(205 days)
The T3 Software is intended for the recording and display of multiple physiological parameters of adult, pediatric and neonatal patients from supported bedside devices. T3 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. T3 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.
T3 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)
It can also display laboratory measurements including arterial and venous blood gases, complete blood count, and lactic acid.
T3 includes a Patient Risk Analytics Engine that calculates an index (the Inadequate Oxygen Delivery Index) that is indicated for use by health care professionals with postsurgical patients aged zero days to twelve years weighing 2 kg or more under intensive care. The Inadequate Oxygen Delivery Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. When the index is elevated, it means that there is increased risk of inadequate oxygen delivery and attention should be brought to the patient. The 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.
The Tracking, Trajectory, Trigger (T3) 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.
The subject device is a modification of the T3 Software that expands the Indications for Use for the Inadequate Oxygen Delivery Index (IDO2) from patients aged 0 - 28 days to patients aged zero days to twelve years. The IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by T3. This index provides an interpretation of how different the patient's physiologic measures are from normality.
In addition to the expansion in the Indications of Use for the IDO2 Index, T3 release 3.0 contains the following changes:
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- In previous T3 versions, the Inadequate Oxygen Delivery Index is documented as having the following limitation.
The index will not be displayed if the following minimum measurements are not available:
- In previous T3 versions, the Inadequate Oxygen Delivery Index is documented as having the following limitation.
- a. Heart rate from ECG or pulse at a minimum of once every 30 seconds
- b. SpO2 from pulse oximetry at a minimum of once every 30 seconds
- c. Blood Pressure (mean/diastolic/systolic) at a minimum of once every 10 minutes
This limitation has been changed to the following:
The index will not be displayed if the following minimum measurements are not available: - a. Heart rate from ECG or pulse at a minimum of once every 60 seconds
- b. SpO2 from pulse oximetry at a minimum of once every 10 minutes
- c. Blood Pressure (mean/diastolic/systolic) at a minimum of once every 10 minutes
The minimum requirement for Heart Rate data has changed from 30 seconds to 60 seconds, and the minimum requirement for SpO2 has changed from 30 seconds to 10 minutes. -
- In previous T3 versions, the software model used to calculate IDO2 had age independent parameters and did not include a number of potentially useful model relationships. In the updated model, parameters are now dependent on patient age. Also, new model states and relationships have been implemented to improve the performance.
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- In previous T3 versions, the calibration logic for IDO2 utilized the probability distribution of patient states to determine whether or not to display a given IDO2 value. The new calibration logic is simply time based, waiting 5 minutes to display IDO2 values for a new patient. In addition, if the algorithm is re-initialized for any reason, it will undergo an additional 5 minutes of calibration after the re-initialization.
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- The IDO2 labeling contains a list of required and optional algorithm inputs. One required input is SpO2. Previous releases of T3 accepted SpO2 captured by the patient monitor and reported with any of three different labels: "SpO2" (defined as "SpO2 from pulse oximeter"), "SpO2 l" (defined as "arterial oxygen saturation left"), and "SpO2 r" (defined as "arterial oxygen saturation right"). This release of T3 adds SpO2 as reported with two other labels: "SpO2 pr" (defined as "pre-ductal SpO2") and "SpO2 po" (defined as "post-ductal SpO2").
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- T3 version 3.0 also includes the following User Interface changes:
- a. A new user interface mode that displays the data originating from a single bed location, even as new patients are transferred into that location. The benefit of this change is that the T3 user is never auto-logged off due to inactivity. Instead, T3 displays either the view of the patient data or a dialog stating that no data is being received for the bed. The mode is suitable for a bedside display, and saves clinicians the time and effort of logging in and navigating to that patient's data each time they want to use T3. To mitigate possible clinician confusion about which patient the data is for, T3 only displays data for one patient at a time - the current patient. Furthermore, the patient's name, medical record number and date of birth are displayed on the screen.
- b. Views: These are predefined arrangements of labs and measures. Views are accessed through a tabbed display. The first instance of the View functionality is the Hemodynamic View, which presents information about the patient's hemodynamic system. Views save clinicians the time and effort to drag meaningful labs and measures to the central graph area in order to display them.
