(443 days)
The T3 Platform™ software features the T3 Data Aggregation & Visualization software module version 5.0 and the T3 Adult Risk Analytics Engine software module version 1.0.
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 Adult Risk Analytics Engine software module.
The T3 Adult Risk Analytics Engine software module calculates the Adult IDO2 Index for inadequate delivery of oxygen. The Adult IDO2 Index is indicated for use by health care professionals with post-surgical patients 18 years of age or older under intensive care and not on Mechanical Circulatory Support. The Adult IDO2 Index is derived by mathematical manipulations of the physiologic data and laboratory measurements received by the T3 Data Aggregation & Visualization software module. When the Adult IDO2 Index is increasing, it means that there is an increasing risk of madequate oxygen delivery and attention should be brought to the patient. The Adult 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.
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. 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
Here's a breakdown of the acceptance criteria and study details for the T3 Platform™ software:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Discriminatory Power | Met acceptance criteria |
| Range Utilization | Met acceptance criteria |
| Resolution/Limitation | Met acceptance criteria |
| Robustness | Met acceptance criteria |
2. Sample Size and Data Provenance for Test Set
- Sample Size: 4251 mixed venous oxygen saturation measurements from 634 patients.
- Data Provenance: Clinical data from different clinical sites in the US (retrospective). The data were obtained by the T3 Platform software and were de-identified.
3. Number of Experts and Qualifications for Ground Truth Establishment (Test Set)
This information is not explicitly provided in the document. The document states that the Adult IDO2 Index was "retrospectively computed on all de-identified patients" and "evaluated against the same acceptance criteria as the supportive predicate device," implying an objective ground truth related to mixed venous oxygen saturation, but not explicitly stating an expert consensus process for the test set.
4. Adjudication Method for Test Set
This information is not explicitly provided in the document. The evaluation was against objective acceptance criteria and not described as involving human adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A multi-reader multi-case (MRMC) comparative effectiveness study was not explicitly mentioned for this device. The study focused on the standalone performance of the Adult IDO2 Index against established acceptance criteria.
6. Standalone Performance Study
Yes, a standalone study was done. The Adult IDO2 Index algorithm's performance was validated using clinical datasets.
7. Type of Ground Truth Used
The ground truth used was based on mixed venous oxygen saturation measurements, a physiological parameter that the Adult IDO2 Index aims to reflect (likelihood of inadequate delivery of oxygen, specifically defined as mixed venous oxygen saturation below a threshold of 50%).
8. Sample Size for Training Set
The document does not explicitly state the sample size used for the training set. It mentions that the Adult Risk Analytics Engine version 1.0 employs the "same model of human physiology as the one utilized in Risk Analytics Engine version 8.0 cleared under K213230 for the computation of the IDO2 index in pediatric patients (0 to 12 years of age), however, the physiology model has been modified to extend the age-based parameterization." This suggests that a previous model was adapted, but details of the original or updated training data size are not provided.
9. How Ground Truth for Training Set Was Established
The document does not explicitly describe how the ground truth for the training set was established. It states that the Adult Risk Analytics Engine version 1.0 "employs the same model of human physiology" as its predecessor, which was "modified to extend the age-based parameterization." This implies the model was developed based on physiological principles and likely validated against clinical data that included mixed venous oxygen saturation measurements. However, the specific process for establishing ground truth during the training phase is not detailed.
§ 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).