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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.

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The Aware™ Transport Monitor System (includes Aware POD and Aware Transport Monitor) is intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a professional medical facility, such as a hospital, clinic, surgical center or doctor's office. It can be used in multiple areas such as operating room (OR), post anesthesia care unit (PACU), emergency department (ED), critical care, surgical intensive care, respiratory intensive care, coronary care, medical intensive care, pediatric intensive care, or neonatal intensive care.

The Aware POD is intended to provide uninterrupted acquisition of physiologic parameter data on adult, pediatric and neonatal patients during non-transport/bedside and transport patient care episodes. Physiological parameter data acquired by the Aware POD includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. This device acquires, processes and stores information for all aforementioned parameters and transmits this information to a transport or bedside central processing unit for viewing and alarm surveillance purposes.

The Aware Transport Monitor is intended for use as part of a transport monitoring system for intra-healthcare facility transport. When used with the Aware POD or the TRAM acquisition module, this device is intended to provide uninterrupted monitoring of physiologic parameter data for adult, pediatric, and neonatal patients during transport from one area of the healthcare facility to another. Physiological parameter data includes ECG, invasive blood pressure, non-invasive blood pressure, pulse oximetry, temperature, and respiration. Both the Aware POD and TRAM acquisition module acquire, process and store information for all aforementioned parameters.

The Aware™ Transport Monitor System is a complete, high-acuity patient monitoring system composed of two main parts: the Aware POD and Aware Transport Monitor.

The Aware™ Patient Observation Device (POD) is an acquisition module that measures and processes a patient's physiological parameters. Physiological parameter data acquired by the Aware POD includes 12 Lead ECG, respiration, up to four invasive blood pressure channels (as options), non-invasive blood pressure, Masimo SpO2, dual temperature and cardiac output (optional).

The Aware™ Transport Monitor is designed to be lightweight, rugged, and provide continuous monitoring capability when coupled with a compatible acquisition module. The Aware Transport Monitor is designed to facilitate quick, simple connection of either the Aware POD or TRAM 2001 module (K011000). The Aware Transport Monitor provides a means to alert the clinician of limit violations via audible and visual alarms.

Acceptance Criteria and Device Performance Study for Aware™ Transport Monitor System

This document outlines the acceptance criteria and a summary of the study used to demonstrate that the Aware™ Transport Monitor System meets these criteria, based on the provided 510(k) summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document does not explicitly present a table of specific numerical acceptance criteria. Instead, it broadly states that the device "complies with the voluntary standards as detailed in Section 9 of this submission" and that "The results of these measurements demonstrated that the Aware Transport Monitor System is as safe, as effective, and performs as well as the predicate devices."

Based on the information available, the acceptance criteria are implicitly tied to a combination of:

• Compliance with Voluntary Standards: Adherence to established industry and regulatory standards relevant to physiological patient monitors. (Specific standards are not detailed in the provided text.)
• Equivalency to Predicate Devices: Performance characteristics (safety and effectiveness) should be comparable to the legally marketed predicate devices (K011000 TRAM 2001 Module).

Implicit Acceptance Criteria & Reported Performance:

2. Sample Size Used for the Test Set and Data Provenance

The document indicates "Clinical Use Validation" and various levels of testing (unit, integration, final acceptance, performance, safety, environmental). However, it does not specify a distinct "test set" and a corresponding sample size for clinical validation nor does it provide details on the data provenance (e.g., country of origin, retrospective or prospective nature of clinical data). The testing described seems to be more focused on engineering verification and validation rather than a separate clinical performance study with a defined patient cohort.

3. Number of Experts Used to Establish Ground Truth and Qualifications

The provided text does not mention the use of experts to establish ground truth for a test set, nor does it specify their number or qualifications. The clinical validation is mentioned, but the methodology for assessing clinical outcomes or establishing "truth" for the device's physiological parameter measurements is not detailed beyond general testing.

4. Adjudication Method

The document does not describe any adjudication method used for a test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No MRMC comparative effectiveness study is mentioned. The device is a physiological monitor, not an imaging or diagnostic AI-assisted device where such studies are typically performed to assess human reader improvement. There is no information about AI assistance or human-in-the-loop performance improvement.

