(128 days)
AWARE™ is intended for use in the data collection, management and storage of patient information, and is used in conjunction with independent patient bedside devices and Hospital Information Systems connected via a network. This device is indicated for use by health care providing patient care in an ICU and Emergency Department healthcare setting.
AWARE is indicated for use in the clinical care of hospitalized adult and pediatric patient (newborn, infant, child, and adolescent) with or at risk of critical illness.
AWARE is not an Electronic Medical Record (EMR) application and AWARE use is not intended to replace electronic data management systems utilized by healthcare institutions such as an EMR, LIMS (Laboratory Information Management System), PACS (Picture Archive Communication), patient medical device monitoring and alarm systems.
AWARE is not a medical Alarm System and AWARE use is not intended to replace medical Alarm Systems (including monitors) within a healthcare institution. AWARE provides no auditory alerts nor does it provide monitoring and alerting of life threatening situations such as a ventilator disconnection, asystolia, or arthythmia. AWARE provides a visual ICUbased status of events reported from the institutions' source systems to aid in the clinical care decision process.
AWARE ™ is a stand-alone software product used by professional care providers in ICU and Emergency Department healthcare settings for the presentation, collection, management and storage of patient information. The AWARE application was created based on healthcare provider requirements to provide patient data through the use of an interface with built-in tools, practice surveillance, and decision support. The philosophy behind the system is the following:
- Identify and present relevant information from an institution's currently deployed patient . information systems
- Bundle related data into discrete systemic organ based packages to facilitate efficient informed ● decision making in a healthcare setting.
- Automatically collect and display critical patient data ●
This document is a 510(k) premarket notification for the AWARE™ device, a clinical decision support software.
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not explicitly state specific quantitative acceptance criteria or a dedicated performance table comparing AWARE™ to such criteria. Instead, it relies on demonstrating substantial equivalence to predicate devices through non-clinical performance testing and usability studies.
The "Non-clinical Performance" section describes the following activities:
- System level tests
- Performance tests
- Safety testing based on hazard analysis
- Cybersecurity issues addressed
- Verification and validation testing activities
The standards utilized are:
- ISO 14971: Medical Devices – Applications Of Risk Management To Medical Devices
- IEC 62304: Medical Device Software - Software Life Cycle Processes
- IEC 60601-1-8: Medical Electrical Equipment - Part 1-8: General Requirements For Basic Safety and Essential Performance – Collateral Standard: General Requirements, Tests and Guidance For Alarm Systems In Medical Electrical Equipment And Medical Electrical Systems
Reported Device Performance:
The "Conclusions from Non-clinical Performance Testing" states: "The AWARE™ 510(k) package and results on non-clinical testing demonstrate AWARE™ is substantially equivalent to the predicate devices, the iMDsoft MetaVision Graphical Patient Information System and the Philips Intellivue Clinical Information Portfolio."
The usability studies cited discuss "reducing information overload," "effect of two different electronic health record user interfaces on intensive care provider task load, errors of cognition, and performance," "representation of organ system domains," "interpretation of graphical icons," and "comparing accuracy, efficiency, and user satisfaction of two EMR [interfaces]." While these studies indicate performance related to usability, they do not provide specific quantitative metrics that directly map to "acceptance criteria" for the device's core functionality in collecting, managing, and storing patient information.
2. Sample Size Used for the Test Set and the Data Provenance:
Test Set Sample Size: Not explicitly stated for any of the non-clinical or usability tests. The usability studies describe methodologies but do not detail the number of "cases" or "patients" used for evaluation.
Data Provenance: Not specified for the non-clinical or usability tests. Given the nature of usability studies for a clinical interface, it is likely that simulated or retrospective data would be used, but this is not stated. The device itself is designed to interface with "an institution's currently deployed patient information systems," implying it processes real-world clinical data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
The document does not describe the establishment of a "ground truth" in the traditional sense of diagnostic accuracy for the test set, as AWARE™ is a data management and presentation system, not a diagnostic tool.
The usability studies referenced involve clinical professionals, but their role is generally as participants providing feedback on the interface's effectiveness and usability, rather than establishing a "ground truth" for a medical condition. For example, the studies involved "intensive care providers" and "clinicians." Specific numbers or detailed qualifications (e.g., years of experience) are not provided in this summary.
4. Adjudication Method for the Test Set:
Not applicable as there is no mention of a ground truth establishment process that would require adjudication. The usability studies would likely involve qualitative and quantitative analysis of user interactions and feedback, but not a consensus-based adjudication of medical findings.
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:
No MRMC comparative effectiveness study was done or reported. The device is described as "clinical decision support software," but its primary function is data collection, management, and storage, with visual presentation to aid decision-making. It does not appear to provide "AI assistance" in the sense of interpreting data or making automated recommendations that would be evaluated for improvement in human reader performance. Its value lies in organizing existing data efficiently.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, in spirit, the primary evaluation is standalone performance for the software's intended function. The regulatory submission focuses on non-clinical performance (system level, performance, safety, cybersecurity, and V&V testing of the software itself) and usability. The "Clinical Performance" section is explicitly marked "Not applicable." This indicates that the device's functionality, as a data aggregation and display system, was evaluated independently of human diagnostic performance.
7. The Type of Ground Truth Used:
Not applicable in the typical sense of a diagnostic device. For AWARE™'s function (data collection, management, storage, and presentation), the "ground truth" would relate to the accuracy and integrity of the data displayed against the source systems, and the usability and effectiveness of the interface in presenting that information. The document focuses on demonstrating that the software correctly processes and displays data from source systems, adhering to standards for risk management, software lifecycle, and alarm systems (even though AWARE™ is not an alarm system, it adheres to relevant safety standards). The usability studies investigate how clinicians interact with and interpret the presented data.
8. The Sample Size for the Training Set:
Not applicable. This device is not described as utilizing a machine learning algorithm that requires a "training set" in the context of AI model development. It is a rules-based and data integration software.
9. How the Ground Truth for the Training Set was Established:
Not applicable, as there is no explicit training set for a machine learning model.
§ 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).