(103 days)
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.
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 5.0 or higher. When the IDO2 Index™ is increasing, it means that there is an increasing 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 5.0 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 IVCO2 Index™ presents partial quantitative information about the patient's respiratory 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. 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 provided text is a 510(k) summary for the Etiometry T3 Platform™ software. It describes the device, its intended use, and a comparison to a predicate device, focusing on changes made since the prior clearance. However, it does not contain the detailed acceptance criteria or the specifics of a study proving the device meets those criteria, especially in the context of an AI/ML device.
The document states: "The changes to the algorithm were validated using clinical data sets. The software verification and validation testing were 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." This indicates that some validation was performed, but the specific metrics, methodologies, and results that would constitute "acceptance criteria" and "detailed performance study" for an AI/ML algorithm are not included in this publicly available summary.
The device includes an "T3 Risk Analytics Engine software module" which calculates two indices: the IDO2 Index™ and the IVCO2 Index™. These are described as being derived by "mathematical manipulations of the physiologic data and laboratory measurements" and they provide "partial quantitative information about the patient's cardiovascular condition" or "respiratory condition." While these are algorithmic calculations, the document does not present them as a typical AI/ML system that would require a ground truth study with human expert readers for "acceptance criteria" based on metrics like sensitivity, specificity, or AUC, as is common for diagnostic AI.
Therefore,Based on the provided text, I cannot extract the specific information requested in your prompt regarding acceptance criteria and a study that proves the device meets them, especially in the context of AI/ML performance. The document focuses on showing substantial equivalence to a predicate device via comparative technological characteristics and a general statement of software verification and validation. It does not contain the detailed breakdown of the
AI/ML specific performance study as requested.
Here's a breakdown of why each point cannot be robustly addressed from the text:
- A table of acceptance criteria and the reported device performance: Not provided. The document states "The performance of the IDO2 Index™ was evaluated with and without regional oximetry to confirm the utility of the measurement as an input," but no specific performance metrics or acceptance criteria are listed.
- Sample sizes used for the test set and the data provenance: Not mentioned. It only states "validated using clinical data sets."
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned. The ground truth method is not explicitly detailed beyond the indices being "derived by mathematical manipulations of the physiologic data and laboratory measurements."
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not mentioned.
- 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: Not mentioned. The IDO2 and IVCO2 indices are described as providing "partial quantitative information" and not something on which therapy or drugs can be administered solely. There is no indication of a human-in-the-loop study to demonstrate improvement.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: The indices are calculated by the software ("algorithm only"), but the performance metrics for these calculations (e.g., accuracy against a gold standard for the derived "risk") are not presented.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The indices are mathematically derived from physiological data and lab measurements. The "ground truth" for these indices would likely be the accurate calculation based on these inputs, or potentially a correlation with actual patient outcomes (though no such correlation study is detailed here). The text mentions the indices represent "increasing risk of inadequate oxygen delivery" or "inadequate carbon dioxide ventilation," but how this "risk" itself is ground-truthed is not explained.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
In summary, the provided FDA 510(k) summary focuses on demonstrating substantial equivalence based on the device's intended use and technological characteristics compared to a previously cleared predicate and generalized statements of V&V. It does not provide the specific performance study details, particularly those related to acceptance criteria, ground truth establishment, and reader studies that are typically associated with AI/ML devices making diagnostic assertions.
§ 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).