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The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is intended for Peripheral Vessel applications. The system provides an automated intima-media thickness measurement of peripheral vessels such as the common carotid in the BIMT-mode of operation for heart rate range of 20-150 beats per minute. The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is contraindicated for fetal use.

The AIDA V1.5 Diagnostic Ultrasound System GM-72P00A is a portable ultrasound system optimized to perform a non-invasive examination of the peripheral vessels. It provides an automated measurement of the intima-media thickness (IMT) of peripheral arteries such as the common carotids and allows the user to search for arterial plaques using real-time Brightness and Color Doppler imaging modes. The touchscreen keyboard allows the user to input various parameters relating to traditional cardiovascular risk factors. A built in calculator provides risk scores commonly used in a variety of geographical locations (Framingham Risk Score, PROCAM Health Check Score, Reynolds Risk Score, Risk score based on the SCORE Project). This information is supplemented with an IMT measurement of the artery to generate a comprehensive report of cardiovascular risk assessment.

The provided text does not contain information regarding acceptance criteria for a device's performance, nor does it describe a study proving the device meets said criteria.

The document is a 510(k) Premarket Notification for the AIDA V1.5 Diagnostic Ultrasound System GM-72P00A. It primarily focuses on:

• Administrative Information: Submitter's name, address, contact, date, trade name, model, common name, classification, regulatory class.
• Device Description: A portable ultrasound system optimized for non-invasive examination of peripheral vessels, providing automated Intima-Media Thickness (IMT) measurement and allowing search for arterial plaques using B and Color Doppler imaging. It also includes a touchscreen keyboard for inputting cardiovascular risk factors and a built-in calculator for risk scores (Framingham, PROCAM, Reynolds, SCORE).
• Standards Compliance: Lists various UL, IEC, ISO, and NEMA standards the device complies with.
• Intended Use: Specifically for Peripheral Vessel applications, providing automated IMT measurement of peripheral vessels (e.g., common carotid) in BIMT-mode for heart rates of 20-150 bpm. It is contraindicated for fetal use.
• Technological Comparison to Predicate Devices: States substantial equivalence to previously cleared devices (K103148 and K093171), noting they all transmit ultrasonic energy, perform post-processing, and allow specialized measurements.
• FDA Clearance Letter: Official communication from the FDA confirming substantial equivalence and allowing marketing.
• Indications for Use Statement: Reiterates the intended use as described in the device description.
• Intended Use Tables (Clinical Application and Mode of Operation): These tables list various clinical applications and modes of operation. For "Peripheral Vessel," it indicates the device supports "P" (previously cleared by FDA) in B-mode and "N" (new indication) in Combined mode (BIMT: B + IMT).

Therefore, I cannot provide the requested information as it is not present in the given text. The document describes what the device does and its regulatory clearance, but not the specific performance metrics or the details of any study used to validate those metrics.

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