(255 days)
The Fingertip Pulse Oximeter MD300CG11/MD300CG51 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent, child and infant patient with the fingers between 0.9 - 2.2 cm (0.4 - 0.9 inch) thick in hospital.
The proposed devices Fingertip Pulse Oximeter MD300CG11/MD300CG51 are battery powered devices, which can detect and display the measured %SpO2 and pulse rate working 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 940nm, 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 devices are normally applied to adult, adolescent, child and infant in hospital and home environments.
The Proposed devices MD300CG11 and MD300CG51 consist of power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit.
The provided document describes the Beijing Choice Electronic Technology Co., Ltd. Fingertip Pulse Oximeter MD300CG11/MD300CG51 and its substantial equivalence to a predicate device (MD300CB3).
Here's an analysis of the acceptance criteria and the study that proves the device meets them:
1. A table of acceptance criteria and the reported device performance
The document provides a detailed comparison table between the proposed devices (MD300CG11/MD300CG51) and the predicate device (MD300CB3). This table essentially serves as the acceptance criteria for the proposed device, demonstrating that its performance characteristics are substantially equivalent to the legally marketed predicate.
| Characteristic | Acceptance Criteria (Predicate Device Performance) | Reported Device Performance (Proposed Device) |
|---|---|---|
| Intended Use | Spot checking SpO2 and pulse rate of adult, adolescent, child, and infant patients in hospital | Spot checking SpO2 and pulse rate of adult, adolescent, child, and infant patients with fingers between 0.9 - 2.2 cm thick in hospital |
| Design Principle | Same (light absorption by pulsating arteriolar beds) | Same (light absorption by pulsating arteriolar beds) |
| Components | Power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit | Power supply module, detector and emitter LED, signal collection and process module, display module, user interface and button control circuit |
| Power | Internal powered equipment (1 AAA-size alkaline battery) | Internal powered equipment (1 AAA-size alkaline battery) |
| Display Screen Type | OLED | MD300CG11: LED, MD300CG51: LCD |
| Display Mode | 6 directions for display | MD300CG11: 1 direction, MD300CG51: 2 directions |
| Interface Display | SpO2, PR, SpO2 Waveform, Pulse bar graph, Low power indicator | MD300CG11/MD300CG51: SpO2, PR, Pulse bar graph, Low power indicator |
| LED Specification (RED) | 660±2nm | 660±2nm |
| LED Specification (IR) | 940±10nm | 940±10nm |
| SpO2 Display Range | 0-100% | 0-99% |
| SpO2 Measurement Range | 70-100% | 70-99% |
| SpO2 Accuracy | 70%-100%: ±2%; 0%-69% no definition | 70%-99%: ±2%; 0%-69% no definition |
| SpO2 Resolution | 1% | 1% |
| PR Display Range | 0-254BPM | 0-254BPM |
| PR Measurement Range | 30-235BPM | 30-235BPM |
| PR Accuracy | 30-99bpm, ±2bpm; 100-235bpm, ±2% | 30-99bpm, ±2bpm; 100-235bpm, ±2% |
| PR Resolution | 1bpm | 1bpm |
| Patient Contacting Material | Medical silicone gel, ABS plastic | Medical silicone gel, ABS plastic |
| Material of Shell | Medical silicone gel, ABS plastic | Medical silicone gel, ABS plastic |
Key takeaway on acceptance criteria and performance: The acceptance criteria are implicitly defined by the specifications of the predicate device (MD300CB3). The reported performance shows that the proposed devices (MD300CG11/MD300CG51) meet or are substantially equivalent to these criteria. Minor differences in display type, direction, and SpO2 display/measurement range (99% vs 100%) are noted, but these are considered not to affect the substantial equivalence for regulatory purposes.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Clinical Test: The proposed device MD300CG11/MD300CG51 and the predicate device MD300CB3 have the same electro-optical component, SpO2 module and have equivalent sensor characteristics. We state that clinical testing is not necessary because the differences between the subject and predicate devices do not affect calculation of SpO2."
Therefore, no clinical test set was used for the demonstration of substantial equivalence given the product's classification and similarity to the predicate. The device's performance was evaluated through non-clinical testing. The provenance of any underlying test data from these non-clinical tests is not specified, but the applicant company is based in China.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Since no clinical test set was used, there were no experts required to establish ground truth from clinical data. The accuracy claims for SpO2 and PR are based on engineering performance tests against established standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
No adjudication method was used for clinical data as no clinical test set was deemed necessary.
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. The device is a standalone medical device (Fingertip Pulse Oximeter) and does not involve AI assistance for human readers or interpretation of medical images.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Yes, the device's performance was evaluated as a standalone product. The non-clinical tests described (SpO2 and PR range & accuracy Test, Weak Perfusion Test, High and Low Temperature & Humidity Test, Performance Test after Disinfection, Shelf-life Test) evaluate the device's intrinsic performance against established standards like ISO 80601-2-61.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
For the non-clinical performance tests, the "ground truth" is defined by the calibrated reference measurements and standards outlined in ISO 80601-2-61:2011 Medical electrical equipment – part2-61: Particular requirements for the basic safety and essential performance of pulse oximeter equipment. This standard specifies a method for evaluating pulse oximeter accuracy against a co-oximeter or other reference method under controlled hypoxia conditions. The document mentions that performance tests were conducted "in accordance with ISO 80601-2-61."
8. The sample size for the training set
This is not applicable. The Fingertip Pulse Oximeter is a hardware device that directly measures and displays physiological parameters. It does not use machine learning or AI algorithms that would require a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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).