(141 days)
The MD300C318T2 is intended for spot checking in measuring and displaying functional arterial hemoglobin (SpO2) and pulse rate. It is intended for adult, adolescent, child and infant users in hospitals, hospital facilities and home healthcare environments.
The proposed device of Fingertip Pulse Oximeter MD300C318T2 is a battery powered fingertip device, with the Durable and Deluxe design. The new kind of fingertip pulse oximeter integrated with Bluetooth wireless technology is designed to monitor SpO2 and pulse rate and connect with telemedicine.
The proposed device consists of power supply module, detector and emitter LED, signal collection and process module, display module, Bluetooth® module, voice indicator module, USB module, user interface.
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 940nm, which is ultra red light. Skin, bone, tissue, and venous vessels normally absorb a constant amount of light over time. The photodetector 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 power sources of the proposed device are 2 AAA alkaline batteries. The proposed device has low battery voltage indicator function and the proposed device will automatically power off when there is no signal for longer than 8 seconds.
The proposed device is not for life-supporting or life-sustaining, not for implant. The device or transducers are not sterile and the transducer is reusable and does 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 Section of Software.
The document describes the acceptance criteria and the study that proves the device (Fingertip Pulse Oximeter MD300C318T2) meets these criteria.
Here's the breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
| Performance Metric | Acceptance Criteria (Predicate Device) | Reported Device Performance (Proposed Device MD300C318T2) | Meets Criteria? |
|---|---|---|---|
| SpO2 Accuracy | 70%~100%: ±3% | 70%~100%: ±2% (specifically 70%~80%: ±2%; 80%~90%: ±2%; 90%~100%: ±1%) | Yes |
| PR Accuracy | 30 | 30 | Yes |
Note: The document implies that meeting the predicate device's accuracy specifications is the acceptance criterion for the proposed device to demonstrate substantial equivalence. The proposed device shows better accuracy than the predicate in all SpO2 ranges.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size (Clinical Test Set): 12 healthy adult volunteer subjects
- Data Provenance: Prospective clinical study, conducted in an unspecified country (Yue Bei People's hospital mentioned for the predicate device's clinical test, but the proposed device's clinical test states "conducted ... to evaluate..."). Given the submission is from Beijing Choice Electronic Technology Co., Ltd., it is highly probable the study was conducted in China.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number or qualifications of experts involved in establishing the ground truth for the clinical test. It states "Arterial blood samples were drawn during simultaneous data collection from the test devices. The blood was immediately analyzed on Reference CO-Oximetry providing functional SaO2 for the basis of the SpO2 accuracy comparison." This indicates that the ground truth was established by laboratory analysis using a reference CO-Oximeter, rather than by human expert consensus or interpretation.
4. Adjudication Method for the Test Set
Not applicable. The ground truth was established by direct measurement with a reference CO-Oximeter. There was no mention of human adjudication for the clinical accuracy study.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not done. The study focused on the device's standalone accuracy against a reference method.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
Yes, a standalone clinical performance study was done. The study measured the accuracy of the MD300C318T2 Fingertip Pulse Oximeter against a reference CO-Oximetry method.
7. The Type of Ground Truth Used
The ground truth used for the SpO2 accuracy assessment was Reference CO-Oximetry applied to arterial blood samples. This is considered an objective, gold-standard method for determining arterial oxygen saturation (SaO2).
8. The Sample Size for the Training Set
The document does not explicitly mention a "training set" or "training data" for the device. Pulse oximeters are typically hardware-based devices with embedded algorithms, and while those algorithms are developed and refined, the document does not break down data into training and test sets in the typical AI/ML sense. The performance study refers to the test data for demonstrating accuracy.
9. How the Ground Truth for the Training Set Was Established
As no specific training set is outlined in the provided text for an AI/ML context, this question is not directly applicable. The development of the oximeter's algorithm would be based on physiological principles and likely extensive previous data, but the creation of a "ground truth" for a training set in the way a machine learning model would use it is not described.
§ 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).