(222 days)
The Pulse Oximeter is intended for continuous monitoring, spot-checking of functional pulse oxygen saturation (SpO2) and pulse rate (PR) of single adult, adolescent, child and infant patients in hospitals and clinics.
The Pulse Oximeter MD300M/MD300K2 can display the SpO2%, pulse rate, Pulse Amplitude Index and other indication parameters, such as time, ID number, pulse amplitude bar and battery power status, alarm limits and the connections of sensors. It is used for adult, adolescent, child and infant patients. The device has physiological alarm and technology alarm function. There are two-level alarm priorities in oximeter. High priority: "Di-Di-Di-----------Di-Di" indicates the patient is in the very dangerous situation. Low priority: "Di" indicates the technical alarm caused by the device itself. The device also has visual alarm function to indicate users by lamp and information on the device. The power supply of the applicant device is 3 AA alkaline batteries, rechargeable batteries or adapter.
The proposed device consists of photo detector, display screen, signal amplify unit, CPU, display unit and power supply unit.
Principle of the oximeter is as follows: A mathematic formula is established making use of Lambert Beer Law according to Spectrum Absorption Characteristics of Reductive hemoglobin (RHb) and Oxyhemoglobin (HbO2) in red and near-infrared zones. Operation principle of the instrument: Photoeletric Oxyhemoglobin Inspection Technology is adopted in accordance with Capacity Pulse Scanning and Recording Technology, so that two beams of different wavelength of lights (660nm red and 905nm near infrared light) can be focused on a human nail tip through a clamping finger-type sensor. A measured signal obtained by a photosensitive element, will be shown on the oximeter's display through process in electronic circuits and microprocessor.
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.
Here's an analysis of the acceptance criteria and study details for the Pulse Oximeter (MD300M, MD300K2) based on the provided FDA 510(k) summary:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for SpO2 and PR accuracy are presented as part of the device's technical specifications and were evaluated through a clinical study.
| Parameter | Acceptance Criteria (Target/Claimed) | Reported Device Performance (MD300M with M-50E012CS09/M-50J033CS045 probes) | Reported Device Performance (MD300M with M-50B008CS09 probe) |
|---|---|---|---|
| SpO2 Accuracy (70-100%) | ± 2% | Arms of 1.75% | Arms of 1.48% |
| PR Accuracy | 30bpm | (Implicitly met as accuracy results provided for SpO2) | (Implicitly met as accuracy results provided for SpO2) |
Note: The document explicitly states the SpO2 accuracy (reported as Arms) as a result of the clinical study, which implicitly confirms it meets the claimed ± 2% accuracy. PR accuracy is listed as a specification but a specific Arms value from the clinical study is not provided in the summary, though it's implied to have been met. The relevant standard (ISO 80601-2-61) generally requires Arms to be less than or equal to the claimed accuracy.
2. Sample Size and Data Provenance for the Test Set
- Sample Size: 12 healthy adult volunteer subjects.
- Data Provenance: The study was conducted in Yue Bei People's Hospital (China). It was a prospective study.
- Subject Demographics: 6 females and 6 males, ages 21-43 years, 47-82 kg, 155-185 cm. The subject pool included diverse pigmentation: 6 with light pigmentation from Asian, 3 with light (white) pigmentation from Caucasian, and 3 with dark pigmentation from African.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number or qualifications of experts used to establish the ground truth. For pulse oximetry clinical studies, the ground truth for SpO2 is typically established using a co-oximeter on arterial blood samples, which is a gold standard measurement, not usually based on expert consensus of visual or imaging data.
4. Adjudication Method
Not applicable. This is not a study involving expert readers or image interpretation requiring adjudication. The ground truth for SpO2 accuracy is based on objective laboratory measurements (co-oximetry).
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for imaging devices or AI-assisted diagnostic tools where human interpretation is a primary component. The Pulse Oximeter is a physiological monitoring device.
6. Standalone Performance Study
Yes, a standalone study was performed. The clinical test described evaluates the accuracy of the device itself (algorithm only, as there’s no human-in-the-loop interpretation) by comparing its SpO2 readings to arterial blood gas measurements (co-oximetry), which serve as the ground truth.
7. Type of Ground Truth Used
The ground truth for the clinical accuracy study was established using arterial blood co-oximetry, which is considered the gold standard for measuring arterial oxygen saturation (SaO2) in pulse oximeter validation studies.
8. Sample Size for the Training Set
The document does not specify a separate training set. For pulse oximeters, the core algorithm for SpO2 calculation is based on established physiological principles and spectrophotometry (Lambert Beer Law) rather than a deep learning model requiring a large training dataset in the same way an AI diagnostic algorithm would. While manufacturers develop and refine their algorithms, this development process is not typically detailed as a "training set" in a 510(k) in the way AI/ML algorithms are. The "training" in this context would be more analogous to calibration and algorithm refinement based on engineering principles and potentially internal validation data.
9. How Ground Truth for the Training Set Was Established
As noted above, a distinct "training set" with ground truth in the AI/ML sense is not described. The fundamental principle (Lambert Beer Law) and device design are based on established science. Any internal calibration or algorithm development would use similar ground truth methodologies (e.g., co-oximetry data from desaturation studies) as the validation study to ensure accuracy across the measurement range, but these details are not provided as a "training set ground truth" in this 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).