T3 Platform software

• K Number: K190273
• Device Name: T3 Platform software
• Manufacturer: Etiometry, Inc.
• Date Cleared: 2019-12-08 ( 303 days)
• Product Code: MWI , PLB
• Regulation Number: 870.2300
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K163065

Intended Use

The T3 Data Aggregation & Visualization software module is intended for the recording and display of multiple physiological parameters of the adult, pediatric, and neonatal patients from supported bedside devices. The software module is not intended for alarm notification or waveform display, nor is it intended to control any of the independent bedside devices to which it is connected. The software module is intended to be used by healthcare professionals for the following purposes:
· To remotely consult regarding a patient's status, and
• To remotely review other standard or critical near real-time patient data in order to aid in clinical decisions and deliver patient care in a timely manner.

The T3 Data Aggregation & Visualization software module can display numeric physiologic data captured by other medical devices:

• · Airway flow, volume, and pressure
• · Arterial blood pressure (invasive and non-invasive, systolic, diastolic, and mean)
• · Bispectral index (BIS, signal quality index, suppression ratio)
• Cardiac Index
• Cardiac output
• Central venous pressure
• · Cerebral perfusion pressure
• · End-tidal CO2
• · Heart rate
• · Heart rate variability
• · Intracranial pressure
• Left atrium pressure
• · Oxygen saturation (intravascular, regional, SpO2)
• · Premature ventricular counted beats
• · Pulmonary artery pressure (systolic, diastolic, and mean)
• · Pulse pressure variation
• · Pulse Rate
• · Respiratory rate
• · Right atrium pressure
• · Temperature (rectal, esophageal, tympanic, blood, core, nasopharyngeal, skin)
• · Umbilical arterial pressure (systolic, diastolic, and mean)

The T3 Data Aggregation & Visualization software module can display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.

The T3 Data Aggregation & Visualization software module can display information captured by the T3 Risk Analytics Engine software module.

The T3 Risk Analytics Engine software module calculates two indices: the IDO2 Index™ for inadequate delivery of oxygen and the IVCO2 Index™ for inadequate ventilation of carbon dioxide.

IDO2 Index™ is indicated for use by health care professionals with post-surgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. IDO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module, version 3.3 or higher. When the IDO2 Index™ is elevated. it means that there is an increased risk of inadequate oxygen delivery and attention should be brought to the IDO2 Index™ presents partial quantitative information about the patient's cardiovascular condition, and no therapy or drugs can be administered based solely on the interpretation statements.

IVCO2 Index™ is indicated for use by health care professionals with invasively ventilated patients aged 29 days to 12 years weighing 2 kg or more under intensive care. IVCO2 Index™ is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation and Visualization software module, version 3.3 or higher. When the IVCO2 Index™ is increasing, it means that there is an increasing risk of inadequate carbon dioxide ventilation and attention should be brought to the patient.

Device Description

The Tracking, Trajectory, Trigger (73) intensive care unit software solution allows clinicians and quality improvement teams in the ICU to aggregate data from multiple sources, store it in a database for analysis, and view the streaming data in real-time. System features include:

• Customizable display of physiologic parameters over entire patient stay
• Configurable annotation
• Web-based visualization that may be used on any standard browser ●
• . Minimal IT footprint
• Software-only solution no new bedside hardware required .
• . Highly reliable and robust operation
• Auditable data storage

This release of the T3 Platform Software contains the following software module changes:

T3 Risk Analytics Engine software module version 5.0

1. IVCO2 Index™. The subject device is a modification of the T3 Platform software clearance under K163065 that expands the Indications for Use for inadequate ventilation of carbon dioxide index (IVCO2 Index™). The IVCO2 Index™ calculates a patient status index. This is a measure of the likelihood that an arterial blood gas measurement of carbon dioxide would indicate a partial pressure greater than 50 mmHg.
2. Minor changes to maintain the performance of the IDO2 Index™ when external factors exist. Minor changes to the IDO2 Index™ have been made to maintain the specified performance of the IDO2 Index™ when variations in external factors exist. Specifically, these included changes in the initialization routine to ensure that the algorithm converges to stable behavior within the required time window, and changes in the artifact rejection logic of noninvasive blood pressure measurements to ensure that these measurements are not ignored when only minimum data is available thus providing required minimum data performance.

