(88 days)
The Aïmago EasyLDI microcirculation camera is intended for blood flow measurements in the microcirculation. / The Aimago EasyLDI Microcirculation Camera is intended for blood flow measurements in the microcirculation.
The Aimago EasyLDI microcirculation camera is a device for imaging blood flow in the microcirculation. It uses the established laser Doppler technique to quantify movement of blood cells beneath the skin surface. Unlike the predicate devices, the EasyLDI performs a 2dimensional Laser Doppler area scan to build up a color coded image of blood flow more rapidly than either predicate device.
The provided text describes a 510(k) submission for the Aïmago EasyLDI Microcirculation Camera. This document focuses on establishing substantial equivalence to predicate devices based on technological characteristics and safety testing, rather than reporting on clinical performance metrics or specific acceptance criteria met through a clinical study.
Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, expert involvement, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for a clinical study cannot be extracted from the provided text.
The document states:
- Summary of Testing: "Testing has been performed in-house as well as at contract laboratories has demonstrated that the Aïmago EasyLDI fulfills the requirements for Subpart B of Part 15 for Class A digital devices according to the FCC Rules for Digital Devices, the requirements ESD safety and electromagnetic immunity according to standard IEC 60601-1-2 and all electrical safety requirements from IEC 60601-1."
This indicates that the testing performed was primarily for electrical safety and electromagnetic compatibility, not clinical performance or accuracy in blood flow measurement against a defined ground truth or expert consensus. The FDA's substantial equivalence determination is based on these technical and safety tests, and the device's technical similarity to predicate devices that also use Laser Doppler imaging.
In summary, none of the requested information regarding the acceptance criteria and a study proving the device meets those criteria for clinical performance is available in the provided text. The submission focuses on regulatory compliance for electrical safety and comparison of technological features for substantial equivalence.
§ 870.2120 Extravascular blood flow probe.
(a)
Identification. An extravascular blood flow probe is an extravascular ultrasonic or electromagnetic probe used in conjunction with a blood flowmeter to measure blood flow in a chamber or vessel.(b)
Classification. Class II (performance standards).