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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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The SuperSonic Imagine AIXPLORER® MACH / 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 SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH ultrasound diagnostic systems are indicated for use in the following applications, for imaging and measurement of anatomical structures: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® MACH / SUPERSONIC MACH 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 Imagine AIXPLORER® MACH / 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 masses 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.

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 submodes 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 ShearWave™ elastography and Strain Elastography.

Here's an analysis of the provided text regarding the acceptance criteria and study proving device performance:

Device: SuperSonic Imagine AIXPLORER® MACH30/SUPERSONIC MACH30, AIXPLORER® MACH20/SUPERSONIC MACH20, SUPERSONIC MACH40 Ultrasound Diagnostic Systems.

1. Table of Acceptance Criteria and Reported Device Performance

The provided text does not explicitly state specific numerical acceptance criteria for performance metrics. Instead, the submission focuses on demonstrating "substantial equivalence" to a predicate device (AIXPLORER® MACH range sw V2, K191007) and adherence to recognized standards.

However, based on the intended use for liver disease and breast masses, and the discussion of ShearWave™ Elastography (SWE), we can infer the acceptance criteria and reported performance qualitatively:

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not specified. The submission refers to a "clinical evaluation by literature route" and provides a "Summary of literature review." This implies that the performance claims are based on published studies, not a new clinical trial conducted specifically for this 510(k) submission.
• Data Provenance: Retrospective, as it relies on a "literature review." The specific countries of origin for the studies included in the literature review are not mentioned in this document.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable in the context of this submission. Since the clinical evidence is based on a literature review, the experts establishing ground truth would be those involved in the original studies cited, but these details are not provided in this 510(k) summary.

4. Adjudication Method for the Test Set

Not applicable, as a new test set requiring adjudication was not explicitly created for this submission. The clinical evidence relies on previously published research.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of Human Improvement with AI vs. without AI Assistance

• MRMC Study: The document explicitly mentions that "Addition of Shear Wave elastography to conventional B-mode Ultrasound increased the specificity of breast mass assessment" and "increases the inter-observer agreement." This strongly suggests that a form of comparative effectiveness study was done in the literature reviewed, comparing human interpretation with and without SWE. However, it is not explicitly stated as a new MRMC study conducted for this specific 510(k) submission.
• Effect Size: The document uses qualitative terms like "increased specificity" and "significantly improve the positive predictive value," and "almost perfect" intra-operator repeatability and "high inter-observer reproducibility" for SWE. However, no specific numerical effect sizes (e.g., AUC improvement, percentage increase in sensitivity/specificity, or agreement metrics) are provided in this summary.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

The device is an ultrasound diagnostic system that includes ShearWave™ Elastography functionality. The "clinical evaluation by literature route" focuses on the utility of SWE as an aid to human interpretation. Phrases like "Addition of Shear Wave elastography to conventional B-mode Ultrasound" and "shearwave elastography in conjunction with 2D gray scale imaging and vascularization provides added information to better characterize breast masses" indicate that the performance described is a human-in-the-loop scenario, where SWE provides information to aid the clinician. Therefore, a standalone (algorithm only) performance study as typically understood for an AI diagnostic device is not described here. The SWE technology itself generates quantitative data (shear wave speed, stiffness) that is interpreted by the user.

7. The Type of Ground Truth Used

Based on the literature review summary for breast masses, the ground truth likely involved:

• Pathology: "Improve the diagnostic accuracy of ultrasound" and "assess the risk of lesion malignancy" strongly imply pathological diagnosis (biopsy results) as the ground truth for breast mass characterization.
• Outcomes Data: "More appropriate management strategies," "accurate cancer size measurements," "correlation with cancer aggressiveness and response to neo-adjuvant chemotherapy treatment" suggest that long-term patient outcomes or confirmed clinical diagnoses were used as ground truth in the cited literature.

For liver disease, although not explicitly stated, ground truth would similarly rely on established diagnostic methods for liver pathology and progression.

8. The Sample Size for the Training Set

Not applicable. This submission is for an ultrasound system with enhanced features (including ShearWave™ Elastography), not a standalone AI model that undergoes a distinct training phase in the typical sense of deep learning or machine learning. The underlying SWE algorithms would have been developed and validated through extensive research, but a "training set" as understood for a new AI algorithm is not detailed here.

9. How the Ground Truth for the Training Set Was Established

Not applicable for the same reasons as #8. The document does not describe a new AI model with a dedicated training set. The clinical evaluation relies on previously established literature for the performance of SWE technology.

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