(101 days)
The BCI® 3420 Digit™ Pulse Oximeter is a handheld, finger-mounted pulse oximeter that combines the monitor and sensor into one assembly that measures SpO2, pulse rate, and pulse strength. It may be used as a spot check device in the home, hospital or clinical environments, including patient ground transport in clinical and EMS (Emergency Medical Services) settings. The BCI 3420 Digit™ Pulse Oximeter will provide reliable measurements on patients ranging from pediatric to adults.
The BCI® 3420 Digit™ Pulse Oximeter consists of an pulse oximeter monitor and sensor contained on a single assembly. The device includes an LED display and power on key, and is powered by two "AAA" batteries.
The provided documentation for the BCI® 3420 Digit™ Pulse Oximeter describes safety and performance testing to demonstrate substantial equivalence to predicate devices, but it does not detail specific acceptance criteria as numerical thresholds or perform a statistical study against such criteria. The document focuses on compliance with general medical device standards and functional equivalence rather than a precise quantitative evaluation against predefined acceptance metrics.
Therefore, many of the requested elements for a detailed acceptance criteria and study description cannot be extracted directly from this document.
Here's an attempt to answer based on the available information, with clear indications where information is not provided:
Acceptance Criteria and Device Performance Study for BCI® 3420 Digit™ Pulse Oximeter
1. Table of Acceptance Criteria and Reported Device Performance
| Feature/Parameter Tested | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Safety Testing | Compliance with Reviewer's Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993. | Demonstrated compliance with referenced guidelines and standards. |
| Environmental Testing | Compliance with Reviewer's Guidance for Respiratory Devices, 1993, EN 60601-1: 1990, and EN 60601-1-2: 1993 for EMC, electrical, mechanical durability, safety (operator and patient), and temperature/humidity. | Demonstrated compliance with referenced guidelines and standards. |
| SpO2 Performance | Within device specifications. | Performed within its specifications. |
| Software Validation | Not specified | Performed within its specifications. |
| Functional Equivalence to Predicate | "No functional difference" from predicate devices. | "No functional difference" found between the operation of the BCI® 3420 Digit™ pulse oximeter and the predicate devices. |
2. Sample size used for the test set and the data provenance
- Sample Size (Clinical Testing for SpO2): Not specified. The document mentions "clinical testing of the SpO2 parameter" but does not provide details on the number of subjects or data points.
- Data Provenance: Not specified. It's unclear if the data was retrospective or prospective, or the country of origin.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not specified. The document does not describe the establishment of a "ground truth" using experts in the context of a performance study with a test set. The focus is on compliance with standards and functional equivalence to predicate devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified. This level of detail about adjudication methods is not present in the document.
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
- No. This document describes a pulse oximeter, which is a medical device for direct measurement, not an AI-assisted diagnostic tool involving human readers. Therefore, an MRMC study or AI-related effectiveness is not applicable and was not performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- This device is a standalone pulse oximeter that directly measures physiological parameters. Its performance is inherently "standalone" in this context, meaning it operates without a human-in-the-loop for interpreting the core measurement output beyond standard clinical use. The "clinical testing of the SpO2 parameter" would evaluate this standalone performance.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- For SpO2 measurement, the "ground truth" (or reference standard) in clinical testing typically involves simultaneous measurements against a well-calibrated co-oximeter or arterial blood gas analysis. The document states "clinical testing of the SpO2 parameter" was performed, implying such a reference standard would have been used, but the specific method is not detailed.
- For safety and environmental testing, the "ground truth" is compliance with the specified international and national standards (e.g., EN 60601-1).
8. The sample size for the training set
- Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for this type of device.
§ 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).