(86 days)
MD300C1 Fingertip Pulse Oximeter is a portable non-invasive, spot-check, 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 and etc). Not for continuously monitoring.
The applicant device of MD300C1 Fingertip Pulse Oximeter is a fingertip device, which can display % SpO2, pulse rate value. The applicant device consists of detector and emitter LED, signal amplify unit, CPU, data display unit and power unit. The Pulse oximetry 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 p venous vessels normally absorb a constant amount of light over time. The photodetector in fingersensor 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 device has low battery voltage alarm function and automatically power of function. The power source of the applicant device is 2 AAA alkaline or rechargeable batteries. The applicant 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 provided text (K093757) is a 510(k) summary for a pulse oximeter. It does not contain information about the device's acceptance criteria, studies proving its performance, or details about ground truth establishment, sample sizes for training/test sets, or expert involvement as requested.
The document primarily focuses on establishing "Substantial Equivalence" to a predicate device (MD300C, K070371) by demonstrating similar design principles, intended use, materials, and performance. It references compliance with various standards (IEC60601-1, IEC60601-1-2, ISO 9919, ISO 10993) and FDA guidance for software validation, which are general safety and performance requirements, not specific performance acceptance criteria for the device's SpO2 and pulse rate measurements.
Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, and ground truth from the given information. The document explicitly states: "Performance test results do not raise new questions of safety and effectiveness when compared to the legally marketed devices." This implies that the performance aspects were assessed against the predicate, but the specifics of those performance tests or acceptance criteria are not detailed 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).