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The Mon-a-Therm™ General Purpose Temperature Probe 400TM is indicated for use in the routine monitoring of temperature in an anesthetized patient. The device is intended primarily for insertion into the esophagus or rectum, although medical judgment may dictate the selection of other anatomical sites such as the nasopharynx for some patients.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is a finished medical device that monitors temperature and are versatile probes that may be used for esophageal, nasopharyngeal or rectal placement.

Features and benefits:

• Fully enclosed sensor helps ensure patient safety
• Satin Slip™ finish for easy insertion ●
• Compatible with most multifunction patient monitors. Refer to Table 1: Summary of Mon-a-. Therm™ 400 Series Thermistor Interface Cables.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM is packaged individually as a sterile, single-use device and is available in the following sizes: 9 Fr 100/case CFN 90050 and 12 Fr 100/case, CFN 90050.The device and its packaging are not made with natural rubber latex or phthalates. The type of probe and device size are designated on the unit package.

The Mon-a-Therm™ General Purpose Temperature Probe 400TM components are illustrated in Figure 2.

• 1. Tube Blue
• 2. Sleeve GP
• 3. Thermistor Assembly
• 4. Slurry Mixture

The structure of Mon-a-Therm™ General Purpose Temperature Probe 400TM is illustrated in Figure 3 below. The tip of the probe is sealed with PVC and silicone at the end of the thermistor which is where the sealed tube directly contacts the mucosa as shown in "Detail A".

A temperature probe is located near the distal tip. Refer to Figure 3: Structure of Subject Device. The catheter of the subject device features a frosted external surface, referred to as Satin Slip surface. This specialized surface coating extends across the entire external area of the subject device.

Each probe is electrically connected to a compatible reusable cable which is specified in Table 1: Summary of Mon-a-Therm™ 400 Series Thermistor Interface Cables and compatible monitors by the connector in the tail of the probe. The reusable connects the probe to a patient monitor, which is compatible with YSI-400 Series thermistor, so that the temperature measurement value is displayed on the screen of monitor. All patient monitors that meet the specifications for YSI-400 thermistor, temperature accuracy, and compatible interface cables are compatible. Refer to Figure 4: Illustration of Patient Monitor Compatibility.

The provided text is a 510(k) summary for the Mon-a-Therm™ General Purpose Temperature Probe 400TM. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on benchtop performance testing and adherence to relevant standards. It does not describe an AI/ML-based device or a study involving human readers or ground truth established by experts for image analysis.

Therefore, many of the requested details regarding acceptance criteria for an AI/ML device, and studies involving human readers, ground truth establishment, or multi-reader multi-case (MRMC) studies, are not applicable or described in this document.

However, based on the provided text, I can infer the acceptance criteria for the temperature probe's performance and what demonstrates that the device meets those criteria for certain aspects, primarily focusing on its temperature measurement accuracy.

Here's a breakdown of the available information:

Implied Acceptance Criteria and Reported Device Performance for the Mon-a-Therm™ General Purpose Temperature Probe 400TM

Since this is a thermal probe and not an AI/ML device, the acceptance criteria are not for diagnostic performance metrics like sensitivity, specificity, or AUC, but instead for physical and performance characteristics of a temperature measurement device.

1. Table of Acceptance Criteria and the Reported Device Performance:

The document states that the subject device (Mon-a-Therm™) has been updated to align with the latest regulation EN ISO 80601-2-56:2017, which expanded the required temperature range.

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

• The document mentions "Bench Performance Testing" and specifically a "Verification Test Report for Temperature Accuracy and Storage Temperature" for assessing the impact of PVC material changes on temperature accuracy.
• However, no specific sample sizes (number of probes tested) are provided for these bench tests.
• Data Provenance: This is not explicitly stated in terms of country of origin but is implied to be internal testing conducted by Covidien, Ilc, which is located in Boulder, CO, USA. The testing is described as validation and verification testing, which is typically prospective for new product development.

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

• Not applicable. This is a temperature probe, not an AI/ML device requiring clinical expert interpretation for ground truth. Ground truth for temperature accuracy is established via calibrated reference thermometers and controlled environmental conditions.

4. Adjudication method for the test set:

• Not applicable. No expert adjudication process is described or relevant for this type of device testing.

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:

• Not applicable. This device is a temperature probe, not an AI-assisted diagnostic tool. No MRMC study was conducted.

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

• Not applicable. There is no "algorithm only" performance for this device in the context of AI/ML. The device's "standalone" performance refers to its accuracy and other physical characteristics measured against established standards.

7. The type of ground truth used:

• For temperature accuracy, the ground truth is established by calibrated reference standards/thermometers in controlled environments, as per the requirements of standards like EN ISO 80601-2-56.
• For biocompatibility, safety, EMC, usability, and sterilization, the "ground truth" is compliance with the specific requirements and test methods outlined in the cited international standards (e.g., ISO 10993 series, IEC 60601 series).

8. The sample size for the training set:

• Not applicable. This device does not involve a "training set" in the context of machine learning.

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

• Not applicable. No training set for machine learning.

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