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The Hologic SuperSonic Imagine SUPERSONIC MACH range ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue viscoelasticity imaging, doppler fluid flow analysis of the human body. The Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnosic systems are indicated for use in the following applications, for imaging and measurement of anatomical Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

Modes of operation include: B-mode [2D ; 3D ; Panoramic Imaging; Spatial Compounding ], M-mode , Doppler [Continuous Wave (CW); Pulsed Wave (PW); Color and Power Doppler (Color Flow Imaging). Color Doppler (Angio PL.U.S) ], Strain Elastography, Tissue Harmonic Imaging, Contrast Enhanced Ultrasound Imaging (CEUS); Shear Wave Elastography (SWE); ShearWave dispersion Viscosity (Vi PLUS); Combination Modes [ (B/Color Flow) ; (B/SWE), ( B/ PW), {B/PW/Color Flow); (B/ M-mode); (B/Color flow/SWE); (B/M-mode/Color flow); (B/Strain Elastography/SWE)].

In addition, the Hologic SuperSonic SUPERSONIC MACH range ultrasound diagnostic systems and associated transducers are intended for:

-Measurements of abdominal anatomical structures,

• Measurements of broad band shear wave speed, and tissue stiffness in internal structures of the liver and the spleen,
• Measurements of brightness ratio between liver and kidney,
• Visualization of abdominal vascularization, microvascularization and perfusion,
• Quantification of abdominal vascularization and perfusion.

The shearwave speed, beam attenuation, viscosity and stiffness measurements, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult and pediatric patients with liver disease.

Furthermore, the SUPERSONIC MACH ultrasound diagnostic systems and associated transducers are intended for:

• Measurements of breast anatomical structures
• Measurements of broad band shear waves speed and tissue stiffness in internal structures of the breast
• Visualization of breast structures and micro-vascularization
• · Visualization of breast morphology using shearwave elastography and micro-vascularization 2D mapping.

The shear waves speed and stiffness measurements may be used as an aid to management of women patients with breast masses, as shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses and improve the diagnostic accuracy of ultrasound.

This device is intended for use by, or by the order of, and under the supervision of a licensed physician qualified to use or direct the use of the device. This device is intended for use in hospital environment or physician's office, This system should only be used by trained Health Care Professionals (HCP) who are knowledgeable about the risk of excessive acoustic energy in the body, particularly in the case where a great amount of fluid is present in the scanning area.

The SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH systems are cart based ultrasound imaging systems used to perform non-invasive diagnostic general purpose ultrasound imaging studies.

The system contains a scan converter and can be coupled to a variety of linear, curved, micro-convex, and motorized linear and phased array transducers to produce images, which are displayed on a LCD monitor. An adjustable control panel with integrated touch screen allows the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles.

The system also allows the user to perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in the form of a report. The system functions in a manner identical to the predicate devices and transducers for the imaging modes: B-Mode (harmonic or fundamental), M-mode, Color Flow (and sub-modes as CFI-ColorFlow Imaging, CPI-ColorPower Imaging- also called Amplitude Doppler, dCPI-directional Color Power Imaging and Angio PL.U.S), Pulsed Wave Doppler, Continuous Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWaveTM elastography and Strain Elastography.

The provided text is a 510(k) Summary for an ultrasound diagnostic system. It explicitly states in section 8, "A brief discussion of the clinical tests submitted, referenced, or relied on in the premarket notification submission for a determination of substantial equivalence: Not applicable.".

Therefore, the document does not contain information regarding:

• Acceptance criteria and reported device performance (beyond compliance with technical standards).
• Details of a study proving the device meets acceptance criteria.
• Sample size used for a test set or data provenance.
• Number of experts used to establish ground truth or their qualifications.
• Adjudication method for a test set.
• Multi-reader multi-case (MRMC) comparative effectiveness study, effect size.
• Standalone algorithm performance.
• Type of ground truth used.
• Sample size for the training set.
• How ground truth for the training set was established.

The document only discusses non-clinical tests (electrical safety, EMC, acoustic output, biocompatibility) which confirmed the device performs according to its intended use and complies with relevant standards. It concludes that the device is "at least as safe and effective as the predicate devices".

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