(121 days)
The Fingertip Pulse Oximeter MD300CN310 is a handheld non-invasive device intended for spot-checking of oxygen saturation of arterial hemoglobin (SpO2) and Pulse Rate of adult, adolescent and child patients in hospitals, hospital-type facilities and homecare.
The proposed device Fingertip Pulse Oximeter MD300CN310 is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value. The device is adopted dual color OLED screen to display SpO2 and pulse rate value, pulse bar and waveform. The device has 6 display modes. The device is normally applied to adult, adolescent and child patients in hospital facilities and homecare environment.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
Principle of the oximeter is as follows:
The 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 software validation is provided in Section XI Software.
The provided document details the 510(k) submission for the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CN310. It establishes the substantial equivalence of the proposed device to a predicate device (MD300C29-H) and outlines the testing conducted to support this claim.
Here's a breakdown of the requested information:
1. A table of acceptance criteria and the reported device performance
The document provides performance specifications for SpO2 and Pulse Rate accuracy. Since this is a 510(k) submission primarily focused on substantial equivalence, the "acceptance criteria" are generally aligned with demonstrating that the new device performs at least as well as the predicate device and meets recognized standards. The reported device performance is listed as identical to the predicate device in terms of these accuracy specifications.
| Performance Metric | Acceptance Criteria (from predicate/standards) | Reported Device Performance (MD300CN310) |
|---|---|---|
| SpO2 Measurement Range | 70%~100% | 70%~100% |
| SpO2 Accuracy (70%~100%) | ±2% | ±2% |
| SpO2 Accuracy (0%~69%) | No definition | No definition |
| SpO2 Resolution | 1% | 1% |
| PR Measurement Range | 30bpm~250bpm | 30bpm~250bpm |
| PR Accuracy (30bpm~99bpm) | ±2bpm | ±2bpm |
| PR Accuracy (100bpm~250bpm) | ±2% | ±2% |
| PR Resolution | 1bpm | 1bpm |
| Operating Temperature | 5°C~40°C | 5°C~40°C |
| Storage/Transport Temperature | -40°C~55°C (predicate) | -25°C~70°C (proposed) - Note: Difference, but implied as acceptable due to SE determination |
| Relative Humidity (Operation) | ≤80% no condensation (predicate) | 15%~93% no condensation |
| Relative Humidity (Storage/Transport) | ≤93% no condensation | ≤93% no condensation |
| Atmosphere Pressure | 86kPa~106kpa | 70kPa~106kPa |
2. Sample size used for the test set and the data provenance
The document mentions "SpO2 and PR accuracy Test" and references ISO 80601-2-61. This standard outlines requirements for clinical testing with human subjects. However, the specific sample size used for the test set is NOT explicitly stated in this document.
The data provenance is implied to be prospective clinical data for the SpO2 and PR accuracy testing, as it states "We have also conducted other performance test including SpO2 and PR Accuracy Test... Per Guidance for Industry and FDA Staff: Pulse Oximeter-Premarket Notification submission [510(k)s]". Clinical testing for pulse oximeters involves human subjects whose oxygen saturation is varied, and measurements from the device are compared to reference measurements. The country of origin for the data is not specified, but the manufacturer is based in Beijing, China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
For a pulse oximeter, the "ground truth" for SpO2 accuracy is typically established by simultaneously measuring arterial oxygen saturation (SaO2) from blood samples analyzed by a co-oximeter, while the subject is varying oxygen levels. It does not involve human experts in the typical sense of radiologists reviewing images. Instead, it relies on highly precise laboratory equipment and trained medical staff for blood sampling and co-oximetry. The document does not specify the number or qualifications of clinicians/technicians involved in conducting such a study.
4. Adjudication method for the test set
Not applicable in the typical sense of expert adjudication for diagnostic imaging or subjective assessments. The "ground truth" for SpO2 and PR accuracy is derived from objective, quantitative measurements (co-oximetry for SaO2 and ECG for heart rate) compared against the device's readings. Discrepancies would be analyzed statistically, not through an adjudication process among experts.
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, a multi-reader multi-case (MRMC) comparative effectiveness study was not mentioned or required for this type of device (a pulse oximeter). MRMC studies are typically used for diagnostic devices that involve human interpretation of complex data (e.g., medical images), often in the context of Artificial Intelligence (AI) assistance. This device is a direct measurement tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the inherent performance of the device's algorithms for calculating SpO2 and Pulse Rate. The "SpO2 and PR Accuracy Test" performed according to ISO 80601-2-61 serves as the standalone performance evaluation. This test directly assesses the device's ability to accurately measure SpO2 and PR against a known reference, without human interpretation influencing the measurement itself.
7. The type of ground truth used
The ground truth used for the SpO2 and PR accuracy testing is implicitly reference measurements from established medical standards. For SpO2, this means arterial blood gas analysis using a co-oximeter (measuring SaO2). For pulse rate, it would typically involve an independent, highly accurate heart rate measurement method, such as an electrocardiogram (ECG). This falls under the category of objective physiological measurements rather than expert consensus or pathology.
8. The sample size for the training set
The document describes the device itself and its testing for regulatory approval. It does not mention any "training set" because this device is a traditional medical measurement device, not an AI/machine learning algorithm that requires a training set. Its algorithms are based on established biophysical principles of light absorption by blood.
9. How the ground truth for the training set was established
As there is no training set for this type of device, this question is not applicable.
§ 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).