(90 days)
The Flexi-Stat SpO2 Sensor is indicated for continuous, non-invasive functional arterial oxygen saturation and pulse rate monitoring in adult, pediatric, and neonatal patients.
The Flexi-Stat(tm) SpO2 Sensor is an electro-optical sensor that functions without skin penetration, electrical contact, or heat transfer. The sensor uses optical means to determine the light absorption of functional arterial hemoglobin by being connected between the patient and the oximeter. The sensor contains three optical components: two light emitting diodes (LED) that serve as light sources and one photodiode that acts as a light detector. The optical components are housed in adhesive film. The sensor cable is terminated in a DB-9 style connector, with an adapter cable for Datexcompatible models.
The provided text describes a 510(k) summary for the Flexi-Stat SpO2 Sensor. However, it does not contain the detailed information necessary to fully answer all aspects of your request regarding acceptance criteria and a detailed study description. The document focuses on demonstrating substantial equivalence to a predicate device rather than providing a comprehensive clinical study report with specific acceptance criteria.
Based on the available information:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that the device was "found to be equivalent to predicate device accuracy claims." It does not provide specific numerical acceptance criteria (e.g., A_rms values, bias, precision) or the detailed performance metrics of the Flexi-Stat against those criteria. The predicate device's accuracy claims are not specified in this document.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| *Specific SpO2 accuracy (e.g., A_rms |
§ 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).