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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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The SuperSonic Imagine AIXPLORER® 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 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-CYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® 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.

The SuperSonic Imagine AIXPLORER® 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-Color Flow Imaging, CPI-Color Power 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 ShearWaye™ elastography and Strain Elastography.

Here's an analysis of the acceptance criteria and study information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text focuses on establishing substantial equivalence for the AIXPLORER® MACH 30 and AIXPLORER® MACH 20 Ultrasound Diagnostic Systems to predicate devices. It doesn't explicitly state numerical acceptance criteria in the format of a performance table like sensitivity/specificity thresholds. Instead, the acceptance criteria are implicitly that the new device performs at least as safely and effectively as the predicate devices and complies with relevant regulatory standards.

The device performance is demonstrated through compliance with a set of international and FDA-recognized standards and through a comparative engineering test.

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

The document does not explicitly mention "test set" in the context of clinical images or patient data for evaluating AI performance. The studies described are primarily non-clinical engineering and regulatory compliance tests.

For the Strain Elastography engineering test, a specific sample size of cases or patients is not provided. It mentions a comparison "between Aixplorer® MACH and Mindray Resona 7," implying a technical evaluation rather than a clinical study with a patient cohort.

Data Provenance: Not applicable in the context of detailed clinical study data for AI performance. The regulatory compliance testing refers to international standards.

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

Given that the primary evidence cited is non-clinical engineering tests and adherence to standards, there is no mention of "experts" establishing ground truth for a clinical test set in the conventional sense of human readers. The "ground truth" for the engineering tests would be derived from the specifications and established performance of the predicate device and the physical principles verified by the tests themselves.

4. Adjudication Method for the Test Set

Not applicable, as a clinical test set with human readers and adjudication is not described.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study involving human readers and AI assistance is mentioned in the provided text. The submission focuses on establishing substantial equivalence to predicate devices for the ultrasound system itself and new indications, rather than the performance of AI-assisted interpretation by human readers.

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

No standalone algorithm-only performance study is explicitly mentioned. The "AIXPLORER® MACH" systems themselves perform diagnostic ultrasound imaging, and newer functionalities like "Vi PLUS," "Att PLUS," and "SSp PLUS" are described as features of the diagnostic system, not necessarily as standalone AI algorithms for image interpretation or diagnosis. The "engineering test of Strain Elastography" compares the device's technical output to a predicate, not an AI algorithm's diagnostic output.

7. The Type of Ground Truth Used

For the engineering tests and compliance studies, the "ground truth" is based on:

• Regulatory Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-37, NEMA UD 2, NEMA UD 3, ISO 10993-1. These standards define the acceptable technical and safety performance.
• Predicate Device Performance: The performance of the predicate ultrasound systems (AIXPLORER® MACH range sw V1, Aplio i900, i800, i700 V2.0, Resona 7) serves as the benchmark for "equivalence" in aspects like imaging modes and intended use.
• Physical Measurements and Quantitative/Qualitative Comparison: For the Strain Elastography test, the ground truth would be the known and verifiable measurements and output of the predicate Mindray Resona 7.

8. The Sample Size for the Training Set

No information about a training set for an AI/algorithm is provided. The document describes a medical device (ultrasound system) that relies on engineering principles and established imaging techniques, not a deep learning or AI model that requires a training set.

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

Not applicable, as no training set for an AI/algorithm is mentioned.

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The SuperSonic Imagine AIXPLORER® MACH ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body. The SuperSonic Imagine AIXPLORER® 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, Peripheral Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Transrectal, Trans-vaginal and Neonatal/Adult Cephalic, Non-invasive Cardiac.

In addition, the SuperSonic Imagine AIXPLORER® 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 shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization,

microvascularization and perfusion, the quantification of vascularization may be used as an aid to clinical management of adult and pediatric patients with liver disease.

The SuperSonic Imagine AIXPLORER® 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 ShearWave™ elastography.

The provided document is a 510(k) Summary for the SuperSonic Imagine AIXPLORER® MACH Ultrasound Diagnostic Systems. It describes the device, its intended use, and its substantial equivalence to predicate devices, supported by non-clinical testing and clinical evaluation via literature review. No primary clinical study data with specific acceptance criteria and detailed performance metrics of the device are present in this document.

Therefore, many of your requested details cannot be extracted from this specific 510(k) summary as it does not contain a primary clinical study description with acceptance criteria, sample sizes, expert ground truth establishment, or multi-reader multi-case study data.

