(138 days)
The Pulse Oximeters are intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display.
These devices are used for spot-checking a patient's SpO2 and pulse rate in a home or clinical environment. They are used by adult and pediatric patients. These devices are recommended for use on the index fingers of 1.0 - 2.2 cm thick.
A blood-oxygen saturation reading indicates the percentage of hemoglobin molecules in the arterial blood which are saturated with oxygen. The reading may be referred to as SaO2. Readings vary from 0 to 100%. Normal readings in a healthy adult, however, range from 94% to 100%. The term SpO2 means the SaO2 measurement determined by pulse oximetry. In its most common (transmissive) application mode, a sensor device is placed on a thin part of the patient's body. The device passes two wavelengths of light through the body part to a photodetector. It measures the changing absorbance at each of the wavelengths, allowing it to determine the absorbances due to the pulsing arterial blood alone, excluding venous blood, skin, bone, muscle and fat. For the purpose of measuring the SpO2 more easily and accurately, our company developed the Fingertip Oximeter. The device can measure SpO2 and body pulse simultaneously.
The PC-66A; PC-66B; PC-66C;PC-60B1; PC-60B5; PC-60D; PC-60D2; PC-60E; PC-60N; POD-1; POD-2; POD-3; PC-68A; PC-68B; PC-68C; POD-1W; POD-60NW-1 Fingertip Oximeter is intended for measuring the pulse rate and functional oxygen saturation (SpO2) through patient's finger, indicating the pulse intensity by a bar-graph display. This device is powered by 2 AAA batteries. This device is applicable for spotchecking of SpO2 and pulse rate in a home and clinical environment. The index finger is the recommended site. It is intended for spot-checking adult and pediatric patients on fingers between 1.0 -2.2 cm thick.
This oximeter has a wireless data transmission function. The user can transmit the SPO2 and pulse rate data to a computer through the wireless communication module.
This document, a 510(k) summary for various Pulse Oximeter models from Shenzhen Creative Industry Co., Ltd., primarily asserts substantial equivalence to predicate devices and focuses on mechanical, electrical, and biocompatibility testing. It does not describe a study to prove the device meets acceptance criteria for its core function (SpO2 and pulse rate measurement) beyond a "Bench Test of SpO2 and Pulse Rate" which references accuracy ranges using a simulator.
Therefore, many of the requested details about a study proving the device meets acceptance criteria are not available in this document. The document explicitly states: "In that the measuring device in the electro-circuit module, cushion rubber, emitter and receiver are the same as predicate devices, we concluded that this will not affect the device performance. No new clinical validation needed." This implies reliance on the predicate device's clinical validation.
Here's an analysis of the provided information based on your requests:
1. A table of acceptance criteria and the reported device performance
Based on the document, the "performance" for SpO2 and Pulse Rate is presented as a target accuracy range tested using a simulator.
| Measurement Parameter | Acceptance Criteria (Target) | Reported Device Performance (Tested via Simulator) |
|---|---|---|
| SpO2 Measuring Range | Not explicitly stated | 0%-99% |
| SpO2 Measuring Accuracy | Not explicitly stated | 70%-100% ±3%; 69% no defined 0% |
| PR Measuring Range | Not explicitly stated | 30bpm-240bpm |
| PR Measuring Accuracy | Not explicitly stated | ±2bpm or ±2% (whichever is greater) |
Note: The document only provides the tested accuracy range with the simulator, not explicit acceptance criteria from an independent study. The wording "we conducted additional verification to show it complies with the requirement" implies these ranges are the requirements, but they are presented as results from a bench test with a simulator, not from a clinical study on human subjects.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not available in the provided document for the SpO2 and pulse rate accuracy claims. The document states a "Bench Test of SpO2 and Pulse Rate" was performed using an "SpO2 simulator method (simulator model: Index 2 series)". This is a laboratory test, not a clinical study on a human test set. Therefore, there is no information on human sample size, data provenance, or retrospective/prospective nature.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not available. Since the primary claims for SpO2 and pulse rate accuracy were validated using a simulator, there were no human experts involved in establishing ground truth for a clinical test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not available. As there was no clinical test set involving human subjects to establish ground truth, an adjudication method for such a test set is not applicable.
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
This is not applicable to the device described. This document pertains to a pulse oximeter, which is a standalone measurement device, not an AI-assisted diagnostic tool that would involve human "readers" or interpretation in the way an MRMC study evaluates.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Yes, in the context of a pulse oximeter, its performance is inherently standalone. The "Bench Test of SpO2 and Pulse Rate" using a simulator can be considered a standalone performance evaluation of the device's measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the "Bench Test of SpO2 and Pulse Rate," the ground truth was based on the output of an SpO2 simulator (Index 2 series). This is a synthetic ground truth, not derived from biological sources like expert consensus, pathology, or outcomes data.
8. The sample size for the training set
This information is not available and likely not applicable in the traditional sense of machine learning. The device is a hardware-based measurement instrument, and while it contains embedded software/firmware, the document does not describe it as an AI/ML device that requires a "training set." The performance relies on the physics of pulse oximetry and the calibration of its components.
9. How the ground truth for the training set was established
This information is not available and not applicable. As explained above, the device is not described as an AI/ML device that typically uses a training set with established ground truth.
§ 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).