(822 days)
The pulse oximeter is a non-invasive device and intended for spot-checking of oxygen saturation and pulse rate for use with the finger of adult patients in healthcare environments. And it is not intended to be used under motion or low perfusion scenarios. The device is reusable.
The oximeter consists of probe, electronic circuits, and display and plastic enclosures. And one side of probe is designed to locate light emitting diodes and a light detector (called a photo-detector). Red and Infrared lights are shone through the tissues from one side of the probe to the other. Then parts of the light emitted absorbed by blood and tissues. The light absorbed by the blood varies with the oxygen saturation of haemoglobin. After that, the photo-detector detects the light volume transmitted through the tissues which depends on blood pulse, Hereafter, the microprocessor calculates a value for the oxygen saturation (SpO2). The subjected device is a reusable device, and need to reprocess as suggested in the user manual after each use. And the device is intended to be used on the finger, and powered by 2*1.5V AAA battery.OP-101 display the measuring results on 1.5' LED screen, and the backlight of the three models are red, white and green respectively. And the screen of OP-102 and OP-103 are 0.96' OLED and 1.3' OLED. Additionally, battery indicator and pulse waveform can be displayed on OP-102 and OP-103. The subjected device is indicated for continuous or spot check monitoring of functional arterial oxygen saturation (SpO2) and pulse rate of adult patients in hospitals and clinics.
This document describes the validation of a Pulse Oximeter device (models OP-101 and OP-102).
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the ISO 80601-2-61:2017 standard for pulse oximeters, particularly for SpO2 accuracy.
| Metric | Acceptance Criteria (ISO 80601-2-61:2017) | Reported Device Performance (OP-101, OP-102) | Predicate Device Performance (C101H1) |
|---|---|---|---|
| SpO2 Accuracy (70-100% range) | (Not explicitly stated as a single value criterion in the provided text, but implied by adherence to ISO 80601-2-61 guideline which involves comparing device SpO2 readings to arterial oxygen saturation (SaO2) measurements obtained from a co-oximeter.) The standard requires the root mean square deviation (ARMS) between SpO2 and SaO2 to be within a specified range, and typically, individual readings within a certain accuracy range (e.g., ±2% or ±3%). | 70-100%: ±2% | 70-100%: ±3% |
| SpO2 Accuracy (0-69% range) | Unspecified per the standard's current scope for typical physiological measurements. | 0-69%: unspecified | 0-69%: unspecified |
| Pulse Rate Accuracy | Not explicitly detailed but implied that the device meets the "pre-specified criteria" of the clinical trial and related standards. | ±3 bpm or ±1%, whichever is greater | ±1 bpm or ±1%, whichever is greater |
| Biocompatibility | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 | Passes Cytotoxicity, Skin Sensitization, Skin Irritation tests | Compliance with ISO 10993-1, ISO 10993-5, ISO 10993-10 |
| Electrical Safety | Compliance with IEC 60601-1 and IEC 60601-1-11 | Complies with IEC 60601-1: 2005+CORR. 1 (2006)+CORR. 2 (2007)+AM1 (2012) and IEC 60601-1-11:2015 | Complies with IEC 60601-1 and IEC 60601-1-11 |
| Electromagnetic Compatibility (EMC) | Compliance with IEC 60601-1-2 | Complies with IEC 60601-1-2: 2014 | Complies with IEC 60601-1-2 |
| Performance Effectiveness (General) | Compliance with ISO 80601-2-61:2017 | Complies with ISO 80601-2-61: 2017 | Complies with ISO 80601-2-61 |
| Software Verification and Validation | Adherence to FDA Guidance for content of premarket submissions for software contained in medical devices (moderate level of concern) | Software works as expected, stable performance | (Not explicitly stated for predicate in comparison table, but assumed compliance for clearance) |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (Clinical Data): 12 adult volunteers were used to validate the accuracy of the finger pulse oximeter (Model: OP-101).
- Data Provenance: The clinical study was conducted outside of the United States. It was a prospective, randomized clinical study.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The document does not specify the number or qualifications of experts directly involved in establishing the ground truth measurements. However, the ground truth was established by measuring SaO2 with a blood gas analyzer, which is a standard method that implicitly relies on trained medical professionals to operate and interpret.
4. Adjudication Method for the Test Set
The document does not describe an adjudication method for the test set in the sense of expert review of discrepancies. The accuracy validation appears to be a direct comparison between the device's SpO2 readings and the SaO2 measurements from the blood gas analyzer.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No multi-reader multi-case (MRMC) comparative effectiveness study was done or reported in this document. This type of study is more common for diagnostic imaging devices where human interpretation is a key component. For a pulse oximeter, the primary comparison is between the device's output and a gold standard physiological measurement.
6. Standalone Performance Study
Yes, a standalone performance study was done. The clinical study described involved evaluating the algorithm's performance (SpO2 and pulse rate measurements) against a recognized gold standard (blood gas analyzer) without human input / assistance in the measurement itself (beyond initial placement of the device and blood sample collection).
7. Type of Ground Truth Used
The ground truth for the clinical accuracy validation was arterial oxygen saturation (SaO2) measured by a blood gas analyzer. This is considered a gold standard for oxygen saturation in medical contexts.
8. Sample Size for the Training Set
The document does not explicitly mention a separate "training set" or its sample size. For medical devices like pulse oximeters, the development typically involves calibration data, and potentially internal validation data, but the focus of regulatory submissions is often on the performance demonstration of the final device (test set). Given the nature of a hardware-based measurement device, "training set" in the machine learning sense is less applicable here unless specific algorithms for signal processing or artifact rejection were developed with a dedicated training phase, which is not detailed.
9. How the Ground Truth for the Training Set Was Established
As no specific "training set" is described for this device in the provided document, the method for establishing its ground truth is not detailed.
§ 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).