Search Results

The Unity Network ID is indicated for use in data collection and clinical information management through networks with independent bedside devices. The Unity Network ID is not intended for monitoring purposes, nor is the Unity Network ID intended to control any of the clinical devices (independent bedside devices/ information systems) it is connected to.

The Unity Network ID system communicates patient data from sources other than GE Medical Systems Information Technologies, Inc. equipment to a clinical information system, central station, and/or GE Medical Systems Information Technologies Inc. patient monitors.

The Unity Network ID acquires digital data from eight serial ports, converts the data to Unity Network protocols, and transmits the data over the monitoring network to a Unity Network device such as a patient monitor, clinical information system or central station.

The provided document is a 510(k) summary for the GE Healthcare Unity Network ID V7. It describes a data collection and clinical information management system.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly list specific quantitative acceptance criteria (e.g., accuracy, sensitivity, specificity) for the Unity Network ID V7, nor does it present device performance against such. Instead, it focuses on demonstrating that the device meets design specifications and complies with applicable voluntary standards.

The "Determination of Substantial Equivalence: Summary of Non-Clinical Tests" section indicates: "The Unity Network ID V7 and its applications were tested to, and comply with, applicable voluntary standards. The Unity Network ID V7 was tested to assure that the device meets its design specifications."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical or performance data from a specific dataset of patients or cases. The testing described is primarily software and hardware verification and validation, rather than an evaluation against a clinical dataset. Therefore, there is no mention of sample size or data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Since there is no "test set" based on patient data, there is no mention of experts needed to establish ground truth or their qualifications. The "ground truth" in this context refers to the successful functionality and compliance of the device against its specifications and standards.

4. Adjudication Method for the Test Set

Not applicable, as there is no mention of a test set requiring adjudication by experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and Effect Size

No, an MRMC comparative effectiveness study was not done. The device is a data collection and management system, not an interpretive diagnostic tool that involves human readers interpreting clinical output. The document explicitly states: "The subject of this premarket submission, Unity Network ID V7, did not require clinical studies to support substantial equivalence."

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

The "testing included all new or modified features" and involved various quality assurance measures like unit-level testing, integration testing, performance testing, and safety testing. These tests would evaluate the algorithm's functionality and accuracy in its intended role of data conversion and transmission. So, in essence, the "standalone" performance of the data conversion and routing algorithms was assessed as part of these non-clinical tests. However, it's not a "standalone performance study" in the typical sense of evaluating diagnostic accuracy.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical tests appears to be:

• Design specifications: The device's output and functionality were compared against predefined technical and functional specifications.
• Voluntary standards: Compliance with relevant engineering and medical device standards (though specific standards are not listed in this summary, they are implied).
• Expected behavior: For simulated use testing and verification, the "ground truth" would be the expected correct data conversion and transmission as per the device's design and independent bedside device protocols.

8. The Sample Size for the Training Set

Not applicable. This device is a data integration and conversion system, not an AI/ML model that requires a "training set" in the typical sense of machine learning for image analysis or diagnostics. Its functionality is based on established communication protocols and data mapping.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set for this type of device.

Ask a specific question about this device

Indications for use E-PiCCO Continuous Cardiac Output Module: The E-PiCCO is intended for determination and monitoring of cardiopulmonary and circulatory variables. Cardiac output is determined both continuously through pulse contour analysis and intermittently through thermodilution technique. In addition, the E-PiCCO measures systolic, and diastolic and derives mean arterial pressure. Analysis of thermodilution curve in terms of mean transit time and downslope time is used for determination of intravascular and extravascular fluid volumes. If a patient's weight and height are entered. the compatible patient monitor presents the derived parameters indexed to body surface area. The E-PiCCO is intended for hospitalized patients. The E-PiCCO and accessories are for use by qualified medical personnel only. The E-PiCCO patient module is intended for use on one patient at a time. Cardiac output measurement with E-PiCCO is intended for patients weighing over 2 kg (4.4 lb) and therefore it is not available for smaller patients. E-PiCCO indexed values are available for patients weighing over 15 kg (33 lb) only.

Indications for use PiCCO Continuous Cardiac Output Cable (M1154585): The reusable, continuous cardiac output adapter cables are intended to be used for connecting a continuous cardiac output catheter to GE Medical Systems Information Technologies monitoring equipment requiring a rectangular 11-pin connector cable. These accessories are indicated for use by qualified medical personnel only.

Indications for use PiCCO Injectate Sensor Cable (M1182448): The reusable PiCCO Injectate Sensor Cable (M1182448) is intended to be used for connecting the PiCCO Injectate Sensor Housing (PV4046) to PiCCO Continuous Cardiac Output Cable (M1154585) of GE Healthcare monitoring equipment. These accessories are indicated for use by qualified medical personnel only.

The E-PiCCO Continuous Cardiac Output Module and accessories is a new, single width E-series plug-in parameter module for pulse contour continuous cardiac output (PCCO) measurement and associated parameters. E-PiCCO Continuous Cardiac Output Module and accessories uses interconnect cables for both for injected bolus temperature measurement and for continuous cardiac output measurement. Patient access is via a clinician inserted arterial catheter, provided by Pulsion Medical Systems AG. The E-PiCCO Continuous Cardiac Output Module and accessories can be used with the CARESCAPE Monitor B850 with ESP V2 software, the CARESCAPE Monitor B650 with ESP V2 software and CARESCAPE Monitor B450 with ESP V2 software.

The provided text does not contain information about acceptance criteria and a study proving a device meets them. Instead, it is a 510(k) summary for the GE Healthcare E-PiCCO Continuous Cardiac Output Module and accessories, focusing on regulatory information, device description, intended use, and a determination of substantial equivalence to a predicate device.

Specifically, the document states: "The subject of this premarket submission, the E-PiCCO Continuous Cardiac Output Module and accessories did not require clinical studies to support substantial equivalence." This means no clinical study, with acceptance criteria, sample sizes, ground truth, or MRMC analysis, was conducted or reported in this submission for this device.

The study described here relates to non-clinical tests focused on quality assurance, risk analysis, requirements reviews, design reviews, and various levels of testing (unit, integration, final acceptance, performance, safety) to ensure compliance with relevant IEC standards. However, these are not tied to specific performance metrics or acceptance criteria as would be found in a clinical study report.

Ask a specific question about this device