(315 days)
The Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate (PR). The portable fingertip device is indicated for adult and pediatric patients in home and hospital environments (including clinical use in internist/ surgery, anesthesia, intensive care, etc).
The Fingertip Pulse Oximeteris intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of adult and pediatric patients in the home and hospital.
The fingertip pulse oximeter features a small size, low power consumption, a convenient operation, and portability.It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement.
Principle of the fingertip pulse oximeter as follows:
A mathematical formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and infrared zones.
Operation principle of the instrument:
Photoelectric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm infrared light) can be focused onto a human nail tip through a clamping finger-type sensor. Relevant data is shown on the Oximeter's display through electronic circuits and a microprocessor.
Here's a breakdown of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Acceptance Criteria and Device Performance
The core acceptance criteria for the Fingertip Pulse Oximeter relate to its accuracy in measuring SpO2 and Pulse Rate.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| SpO2 Accuracy | ±2%: (70%~100%) |
| Pulse Rate | ±2 bpm |
Note: For SpO2, no definition is provided for the 0%~69% range, implying the device is not specified to be accurate in this range.
The device's performance is stated to meet the criteria specified in ISO 80601-2-61.
Study Details
The assessment of the device's accuracy was conducted through a clinical study described as a "Clinical hypoxia accuracy testing (controlled desaturation study)."
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Sample Size used for the test set and Data Provenance:
- Sample Size: 12 subjects were enrolled.
- Total Data Sets Collected: 294
- Valid Data Sets: 288 (6 data sets less than 70% SpO2 were excluded).
- Data Provenance: The study was conducted during "induced hypoxia studies on healthy, non-smoking, light-to-dark-skinned subjects in an independent research laboratory." This indicates a prospective study design. The country of origin is not explicitly stated, but the manufacturer and consultant are based in China.
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Number of experts used to establish the ground truth for the test set and their qualifications:
The text does not explicitly state the number of experts used to establish ground truth or their specific qualifications (e.g., "radiologist with 10 years of experience"). However, the ground truth was established by a "CO-oximeter (control device)" from arterial blood samples. This implies that medical professionals (e.g., lab technicians, clinicians) would have been involved in collecting and analyzing these samples, but their specific roles or qualifications are not detailed. -
Adjudication method for the test set:
The text does not mention an adjudication method (like 2+1, 3+1). The "ground truth" was directly compared from the CO-oximeter. -
If a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was done:
No, an MRMC comparative effectiveness study was not done. The study focused on the standalone performance of the device against a ground truth, not on how human readers' performance improved with or without AI assistance. -
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
Yes, a standalone performance study was done. The "measured arterial hemoglobin saturation value (SpO2) of the subject device" was directly compared to the arterial blood samples, indicating an assessment of the device's accuracy on its own. -
The type of ground truth used:
The ground truth was established using arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter (control device). This is considered a highly accurate and direct measurement suitable for establishing ground truth for oxygen saturation. -
The sample size for the training set:
The document does not provide information about a specific training set or its size. This submission is for the device's performance evaluation, implying the device (or its underlying algorithms) would have been developed and "trained" prior to this evaluation. -
How the ground truth for the training set was established:
As no information about a training set is provided, how its ground truth was established is also not available in this document.
§ 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).