(126 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 count, and lactic acid.
WARNING: T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring. Do not rely on the T3 Software Solution as the sole source of patient status information.
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 .
The T3 Software is intended for the display and recording of multiple physiological parameters of adult, pediatric and neonatal patients. T3 is not intended for alarm notification, nor is it intended to control any of the independent bedside devices to which it is connected
The T3 software can display user-defined, derived measures. These measures include the percentage of time within a time period that a particular variable is above or below a threshold. The user can configure the time period, threshold, and label of the resulting derived measure for ease of use considerations, only.
The T3 Software is not an active patient monitoring system. It is intended to supplement and not replace any part of the hospital's device monitoring.
T3 has a web architecture consisting of a user interface that runs in a browser, and a central web server. The T3 server, a set of cooperating web services written in Java, processes data as it is received, caches it in memory, and writes out copies of the data to a relational database and to the file system. In this manner, the data is available to the user interface to be visualized by the end user - a clinician.
Clinicians access the T3 user interface in a web browser. T3 runs in current browsers that support HTML5, Javascript and web sockets, such as Chrome, Firefox, Safari and Internet Explorer. The clinicians may be in the hospital, or may be outside the hospital accessing T3 over a Virtual Private Network (VPN). Clinicians use T3 in addition to the physiometric devices themselves and other information sources such as the electronic medical record to monitor the patient's condition.
The provided document is a 510(k) premarket notification for the Etiometry T3 Software Version 1.9. It outlines the device's indications for use and compares its technological characteristics to a predicate device. However, it explicitly states that clinical testing was not required for this submission.
Therefore, the document does not contain a study that proves the device meets specific acceptance criteria in terms of clinical performance. Instead, its substantial equivalence is based on software verification and validation, and comparison to a predicate device.
Given that no clinical study was conducted as part of this submission, I cannot provide the requested information about acceptance criteria, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, or ground truth details.
The document states:
- "Software verification and validation testing has been conducted for T3 Software and documentation has been provided in accordance with FDA 's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices", May 11, 2005."
- "Clinical testing was not required."
This indicates that the "performance data" referred to in Section VII primarily pertains to software V&V, ensuring the software performs as designed and intended, rather than proving clinical efficacy or diagnostic accuracy against a clinical ground truth.
If you have other documents that describe clinical performance studies for this device, please provide them.
§ 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).