Here's a breakdown of what can be extracted and what information is not available from this document:

1. A table of acceptance criteria and the reported device performance

• Not Available. This document does not specify quantitative acceptance criteria for device performance nor does it report specific performance metrics from a clinical study for the AIXPLORER® MACH systems.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Not Available. The document states that a "clinical evaluation by literature route" was performed, indicating no new primary clinical test set was used for the AIXPLORER® MACH device for this submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

• Not Available. Since no new primary clinical test set was used, there is no information on experts establishing ground truth for such a set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not Available. As no new primary clinical test set was used, no adjudication method is mentioned.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

• Not Available. This document does not describe an MRMC comparative effectiveness study. The AIXPLORER® MACH is an ultrasound diagnostic system and is not presented as an AI-assisted reading device in this context. The "AIXPLORER® MACH" name refers to the product family and not necessarily a specific AI algorithmic component for interpretation.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not Available. This document describes an ultrasound diagnostic system, not a standalone algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Not Available. Since no new primary clinical study was conducted for this submission, no specific ground truth type is mentioned for a test set. The clinical evaluation relied on literature, implying that existing, previously established diagnostic methods or outcomes referenced in that literature would have served as de facto ground truth for those earlier studies.

8. The sample size for the training set

• Not Applicable / Not Available. This document describes the 510(k) clearance for an ultrasound diagnostic system, which is a hardware and software system for image acquisition and display, not a machine learning algorithm requiring a "training set" in the typical sense. Any internal algorithm development for image processing would not be detailed in this summary with specific training set sizes.

9. How the ground truth for the training set was established

• Not Applicable / Not Available. See point 8.

Summary of available information regarding compliance and equivalence:

The document focuses on establishing substantial equivalence to previously cleared predicate devices:

• AIXPLORER® Ultrasound Imaging System (K173021)
• FibroScan (K160524)
• Epiq 7 (K163120)

Non-Clinical Testing:
Non-clinical testing was performed according to several international and FDA-recognized standards to support substantial equivalence:

• IEC 60601-1 Ed.3.1 (Electrical, basic safety, and essential performance)
• IEC 60601-1-2 Ed.4 (Electromagnetic compatibility)
• IEC 60601-2-37 Ed.2.1 (Particular requirements for safety of ultrasonic medical diagnostic and monitoring equipment)
• NEMA UD 2 (Rev. 3) (Acoustic Output Measurement Standard)
• NEMA UD 3 (Rev. 2) (Real Time Display of Thermal and Mechanical Acoustic Output Indices)
• ISO 10993-1 (Biocompatibility)

The document states: "All data fell within pre-determined product specifications and external standard requirements. Results of non-clinical testing confirmed the substantial equivalence of the Aixplorer® MACH Systems to the predicate device(s)."

Clinical Evaluation:
A clinical evaluation was conducted "by literature route" to support substantial equivalence and to potentially expand the indications for use. This means existing scientific literature and studies related to similar ultrasound technologies and their clinical performance were reviewed, rather than conducting a new, dedicated clinical trial for the AIXPLORER® MACH systems themselves.

Conclusion stated in the document:
"The manufacturer and the design and development of the submission device comply with 21 CFR Part 820 and ISO 13485 (2016) Quality Standards. The submission device, designed to comply with applicable safety standards, is tested during the manufacturing process to ensure compliance with these standards. Performance testing demonstrated that the submission device is at least as safe and effective as the predicate devices listed in item 3."

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The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems and transducers are intended for general purpose pulse echo ultrasound imaging, soft tissue elasticity imaging, doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® & AIXPLORER® Ultimate 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® & AIXPLORER® Ultimate 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 spleen,- Measurements of brightness ratio between liver and kidney, - Visualization of abdominal vascularization, microvascularization and perfusion, - Quantification of abdominal vascularization and perfusion.

The shear wave speed and stiffness measurements, the brightness ratio, the visualization of vascularization, microvascularization and perfusion of vascularization and perfusion may be used as an aid to clinical management of adult patients with liver disease.

The SuperSonic Inagine AIXPLORER® & AIXPLORER® Utimate systems are a cart based ultrasound imaging system used to perform noninvasive diagnostic general purpose ultrasing 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 aqustable control panel with integrated touch the user to perform an ultrasound exam quickly and efficiently in accordance with ALARA principles. The system also allows the perform measurements, capture images to digital memory or to an external device (such as a printer), and review diagnostic studies in 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 CFF-ColorFlow Imaging, CP-ColorPower Imaging- aso called Amplitude Dopper, dCP-drectional Color Power Imaging and Angio PLU.S), Pulsed Wave Doppler, 3D imaging, CEUS-Contrast Enhanced Ultrasound Imaging and for ShearWave™ elastography.

Here's an analysis of the acceptance criteria and supporting studies for the AIXPLORER® & AIXPLORER® Ultimate Ultrasound Diagnostic Systems, based on the provided text:

Acceptance Criteria and Reported Device Performance

The provided text focuses on demonstrating substantial equivalence to predicate devices rather than defining new, specific performance metrics with acceptance criteria for an AI component. The device is a general-purpose ultrasound system with several imaging modes, including ShearWave™ Elastography, and features for vascularization and perfusion.

The document states that a "clinical evaluation by literature route" was performed to support substantial equivalence and to widen the indications for use. This suggests reliance on existing published data about the performance of ultrasound systems with similar functionalities, particularly ShearWave™ Elastography, rather than a new performance study with predefined acceptance criteria.

