(237 days)
This Pulse Oximeter is intended for measuring the functional oxygen saturation (SpO2) and pulse rate (PR). It is intended for spot check and continuous recording of SpO2, PR of adult or pediativ patients in hospitals, clinics, or home. This device is not intended for continuous monitoring.
This AP-10 Pulse Oximeter is wrist-worn. It measures the SPO2 physiological parameter, and the measurement results are displayed and stored. The data can be transferred to a phone or PC via a USB connection or via Bluetooth. The AP-10 Pulse Oximeter measures SPO2 and Pulse Rate simultaneously. The device can store up to 500 hours of SPO2 and Pulse rate data.
The Shenzhen Creative Industry Co., Ltd. Pulse Oximeter, AP-10, underwent a clinical study to establish its accuracy for measuring oxygen saturation (SpO2). The study was conducted in accordance with Annex EE of ISO 80601-2-61:2018 (or 2011, as listed in the provided text).
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Parameter | Acceptance Criteria (ISO 80601-2-61) | Reported Device Performance (AP-10) |
|---|---|---|
| SpO2 Accuracy | ±3% (during 70%-100% SpO2) | ±3% (during 70%-100% SpO2) |
| Pulse Rate Accuracy | ±2bpm or ±2% (whichever is greater) | ±2bpm or ±2% (whichever is greater) |
Note: The document explicitly states that the AP-10's reported performance for SpO2 and Pulse Rate accuracy meets the ISO 80601-2-61 standard's requirements, which are the acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document states that clinical testing was conducted. However, it does not explicitly mention the sample size for the test set or the country of origin. It refers to the "Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011." This guideline typically involves healthy volunteers studied under controlled hypoxia conditions. Therefore, the data would be prospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
The provided text does not contain information regarding the number of experts or their qualifications used to establish ground truth for the test set. For pulse oximetry, the "ground truth" for SpO2 is usually established via a co-oximeter measuring arterial blood gas (PaO2), overseen by medical professionals, but this detail is not present in the document.
4. Adjudication Method
The document does not specify an adjudication method. For pulse oximetry studies, adjudication typically refers to how reference SpO2 values are determined from blood samples, which doesn't usually involve multiple human readers in the same way imaging studies might.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed or described. This type of study is typically used for diagnostic imaging devices where human readers interpret results, and the AI's impact on their performance is being evaluated. The AP-10 is a direct measurement device (pulse oximeter), so this type of study is not applicable.
6. Standalone (Algorithm Only) Performance
Yes, a standalone performance evaluation was conducted. The "Reported Device Performance" in the table above reflects the algorithm's accuracy in measuring SpO2 and pulse rate as a standalone device. The clinical study mentioned in "Clinical: Clinical testing was conducted per Annex EE Guideline for evaluating and documenting SpO2 accuracy in human subjects of ISO 80601-2-61:2011" specifically evaluates the device's intrinsic accuracy.
7. Type of Ground Truth Used
The type of ground truth used, though not explicitly stated as "co-oximetry," is implied by the reference to Annex EE of ISO 80601-2-61. This standard's Annex EE describes a method where arterial oxygen saturation (SaO2) measured by a co-oximeter from arterial blood samples is considered the ground truth against which the pulse oximeter's SpO2 readings are compared.
8. Sample Size for the Training Set
The document does not provide any information about the sample size for the training set. It refers to non-clinical and clinical testing for the current device's performance validation, but not to machine learning model training data. Given that pulse oximeters primarily rely on established biophysical principles (light absorption at different wavelengths by oxygenated and deoxygenated hemoglobin) rather than complex machine learning models directly trained on vast datasets in the same way an AI diagnostic tool might, the concept of a "training set" for the core physiological measurement might not be directly applicable or detailed in this type of submission.
9. How the Ground Truth for the Training Set Was Established
As with the previous point, the document does not provide information on how ground truth for a training set (if one was used for specific algorithm development within the device) was established. The focus of the submission is on the device's adherence to established performance standards for pulse oximetry.
§ 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).