(89 days)
The BCI® 3178 Pediatric Pulse Oximetry Sensor is a reusable finger sensor that can be used to non-invasively measure oxygen saturation (SpO2), pulse rate and wethysmographic pulse waves. It's performance was validated with the BCI® 3304 pulse oximeter. The BCT® 3178 Pediatric Pulse Oximetry Sensor will provide reliable spot check measurements on patients weighing from 10 to 100 lbs (5 -45 kg). The sensor is not intended for prolonged use.
The BCI® 3178 pediatric pulse oximetry sensor is similar to other existing finger sensors, legally marketed by BCI, Inc. and others. This new finger sensor is designed to work with all BCI pulse oximeters on pediatric patients from 10 to 100 lbs. The sensor is made up of three major parts, the cable with the molded connector, the top part of the shell containing the LEDs and the bottom part of the shell containing the photo detector.
This document describes the regulatory submission for the BCI® 3178 Pediatric Pulse Oximetry Sensor. It focuses on demonstrating its substantial equivalence to predicate devices rather than providing detailed acceptance criteria and a study report with specific performance metrics as might be found in a more comprehensive clinical study report.
However, based on the provided text, we can extract information regarding overall performance and the studies conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state numerical acceptance criteria for SpO2 accuracy for this specific device. Instead, it relies on demonstrating that the new device performs "within its specifications" and "as well as the legally marketed predicate device(s)."
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Safe operation (electrical, mechanical, thermal) as per standards (EN 60601-1: 1990, Reviewer's Guidance for Respiratory Devices, 1993) | "The results demonstrate that the BCI® 3178 pediatric pulse oximetry sensor is in compliance with the guidelines and standards referenced in the reviewer's guides and that it performs within its specifications and functional requirements." |
| Accurate SpO2 measurement during desaturation conditions (for adults) | "Tests on adults showed the sensor to be accurate during desaturation conditions." |
| Functionality over the indicated size range (pediatric patients 10-100 lbs) | "Additional tests on pediatric subjects (not desaturated) demonstrated the functionality of the sensor over the indicated size range. The results demonstrated that the BCI® 3178 pediatric pulse oximetry sensor performed within its specifications." |
| No functional difference compared to predicate devices | "The testing described above indicate that there is no functional difference between the operation of the BCI® 3178 pediatric pulse oximetry sensor and the predicate devices." |
2. Sample Size Used for the Test Set and Data Provenance
- Adults: The sample size for adults tested under desaturation conditions is not specified ("Tests on adults showed...").
- Pediatric Subjects: The sample size for pediatric subjects (not desaturated) is not specified ("Additional tests on pediatric subjects...").
- Data Provenance: The document does not specify the country of origin. It implicitly describes prospective testing as part of the device's validation.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For pulse oximetry, the "ground truth" for SpO2 accuracy is typically established using arterial blood gas (ABG) analysis with a co-oximeter, not usually expert consensus in the same way it would be for interpreting images or clinical findings. The text only states that testing was done under "desaturation conditions," implying a controlled study where reference measurements (like ABG) would be taken.
4. Adjudication Method for the Test Set
This information is not applicable to pulse oximetry accuracy testing, as the "ground truth" (e.g., co-oximetry via ABG) is an objective measurement, not subject to interpretation that would require expert adjudication.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No, an MRMC comparative effectiveness study was not done. This type of study is specifically relevant for diagnostic imaging or interpretation tasks where multiple readers evaluate cases. Pulse oximetry involves direct measurement, not interpretation of cases by multiple readers.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
- Yes, a standalone performance study was done. The described testing of the BCI® 3178 Pediatric Pulse Oximetry Sensor for SpO2 accuracy and functionality is by its nature a standalone performance evaluation of the device itself. The sensor produces an output (SpO2, pulse rate) based on its algorithm and hardware, independent of human interpretation or assistance beyond initial placement and monitor reading.
7. Type of Ground Truth Used
The document does not explicitly state the type of ground truth. However, for pulse oximetry accuracy testing, especially during desaturation studies, the gold standard for ground truth is typically arterial blood gas (ABG) analysis using a co-oximeter. The statement "Tests on adults showed the sensor to be accurate during desaturation conditions" strongly implies the use of such a reference method.
8. Sample Size for the Training Set
- This information is not applicable or not provided in the context of this traditional medical device submission. Pulse oximeters, like the BCI® 3178, typically rely on established optical and physiological principles, not on machine learning algorithms trained on large datasets in the way an AI diagnostic algorithm would be. Therefore, there wouldn't be a "training set" in the sense of AI/ML development. The design is based on known physics and engineering, refined through testing.
9. How the Ground Truth for the Training Set Was Established
- As a training set is not applicable (see point 8), this question is also not applicable.
§ 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).