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DynaSense monitors orientation and activity of patients susceptible to pressure ulcers. It allows healthcare providers to implement individualized turn management plans and continuously monitor each patient. DynaSense provides alerts when patient orientation or activity deviates from parameters set by healthcare providers. The device is intended for use in medical, nursing and long-term care facilities including independent living, assisted living and rehabilitation facilities.

DynaSense is a patient monitoring system that has been designed for use in hospitals, nursing homes, or other patient care facilities to aid standard care procedures for patients who are susceptible to pressure ulcers. The system monitors and reports patient activity and orientation as well as alerts the user (i.e., healthcare provider) when activity levels deviate from parameters set by healthcare providers. DynaSense is comprised of Patient Sensors, Relay Antennas, a USB RF Transceiver, Mesh Network Server Software, and User Interface software.

Each Patient Sensor is associated with a single patient, such that the patient's orientation and activity can be monitored. Data collected by the Patient Sensor is automatically communicated wirelessly to a nearby Relay Antenna, which subsequently relays these data to be displayed on the User Interface and maintained in a database. The system's Relay Antennas that are plugged into electrical outlets on the walls of the facility and the USB RF Transceiver that is plugged into the computer, on which the Mesh Network Server Software is installed or accessed, form a wireless network that allows data to be transmitted for display. The Mesh Network Server Software manages this network of Relay Antennas and USB RF Transceiver and collects the data from the Patient Sensors to allow monitoring of multiple patients on a single screen within the User Interface.

The Centauri Medical, Inc. DynaSense System, a bed-patient monitor, was reviewed for substantial equivalence (K130752). The device is intended to monitor patient orientation and activity to aid in pressure ulcer prevention.

Acceptance Criteria and Device Performance:

The provided document does not explicitly state quantitative acceptance criteria or a detailed table of device performance against such criteria. Instead, it broadly states that "the collective results of the testing demonstrate that the chosen materials, the manufacturing processes, and design of DynaSense meet the established specifications necessary for consistent performance during its intended use." It also concludes that the device "does not raise new questions of safety or effectiveness for monitoring patient activity when compared to the predicate devices."

The study described primarily focuses on qualitative assessments and established engineering standards to demonstrate substantial equivalence to predicate devices (Wireless MedCARE VivaTRAK™ System (K101109) and AFrame Digital MobileCare Monitor™ (K090138)).

Key Information from the Study:

1. Acceptance Criteria and Reported Device Performance:

   Acceptance Criteria Type	Reported Device Performance
   Design Verification (e.g., software verification)	The collective results of testing demonstrate that the design meets established specifications necessary for consistent performance.
   Electrical Safety Testing	The collective results of testing demonstrate that the device performs as intended in its intended use environment and does not raise new questions of safety or effectiveness.
   Electromagnetic Compatibility (EMC) Testing	The collective results of testing demonstrate that the device performs as intended in its intended use environment and does not raise new questions of safety or effectiveness.
   Safety and Effectiveness compared to Predicate Devices	"The collective testing results demonstrated that DynaSense does not raise new questions of safety or effectiveness for monitoring patient activity when compared to the predicate devices." Implies performance comparable to predicate devices in terms of patient activity monitoring, orientation tracking, and alert functionality to aid in pressure ulcer prevention. The device has "the same intended use and similar technological characteristics" as the predicate devices, with no differences raising new safety or effectiveness concerns. The device “performs as intended in its intended use environment.”

2. Sample size used for the test set and the data provenance:

   The document does not explicitly state the sample size of a test set, nor does it detail the specific data provenance (e.g., country of origin, retrospective/prospective). The performance testing mentioned is "design verification (e.g., software verification), Electrical Safety, and Electromagnetic Compatibility testing," which are typically conducted in a laboratory or controlled environment rather than with patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   This information is not provided in the document. The testing described focuses on engineering validation and regulatory compliance, not clinical performance assessed by experts against a ground truth in a clinical setting.

4. Adjudication method for the test set:

   This information is not provided. Given the nature of the testing (design, electrical, EMC), clinical adjudication methods would not typically apply.

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, as this is a patient monitoring device, not an imaging interpretation or diagnostic AI tool that would involve human "readers" or AI assistance for interpretation. The device itself provides alerts to healthcare providers based on set parameters.

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

   The device is a standalone monitoring system. It operates to detect patient orientation and activity and generate alerts based on predefined parameters. The "human-in-the-loop" component is where healthcare providers respond to these alerts and use the information to implement turn management plans. The core functionality of monitoring and alerting is performed by the algorithm/system autonomously.

7. The type of ground truth used:

   The document does not specify a "ground truth" in the clinical sense (e.g., pathology, outcomes data). The "ground truth" for the engineering tests would be the established specifications and accepted standards for electrical safety, EMC, and software functionality. For example, in electrical safety testing, the ground truth is adherence to voltage, current, and insulation limits.

8. The sample size for the training set:

   This information is not provided. The development of monitoring systems like DynaSense typically involves engineering design, calibration, and validation, rather than the "training set" concept common in machine learning or AI models developed from large datasets. While there is "Mesh Network Server Software" and "User Interface software," the description does not suggest a deep learning or similar AI model that would require a distinct "training set" for classification or prediction tasks.

9. How the ground truth for the training set was established:

   This information is not applicable, as no explicit "training set" in the context of machine learning/AI models is mentioned. Rather, the device's functionality is based on programmed logic and sensor data interpretation.

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