Therefore, a table of acceptance criteria and reported device performance directly from a standalone AI study is not present in this document. Instead, the "reported device performance" is implicitly that the device is "at least as safe and effective as the predicate devices" based on non-clinical testing and clinical literature review.

However, the "Indications for Use" section (pages 2-14) outlines the specific capabilities of the AIXPLORER® & AIXPLORER® Ultimate ultrasound diagnostic systems, particularly emphasizing:

• 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.

These capabilities, particularly the ShearWave™ Elastography, visualization, and quantification of vascularization/perfusion, represent the "performance" that is being claimed as substantially equivalent to the predicate devices. The implicit acceptance criteria are that these functions operate within expected diagnostic ranges and provide information comparable to or better than the predicate devices, as supported by the literature review.

Specific Study Information from the Text:

1. A table of acceptance criteria and the reported device performance:
   As mentioned above, specific quantitative acceptance criteria or a direct performance table for a new AI feature is not provided. The entire submission focuses on establishing substantial equivalence to existing ultrasound devices (K171105, K170445, K160524) for its various imaging modes, including ShearWave™ Elastography and vascularization/perfusion features. The performance is validated indirectly through non-clinical testing against industry standards and a clinical literature review.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
   The document mentions a "clinical evaluation by literature route," which implies no specific new test set was generated for this submission. Therefore, information regarding sample size, data provenance, or retrospective/prospective nature of a dedicated test set is not provided. The data would originate from the cited literature.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
   Since there was no specific new test set to establish ground truth for this submission, this information is not applicable and not provided in the document. The "ground truth" for the literary review would be inherent to the studies cited, established by the experts in those original publications.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
   Not applicable, as no new test set with human adjudication was created for this submission.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
   No MRMC study is mentioned. The submission focuses on the device itself and its equivalence to other devices, not specifically on human reader improvement with AI assistance. The term "AI" is not explicitly used to describe the ShearWave Elastography or vascularization quantification features, although these advanced image analysis techniques often incorporate intelligent algorithms.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
   The document describes an ultrasound system (hardware and software) used for diagnostic imaging, with features like ShearWave™ Elastography, vascularization visualization, and quantification. These are integrated functions of the device. There is no mention of a separate "algorithm only" performance study. The device, as a whole, performs these measurements and displays the results for interpretation by a human clinician.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
   For the "clinical evaluation by literature route," the ground truth would depend on the methodologies of the individual studies cited in the literature. These could include pathology, clinical follow-up, or expert consensus, but this document does not specify the type of ground truth used in the underlying scientific literature.

8. The sample size for the training set:
   As this is a premarket notification for device equivalence and not a submission detailing the development of a novel machine learning algorithm that requires a dedicated training set, no information about a training set size is provided. The device's algorithms for ShearWave™ Elastography, vascularization, and perfusion would have been developed and validated internally by the manufacturer, presumably using relevant data, but details about such training are not part of this 510(k) summary.

9. How the ground truth for the training set was established:
   Not applicable, as no training set information is provided in this regulatory submission.

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The SuperSonic Imagine AIXPLORER® ultrasound system and transducer are intended for general purpose pulse echo ultrasound imaging and Doppler fluid flow analysis of the human body.

The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal and Peripheral Vascular.

The system also provides the ability to measure anatomical structures (abdominal, small organs, musculoskeletal, superficial musculoskeletal and peripheral vascular).

The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a linear array transducer 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 and associated calculations, 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 external domes (subm as the predicate devices (see section 4.5.2 for predicate devices) and transducers for the imaging modes: B-Mode imaging, Color Flow imaging, Color Power imaging, Pulsed Wave Doppler, and Elastography Imaging.

This document is a 510(k) summary for the SuperSonic Imagine AIXPLORER® Ultrasound System. It mostly focuses on substantial equivalence to predicate devices and safety considerations for an ultrasound system, not the performance of an AI application. Therefore, most of the requested information regarding acceptance criteria and the study proving an AI device meets these criteria is not available in the provided text.

Specifically, the document does not contain details about:

• Acceptance criteria for an AI device's performance.
• A study validating the performance of an AI component, including sample sizes, data provenance, expert qualifications, or adjudication methods for ground truth establishment.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone performance studies for an AI algorithm.
• Ground truth types or training set details for an AI component.

The document primarily describes a diagnostic ultrasound system and its general features, modes of operation, and acoustic output limits, comparing them to legally marketed predicate devices. The "AIXPLORER" name refers to the ultrasound system itself, not necessarily an AI-powered diagnostic tool in the sense of an algorithm making clinical interpretations. The only mention of "AI" is within the trade name "AIXPLORER®".

Therefore, I cannot provide a table of acceptance criteria, device performance, or details about a study proving an AI device meets these criteria based on the provided text. The document does not describe such acceptance criteria or a study for an AI component.

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