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The Cadi SmartSense Wireless Temperature Monitoring System is intended to measure abdominal surface temperature in adults through neonates. The ThermoSENSOR, a reusable temperature sensor, is applied to the patient by means of single use application tapes.

The ThermoSENSOR provides periodic wireless transmission of temperature data which is utilized by the SmartNODE wireless receiver and the SmartSense PC application program to record, store, and display the temperature information.

Warning: This equipment measures and reports abdominal surface temperature – where direct measurements of body core temperature are required, it is recommended to utilize appropriate core temperature monitoring devices for this purpose.

Prescription Use X (Part 21 CFR 801 Subpart D) AND / OR

Over-The-Counter Use (21 CFR 807 Subpart C)

The Cadi SmartSense Wireless Temperature Monitoring System is intended for wireless automated measurement of abdominal surface temperature in adults through neonates used in any instance where quantifiable measurement of temperature data is desirable.

The system further provides the SmartSense PC Application with a dataentry interface that allows users to manually enter other vital signs parameters.

The SmartSense PC Application additionally provides a Vital Signs Dashboard view for convenient viewing and monitoring of patients' monitored temperature and manually entered vital signs.

The Cadi SmartSense Wireless Temperature Monitoring System consists of the following proprietary components:

• ThermoSENSOR patient applied wireless temperature sensor .
• SmartNODE wireless telemetry receiver receives ThermoSENSOR . data
• SmartSWITCH sensor activator accessory .
• SmartSense PC Application PC application software .

Additional system elements include information technology (IT) equipment used in a local area Ethernet network such as routers and switches.

Here's a breakdown of the acceptance criteria and study information for the Cadi SmartSense Wireless Temperature Monitoring System, based on the provided 510(k) summary:

The device is a Cadi SmartSense Wireless Temperature Monitoring System designed for wireless automated measurement of abdominal surface temperature in adults through neonates.

1. Table of Acceptance Criteria and Reported Device Performance:

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

No clinical test set was used, as it was stated that clinical tests were "none / none required." Therefore, information regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set is not applicable. The non-clinical tests involved various engineering and software tests on the device components.

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

Not applicable, as no clinical test set requiring expert-established ground truth was performed. Ground truth for the non-clinical tests would be established by validated test methodologies and measurement equipment in engineering labs.

4. Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring adjudication was performed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done. The document explicitly states "Clinical Tests Submitted: (none / none required)."

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document focuses on the performance of the integrated system, including the hardware (ThermoSENSOR, SmartNODE, SmartSWITCH) and software (SmartSense PC Application). While the software itself was validated (SmartSense PC/host software and embedded software... validated to meet intended use by software and system level performance testing), the overall evaluation was of the device as a system for temperature monitoring, not just a standalone algorithm's performance independent of the human user or other device components.

7. The Type of Ground Truth Used:

For the non-clinical tests, the "ground truth" was established by compliance with recognized standards and established engineering test methodologies. This would include:

• Reference electrical safety and EMC equipment
• Environmental chambers for temperature, humidity, shock, and vibration testing
• Calibrated measurement devices for software and system performance testing
• Biocompatibility testing against ISO standards.

For clinical validation (which was not performed), the implied "ground truth" would likely have been direct measurements of body core temperature using appropriate core temperature monitoring devices, as the device itself measures abdominal surface temperature with a warning that direct core temperature measurements might be needed for certain situations.

8. The Sample Size for the Training Set:

The document does not mention a "training set" in the context of an AI/ML algorithm or a learning system. The device uses a thermistor-based technology, which is a traditional sensor principle, not a machine learning model that requires a training set. The software mentioned ("SmartSense PC/host software and embedded software") would have undergone typical software development and testing, but not "training" in the AI sense.

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

Not applicable, as there was no training set for an AI/ML algorithm.

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