Search Results

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.

Ask a specific question about this device