(89 days)
The OxiprobE is indicated for non-invasive, continuus, beat-by-beat monitoring of oxygen saturation of functional arterial hemoglobin, pulse rate and pulse amplitude. Individual models are labeled specifically for either adult or pediatric use. It is for prescription use only.
The Oxiproble is Pulse Oximetry sensors and cables used for non-invasive measurement of blood oxygen saturation and pulse rute measurement. It consists of Connector, Cable and sensor. Bio Medical Technologies Co., Ltd. supplies both disposable and reusable sensors. Disposable sensors are designed to enable the sensor's light source and photo detector to be securely and properly positioned on the patient. The adhesive stabilizes these important optical components and provides a comfortable fit. Adhesive sensors are patient-dedicated and can travel with your patients. Single-use sensors do not present the risk of cross-contamination caused by products that are reused from patient up patient. Reusable sensors are designed to monitor various sizes of relatively immobile patients. When short-term or intermittent monitoring is necessary, these reusable, nonsterile sensors are an effective monitoring alternative.
The provided document is a 510(k) summary for the OxiprobE oximetry sensor, which is a medical device for non-invasive measurement of blood oxygen saturation and pulse rate. It establishes substantial equivalence to predicate devices (K993637 and K063783), but does not contain a study or data on its performance against acceptance criteria.
Therefore, I cannot fulfill your request for:
- A table of acceptance criteria and reported device performance.
- Sample size for the test set or data provenance.
- Number of experts or their qualifications for establishing ground truth.
- Adjudication method for the test set.
- MRMC comparative effectiveness study results.
- Standalone performance data.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
This document focuses on the regulatory submission process and establishing substantial equivalence, rather than providing detailed performance data from a clinical or technical study.
§ 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).