(217 days)
The IMEXLAB 9000 is a non-invasive diagnostic system designed to assist in the detection of peripheral vascular diseases. Instrument is used in a vascular laboratory, clinic or hospital. It for use by or on order of a physician. It is not indicated for use near non-intact skin or the eyes. It is not intended for home use.
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I am sorry, but the provided document does not contain information on acceptance criteria, device performance, details of a study (like sample size, data provenance, number of experts, adjudication methods, MRMC studies, or standalone algorithm performance), or how ground truth was established for the IMEXLAB 9000.
The document is a 510(k) clearance letter from the FDA, which declares the IMEXLAB 9000 Diagnostic Ultrasound Device as substantially equivalent to devices marketed prior to May 28, 1976, for the stated indications for use. It lists the approved transducers and reminds the manufacturer of regulatory compliance requirements. The "Indications for Use Form" (pages 3 and 4) specifies the clinical applications and modes of operation for which the device is intended, indicating its use in "Peripheral Vascular" applications with "CW" (Continuous Wave Doppler) and "Amplitude Doppler" modes, as well as a "Bidirectional Transducer".
However, it does not provide any performance metrics, study designs, or data related to the device's accuracy, sensitivity, or specificity against any defined acceptance criteria.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.