Search Results

The diagnostic ultrasound system and probes are designed to obtain ultrasound images and analyze body fluids.

The clinical applications include: Fetal/Obstetrics, Abdominal, Gynecology, Pediatric, Small Organ, Neonatal Cephalic, Adult Cephalic, Trans-rectal, Trans-vaginal, Transesophageal (Cardiac), Muscular-Skeletal (Conventional, Superficial), Urology, Cardiac Adult, Cardiac Pediatric, Peripheral vessel and Lung.

It is intended for use by, or by the order of, and under the supervision of, an appropriately trained healthcare professional who is qualified for direct use of medical devices. It can be used in hospitals (includes emergency room), private practices, clinics and similar care environment for clinical diagnosis of patients.

Modes of Operation: 2D mode, Color Doppler mode, Power Doppler (PD) mode, M mode, Pulsed Wave (PW) Doppler mode, Continuous Wave (CW) Doppler mode, Tissue Doppler Imaging (TDI) mode, Tissue Doppler Wave (TDW) mode, ElastoScan Mode, Combined modes, Multi-Image mode(Dual, Quad), 3D/4D mode.

The HM70 EVO is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging (including Directional Power Doppler mode; S-Flow), PW Spectral Doppler mode. CW Spectral Doppler mode, Harmonic imaging(S-Harmonic), Tissue Doppler imaging, Tissue Doppler Wave, Panoramic Imaging, Freehand 3D, 3D imaging mode (real-time 4D imaging mode), Elastoscan Mode or as a combination of these modes. The HM70 EVO also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information that is used to make a diagnosis by competent health care professionals. The HM70 EVO has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed.

The provided text is a 510(k) Premarket Notification for the HM70 EVO Diagnostic Ultrasound System. It describes the device, its intended use, and comparative information to predicates to demonstrate substantial equivalence. However, it explicitly states that clinical studies were not required to support substantial equivalence for this device. Therefore, the document does not contain information about acceptance criteria, a study proving the device meets those criteria, sample sizes, expert involvement, or MRMC studies for AI-assisted performance.

The "Summary of Clinical Tests" section on page 5, point 12, clearly states:
"The subject of this premarket submission, HM70 EVO, is not required clinical studies to support substantial equivalence."

Without a clinical study, none of the requested information regarding acceptance criteria, performance metrics, sample sizes, ground truth establishment, or expert involvement can be extracted from this document. The provided text only discusses non-clinical tests related to safety standards, acoustic output, biocompatibility, software function, cleaning, disinfection, thermal, electrical, electromagnetic, and mechanical safety.

Ask a specific question about this device