(217 days)
The Pulse Oximeter is a non-invasive device intended for spot checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in clinical institution and home environments.
The Pulse Oximeter is a battery powered device intended for use in measuring and displaying functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The Pulse Oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660 nm, which is red light; the other is 905 nm, which is Infrared light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The device mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, Bluetooth® module and plastic shell. The device has wireless connection via Bluetooth®. The device is a spot-check pulse oximeter and does not include alarms. The device is not intended for life-supporting or life-sustaining.
The provided document is a 510(k) premarket notification for a Pulse Oximeter, establishing its substantial equivalence to a previously cleared predicate device. It includes sections on the device description, intended use, comparison to the predicate, and performance data. The following details are extracted to answer your request:
Here's an analysis of the acceptance criteria and the study proving the device meets them:
1. A table of acceptance criteria and the reported device performance
Based on the "Comparison to the Predicate Device" table and "Clinical data" section:
| Parameter | Acceptance Criteria (Predicate / Standard) | Reported Device Performance (Subject Device) |
|---|---|---|
| SpO2 Measuring Range | 0%-100% | 0%-100% |
| SpO2 Resolution | 1% | 1% |
| SpO2 Accuracy (Arms) | 70~100%, ±3% (based on ISO 80601-2-61) | ±3% for saturations from 70% to 100% |
| SpO2 Accuracy (0-69%) | Unspecified | Unspecified |
| PR Measuring Range | 30-250 bpm | 30-250 bpm |
| PR Resolution | 1 bpm | 1 bpm |
| PR Accuracy | ± 2 bpm | ± 2 bpm |
| Biocompatibility | In accordance with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Testing conducted and considered surface contacting (exceeds 24 hours but not 30 days) |
| Electrical Safety/EMC | IEC 60601-1, IEC 60601-1-2 | Compliance via testing |
| Home Healthcare Env. | IEC 60601-1-11 | Compliance via testing |
| Software Validation | FDA Guidance for Content of Premarket Submissions for Software Contained in Medical Devices | Software validated |
| Cybersecurity | FDA Guidance for Content of Premarket Submissions for Management of Cybersecurity in Medical Devices | Software validated according to guidance |
| Wireless Coexistence | ANSI C63.27L: 2017, AAMI TIR69: 2017, FDA Guidance Radio Frequency Wireless Technology in Medical Devices | Testing conducted |
| Bluetooth Compliance | FCC CFR Title 47 Part 15 Subpart C | Testing conducted |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Clinical Test Set: 12 healthy adult volunteers (4 men and 8 women).
- Data Provenance: The document does not explicitly state the country of origin for the clinical data. It generally refers to "laboratory CO-Oximeter," implying a controlled clinical setting. The study was prospective in nature, involving desaturation of subjects to collect data across the specified SpO2 range.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The ground truth for SpO2 accuracy was established by a laboratory CO-Oximeter analysis of arterial blood samples. This does not involve human experts establishing ground truth in the traditional sense of image interpretation. The CO-Oximeter itself serves as the gold standard instrument. The document does not specify the number or qualifications of personnel operating the CO-Oximeter or analyzing blood samples, but it implies a standard laboratory setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for this type of device and study. The ground truth (SpO2 values from CO-Oximeter, PR from reference method implied by the standard) is objective and instrument-based, not based on expert consensus or adjudication. The agreement was analyzed using Bland and Altman statistics.
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
There was no MRMC comparative effectiveness study done. This device is a standalone measurement device (pulse oximeter) and does not involve AI assistance for human readers/interpreters. The focus is on the accuracy of the device's measurements compared to a recognized standard.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, the primary performance evaluation for SpO2 and PR accuracy was a standalone performance study of the device's measurements against a reference method (CO-Oximeter for SpO2).
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For SpO2, the ground truth was instrumental measurement (CO-Oximeter) of arterial hemoglobin oxygen (SaO2) from blood samples. This is considered a highly accurate and objective gold standard for oxygen saturation.
For Pulse Rate (PR), while not explicitly detailed for ground truth method, given the context of ISO 80601-2-61, it would typically involve a reference ECG or other validated heart rate measurement.
8. The sample size for the training set
This document describes a clinical validation study for a medical device, not a machine learning model specific training and test set. Therefore, there is no "training set" in the context of AI/ML. The clinical data of 12 healthy adult volunteers and 1440 data points were used for performance validation.
9. How the ground truth for the training set was established
As there is no "training set" for an AI/ML model, this question is not applicable. The device's underlying principle relies on light absorption, not trained algorithms in the sense of deep learning or similar AI methodologies that require large labeled training datasets.
§ 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).