(163 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 mm, 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. This equipment mainly composed of PCB board, On/Off button, mode button, OLED&LED screen, battery compartment, and plastic shell. 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 text details the 510(k) summary for a Pulse Oximeter (K190869). While it doesn't use the exact term "acceptance criteria" for all performance aspects, it does specify accuracy requirements and the study conducted to demonstrate compliance.
Here's a breakdown of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (Required Performance) | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (70-100%) | ±3% (Per ISO 80601-2-61) | Root-mean-squared (Arms) value of ±3% with saturations from 70% to 100%. |
| SpO2 Measuring Range | N/A (Compared to predicate, which was 0-100%) | 35%-100% |
| SpO2 Resolution | N/A (Compared to predicate, which was 1%) | 1% |
| PR Accuracy | N/A (Improved compared to predicate's variable accuracy) | ±2 bpm (across the entire range) |
| PR Measuring Range | N/A (Compared to predicate, which was 30-235 bpm) | 30-250 bpm |
| PR Resolution | N/A (Compared to predicate, which was 1 bpm) | 1 bpm |
| Home-Used Compliance | Compliance with IEC 60601-1-11 | Performance testing shows compliance. |
| Biocompatibility | Compliance with ISO 10993-1 (Cytotoxicity, Sensitization, Irritation) | Testing conducted in accordance with the standard. |
| Electrical Safety/EMC | Compliance with IEC 60601-1, IEC 60601-1-2 | Testing conducted successfully. |
Note: The document explicitly states the SpO2 accuracy and lists successful compliance with relevant standards. For other parameters like SpO2/PR range and resolution, the reported performance matches or exceeds that of the predicate device, implicitly meaning they meet the "acceptance criteria" of being comparable or better.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Physiological (Clinical) Test Set (SpO2 Accuracy): 12 healthy adult volunteers (4 men and 8 women).
- Data Points Collected: Total 1440 data points were sampled for analysis.
- Data Provenance: The study was clinical testing of human subjects. The document does not specify the country of origin for the clinical study, but the submitting company and correspondent are based in Shenzhen, China. It was a prospective study involving human subjects for direct measurement.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The ground truth for SpO2 accuracy was established against a laboratory CO-Oximeter, which is an objective, gold-standard laboratory instrument for measuring arterial blood gas saturation (SaO2). Therefore, "experts" in the sense of human readers interpreting data were not used for the primary SpO2 accuracy ground truth. The expertise would lie in the accurate operation and calibration of the CO-Oximeter and the proper execution of the clinical trial protocol.
4. Adjudication Method for the Test Set
Not applicable. The ground truth for SpO2 accuracy was established using a laboratory CO-Oximeter, which provides a direct, objective measurement (SaO2) from blood samples. This does not involve human interpretation or subjective assessment that would require an adjudication method.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. The document describes a clinical study to assess the device's accuracy against a laboratory reference standard (CO-Oximeter), not a comparative effectiveness study involving multiple human readers with and without AI assistance (as this is a standalone measurement device, not an AI interpretation tool).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Yes, for its primary function (SpO2 and PR measurement), the device operates in a standalone manner. The clinical study described evaluates the device's direct measurement performance (algorithm only) against a gold standard, without human interpretation in the loop influencing the measurement itself.
7. The Type of Ground Truth Used
The primary ground truth for the clinical accuracy study was objective laboratory measurement data: arterial hemoglobin oxygen (SaO2) values determined from blood samples using a CO-oximeter.
8. The Sample Size for the Training Set
The document does not specify a separate "training set" sample size. This is a medical device (pulse oximeter) that performs real-time physiological measurements based on established physical principles of light absorption, rather than an AI/machine learning algorithm that requires a distinct training phase on a large dataset. The device's underlying principles (e.g., Beer-Lambert Law principles applied to pulsatile blood flow) are physics-based, not learned from a training dataset in the AI sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As explained in point 8, this is not an AI/machine learning device requiring a training set and associated ground truth establishment in that context. The device's operation is based on fundamental optical and physiological principles. The "training" for such devices typically involves extensive engineering, calibration, and verification against physical models and known physiological responses, rather than data-driven learning from a labeled training set.
§ 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).