(114 days)
The Fingertip Pulse Oximeter MD300C208/MD300C198 is a 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 and hospital facilities.
The Fingertip Pulse Oximeter features low power consumption, convenient operation and portability. Place one fingertip into the photoelectric sensor for diagnosis and the pulse rate and oxygen saturation will appear on the display.
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 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 acceptance criteria and a study conducted for a Fingertip Pulse Oximeter (models MD300C208/MD300C198).
Here's an analysis of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The documents do not explicitly present a "table of acceptance criteria" in the typical format of pass/fail metrics. Instead, the performance specifications are presented as a comparison between the proposed device and the predicate device. The underlying acceptance criteria are implied by the conformance to recognized standards and the demonstration of "similar product specification" and "same performance" as the predicate device.
However, based on the "Performance Specification" section in the comparison tables (Table 3-1 for MD300C208 and Table 3-2 for MD300C198), we can infer the performance metrics and their reported values. The acceptance criteria for the new devices are implicitly that they achieve performance similar to or better than the predicate, and meet the specific accuracies outlined below.
| Acceptance Criteria (Implied from Predicate/Standards) | Reported Device Performance (MD300C208 & MD300C198) |
|---|---|
| SpO2 Display Range: 35%-100% (MD300C208); 35%-99% (MD300C198) | MD300C208: 35%-100% |
| MD300C198: 35%-99% | |
| SpO2 Measurement Range: 70%-100% (MD300C208); 70%-99% (MD300C198) | MD300C208: 70%-100% |
| MD300C198: 70%-99% | |
| SpO2 Accuracy (70-100%): ±2% | |
| SpO2 Accuracy (0-69%): No definition | MD300C208: 70%-100%, ±2%; 0-69% no definition |
| MD300C198: 70%-99%, ±2%; 0-69% no definition | |
| SpO2 Resolution: 1% | MD300C208: 1% |
| MD300C198: 1% | |
| PR Display Range: 30bpm-250bpm | MD300C208: 30bpm-250bpm |
| MD300C198: 30bpm-250bpm | |
| PR Measurement Range: 30bpm-250bpm | MD300C208: 30bpm-250bpm |
| MD300C198: 30bpm-250bpm | |
| PR Accuracy (30-99bpm): ±2bpm | |
| PR Accuracy (100-250bpm): ±2% | MD300C208: 30bpm-99bpm, ±2bpm; 100bpm-250bpm, ±2% |
| MD300C198: 30bpm-99bpm, ±2bpm; 100bpm-250bpm, ±2% | |
| PR Resolution: 1% | MD300C208: 1% |
| MD300C198: 1% |
2. Sample Size Used for the Test Set and the Data Provenance
The document mentions "clinical accuracy testing" was performed, but does not specify the sample size used for either the clinical or laboratory test sets or the data provenance (e.g., country of origin, retrospective/prospective nature of the data). It only states that the testing was "in order to ensure that they were appropriate performance and functional features..."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
The document does not provide information on the number of experts used or their qualifications for establishing ground truth.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
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 device is a Fingertip Pulse Oximeter, which is a direct measurement device and not an AI-assisted diagnostic tool for interpretation by human readers. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is not applicable and was not performed.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This is fundamentally a standalone device. The device itself performs the measurement of SpO2 and pulse rate. The "Performance Test according to ISO 80601-2-61" and "SpO2 and PR Accuracy Test" are examples of standalone performance evaluations. The results of these tests (the accuracy specifications listed above) reflect the device's performance without human intervention in the measurement process itself, beyond placement of the device.
7. The Type of Ground Truth Used
For the accuracy testing of pulse oximeters, the ground truth for SpO2 is typically established through arterial blood gas analysis (co-oximetry), and for pulse rate, direct physiological measurement. The document mentions "SpO2 and PR Accuracy Test" and adherence to "ISO 80601-2-61," which details requirements for oximeter accuracy including testing against a reference oximeter or co-oximeter. While not explicitly stated as "co-oximetry," this is the standard method for establishing ground truth for SpO2 in such devices.
8. The Sample Size for the Training Set
The document does not mention a training set sample size. This device is likely based on traditional signal processing and calibration, rather than machine learning models that require explicit training sets.
9. How the Ground Truth for the Training Set was Established
As no explicit "training set" for a machine learning model is mentioned or implied, this question is not applicable. The device's calibration and performance are established through adherence to standards and direct physical testing, not machine learning training.
§ 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).