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Orantech Temperature Probes are intended to be used for monitoring temperature. The temperature probes are reusable and designed for use with monitors of Philips Model MP30 and Nihon Kohden Model BSM-6301A. These devices are indicated for used by qualified medical personnel only.

Reusable temperature probes are used during patient temperature measurement for multi-patient use. These probes consist of a phone plug connector on the monitor end and a thermistor on the patient end. Temperature probes measure temperature by a resistor that is sensitive to temperature changes. These probes are connected to the patient monitor either directly by using a phono plug or by an interconnect cable. These probes have a skin or core contact with a patient.

These temperature probes are typically used with legacy Philips monitor model MP30 and Nihon Kohden monitor model BSM-6301A.

The medical device in question is the Orantech Inc. Temperature Probe, models TS-Y400-AG30, TS-Y400-AS30, TS-PH-AG30, and TS-PH-AS30.

Here's an analysis of the acceptance criteria and the study that proves the device meets those criteria:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Accuracy: The 'Product Specification' table explicitly states an accuracy of "± 0.1°C" for all models within the 25-45°C range. The "Laboratory accuracy" test result states "Not greater than 0.3°C", which is a broader allowance than the stated ± 0.1°C. Assuming the ± 0.1°C is the target, 'Not greater than 0.3°C' still indicates compliance.

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

The provided document does not specify the sample size used for the test set for any of the performance studies (biocompatibility, safety, accuracy, time response, use life, cleaning/disinfection).

The document does not specify the data provenance (e.g., country of origin of the data, retrospective or prospective). The testing was conducted by or for Orantech Inc., which is based in China.

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

This information is not provided in the document. The type of device (temperature probe) and the nature of the tests (laboratory accuracy, electrical safety, biocompatibility) typically do not involve establishing ground truth through human experts in the same way, for example, an AI diagnostic imaging device would. The "ground truth" for these tests would be derived from calibrated equipment and established scientific methods, rather than expert consensus on interpretation.

4. Adjudication Method for the Test Set

This information is not applicable/provided. Adjudication methods like 2+1 or 3+1 are typically used in studies involving human interpretation (e.g., radiology reads) to resolve discrepancies in ground truth establishment. For the types of tests conducted for a temperature probe, such methods are not relevant.

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

There was no MRMC comparative effectiveness study done. This type of study is relevant for AI-powered diagnostic devices that assist human readers (e.g., radiologists interpreting images). The Orantech Temperature Probe is a physical medical device for direct measurement, not an AI software.

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

This concept is not applicable to the Orantech Temperature Probe. It is a physical device, not an algorithm. The performance tests (laboratory accuracy, time response, etc.) represent its "standalone" performance in a controlled environment, but it's not an algorithm whose performance can be evaluated independently of human interaction in the clinical use context that AI devices are.

7. The Type of Ground Truth Used

The ground truth for the various tests was established through:

• Biocompatibility: Adherence to established international standards (ISO 10993 series) using laboratory testing for cytotoxicity, sensitization, and irritation. The "ground truth" is the scientific determination of biological response to the materials.
• Safety: Compliance with electrical safety standard (IEC 60601-1) through testing. The "ground truth" is the objective measurement of electrical parameters against the standard's limits.
• Performance (Laboratory Accuracy, Time Response, Use Life): Measurement against calibrated reference instruments and established performance criteria defined by medical device standards or internal specifications. For accuracy, the "ground truth" is the actual temperature measured by a highly accurate reference thermometer.
• Cleaning and Disinfection: Validation against AAMI TIR documents and FDA guidance, likely involving microbiological testing to confirm the reduction/elimination of pathogens. The "ground truth" is the demonstrably effective reduction of microbial load.

8. The Sample Size for the Training Set

This information is not applicable as the device is a physical temperature probe and not an AI/ML algorithm that requires a training set.

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

This information is not applicable for the same reason as above (not an AI/ML algorithm).

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