(175 days)
The JPD-500A Fingertip Pulse Oximeter is non-invasive device intended for spot-checking of functional oxygen saturation of arterial hemoglobin (Spo2) and pulse rate. 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 JPD-500A fingertip pulse oximeter is intended for spot-checking of functional pulse oxygen saturation (SpO2) and pulse rage (PR) of single adult and pediatric patient in home and hospital.
The fingertip pulse oximeter features small size, low power consumption, convenient operation and portability. Power consumption of the product is low and two AAA batteries can be operated continuously for 24 hours. It is only necessary for a patient to put one of his/her fingers into the fingertip clips for measurement, very easy to use it.
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 glow and near-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 glow and 905nm near 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.
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Acceptance Criteria and Study for JPD-500A Fingertip Pulse Oximeter
This document describes the JPD-500A Fingertip Pulse Oximeter, a non-invasive device intended for spot-checking functional oxygen saturation of arterial hemoglobin (SpO2) and pulse rate in adult and pediatric patients in home and hospital environments.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SpO2 accuracy are implicitly derived from the comparison to the predicate device and the standard ISO 80601-2-61. For pulse rate accuracy, it is directly stated.
| Metric | Acceptance Criteria (Predicate) | Reported Device Performance (JPD-500A) |
|---|---|---|
| SpO2 Accuracy | 70%-100%: ± 2% | 70%-100%: ± 2% |
| 35%-69%: no definition | 0%-69%: no definition | |
| Pulse Rate Accuracy | ± 2bpm or ± 2% (whichever is greater) | ± 2bpm |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 10 healthy, non-smoking, light-to-dark-skinned subjects were used for the clinical hypoxia accuracy testing. An additional 5 subjects were enrolled but excluded, bringing the initial enrollment to 15 subjects.
- Data Provenance: The study was conducted in an independent research laboratory, implying prospective data collection specifically for this device's validation. The country of origin of the data is not explicitly stated, but the device manufacturer is Shenzhen Jumper Medical Equipment Co., Ltd. in China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The ground truth was established by a CO-oximeter, not by human experts.
4. Adjudication Method for the Test Set
Not applicable, as the ground truth was derived from instrumental measurement (CO-oximeter) rather than expert review requiring 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
Not applicable. This device is a standalone medical instrument (pulse oximeter) and does not involve AI or human reader interpretation for its primary function.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone study was performed. The device's performance was compared directly to a CO-oximeter (the gold standard) in a controlled desaturation study. This assesses the algorithm/device's accuracy independently.
7. The Type of Ground Truth Used
The ground truth for the SpO2 accuracy was the arterial hemoglobin oxygen (SaO2) value, determined from blood samples with a CO-oximeter. This is an objective, instrumental measurement.
8. The Sample Size for the Training Set
The document does not mention a training set, as this is a medical device (pulse oximeter) validated through clinical accuracy studies against a gold standard, not a machine learning algorithm that requires a separate training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is mentioned or implied for this type of device validation.
§ 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).