T3 Data Aggregation & Visualization software module version 3.3

1. Index Displayed on Census View. IDO2 Index™ and the IVCO2 Index™ are not displayed on the Census View and the requirement was removed.
2. Blackout. To mitigate potential misuse of active patient monitoring with Persistent Displays in the ICU, the IDO2 Index™ and the IVCO2 Index™ are blacked out in the near-real-time, a warning label is placed above the Index, and a user is prompted to acknowledge warnings when selecting an Index to be graphed.
3. Measure synonyms. Certain measures, while not identical to each other, are nevertheless closely related and can be thought of as "synonyms" for each other. For example, "Temp" (Generic Temperature), "Tairwy" (Airway Temperature), "Tesoph" (Esophogeal Temperature), and "Ttymp" (Tympanic Temperature) are all measures of the patient's temperature. In this example, the measure synonym feature would allow T3 Data Aggregation & Visualization software module to continuously report a value for "Temperature" based on whatever values were being received for Temp, Tairwy, Tesoph and/or Ttymp. The raw (source) variables continue to be available to be seen or graphed. In addition, this feature includes an "explain" function that allows the clinician to examine measure synonyms to see the source of the displayed data value at each moment in time.
4. Respiratory View. T3 Data Aggregation & Visualization software module now includes a screen that displays measures and laboratory results related to the patient's respiratory system. This predefined arrangement, accessed by clicking on the "Respiratory" tab beside the previously released "Hemodynamic" view, saves the clinician the time and effort of graphing these laboratory data and measures in order to understand the status and trend of the patient's respiratory system. The respiratory view includes Smart Visualization Groups that show measures and labs related to respiratory rate, ventilation pressure, respiratory volume, oxygenation, and ventilation.
5. Placement of IDO2 at the top of the Patient View. In the T3 Data Aggregation & Visualization software module, the display canvas for IDO2 Index™ has been moved to the top of the Patient View.
6. Current measure value is shown on the graph instead of the legend. When the user positions the mouse cursor in the central graph area, T3 Data Aggregation & Visualization software module displays the value of all graphed measures for the time corresponding to the cursor location. Previous releases of T3 Data Aggregation & Visualization software module displayed this information on the legend (the label for each measure or laboratory result that is shown to the left of the graph area). This release of T3 Data Aggregation & Visualization software module instead shows the value beside a light vertical line that is drawn at the mouse cursor position. This moves the information closer to the user's focus of attention (the mouse cursor).
7. Ability to receive and merge multiple data interfaces of the same type. T3 Data Aggregation & Visualization software module currently receives three types of data interfaces: patient registration (ADT), laboratory results, and physiometric data. This release allows T3 Data Aggregation & Visualization software module to receive and merge data interfaces of the same type coming from two or more sources. For example, a physiometric data interface for beds from a particular floor of the hospital can now be merged with a separate physiometric data interface with beds from a different floor or unit. This feature allows clinicians to view collections of beds that correspond to patient care trajectories such as the operating room and recovery unit, or intensive care and step-down unit.
8. Ability to receive data through SQL relational database query. Previous releases of T3 Data Aggregation & Visualization software module received data exclusively through HL7-based data interfaces. However, depending on a hospital's IT infrastructure, data from peripheral devices like ventilators may be sent to the hospital electronic medical record but not broadcast through an HL7 data interface. This release of T3 Data Aggregation & Visualization software module retains its HL7 functionality, but also supplements it with the ability to simultaneously receive other data through periodic SQL relational database queries. (SQL, structured query language, is the ANSI standard language for relational database management systems). For example, T3 Data Aggregation & Visualization software module can query a hospital database periodically to read validated ventilator values that are not otherwise transmitted through HL7 data interfaces, while simultaneously receiving device and lab data through HL7.
9. Support for an expanded number of beds. This release of T3 Platform software of T3 web server to support up to 128 intensive-care beds. Previously an instance of T3 web server could only support 30 intensive-care beds. The server-side hardware requirements have been modified to request additional hard disk space for T3 web server to support more beds.

AI/ML Overview

The T3 Platform software (T3 Data Aggregation & Visualization software module version 3.3 and T3 Risk Analytics Engine software module version 5.0) was evaluated for its IVCO2 Index™ for inadequate ventilation of carbon dioxide.

1. Table of Acceptance Criteria and Reported Device Performance (Focus on IVCO2 Index™):

The document does not explicitly state quantitative acceptance criteria for the IVCO2 Index™ performance. However, it states the index's ability to "correctly discriminate the physiologic state of inadequate ventilation of carbon dioxide though its whole range" and its robustness "against different data availability" was validated. The reported performance is that the validation study demonstrated this ability.

Acceptance Criteria (Inferred from study description)	Reported Device Performance
Ability to correctly discriminate the physiologic state of inadequate ventilation of carbon dioxide through its whole range.	The IVCO2 Index™ was validated retrospectively on clinical data and demonstrated its ability to correctly discriminate the physiologic state of inadequate ventilation of carbon dioxide through its whole range.
Robustness against different data availability.	The IVCO2 Index™ was validated retrospectively on clinical data and demonstrated its robustness against different data availability.

2. Sample Size and Data Provenance for Test Set:

• Sample Size: 951 patients.
• Data Provenance: The data was clinical data gathered in the intended patient population, implying it's from a healthcare setting. The document does not specify a country of origin. The study was retrospective.

3. Number of Experts and Qualifications for Ground Truth:

The document does not specify the number or qualifications of experts used to establish the ground truth.

4. Adjudication Method for Test Set:

The document does not describe an adjudication method for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not reported in this document. The focus of the validation was on the algorithm's standalone performance against a clinical gold standard.

6. Standalone Performance Study:

Yes, a standalone study of the algorithm's performance (without human-in-the-loop) was done. The IVCO2 Index™ was retrospectively computed on patient data and validated against a gold standard.

7. Type of Ground Truth Used:

The ground truth used was arterial blood gases.

8. Sample Size for Training Set:

The document does not specify a separate sample size for a training set. The descriptions focus on the validation study using clinical data.

9. How Ground Truth for Training Set Was Established:

The document does not provide information on how ground truth was established for a training set, as a specific training set size is not mentioned. For the validation set, the ground truth was established using arterial blood gases.

Regulation Number and Section

§ 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).