(29 days)
The BCI 3401 Pulse Oximeter is a handheld, low cost monitor for spot checking or attended monitoring of SpO2, pulse rate and pulse strength. The 3401 is a battery powered pulse oximeter with an optional built-in printer. It may be used in the hospital or clinical environment, and during emergency land transport. The oximeter will operate accurately over an ambient temperature range of 32 to 131°F (0 to 55°C). The oximeter works with all BCI oximetry sensors providing SpO2 and pulse rate on all patients from neonate to adult. This device is not intended for continuous patient monitoring. There are no audible or visable patient alarms. The device is not intended for home use.
The BCI 3401 Handheld Pulse Oximeter is an updated version of an existing pulse oximeter legally marketed by BCI International. The system consists of two major elements. The first is the oximeter featuring the oximeter sensor interface, the LED display, and the keypad. The second element is the optional internal printer. The device is powered by four "AA" batteries.
Here's a breakdown of the requested information based on the provided text, outlining the acceptance criteria and study details for the BCI 3401 Handheld Pulse Oximeter:
Acceptance Criteria and Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Accuracy of blood oxygen level (SpO2) within a specified range compared to a co-oximeter. | Standard deviation of 1.97% for the measurement range of 70-100%. |
| R-squared value for the accuracy comparison. | R-squared value of 0.96 over the entire measurement range (70-100%). |
| Compliance with established guidelines and standards for respiratory devices (e.g., EMC, electrical, mechanical durability, safety, temperature humidity). | "The results of the testing demonstrated that the device was in compliance with the guidelines and standards referenced in the reviewers guide and that it performed within its specifications and functional requirements." |
Study Details
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Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated. The document mentions "clinically controlled desaturation studies" and "data collected from the studies," implying a sufficient number of subjects were involved to produce statistically significant results, but no specific human subject count is provided.
- Data Provenance: Prospective. The studies were "clinically controlled desaturation studies," indicating they were conducted specifically to test the device's performance. The location of the studies is not specified (e.g., country of origin).
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This information is not provided. The ground truth was established by a co-oximeter (OSM-3), which itself is a medical device, not human experts in this context.
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Adjudication method for the test set:
- Not applicable as the ground truth was established by a co-oximeter, not human adjudicators.
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. The study focused on the device's accuracy against a reference device (co-oximeter), not on comparing human reader performance with and without AI assistance.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Yes, the performance described is a standalone evaluation of the pulse oximeter's accuracy in measuring SpO2 compared to a co-oximeter. There is no mention of a human-in-the-loop component for the accuracy assessment.
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The type of ground truth used:
- Reference Device/Instrumental: The ground truth for SpO2 measurements was established by a co-oximeter (OSM-3), which is considered a more accurate and reliable method for blood oxygen analysis.
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The sample size for the training set:
- Not applicable. This device is a pulse oximeter that uses established physiological principles and signal processing, not a machine learning model that typically requires a distinct training set. The performance data refers to validation/testing, not training.
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How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for a machine learning model. The device's operation is based on physical principles, not on "learning" from a dataset in the modern AI sense.
§ 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).