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The MEDLOG System is indicated for the use in data collection and clinical information management. MEDLOG is connected with independent and onlinedial or clinical devices either directly of through networks.

MEDLOG is not intended for monitoring purposes, nor is the software intended to control any of the clinical devices, which is connected to.

MEDLOG is based of open-architecture design using JAVA Technology. MEDLOG is a data acquisition and distribution software. It retrieves data from serial or network devices and makes thes data available over networks or any other type of communication for us in software applications. BMC customers can buy cables and can connect the devices directly to the COM Port or they can use a multiport box. Customers also can use Serial/Ethernet converters if needed. BMC not recommends hardware suppliers. MEDLOG enables the interfacing of medical devices, which are types of blood-gas analyzers or cardiac-monitoring systems. It is a matter of principle, that MEDLOG is able to support other kind of connected devices. The basic componente of MEDLOG ist the MCS Communication server, which runs and controls MMD Device Drivers. The collected device data can stored temporarily may MCS. The MEI External Interfaces makes data available for other external systems.

I am sorry, but based on the provided text, there is no information about acceptance criteria, a study that proves device performance, sample sizes, data provenance, expert involvement, adjudication methods, MRMC studies, standalone performance, or training set details.

The document is a 510(k) summary for the MEDLOG device, which is a data collection software. It primarily focuses on demonstrating substantial equivalence to a predicate device (DataCaptor Software, K032142) by comparing their indications of use, interfaces, where used, and computer compatibility. The key difference highlighted is the technology used (JAVA for MEDLOG vs. Windows/DCOM for DataCaptor).

Therefore, I cannot provide the requested table and study details.

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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.

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