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Sensatronic Reusable Temperature Probes are intended to be used for monitoring temperature. The temperature probes are designed for use with GE Healthcare monitoring systems, Schiller and other monitors compatible with YSI 400 Series temperature probes.

The probes are indicated for use by qualified medical personnel only.

Prescription use only.

Device Description

Sensatronic Reusable Temperature Probes(s) are designed and constructed for for compatibility with monitoring systems the using YSI 400 series temperature measurements specification.

Sensatronic Reusable Temperature Probes are constructed with the following features:

. Sealed phone plug design suitable for immersion cleaning and disinfection and steam sterilization
. Two internal conductors for connection to the thermistor
. Internal Kevlar fibers for strength and pull resistance
Biocompatible outer jacket of thermoplastic rubber (TPR)
. The general purpose esophageal/rectal probes are available in three sizes/diameters: 4 mm, 3.2 mm, 2.3 mm, in a 275 cm standard probe length (the -275 denotes the length in centimeters, other lengths available as shown below)
The probes for skin application are available in three ■ disk sizes/diameters: 16 mm, 10 mm, and 6 mm
트 The probes are offered with straight and right-angle 1/4 inch (6.35 mm) phono plug type connectors, as well as connectors for Schiller monitoring systems.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text for the Sensatronic Reusable Temperature Probes:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Accuracy (Temperature Measurement)	± 0.1 °C (25 °C – 45 °C) [This is the predicate's accuracy in the physiological range, implying the new device meets this for substantial equivalence.]	± 0.1 °C (25 °C – 45 °C)
Measurement Range	0°C to 50°C	0°C to 50°C
Electrical Safety	Compliance with IEC 60601-1	The probes met acceptance criteria for compliance to IEC 60601-1.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2	The probes met acceptance criteria for compliance to IEC 60601-1-2.
Usability	Compliance with IEC 60601-1-6 and IEC 62366 for professional use	Usability evaluation per IEC 60601-1-6 and IEC 62366 for professional use was conducted, and the probes met acceptance criteria.
Clinical Thermometer Specific Regs.	Compliance with ISO 80601-2-56 (including accuracy)	The probes met acceptance criteria for compliance to ISO 80601-2-56.
Environmental Storage	Compliance with IEC 60068-2-78 and IEC 60068-2-1	Environmental storage testing was performed per IEC 60068-2-78 and IEC 60068-2-1, and the probes met acceptance criteria.
Risk Management	Compliance with ISO 14971 (acceptability of residual risks)	The probes met risk management criteria for acceptability of residual risks.
Biocompatibility	Compliance with ISO-10993-1, ISO-10993-5 (Cytotoxicity), and ISO-10993-10 (Irritation, Sensitization)	The probe materials met the acceptance criteria for biocompatibility based on cytotoxicity, irritation, and sensitization tests.
Cleaning/Disinfection Efficacy	Compliance with ISO 15583-5, AAMI TIR30, FDA Guidance for Reprocessing Medical Devices in Health Care Settings (bioburden removal, disinfection efficacy)	The probes met acceptance criteria for cleaning and disinfection.
Steam Sterilization Efficacy	Compliance with ISO 17665-1 and ISO 11737-2	The probes met the acceptance criteria for steam sterilization.
Reuse Life Durability (Manual Cleaning)	Up to 300 cycles (performance maintained after testing)	The probes met acceptance criteria for durability and performance after testing up to 300 cycles for manual cleaning/disinfection.
Reuse Life Durability (Machine Wash)	Up to 300 cycles (performance maintained after testing)	The probes met acceptance criteria for durability and performance after testing up to 300 cycles for machine washing/disinfection.
Reuse Life Durability (Steam Sterilization)	Up to 100 cycles at 132°C/4 minutes (performance maintained after testing)	The probes met acceptance criteria for durability and performance after testing up to 100 cycles for steam sterilization.

Study Information

Sample size used for the test set and the data provenance:
- The document does not specify a numerical sample size for the test set in terms of individual devices tested for each criterion. The studies are referred to as "laboratory tested."
- Data Provenance: The studies were "laboratory tested," implying a controlled environment. The country of origin of the data is not explicitly stated, but the manufacturer is Sensatronic GmbH, located in Germany, suggesting the testing likely occurred there or at a contract lab. The studies were non-clinical.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable as the device is a temperature probe, and its performance is evaluated against physical standards (e.g., NIST-traceable temperature references) and established engineering/medical device standards, not against human expert interpretation of data. Therefore, "ground truth" here refers to objective measurements and standard compliance.
Adjudication method for the test set:
- Not applicable. Performance is determined by objective measurement against established standards and criteria, not by expert adjudication.
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. This is a medical device for temperature measurement, not an AI or imaging diagnostic software. Therefore, an MRMC study is not relevant.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Yes, in essence. The testing performed was primarily "standalone" in the sense that the device's technical performance (accuracy, electrical safety, EMC, durability, sterilization efficacy, biocompatibility, etc.) was evaluated objectively against predefined standards, without direct human-in-the-loop performance in a clinical diagnostic sense. Its function is to provide a measurement, which is then used by human medical personnel. However, the term "standalone" is usually used in the context of AI algorithms, which isn't the case here.
The type of ground truth used:
- The ground truth consists of established engineering and medical device standards, physical measurement references, and predefined performance criteria. For instance, temperature accuracy is measured against traceable reference thermometers, and safety/EMC against the limits specified in the relevant IEC standards. Biocompatibility results are compared against the limits defined in ISO 10993.
The sample size for the training set:
- Not applicable. This device is a hardware product (temperature probe), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML. The design and manufacturing processes are likely iterative, but this is not a "training set" in the sense of data used to train an algorithm.
How the ground truth for the training set was established:
- Not applicable for the same reason as point 7.

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