(121 days)
The Fingertip Pulse Oximeter MD300C29-H is a portable, non-invasive device intended for spot checking of oxygen saturation of arterial hemoglobin (SpO2) and pulse rate of adult, adolescent and child patient in hospital.
The proposed device Fingertip Pulse Oximeter MD300C29-H is a battery powered device, which can detect and display the measured %SpO2 and pulse rate value, pulse bar graph and SpO2 waveform. The device is normally applied to adult, child and adolescent patient in the hospital.
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.
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 or 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
Here's an analysis of the acceptance criteria and study information provided in the document:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the SpO2 accuracy are explicitly stated. The device performance (result of the clinical test) is stated to conform to these specifications.
| Parameter | Acceptance Criteria (Predicate) | Reported Device Performance (Applicant) |
|---|---|---|
| SpO2 Accuracy (70-100%) | ±3% | ±2% |
| SpO2 Accuracy (0-69%) | No definition | No definition |
| PR Accuracy (30-99bpm) | ±2bpm | ±2bpm |
| PR Accuracy (100-235bpm) | ±2% | ±2% (100-250bpm) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the clinical test set (number of patients or measurements).
The data provenance is not specified (e.g., country of origin, retrospective or prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the clinical test.
4. Adjudication Method for the Test Set
The document does not describe the adjudication method used for the clinical test set.
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 standalone clinical test to verify the device's accuracy against a reference.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, a standalone clinical test was performed to assess the accuracy of the device. The "Clinical Test" section states: "The results of the study provide supporting evidence that the Fingertip Pulse Oximeter MD300C29-H is compliance to the accuracy specification claimed by the manufacturer."
7. The Type of Ground Truth Used
The ground truth for the clinical test for SpO2 accuracy is based on the reference standard outlined in ISO 80601-2-61:2011, which dictates the methodology for testing pulse oximeter equipment accuracy (clause 201.12.1). This typically involves comparing the device's readings to measurements from a co-oximeter or other reference method during controlled hypoxemia studies in healthy volunteers.
8. The Sample Size for the Training Set
The document does not mention a training set for an algorithm, as this device appears to be a direct measurement device rather than one employing machine learning that requires a distinct training phase. If there were internal algorithm or calibration factors, the training data for those are not described.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set for a machine learning algorithm is mentioned. For the device's internal calibration/development, the ground truth would have been established through a controlled process similar to the clinical test, or using validated calibration artifacts, but this information is not detailed in the provided summary.
§ 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).