- c. Smart Visualization Groups: These are collections of measures and laboratory results that are graphed together as a single unit. T3 is able to insert shading, vertical lines and other visual cues to emphasize relationships in the data. For example, in the Blood Pressure group, the area between systolic and diastolic pressure is shaded. The shading represents "pulse pressure," a standard measure of the force the heart generates each time it contracts. The shading allows the clinician to see increases or decreases in pulse pressure, in addition to the systolic and diastolic blood pressure values from which pulse pressure is calculated.
- d. When T3 displays a measure it inserts the starting and ending values for the period of time being graphed on the left and right edges of the canvas. It inserts the maximum and minimum values for the measure in circles at the point in time when they occur. If two or more of these values would overlap on the graph, T3 omits all but one of them for clarity. Likewise, if one of these values would obscure the graphic icon for a laboratory result, T3 omits it so the laboratory result is shown.
- e. Night Mode. There are now application-wide configuration settings that specify when "night time" starts and ends. For example, night time can be defined to start at 7PM and end at 7AM - or whatever times are desired. When T3 runs "at night," the application recognizes that it is night based on the system clock, and automatically uses a dark background. This reduces the amount of ambient light that the T3 monitor emits. When it runs during the day, T3 similarly recognizes that it is day and automatically uses a light background. It is possible for individual users to manually override the night mode function. On the patient view screen, T3 adds buttons that let the user manually control night mode. There is a sunshine button that lightens the background, and a moon button that darkens the background. A lock button locks in the user's selection of day or night.
- f. If T3 receives data for a patient measure whose unit of measure is different from what was previously received for that patient and measure, it now displays a temporary warning banner at the top of the display that is automatically dismissed after ten seconds. Previously, T3 displayed the warning, but required the user to dismiss it by clicking on it. In many situations, needing to click to dismiss the warning was inconvenient or impractical. An example of this functionality is if T3 is receiving mean airway pressure for a patient. The monitor may report values in "millibars" then switch to "cmH2O." Both are commonly accepted ways of measuring airway pressure. In this case, the warning will say "Measure mnAWp has inconsistent unit codes. T3 is expecting units of mbar, but received data points with units of cmH2O. Those data points will not be displayed."
- g. The dialog showing additional details for a lab value is now invoked by clicking anywhere on the lab icon. Previously it was invoked by hovering the mouse cursor over the exact data point for the lab value. The new functionality is more forgiving if the mouse cursor is slightly misplaced, and is less susceptible to displaying unwanted tooltips when the user moves the mouse cursor around the screen.
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- Typically, a clinician enters the patient's medical record number (MRN) into the bedside monitor. The physio interface sent to T3 from that monitor then includes the MRN and bed location along with the data values for the patient. T3 now supports an alternate workflow where the hospital's Admit, Discharge and Transfer (ADT) interface is used as the definitive source of patient identity and location information. The physio interface contains bed location along with the data values for the patient, but T3 derives the MRN by matching the bed location sent in the physio interface with the bed location / MRN pairing sent in the ADT interface. In order to recover from a situation where an ADT message is not delivered to T3 for some reason, or T3 processes it incorrectly, there is also a user interface in T3 that allows an administrator to explicitly specify the MRN for the patient occupying a bed location. This has the same effect as an ADT message associating a patient with a bed location.
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- T3 can now send an informational email to one or more configured email addresses when it detects that data is being received from a bed location without an associated patient medical record number, or when it detects that data is simultaneously being received from multiple bed locations with the same associated MRN. The recipient of the email can then investigate and correct the problem. The email does not contain protected health information; instead it specifies the bed locations where the issue occurs.
