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Celsi Monitor is intended for use in hospitals under a clinician's supervision or at their direction to assist nurses in continuous temperature monitoring of neonates. The device abdominal skin temperature through direct contact.

Celsi Monitor is a non-invasive continuous temperature monitor. Celsi Monitor achieves its intended purpose by measuring temperature at the surface of a neonate's abdomen by sensing changes in electrical resistance of a thermistor that is in thermal contact with the skin at the measured point. Celsi Monitor is provided with the Celsi Belt. The Celsi Monitor is powered by two rechargeable lithium-ion batteries. Both the Celsi Belt and Celsi Probe are reusable. The device displays measured patient body temperature for up to 12 hours and alarms when the temperature falls outside normothermic levels (37.5 °C). The device is a skin contacting surface device with duration of contact

This document is a 510(k) Premarket Notification from the FDA for the "Celsi Monitor" device. It outlines the device's characteristics, intended use, and a comparison to a predicate device, along with summaries of testing performed.

Acceptance Criteria and Device Performance:

The document doesn't explicitly list "acceptance criteria" in a table form with specific performance thresholds for the Celsi Monitor. Instead, it describes general compliance with standards and comparable performance to a predicate device. Its primary acceptance criterion for the 510(k) clearance is demonstrating substantial equivalence to an existing legally marketed device (the predicate device). This substantial equivalence is shown through similar intended uses, technological characteristics, and a demonstration that any differences do not raise new questions of safety or effectiveness.

The "study that proves the device meets the acceptance criteria" refers to the non-clinical and clinical testing performed to support the claim of substantial equivalence.

Here's an attempt to structure the information based on the prompt's request for acceptance criteria and device performance, drawing from the provided text:

Table of Performance and (Implied) Acceptance Criteria:

Detailed Study Information:

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

   • Test Set Sample Size: Not explicitly stated in terms of number of neonates or temperature readings. The document mentions "A short duration (3 hour) and long duration (12 hour) clinical evaluation was performed".
   • Data Provenance: Not explicitly stated (e.g., country of origin). The studies were "clinical evaluations" and thus would be prospective in nature, designed to test the device's performance directly on subjects.

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

   • Not applicable in the context of this device. This is a temperature monitor; ground truth is established by a reference thermometer (Philips Intellivue MP30) or direct physical measurements, not by expert interpretation.

3. Adjudication Method for the Test Set:

   • Not applicable as the ground truth is objective temperature measurement rather than subjective interpretation requiring adjudication.

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

   • No, a MRMC study was not described. This type of study is typically for evaluating diagnostic imaging AI where human readers interpret cases. The Celsi Monitor is a measurement device.

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

   • Yes, the clinical evaluation directly assessed the device's (Celsi Monitor's) temperature measurement performance. While used by nurses, the core "performance" being evaluated (temperature accuracy) is a standalone function of the device itself.

6. The Type of Ground Truth Used:

   • Reference device measurement: The "subject device was compared to the reference device, the Philips Intellivue MP30 (K061610)." The Philips Intellivue MP30 serves as the ground truth for temperature measurements.

7. The Sample Size for the Training Set:

   • Not applicable. This document describes the clearance of a medical device (a thermometer), not an AI/ML algorithm that requires a "training set" in the conventional sense for machine learning. The device's performance is based on its physical design and calibration, not learned from data.

8. How the Ground Truth for the Training Set was Established:

   • Not applicable, as there is no "training set" for this type of device.

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