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The disposable rectal temperature probes are intended to be used for continually monitoring temperature for up to 10 minutes from the rectum of adults, the probes may be used for up to 24 hours.

The temperature probes are non-sterile and designed for single patient use with monitors of EDAN model iM50. These devices are indicated for use by qualified medical personnel in hospital environment.

Disposable temperature probe is used during patient temperature measurement. The probe consists of a phone plug connector on the adapter cable end and a thermistor on the patient end. The probe measures temperature by a resistor that is sensitive to temperature changes. The probe is connected to the patient monitor by using an interconnect cable.

The probe is used with legacy Edan Instruments, Inc. patient monitors iM50, which was cleared under K113623.

The probe is packed individually into a plastic bag in non-sterile condition. The package label describes product LOT codes, CE-mark, legal entity information and a caution "Rx Only ".

The provided text is a 510(k) Summary for a disposable temperature probe. Based on the content, the acceptance criteria and the study proving the device meets these criteria can be described as follows:

Acceptance Criteria and Device Performance Study for a Disposable Temperature Probe

This medical device is a Disposable Temperature Probe. The acceptance criteria and the performance study were conducted to demonstrate substantial equivalence to a predicate device (Caremed Disposable Temperature Probe K182755).

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a distinct "test set" in terms of subject or patient count for overall device performance. The testing reported appears to be primarily bench testing and standard compliance verification rather than a clinical study with a human subject test set.

• Sample Size: Not applicable in the context of a "test set" for human patients for performance, as the study focuses on bench testing and mechanical/electrical characteristics. The "samples" would refer to the probes themselves tested for accuracy, time response, safety, and EMC. The document does not specify the number of probes tested for each criterion.
• Data Provenance: The studies were conducted as non-clinical testing. There is no indication of country of origin for this specific testing, nor whether it was retrospective or prospective in a clinical setting. It is assumed to be prospective engineering and laboratory testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. This device is a temperature probe, and its performance (e.g., accuracy, time response) is assessed against objective engineering standards and specifications, not against a "ground truth" established by human experts like radiologists.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the performance is measured against objective standards, not subjective assessments requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. An MRMC study is typically performed for AI/image interpretation devices to assess the impact of AI assistance on human reader performance. This device is a temperature probe, not an AI-based diagnostic tool.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Yes, in essence. The "Performance" section explicitly states "Laboratory accuracy" and "Time response" were tested. While the probe needs to be connected to a monitor (EDAN model iM50), the accuracy and time response are inherent characteristics of the probe itself in combination with the specified monitor, and these tests are conducted in a controlled, standalone manner (i.e., without human interpretation or intervention in the measurement process). The safety, EMC, and usability tests are also "standalone" in the sense of directly evaluating the device's compliance with technical standards.

7. The Type of Ground Truth Used

The ground truth for the performance claims (accuracy, time response) would be established by:

• Reference Standards: Highly accurate, calibrated temperature measurement devices used in a laboratory setting.
• Industry Standards: Compliance with established international standards such as ISO 80601-2-56 for essential performance and IEC 60601-1/-2 for safety and EMC.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument (temperature probe), not an AI/machine learning algorithm that requires a "training set" of data.

9. How the Ground Truth for the Training Set Was Established

Not applicable, for the reasons stated in point 8.

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