(233 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.
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 post-surgical neonatal patients 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 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.
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 (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 includes Risk Analytics Engine that computes an Inadequate Oxygen Delivery Index (IDO2). 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.
The provided text describes the T3 Software, version 2.0.1, which includes a Patient Risk Analytics Engine calculating an Inadequate Oxygen Delivery Index (IDO2). The document is a 510(k) summary, making it a submission to the FDA for market clearance, stating that the new version is substantially equivalent to previous versions and other predicate devices.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based only on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly present specific, quantitative acceptance criteria for the IDO2 Index. Instead, it relies on demonstrating that the device's software functions as intended and that the IDO2 Index correlates with changes in physical status, similar to a predicate device.
| Acceptance Criteria (Implicit from document) | Reported Device Performance |
|---|---|
| Software Functionality: The software records and displays multiple physiological parameters accurately from supported bedside devices. | "Software verification and validation testing was conducted for the subject device... The results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9)." (Implies successful operation and comparable accuracy to predicate for data display and recording) |
| IDO2 Index Calculation & Interpretation: The Patient Risk Analytics Engine calculates the IDO2 Index correctly based on mathematical manipulations, and when elevated, indicates an "increased risk of inadequate oxygen delivery." (Accuracy of calculation and qualitative interpretation) | "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..." (The document states how it's derived and what an elevated index means, implying it performs this function as designed.) |
| Clinical Correlation of IDO2 Index: The IDO2 Index correlates with changes in the patient's physical status. | "Additionally, 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, as does the Visensia Index." (Directly states correlation observed in a validation study.) |
| Safety and Effectiveness: The device is safe and effective and raises no new questions of safety or effectiveness compared to predicate devices. | "The results of this testing demonstrate the safety and effectiveness of the subject T3 software product (Ver. 2.0.1) is comparable to that of the predicate T3 software products (Ver. 1.9) and the Visensia device." and "No new questions of safety or effectiveness are raised as a result of the differences when compared to the predicate device and the data provided in the submission show that the subject device is substantially equivalent to the legally-marketed predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states: "Additionally, 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, as does the Visensia Index."
- Sample Size: The sample size for the "validation study" is not specified in the provided text.
- Data Provenance: The country of origin of the data is not specified. The text only mentions "clinical data gathered in the intended patient population." It is also not specified if the data was retrospective or prospective.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
The document does not provide any information regarding the number of experts used or their qualifications for establishing ground truth in the validation study. The ground truth refers to "changes in the patient's physical status," but how this was determined by experts is not detailed.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
The document does not specify any adjudication method used for the test set.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
The document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study. The study focused on the correlation of the IDO2 Index with patient physical status. There is no mention of human readers or their improvement with or without AI assistance. The device is intended to aid clinical decisions and provide quantitative information, but not in a comparative effectiveness study involving human interpretation.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, the validation study appears to be a standalone performance study of the algorithm. The statement "validation study results... demonstrate the IDO2 Index... correlates with changes in the patient's physical status" indicates an evaluation of the algorithm's output (the IDO2 Index) against an independent measure of patient status, without involving human-in-the-loop performance measurement.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The ground truth used is "changes in the patient's physical status." The specific method for determining "changes in the patient's physical status" (e.g., expert consensus, specific clinical criteria, or other outcomes data) is not detailed in the provided text.
8. The sample size for the training set
The document does not specify a separate "training set" or its sample size. The description focuses on the validation of the IDO2 Index, which implies the algorithm's parameters were already established.
9. How the ground truth for the training set was established
Since a "training set" is not mentioned, the document does not provide information on how ground truth for any training set was established. The IDO2 Index is described as being "derived by mathematical manipulations of the physiologic data and laboratory measurements," suggesting a formulaic or rule-based derivation rather than a machine learning model trained on labeled data in the context usually implied by "training set ground truth."
§ 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).