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- The T3 labeling lists a series of clinical calculations that can be configured upon clinician demand. These clinical calculations are simple algebraic formulas that accept raw parameters and output a single result. An example is Pulse Width which is equal to Systolic blood pressure minus Diastolic blood pressure. This release of T3 adds the following calculations to the list that may be requested by clinicians:
| Label | Name | Formula |
|---|---|---|
| P/F | P/F Ratio | PaO2 / FiO2 |
| S/F | S/F Ratio | SpO2 / FiO2 |
| OI | Oxygenation Index | (FiO2 * Mean Airway Pressure * 100) / PaO2 |
| OSI | Oxygen Saturation Index | (FiO2 * Mean Airway Pressure * 100) / SpO2 |
- The T3 labeling lists a series of clinical calculations that can be configured upon clinician demand. These clinical calculations are simple algebraic formulas that accept raw parameters and output a single result. An example is Pulse Width which is equal to Systolic blood pressure minus Diastolic blood pressure. This release of T3 adds the following calculations to the list that may be requested by clinicians:
Here is a summary of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of acceptance criteria with numerical targets and corresponding device performance metrics for the T3 Software (Version 3.0). Instead, it focuses on demonstrating substantial equivalence to its predicate device (T3 Software Version 2.0) and supporting the expanded Indications for Use of the Inadequate Oxygen Delivery Index (IDO2).
The key "performance" aspect discussed is the validation of the IDO2 Index in the expanded patient population.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| IDO2 Index Correlation to Patient Status Change | The validation study results using clinical data gathered in the intended patient population demonstrate the IDO2 Index included in the subject device correlates with changes in the patient's physical status. (Specific metrics of correlation, such as sensitivity, specificity, AUC, or other statistical measures, are not provided in this summary document.) |
| Software Verification and Validation | "Software verification and validation testing was conducted for the subject device, and documentation was provided in accordance with FDA's 'Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices', May 11, 2005. The results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 3.0) is comparable to that of the predicate T3 software products (Ver. 2.0.1)." (No specific test results or metrics are given). |
| Equivalence in Design, Features, and Functionality to Predicate | "The T3 Software has equivalent design, features and functionality as the predicate T3 Software with few exceptions and these exceptions do not affect the safety or effectiveness of the system." (Changes include expanded age range for IDO2, modified calculation parameters for IDO2, changes to minimum measurement requirements for IDO2 display, and various UI/workflow enhancements. These are deemed not to raise new safety/effectiveness concerns). |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Clinical data from 1504 patients were used for the validation study.
- Data Provenance: The data was described as "clinical data gathered in the intended patient population" and covered "the expanded patient age range." The country of origin is not specified, but it's typically assumed to be U.S. clinical data for FDA submissions unless otherwise stated. The document doesn't specify if the data was retrospective or prospective, but clinical validation studies often leverage retrospective data for initial submissions unless a specific prospective trial is mentioned.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications to establish ground truth for the test set. It mentions the "IDO2 Index ... correlates with changes in the patient's physical status," implying that some form of clinical assessment or patient outcome served as the ground truth, but the specifics of its establishment are not detailed.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for establishing ground truth or evaluating the device's performance.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The document does not indicate that an MRMC comparative effectiveness study was done to assess how much human readers improve with AI vs. without AI assistance. The T3 Software, particularly the IDO2 Index, is described as an index that "presents partial quantitative information about the patient's cardiovascular condition" to aid healthcare professionals in clinical decisions, but not as an AI-assisted diagnostic tool requiring reader performance comparison.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a form of standalone performance assessment was conducted for the IDO2 Index. The validation study "using clinical data" to demonstrate correlation with "changes in the patient's physical status" against a ground truth (even if unspecified in detail) is a standalone evaluation of the algorithm's output. The device itself (T3 Software) is also described as a "Software-only solution."
7. The Type of Ground Truth Used
The ground truth implicitly used for the IDO2 Index validation is related to "changes in the patient's physical status." This likely refers to clinically relevant changes as observed by healthcare professionals, or potentially outcomes data, but the specific nature (e.g., expert consensus on patient status, objective physiological changes, or adverse events) is not explicitly defined in this summary.
8. The Sample Size for the Training Set
The document does not provide information about the sample size used for the training set of the T3 Software or the IDO2 algorithm. It only mentions the 1504 patients for the validation study.
9. How the Ground Truth for the Training Set Was Established
The document does not provide information on how the ground truth for the training set was established, as the training set details are not included in this summary.
§ 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).