6. Standalone (Algorithm Only) Performance Study

Given that the device is a physiological patient monitor, its primary function is data acquisition and display. The concept of "standalone (algorithm only)" performance without a human in the loop is not directly applicable in the same way it would be for an AI diagnostic algorithm. The device's performance is inherently tied to its ability to accurately measure and process physiological parameters, which is implicitly evaluated through the "performance testing" and "clinical use validation." However, a specific standalone performance study report with metrics akin to AI algorithms is not provided.

7. Type of Ground Truth Used

The type of "ground truth" used for validating the accuracy of physiological parameter measurements is not explicitly stated. For physiological monitors, ground truth typically involves comparison against established reference devices or invasive measurements (e.g., arterial line for blood pressure, direct temperature probes, or gold-standard ECG recording systems). The document generally refers to "measurements" and "clinical use validation" without specifying the reference methods.

8. Sample Size for the Training Set

The document does not refer to a "training set" as the device is not described as utilizing machine learning or AI that would require a distinct training phase with a dataset. The development process mentions "Requirements Reviews," "Design Reviews," and various levels of testing, which are standard for medical device engineering but do not imply an AI model training paradigm.

9. How the Ground Truth for the Training Set Was Established

As there is no mention of a training set for an AI or machine learning model, the method for establishing ground truth for such a set is not applicable and hence not provided.

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The Aware™ Pad is indicated as an aid for performing breast self-examination.

Aware TM Pad is a thin polyurethane bladder, 9.5 inches in diameter containing a small quantity of silicone fluid. The very thin nature of the polyester polyurethane allows the pad to conform to the shape of the tissues underlying it. The very low coefficient of friction property of the silicone fluid in combination with the very thin and flexible bladder, provides easy sliding between the upper and lower surfaces of the bladder. Therefore, when properly used between the finger and the soft breast tissues of the patient, a reduction of friction is observed.

The provided text is a 510(k) summary for the Aware™ Pad, a device indicated as an aid for performing breast self-examination. This document is a regulatory submission for market clearance and does not contain a study proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a diagnostic or therapeutic device.

Instead, the submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, the Sensor Pad® (K973450). This process does not typically involve the detailed performance studies or pre-defined acceptance criteria that would be seen for higher-risk devices or novel technologies.

Therefore, many of the requested information points (acceptance criteria, specific study details, ground truth, expert qualifications, sample sizes for test/training, MRMC studies, standalone performance) are not applicable or not provided within the scope of this 510(k) summary.

Here's a breakdown based on the information available in the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. The 510(k) submission for the Aware™ Pad does not define explicit performance acceptance criteria and does not report detailed performance metrics from a study in the same way a diagnostic device would. The primary "performance" assessed is its technological characteristics demonstrating substantial equivalence to a predicate device.

2. Sample Size Used for the Test Set and Data Provenance

Not Applicable/Not Provided. A "test set" in the context of device performance testing for the Aware™ Pad is not described in this 510(k) summary. The submission relies on establishing substantial equivalence based on technological characteristics and intended use.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications

Not Applicable/Not Provided. The concept of "ground truth" established by experts for a test set is not presented for this device given the nature of the 510(k) submission and the device's function.

4. Adjudication Method for the Test Set

Not Applicable/Not Provided. As there is no described test set or expert evaluation detailed, an adjudication method is not relevant or described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or reported for the Aware™ Pad in this 510(k) summary. This type of study is typically used for imaging or diagnostic devices to assess reader performance. The Aware™ Pad is a simple aid for self-examination, not a diagnostic tool requiring such rigorous clinical validation.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. The Aware™ Pad is a physical device (a pad to aid tactile examination), not an algorithm or software. Therefore, the concept of "standalone algorithm performance" is not relevant.

7. The Type of Ground Truth Used

Not Applicable/Not Provided. For this device, ground truth in the sense of a clinical outcome or diagnostic truth is not defined. The basis for market clearance is "substantial equivalence" to an existing device, implying that the predicate's effectiveness is already established for its intended use as an aid for breast self-examination.

8. The Sample Size for the Training Set

Not Applicable/Not Provided. The Aware™ Pad is a physical device and does not involve AI/machine learning, and therefore does not have a "training set" in the context of algorithm development.

9. How the Ground Truth for the Training Set was Established

Not Applicable/Not Provided. As there is no training set, this question is not applicable.

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