(680 days)
The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment.
The Pulse Oximeter is a non-invasive device intended for spot checking and/or continuous data collection of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). This portable device is indicated for use in adult patients in home environments and clinical institutions except acute clinical environment. The Pulse Oximeter has two models, PO6 and PO6A, which are almost the same (include principle, structure, material, production process, performance) except appearance color. The device consists of main unit, SpO2 sensor and charging cable. The main unit is mainly composed of MCU, power management circuit, SpO2 measurement circuit, display control circuit, etc. The device is powered by internal battery. The device is not for life supporting or life-sustaining, not for implant. The device or sensor is not sterile, the sensor does not need sterilization, and the sensor is reusable but does not need re-sterilization since it is not sterile. The device is for prescription. The device does not contain drug or biological products.
The provided text describes the 510(k) submission for the Oxyfit Pulse Oximeter, which is a medical device for measuring oxygen saturation (SpO2) and pulse rate (PR). The key study proving the device meets acceptance criteria is a clinical test, specifically a controlled desaturation study.
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 | Reported Device Performance |
|---|---|---|
| SpO2 Accuracy (70%-100%) @ No Motion | ≤ ±2% (Accuracy Root Mean Square - Arms) per ISO 80601-2-61 | 1.57% (Arms) |
| SpO2 Display Range | N/A (Compared to predicate: 0%-100%) | 0%-100% |
| SpO2 Measurement Accuracy (70-80%) | N/A (Compared to predicate: ±3%) | ±3% |
| SpO2 Measurement Accuracy (80-90%) | N/A (Compared to predicate: ±2%) | ±2% |
| SpO2 Measurement Accuracy (90-100%) | N/A (Compared to predicate: ±2%) | ±2% |
| SpO2 Measurement Accuracy (0-69%) | N/A (Compared to predicate: not defined/unspecified) | Not defined |
| SpO2 Resolution | N/A (Compared to predicate: 1%) | 1% |
| Pulse Rate Measurement Range | N/A (Compared to predicate: 30 bpm~250 bpm) | 30 bpm~250 bpm |
| Pulse Rate Accuracy | N/A (Compared to predicate: ±2bpm or ±2% whichever is greater) | ±2bpm or ±2% (whichever is greater) |
| Pulse Rate Resolution | N/A (Compared to predicate: 1bpm) | 1bpm |
Note: The document explicitly states the SpO2 accuracy meets the requirement of "less than or equal to 2% under no motion condition" with an Arms value of 1.57%. For other parameters like pulse rate accuracy and display ranges, the document primarily compares them to the predicate devices, implying that meeting or being comparable to the predicate's performance serves as an implicit acceptance criterion.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: 12 healthy adult subjects.
- Data Provenance: The study was conducted in an "independent research laboratory." While the specific country of origin is not explicitly stated, the manufacturer is Shenzhen Viatom Technology Co., Ltd. in China. The study was a prospective controlled desaturation study where subjects were induced into hypoxia.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document states "The measured arterial hemoglobin saturation value (SpO2) of the subject device was compared with arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device)."
- The ground truth (SaO2) was established by a CO-oximeter, a laboratory instrument considered highly accurate for measuring blood oxygen. The text does not mention the involvement of human experts for establishing the ground truth, as it relies on the direct comparison with an objective measurement obtained from a CO-oximeter.
4. Adjudication Method for the Test Set
- There was no mention of an adjudication method as the ground truth was established by direct comparison with a CO-oximeter measurement from blood samples. This is an objective measurement, not requiring human interpretation or adjudication.
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
- No, an MRMC comparative effectiveness study was not done. The device is a pulse oximeter, which directly measures physiological parameters (SpO2 and PR). It is not an AI-assisted diagnostic tool that would typically involve human readers or image interpretation.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Yes, the performance stated (SpO2 accuracy of 1.57% Arms) is representative of the standalone performance of the pulse oximeter device itself, as it directly measures SpO2 and PR without human intervention for its core function. The study compares the device's readings to reference measurements (CO-oximeter).
7. The Type of Ground Truth Used
- The primary ground truth used for SpO2 accuracy was outcomes data / objective measurement which is the arterial hemoglobin oxygen (SaO2) value determined from blood samples with a CO-oximeter.
8. The Sample Size for the Training Set
- The document describes a clinical validation study and does not provide information about a "training set" in the context of machine learning model development. This is typical for a traditional medical device like a pulse oximeter, which relies on established physical principles for its operation rather than machine learning algorithms trained on large datasets.
9. How the Ground Truth for the Training Set Was Established
- Not applicable, as no training set for an AI/ML model is mentioned in the document. The device's operation is based on optoelectronic principles for measuring oxygen saturation and pulse rate.
§ 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).