(137 days)
The AIDA diagnostic ultrasound system 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 ultrasound system is contraindicated for fetal use.
The AIDA diagnostic ultrasound system 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 B-mode imaging. 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 any information about acceptance criteria or a study proving the device meets acceptance criteria.
The document is a 510(k) Premarket Notification for the AIDA Diagnostic Ultrasound System GM-72P00A. It primarily focuses on:
- Administrative Information: Submitter's name, address, contact, date, trade name, model, common name, classification, and regulatory class.
- Device Description: What the device is (portable ultrasound system optimized for peripheral vessels, automated IMT measurement, plaque search, cardiovascular risk assessment).
- Standards Compliance: List of various UL, IEC, ISO, and NEMA standards the device is designed to comply with.
- Intended Use: Specifically for Peripheral Vessel applications, automated IMT measurement of peripheral vessels (like common carotids) in BIMT mode, heart rate range 20-150 bpm, and contraindication for fetal use.
- Technological Comparison to Predicate Device: States substantial equivalence to previously cleared devices (K093171, K081794, K022567) based on transmitting ultrasonic energy, post-processing echoes for display, and specialized measurement capabilities.
- FDA Correspondence: Letter from FDA confirming substantial equivalence and providing guidance.
- Indications for Use Statement: Reiterates the intended use for peripheral vessels, BIMT mode, and heart rate range.
- Clinical Application Table for Transducer L13-5V1: Specifies the clinical applications for the L13-5V1 transducer, noting "Peripheral vessel" as a new indication (N) using Combined mode B + IMT.
Therefore, I cannot provide the requested information in a table or answer the specific questions about the study, sample sizes, ground truth, or MRMC study, as this data is not present in the provided text.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.