(126 days)
The Fingertip Pulse Oximeter MD300CI218 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent, child and infant patients in hospital-type facilities and homecare environment.
The proposed device Fingertip Pulse Oximeter MD300CI218 is a battery powered device. It can detect and display the measured %SpO2 and pulse rate value and will automatically power off when there is no signal for longer than 8 seconds. The proposed device is adopted colorful color OLED screen to display SpO2, PR and waveform which can be displayed in 2 directions. And it is designed with the battery indicator function to warn the user that the battery power may be low. The proposed device is normally applied to adult, adolescent, child and infant patients in hospitals, hospital facilities and homecare environment. And it can transmit the measurements to Smart Device installed the mobile APP via Bluetooth 4.0 to help the users to organize and track their health information. The proposed device consists of power supply module, detector and emitter LED, signal collection and processor module, display module, Bluetooth module, user interface and button control. The fingertip pulse oximeter works by applying a sensor to a pulsating arteriolar vascular bed. The sensor contains a dual light source and photo detector. The one wavelength of light source is 660nm, which is red light; the other is 905nm, which is infrared-red light. Skin, bone, tissue and venous vessels normally absorb a constant amount of light over time. The photo detector in finger sensor collects and converts the light into electronic signal which is proportional to the light intensity. The arteriolar bed normally pulsates and absorbs variable amounts of light during systole and diastole, as blood volume increases and decreases. The ratio of light absorbed at systole and diastole is translated into an oxygen saturation measurement. This measurement is referred to as SpO2. The proposed device is not for life-supporting or life-sustaining, not for implant. The device is not sterile and the transducers are reusable and do not need sterilization and re-sterilization. The device is for prescription. The device does not contain drug or biological products. The device is software-driven and the software validation is provided in software.
The provided text describes the 510(k) premarket notification for the Fingertip Pulse Oximeter MD300CI218. It includes details about the device, its intended use, comparison to a predicate device, and various tests conducted to demonstrate substantial equivalence.
Here's an analysis of the acceptance criteria and study data based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SpO2 (oxygen saturation) and PR (Pulse Rate) accuracy are implicitly stated as the device's accuracy specifications, which are identical to the predicate device. The performance is reported in the clinical test results.
| Metric | Acceptance Criteria (from Predicate Device) | Reported Device Performance (MD300CI218) |
|---|---|---|
| SpO2 Accuracy | 70% | Arms of 1.66 (during steady state 70-100%) |
| PR Accuracy | 30bpm | Not explicitly stated in the results summary, but stated as compliant with claimed accuracy. |
| SpO2 Display Range | 0~100% | 0~100% |
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| PR Display Range | 0bpm~235bpm | 30bpm~250bpm |
| PR Measurement Range | 30bpm~235bpm | 30bpm~250bpm |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set: 12 healthy adult subjects.
- Data Provenance: The clinical study was conducted from March 9-11, 2018, in the Yue Bei People's Hospital, cardiovascular medicine, in China. It was a prospective study where subjects were intentionally involved for the purpose of testing the device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
The document does not specify the number or qualifications of experts used to establish ground truth for the clinical test (e.g., co-oximeter readings for SpO2 accuracy). It only mentions that the study followed ISO 80601-2-61:2011, which outlines specific methodologies for pulse oximeter testing, implying that the ground truth would have been established using reference methods as per the standard.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication method for the test set. For pulse oximetry accuracy testing as per ISO 80601-2-61, ground truth is typically established by arterial blood gas analysis using a co-oximeter, where direct measurements serve as the reference, rather than expert adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This study is a technical performance test of a medical device (pulse oximeter) against a reference standard, not an AI-assisted diagnostic study involving human readers.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
Yes, this was a standalone performance study. The MD300CI218 Finger Pulse Oximeter is a device that directly measures and displays SpO2 and pulse rate. The clinical test evaluated the accuracy of the device's measurements compared to a reference standard (likely arterial blood sampling and co-oximetry, as per the ISO standard). There is no "human-in-the-loop" interaction for interpreting the device's output, beyond a clinician reading the displayed values.
7. The Type of Ground Truth Used
The type of ground truth used for the clinical study was based on the methodology described in ISO 80601-2-61:2011. This standard typically mandates the use of reference co-oximeter measurements from arterial blood samples (induced hypoxia studies) as the ground truth for SpO2 accuracy. The document states, "The SpO2 accuracy performance results showed the MD300CI218 Fingertip Pulse Oximeter to have an Arms of 1.66 during steady state conditions over the range of 70-100%," which is a standard metric derived from comparing device readings to co-oximeter readings.
8. The Sample Size for the Training Set
This document describes a clinical validation study for a medical device that does not appear to involve a machine learning or AI algorithm that requires a "training set." The device is based on established optical principles (Lambert-Beer Law) for pulse oximetry. Therefore, the concept of a "training set" as it applies to AI models is not relevant here.
9. How the Ground Truth for the Training Set Was Established
As noted in point 8, there is no mention or indication of a "training set" for an AI model. The device operates on optical principles rather than an AI/ML algorithm that is 'trained' on data.
§ 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).