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The DeRoyal Temperature Monitoring Probe is used for routine of the patient's core body or skin surface temperature.

The probe is offered in the following three configurations :

• General Purpose Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion into the nasopharyngeal, esophageal, or rectal cavities.

• Adult Skin Temperature Sensor for routine monitoring of skin temperature by application of the probe's adhesive cover to an adult patient's skin surface.

• Tympanic Temperature Probe for routine monitoring of the core body temperature in adult and pediatric patients by insertion of the ear piece into the auralcanal.

The device is single use and for use by licensed healthcare practitioners only. The probes are designed to interface with DeRoyal- branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport. Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

The DeRoyal Temperature Monitoring Probe is used for routine patient temperature monitoring. Each probe is single use and contains a wire set with a blue connector at the proximal end and a thermistor chip at the distal end. The thermistor passively modifies the electrical current traveling through the probe. The connector interfaces with a cable that is connected to an independent temperature monitor used to display the temperature readings.

There are three probe configurations included in this submission:

• 1. An adult skin temperature sensor that consists of the wire set with an adhesive probe cover that is applied to the patient's intact skin for monitoring of skin surface temperature.
• 2. A tympanic temperature probe that consists of the wire set with a foam ear plug that is inserted into the aural canal for monitoring of core body temperature.
• 3. A general purpose temperature probe that consists of the wire set enclosed in a tube that may be inserted into the esophageal, rectal, or nasopharyngeal cavities for monitoring of core body temperature.

All probes are individually packaged. The tympanic configuration is non-sterile. The other two configurations are sold sterile. The probes are designed to interface with DeRoyal-branded cables for connection with YSI 400 or 700 series compatible monitors, including the following patient monitors and equivalent models: Mindray Passport, Philips IntelliVue, Siemens/Draeger Infinity, and GE Datex-Ohmeda brands.

This document is a 510(k) Premarket Notification for a medical device: the DeRoyal Temperature Monitoring Probe. It focuses on demonstrating substantial equivalence to previously cleared predicate devices rather than proving the device meets an algorithm's acceptance criteria through a study with a test set, ground truth, or expert readers.

Therefore, the provided text does not contain the information required to populate the fields related to an AI/ML algorithm's acceptance criteria and study proving performance. The document is a regulatory submission for a physical thermometer probe, detailing its characteristics, intended use, and comparison to predicate devices, along with the physical tests performed (biocompatibility, electrical safety, accuracy, etc.) to ensure its safety and effectiveness.

Here's why the requested information about AI/ML acceptance criteria and studies is not present:

• Device Type: The device in question is a "DeRoyal Temperature Monitoring Probe," which is a physical clinical electronic thermometer. It measures temperature directly using a thermistor. It is not an AI/ML powered device that would process data or images to provide a diagnosis or prediction.
• Regulatory Pathway: A 510(k) submission for a physical device like this primarily focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, often by comparing technical characteristics and showing adherence to relevant performance standards (e.g., ISO for accuracy and safety). This does not involve large-scale data studies with ground truth established by experts or MRMC studies that are typical for AI/ML device clearances.
• "Acceptance Criteria" in this context: For this type of device, "acceptance criteria" generally refer to the performance specifications (e.g., accuracy within a certain range like ±0.2°C, operating conditions) and safety requirements (biocompatibility, electrical safety) that the device must meet, often defined by recognized national or international standards (e.g., ISO 80601-2-56 for medical thermometers). The study that "proves" these are met involves physical testing of the device prototypes or production samples against these standards, not clinical data studies with expert ground truth.

To directly answer your request based on the provided document, the following points can be extracted, while acknowledging that many of your specific questions are not applicable to this type of regulatory submission:

1. A table of acceptance criteria and the reported device performance:

   • "Study" Name: Summary of Performance Tests (as described in the document)
   • Device Under Test: DeRoyal Temperature Monitoring Probe (General Purpose, Adult Skin Sensor, Tympanic configurations)

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

   • The document refers to "final, finished products manufactured with the proposed modification" being tested (Page 12), implying physical samples of the device. Specific sample sizes for each test (e.g., how many probes were tested for accuracy or biocompatibility) are not provided in this summary, which is common for a 510(k) summary.
   • Data Provenance: This is not a data study in the sense of patient data. The testing described is laboratory-based performance and safety testing of the manufactured device. There is no information on country of origin for the test data, or if it was retrospective or prospective, as these terms are not applicable to this type of device testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This is a physical thermometer, not an AI/ML algorithm that requires expert human interpretation or ground truth labeling from clinical data. The "ground truth" for a thermometer is a calibrated reference thermometer or standard against which its readings are compared, or specific standardized tests for biocompatibility and electrical safety.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There is no adjudication method described as it's not a clinical data review or AI/ML output review.

