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510(k) Data Aggregation
(79 days)
The BCI 3404 Monitor is a portable ECG and oximetry monitor with optional impedance respiration. It continuously and non-invasively monitors and displays functional oxygen saturation of arterial hemoglobin(SpO2), pulse rate, respiration rate, plethysmogram and ECG waveforms. Alarms are available for ECG and oximetry. There are no respiration rate alarms. The 3404 may be used in the hospital or clinical environment, and during emergency land transport.
The device will provide fast, reliable measurements on patients ranging from pediatric to adult when using the appropriate BCI accessories.
The monitor is not intended for home use. The monitor is not intended to be an apnea monitor. It was not designed or validated for use as an apnea monitor. The monitor is not intended for neonatal use.
The BCI 3404 Oximeter / ECG Monitor is a new monitor with the same parameters as existing devices legally marketed by BCI International. This device is designed to provide full featured monitoring capabilities in a table top design. The system features an ECG cable interface, an SpO2 probe interface, display of patient and waveform data via an EL panel, power status LED, and the function keypad area consisting of six keys ( on/off, waveform / trend, alarm silence, up arrow & down arrow). The monitor has a serial port that is used for data communications to a printer or computer and for analog outputs.
Here's a breakdown of the acceptance criteria and study details for the BCI 3404 Oximeter / ECG Monitor, based on the provided text:
1. Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria | Reported Device Performance (Mean Error ± SD) |
|---|---|---|
| Bench Tests | ||
| ECG Rates (beats per minute) | ±2 bpm or ±2% (greater of) | 0 bpm ± 0 bpm |
| Oximetry % SpO2 | ±2% SpO2 (min) | 0.25% ± 0.45% |
| Oximetry Pulse Rate (bpm) | ±2 bpm or ±2% (greater of) | 1.18 bpm ± 0.90 bpm |
| Respiration (breaths per minute) | ±1 bpm or ±5% (greater of) | 0 bpm ± 0 bpm |
| Clinical Tests (Oximetry) | ||
| SpO2 (70% - 100%) | Standard Deviation ≤ 2.0% | 1.8% (Standard Deviation) |
| SpO2 (50% - < 70%) | Standard Deviation ≤ 3.0% | 2.4% (Standard Deviation) |
| Clinical Tests (Respiration) | ||
| Respiration Rate | ±2 bpm or ±2% (greater of) | Mean difference of 0.63 bpm ± 0.80 bpm |
| Performance Standards (ECG) | ||
| ECG (per AAMI EC13-1992 requirements) | Compliance with all applicable requirements | Met all applicable requirements |
2. Sample Size and Data Provenance
- Bench Tests: The specific number of devices tested on simulators was "Three devices." The data provenance for the simulators is that they are "commercially available." There is no explicit mention of data origin (e.g., country) or whether these were retrospective or prospective tests, but simulator tests are inherently prospective.
- Clinical Tests (Oximetry): Not explicitly stated, but implies a cohort of subjects undergoing deep desaturation at the VA Medical Center in Milwaukee. This would be prospective data.
- Clinical Tests (Respiration): "Thirty volunteers were tested." The test was conducted at BCI. This would be prospective data.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts or their qualifications for establishing ground truth in the clinical tests.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method (e.g., 2+1, 3+1). It appears that comparisons were made directly to established reference devices or simulator settings.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was mentioned. The studies focused on the performance of the device against reference standards/devices, not on human readers' improvement with AI assistance.
6. Standalone (Algorithm Only) Performance
- Bench Tests: These tests can be considered standalone performance in that the device's readings are compared directly to simulator settings, without human interpretation for the measurement output itself.
- Clinical Tests: While human volunteers were involved, the performance evaluation compares the device's measurements directly to reference devices (co-oximeter, capnograph), indicating a standalone performance assessment of the device's measurement capabilities.
7. Type of Ground Truth Used
- Bench Tests: Ground truth was established by simulator settings.
- Clinical Tests (Oximetry): Ground truth was established by a reference co-oximeter (OSM-3).
- Clinical Tests (Respiration): Ground truth was established by a reference capnograph (BCI 9004 Capnograph).
- ECG Performance Standards: Ground truth was established by compliance with the ANSI/AAMI EC13-1992 standard.
8. Sample Size for the Training Set
The document does not explicitly mention a "training set" in the context of machine learning or AI. The device described is a monitor utilizing existing technology, and the testing focuses on its performance verification rather than the development of a trained algorithm. Therefore, the concept of a training set as typically understood in AI/ML contexts does not apply here.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set for an AI/ML algorithm, this question is not applicable. The device's underlying technology uses established principles of ECG and oximetry, not a learnable model requiring a specific training dataset from the manufacturer for its core function.
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