(144 days)
The Fingertip Pulse Oximeter MD300CF315 is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). It is not for continuous monitoring.
The applicant device of Fingertip Pulse Oximeter MD300CF315 is a battery powered fingertip device, which can detect, display and speak out the measured %SpO2 and pulse rate value. The device is normally applied to adult and pediatric patient at home, and hospital (including clinical use in internist/surgery, Anesthesia, intensive care etc). The applicant device consists of power supply module, detector and emitter LED, signal collection and process module, display module, user interface, voice module and button control circuit. 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 660 nm, which is red light; the other is 940 nm, which is ultra 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 applicant devices are not for life-supporting or life-sustaining, not for implant. The devices or transducers are not sterile and the transducers are reusable and do not need sterilization or re-sterilization. The devices are for prescription. The devices do not contain drug or biological products. The devices are software -driven and the software validation is provided in Section 11 Software.
Here's an analysis of the provided text regarding the acceptance criteria and study for the Fingertip Pulse Oximeter MD300CF315:
1. Table of Acceptance Criteria and Reported Device Performance:
| Metric / Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device) | Substantial Equivalence Claim |
|---|---|---|---|
| SpO2 Display Range | 0-99% | 0-99% | Met |
| SpO2 Measurement Range | 70-99% | 70-99% | Met |
| SpO2 Accuracy (70-99%) | ±3% | ±3% | Met |
| SpO2 Accuracy (0-69%) | No definition | No definition | Met |
| SpO2 Resolution | 1% | 1% | Met |
| PR Display Range | 0-254 BPM | 0-254 BPM | Met |
| PR Measurement Range | 30-235 BPM | 30-235 BPM | Met |
| PR Accuracy (30-99 bpm) | ±2 bpm | ±2 bpm | Met |
| PR Accuracy (100-235 bpm) | ±2% | ±2% | Met |
| PR Resolution | 1 bpm | 1 bpm | Met |
| LED RED Wavelength | 660±2nm | 660±2nm | Met |
| IR Wavelength | 940±10nm | 940±10nm | Met |
| Operation Temperature | 5~40℃ | 5~40℃ | Met |
| Storage Temperature | -20~55℃ | -20~55℃ | Met |
| Operation Relative Humidity | ≤80%, no condensation | ≤80%, no condensation | Met |
| Storage Relative Humidity | ≤93%, no condensation | ≤93%, no condensation | Met |
Note: The document explicitly states that the proposed device:
- Shares the same Blood Oxygen Module with the predicate device MD300C.
- Meets design specifications and is Substantially Equivalent (SE) to the predicate device based on bench tests.
2. Sample size used for the test set and the data provenance:
- Sample Size: Not explicitly stated for specific clinical data. The document states "Bench tests were conducted to verify that the proposed device met all design specifications." However, for the clinical aspect related to SpO2 and PR accuracy, the crucial sentence is: "The Fingertip Pulse Oximeter MD300CF315 share the same Blood Oxygen Module with the predicate device MD300C, so we believe the clinical test of MD300CF315 can be exempted." This implies that no new clinical test data was gathered for this specific submission to demonstrate clinical performance if the predicate device already had sufficient clinical data.
- Data Provenance: Not applicable as a new clinical test was exempted for the proposed device due to shared components. For the predicate device's data, the provenance is not mentioned in this document.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable, as a new clinical test for the proposed device was exempted. For the predicate device's original clinical validation, this information is not provided in the given text.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable, as a new clinical test for the proposed device was exempted.
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. Pulse oximeters are devices that provide direct measurements (SpO2, PR) and do not involve human "readers" interpreting results in the way an imaging AI might. This type of study is not relevant for this device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- The description of the device's operation ("photo detector ... collects and converts the light into electronic signal...translated into an oxygen saturation measurement") strongly suggests it's a standalone algorithm. The device measures and displays SpO2 and PR. There is no mention of a human-in-the-loop for interpreting the device's primary outputs. The device itself performs the measurement and calculation, fitting the definition of "standalone" algorithm for its core function.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the technical specifications (SpO2, PR accuracy), the ground truth for pulse oximeters is typically established through direct arterial blood gas analysis with an oximeter (Co-oximeter) as the reference method in controlled desaturation studies. While not explicitly stated for this device's exemption, this is the industry standard for validating pulse oximeter accuracy. For other parameters like dimensions, weight, and environmental requirements, the ground truth would be physical measurements and standard environmental testing.
8. The sample size for the training set:
- Not applicable. This device utilizes a direct measurement principle and associated algorithms, not a machine learning model that requires a distinct "training set" in the conventional sense. The algorithms are based on established physiological principles and signal processing, which are "trained" or designed during product development using engineering principles and established calibration methods, rather than by feeding large datasets to an AI model.
9. How the ground truth for the training set was established:
- Not applicable, as per the explanation in point 8. The "ground truth" for calibrating and validating the device's SpO2 and PR measurement algorithms would involve precise measurements from a reference method (e.g., arterial blood gas analysis) during the initial development and verification of the blood oxygen module, which is shared with the predicate 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).