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 is a physical medical device (thermometer probe), not an AI-assisted diagnostic tool. No MRMC study was performed or is relevant.

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

   • Not applicable. No algorithm is being submitted for standalone performance evaluation. The device is a direct measurement instrument.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

   • Not applicable in the AI/ML context. For the accuracy testing, the "ground truth" would be the known, precisely controlled temperatures in a laboratory setting, measured by a validated reference standard. For biocompatibility and electrical safety, the "ground truth" is adherence to the specified limits and test methodologies outlined in the referenced ISO and IEC standards.

8. The sample size for the training set:

   • Not applicable. This device does not have a "training set" as it is not an AI/ML model.

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

   • Not applicable. No training set exists for this device.

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The Disposable Temperature Probe (body surface type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's skin temperature.

The Disposable Temperature Probe (celomic type) is to be used with a compatible medical monitor that has temperature measurement function to continuously measure the patient's oral, rectal, nasopharyngeal cavity temperature.

The Disposable Temperature Probe is a noninvasive, quick-acting, safe and secure way for continuous temperature monitoring. It provides an effective way for doctors to obtain patient's temperature. The Disposable Temperature Probe obtains temperature information through the influence degree that the thermal balance has on the resistance value of thermistor sensor after it has contacted human body. The Disposable Temperature Probe is intended to be connected to a compatible medical monitor which is Model C30 (Manufacturer: COMEN) to continuously measure the patient's temperature, which can only be used by professionals for single use. It has two types which are body surface type (model: TAS03-15. TAS03-16. TAS03-17) and celomic type (model: TAE03-09S, TAE03-10S, TAE03-12S, TAE03-13S, TAE03-13S, TAE03-14S, TAE03-15S, TAE03-16S). The body surface type is mainly pasted under the axilla while the celomic type is inserted into the oral, rectal or nasopharyngeal cavity. The temperature probes should not be used for more than 24 hours. The Disposable Temperature Probe is composed of plug, cable and temperature sensing probe. For patient-contacting components, their materials have all been tested and evaluated for biocompatibility.

The provided text describes the acceptance criteria and the study that demonstrates the performance of the Disposable Temperature Probe.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

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

The document does not specify the sample size used for any test sets (e.g., for accuracy, biocompatibility, electrical safety, or EMC). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective). It generally states that "Non-clinical testings have been conducted" and refers to compliance with international standards.

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 document refers to compliance with international standards for performance and safety tests, which typically involve laboratory testing rather than expert-established ground truth for a clinical dataset.

4. Adjudication method for the test set

This information is not provided in the document. As mentioned above, the tests described are primarily engineering and laboratory-based, not clinical studies requiring adjudications.

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

An MRMC comparative effectiveness study was not conducted. This device is a disposable temperature probe, which is a physical measurement device, not an AI-assisted diagnostic tool for which an MRMC study would be relevant.

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

This concept is not applicable to this device. The Disposable Temperature Probe is a sensor; it does not contain an algorithm in the sense of AI or image analysis. Its performance is evaluated through direct physical measurements against established standards.

7. The type of ground truth used

For accuracy, the ground truth would be precise temperature measurements from calibrated reference instruments or environments during laboratory testing. For biocompatibility, the ground truth is established by the accepted biological responses to materials as defined by ISO 10993 standards. For electrical safety and EMC, the ground truth is compliance with the limits and conditions specified in the respective IEC standards.

8. The sample size for the training set

This device does not involve a "training set" in the context of machine learning or AI. Therefore, this information is not applicable.

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

As there is no training set for this device, this information is not applicable.

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