding your request: The provided document is a regulatory submission focused on demonstrating substantial equivalence to a predicate device, rather than a detailed report of a clinical performance study. It does not contain the specific performance metrics, study designs, or ground truth methodologies that your request asks for.
§ 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).