OXITEMP, 3301T SA by BCI INTL., INC.

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).

Device Description

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.

AI/ML Overview

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

Acceptance Criteria	Reported Device Performance
Oximeter Operation at High Ambient Temperature (130°F)	The oximeter portion of the OxiTemp operated properly at 130°F for almost eight hours (approximately 4.5 hours specifically at 130°F).
Temperature Tracking up to 130°F (Ambient and Target Same)	The 3301T SA correctly operated and tracked the temperature of a target up to 130°F when ambient and target temperatures were the same.
Reading Patient (Target) Temperature (98.6°F) in Ambient up to 130°F	The 3301T SA read a patient (target) temperature of approximately 98.6°F in ambient temperatures up to 130°F.
Reading Patient (Target) Temperature (98.6°F) in Ambient at 32°F	The 3301T SA read a patient (target) temperature of approximately 98.6°F in an ambient temperature of 32°F.
Measuring Target Temperature over Specified Range (65°F to 110°F) compared to Predicate Device	The 3301T SA measured target temperatures over the specified range of 65°F to 110°F, comparing favorably to the predicate device (OtoTemp HTTS-3000-SD). (Implicitly, the device met the comparison standard, but no specific delta is given beyond the overall 1.0°F specification below).
Temperature Reading Accuracy on Human Subjects (OxiTemp vs. OtoTemp & Ear-to-Ear) within 1.0°F (2SD, 95.45%)	For both ear-to-ear measurements on the 3301T SA and OxiTemp vs. OtoTemp comparisons, the device performed within the 1.0°F (two standard deviation, 95.45% population) specification. Statistical methods were used. (The Oxitemp passed all tests).

Study Details:

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.
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.
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.
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.
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.
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.
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.
How the ground truth for the training set was established:
- Not applicable. No training set is involved.

Summary

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MAY 1 5 1996

Summary of Safety and Effectiveness

Submitter: Address:

Telephone: Contact:

Prepared:

Proprietary Name: Common/Classification Name: Predicate Devices:

BCI International, Inc. W238 N1650 Rockwood Drive Waukesha, WI 53188 (414) 542-3100 VP Regulatory Affairs

December 15, 1995

OxiTemp. 3301T SA Oximeter with Ear Thermometer BCI 3301T OxiTemp and Exergen Ototemp

New Device Description:

Intended Use

The oximeter works with all BCI oximusery probes providing SpO2 and pulse rate on all nationts from necessare to adult (see the section CHOOSE THE PROBE under USING THE OXIMETER in the operations manual). For the 3301T the IR ear thermometer must seal the ear canal opening and look into the ear canal to provide an accurate temperature measurement. Therefore, it is restricted to patients over two years of age. The 3301T SA provides tympanic temperature measurements. The probe must be able to fit into the ear canal for proper operation. Therefore, it is restricted to patients over three years of age.

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Performance Data:

Testing of the 3301T SA OxiTemp and the predicate devices ( BCI 3301T oximeter and the Exergen OtoTemp HTTS-3000-SD ) was done to show that the performance of the 3301T SA was equivalent to the predicate devices. The first test showed that the oximeter portion of the OxiTemp would operate properly at a temperature of 1309F. The device was put into an oven for almost eight hours. Approximately 4.5 hours were spent at 130°F.

The second test showed that the 3301T SA would correctly operate and track the temperature of a target up to 130°F. The ambient and target temperatures were the same, The 3301T SA was in the environmental chamber during the entire test.

The third test showed that the 3301T SA would read a patient (target) temperature of approximately 98.6°F in ambient temperatures up to 130°F.

The fourth test showed that the 3301T SA would read a patient (target) temperature of approximately 98.6ºF in an ambient temperature of 32ºF.

The fifth test showed that the 330}T SA would measure a target temperature over the specified range of 65°F to 110°F. It was compared to the predicate device, the OtoTemp HTTS-3000-SD.

The last test was comparing readings between the two devices on 34 people. The first comparison was on ear to ear measurements for the 3301T SA.. The last test also compared the OxiTemp and an OtoTemp in reading temperature on the right ear. The device performed within the 1.0ºF (two standard deviation, 95.45% population) specification for both comparisons. Statistical methods were used because of the technique sensitivity of tympanic temperature measurements.

The Oxitemp passed all the tests.

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

Respectfully.

Donald Alexand

Donald Alexander VP Regulatory Affairs

Regulation Number and Section

§ 870.2700 Oximeter.

(a)
Identification. An oximeter is a device used to transmit radiation at a known wavelength(s) through blood and to measure the blood oxygen saturation based on the amount of reflected or scattered radiation. It may be used alone or in conjunction with a fiberoptic oximeter catheter.(b)
Classification. Class II (performance standards).