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The OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the hospital or clinical environment, and during emergency air or land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 110° F (0 to 43° C). The IR ear thermometer uses a patented ambient temperature compensation technique that allows it to provide accurate patient temperatures over the ambient temperature range 60 to 110° F (16 to 43° C). Below 16°C (60°F) a low ambient message is displayed.

The oximeter works with all BC1 oximetry probes providing SpO2 and pulse rate on all patients from neonate to adult. The IR ear thermometer must seal the ear canal opening and look into the ear canal to provide an accurate temperature measurement. Therefore the adult size temperature probe (3340 series) is restricted to patients over two years of age. The pediatric size temperature probe (3341 series) is restricted to patients over one month of age.

The 3301T Oxitemp, with the 3341 series pediatric temperature probes, is an updated version of the existing 3301T OxiTemp, with the 3340 series adult temperature probes, legally marketed by BCI International. The updated device provides all the features of the 3301T plus provides pediatric IR ear temperature measurement.

1. Table of Acceptance Criteria and Reported Device Performance:

   Test Type	Acceptance Criteria	Reported Device Performance
   Bench Test 1 (3341 vs. LTXP-1)	Largest difference 20 years of age).

   • Data Provenance: The document does not explicitly state the country of origin. It appears to be prospective testing conducted for regulatory submission.

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

   • No external experts were used to establish ground truth in the traditional sense. The "ground truth" for the bench tests was a "floating black body" or a "black plastic block" with known temperature characteristics, and for clinical tests, it was the measurements from predicate devices (OtoTemp LighTouch LTXP-1 and the 3301T with adult probe), implying these are accepted standards. The "user" for the clinical tests was described as "recently trained," but their specific qualifications beyond that are not mentioned.

3. Adjudication method for the test set:

   • No adjudication method (like 2+1 or 3+1) was mentioned. The performance was directly compared against the predicate devices or expected temperature ranges/differences.

4. 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:

   • This is not an AI-enabled device. Therefore, no MRMC study, AI assistance, or effect size related to human reader improvement is applicable or mentioned.

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

   • This is a physical medical device (temperature thermometer), not an algorithm. The reported performance is the standalone performance of the device, with human operation being part of its intended use.

6. The type of ground truth used:

   • Bench Tests: Physical temperature standards (floating black body, black plastic block with controlled temperatures).
   • Clinical Tests: Comparative measurements against legally marketed predicate devices (Exergen LTXP-1 and the BCI 3301T with 3340 adult probe) which serve as the "standard" or reference. "Ear-to-ear" measurements also serve as a measure of repeatability and user technique.

7. The sample size for the training set:

   • This document describes performance testing for a physical device, not development of a machine learning model. Therefore, there is no explicit "training set" in the context of AI/ML. All samples mentioned are for testing and validation of the device's performance against established standards.

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

   • As there is no training set for an AI/ML model, this question is not applicable.

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