Search Results

The 3301T OxiTemp provides fast, reliable SpO2, pulse rate and temperature measurements. It can be used in the houpital or clinical environment, and during emergency air or land transport. The counter 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 tachnique 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 3301T SA OniTemp extends the ambient temperature range the device can operate in up to 130°F (54°C) and down to 32°F (0°C).

The Oxitemp, 3301T SA, pulse coximeter is an updated version of existing 3301T OxiTemp legally marketed by BCI International. The updated device provides all the features of the 3301T plus provides tympanic temperature measurement and extends the ambient operating temperature range.

The information provided focuses on the safety and effectiveness of the BCI 3301T SA Oximeter with Ear Thermometer (OxiTemp). However, it lacks many details typically found in acceptance criteria and study designs for modern AI/ML medical devices. The device described is a physical medical device, not an AI/ML diagnostic tool. Therefore, some of the requested information (like number of experts, adjudication methods, MRMC studies, training set details) is not applicable or not present in the provided text.

Here's an attempt to extract and present the available information according to your requested format, noting where information is missing or not applicable to this type of device:

Acceptance Criteria and Device Performance

Study Details:

1. Sample sizes used for the test set and the data provenance:
   • Human Subjects: 34 people were used for the comparative clinical study involving ear temperature readings.
   • Data Provenance: Not explicitly stated, but given the context of a 510(k) submission, it's highly likely to be within the United States. The studies appear to be prospective, laboratory-based, and human subject (for the last test) evaluations.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
   • Not applicable as this is a physical medical device measuring physiological parameters, not an AI/ML diagnostic device requiring expert interpretation of images or data to establish ground truth.
3. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
   • Not applicable. Ground truth for temperature measurement is typically established by comparing against a highly accurate reference thermometer or by direct measurement. The comparison with a predicate device serves as a form of "ground truth" or equivalence benchmark.
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:
   • Not applicable. This is not an AI/ML device, and no human reader interpretation or assistance is involved in its function or assessment.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   • Yes, implicitly. The tests described (e.g., oximeter operation at temperature, temperature tracking, reading target temperatures) are standalone performance tests of the device itself, without human intervention in the measurement process after initial setup. The last test with 34 people compares the device's readings.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   • For Oximeter Performance/Temperature Tracking: Defined and controlled environmental conditions (e.g., oven, environmental chamber) and calibrated temperature targets up to 130°F.
   • For Human Temperature Readings: The predicate device (Exergen OtoTemp HTTS-3000-SD) served as the reference/comparator for establishing equivalence. The 1.0°F (2SD) specification acts as an acceptable range around these comparative measurements.
7. The sample size for the training set:
   • Not applicable. This device is not an AI/ML device and does not involve a "training set" in the computational sense.
8. How the ground truth for the training set was established:
   • Not applicable. No training set is involved.

Ask a specific question about this device