The 5000 Compact Series Ultrasound Systems
Philips Ultrasound LLCThe 5000 Compact Series Ultrasound Systems by Philips Ultrasound LLC is a diagnostic ultrasound imaging system equipped with an AI-powered Auto Measure feature. It provides semi-automated, editable 2D and Doppler measurements primarily for adult echocardiography, helping clinicians obtain accurate cardiac measures efficiently. The system supports a wide range of clinical applications including cardiac, abdominal, vascular, obstetric, and musculoskeletal imaging, and is used in various clinical settings such as hospitals and clinics.
Intended Use
The 5000 Compact series ultrasound systems are intended for diagnostic ultrasound imaging and fluid flow analysis of the human body across multiple anatomical areas including abdominal, cardiac (adult and pediatric), cerebral vascular, fetal/obstetric, gynecological, musculoskeletal, and more.
Technology
The system uses a locked AI/ML algorithm (Auto Measure Version 2) integrated into the 5000 Compact Ultrasound Series that performs semi-automated measurements during echocardiography. It runs on Philips' VM software platform with additional training on a subset of measurement detectors. No hardware changes are introduced and it operates with existing ultrasound transducers (e.g., S5-1 and S4-2).
Performance
Performance testing included software verification and validation to ensure accuracy aligned with manual clinical measurements using human interobserver variability as a benchmark. Testing was conducted on 500 echocardiography studies from diverse populations, demonstrating that all measurement detectors met acceptance criteria for agreement with expert clinical ground truth. The device complies with applicable standards IEC 62304 and ISO 14971, with no clinical investigations required for this software feature update.
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
9/17/2024
1 month - 2
FDA Approval
11/15/2024
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