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The S2000 and S3000 ultrasound imaging systems are intended for the following applications: Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Transcranial, OB/GYN, Cardiac, Pelvic, Neonatal/Adult Cephalic, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular applications.

The system also provides the ability to measure anatomical structures {fetal, abdominal, intraoperative, intraoperative neurological, pediatric, small organ, neonatal cephalic, adult cephalic, cardiac, trans-esophageal, transvaginal, peripheral vessel, musculoskeletal (conventional), musculo-skeletal (superficial) and neonatal cardiac} and calculation packages that provide information that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The Arterial Health Package (AHP) software provides the physician with the capability to measure Intima Media Thickness and the option to reference normative tables that have been validated and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding state of their cardiovascular system. This feature should be utilized according to the "ASE Consensus Statement: Use of Carotid Ultrasound to Identify Subclinical Vascular Disease and Evaluate Cardiovascular Disease Risk: A Consensus Statement from the American Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients.

The S2000 and S3000 Ultrasound Systems are multi-purpose mobile, software controlled diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to acquire primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D/4D Imaging on a Flat Panel Display.

The provided document is a 510(k) summary for the Acuson S2000 and S3000 Diagnostic Ultrasound Systems, focusing on their Virtual Touch IQ (VTIQ) shearwave elasticity imaging software. The document primarily establishes substantial equivalence to predicate devices and outlines the device's technical characteristics and intended uses.

Here's an analysis of the requested information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" in terms of performance metrics (e.g., sensitivity, specificity, accuracy) for the VTIQ feature. Instead, it argues for substantial equivalence based on technological characteristics and a comparison with the predicate device (Supersonic Imagine Aixplorer).

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

The document does not explicitly mention a formalized "test set" with a specified sample size for validating the VTIQ feature against acceptance criteria. It mentions:

• "Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers."
• "25 example cases submitted (refer to tab 1.7.5.10 D)."

This suggests some form of comparative evaluation on a limited set of cases (at least 25), but details regarding the design of this study (e.g., sample size, prospective/retrospective, country of origin) are missing.

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

The document mentions "biopsy proven breast cancers" as a reference for comparison in the aforementioned "many cases." This implies pathology as ground truth. However, the exact number of experts (e.g., pathologists) involved in establishing this ground truth for the "25 example cases" or more generally for the "many cases" is not specified, nor are their specific qualifications.

4. Adjudication Method for the Test Set

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set or the "many cases" mentioned.

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

The document does not mention a Multi Reader Multi Case (MRMC) comparative effectiveness study. It describes a comparison between the VTIQ device and a predicate device, focusing on technical performance differences rather than human reader performance with or without AI assistance.

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

The document implies a standalone comparison of the VTIQ algorithm's output (shear wave velocity, image quality) against the predicate device's output. The statement, "Using VTIQ and Supersonic Aixplorer in the same lesions on the same subjects, we have encountered many cases where maximum shearwave velocity with VTIQ was higher and more completely filled in with shearwave information throughout the lesion than with the predicate device in biopsy proven breast cancers," highlights an algorithm-only comparison of the imaging capabilities and derived measurements.

7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)

The primary ground truth mentioned that is relevant to disease state is histopathological diagnosis ("biopsy proven breast cancers").

8. The Sample Size for the Training Set

The document does not provide information on a specific training set or its sample size. This filing is a 510(k) for an ultrasound system with new software features, implying that the VTIQ algorithm was likely developed internally and possibly trained on proprietary data which is not described in this summary.

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

Since no training set information is provided, how its ground truth was established is also not available in the document.

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

The SuperSonic Imagine AIXPLORER® ultrasound system is indicated for use in the following applications: Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Vascular, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-vaginal and Neonatal Cephalic.

The system also provides the ability to measure anatomical structures (Abdominal, Small Organs, Musculoskeletal, Superficial Musculoskeletal, Peripheral Vascular, GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal, Neonatal Cephalic).

The SuperSonic Imagine AIXPLORER® system is a cart based ultrasound imaging system used to perform invasive and non-invasive diagnostic general purpose ultrasound imaging studies. The system contains a scan converter and can be coupled to a variety of linear, curved, microconvex, and motorized linear 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, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging, Panoramic Imaging and for ShearWave™ elastography. The addition of the quantification tool allows the user to read the average shear wave propagation speed.

Here's a summary of the acceptance criteria and study information for the Aixplorer® Diagnostic Ultrasound System (K132274), based on the provided text:

Acceptance Criteria and Device Performance

• Mechanical Index: 1.9 (Maximum)
• TIS/TIB: 0.1 - 4.0 (Range)
• ISPTA(d): 720 mW/cm2
• ISPPA(d): 0 - 700 W/cm2
  (Limits are the same as predicate Track 3 devices.) |
  | General Safety and Electrical Standards | Designed to comply with IEC 60101 -1 (2005), IEC 60601-2-37 (2007), and IEC 60601-1-2 (2000). |

Study Information

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

• Sample Size for Shear Wave Speed Tests: Four different cylindrical target types of a CIRS 049A Elasticity Quality Assurance phantom were used. For each target, five independent SWE shear wave speed measurements were taken. (Total of 20 measurements).
• Sample Size for QBox Measurement Tests: Not explicitly stated as a number of samples, but presumably refers to measurements performed on the same phantom targets or similar controlled environments as the shear wave speed tests.
• Data Provenance: The tests were "non clinical testing performed on the modified Aixplorer." This indicates prospective bench testing using a phantom. There is no information regarding country of origin for this test data beyond the manufacturer being in France.

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)

• The ground truth for the test set was established using a CIRS 049A Elasticity Quality Assurance phantom, which has "nominal shear wave speeds" for its targets, implying a pre-defined or manufacturer-provided ground truth.
• For the QBox Measurement Tests, the comparison was against "results obtained by performing the same measurements in Matlab." This suggests the ground truth was derived from a computational standard, not expert consensus.
• Therefore, no human experts were involved in establishing the ground truth for these non-clinical performance tests.

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

• No human adjudication method was used, as the study was a non-clinical, phantom-based bench test comparing device measurements to known phantom properties or computational results (Matlab).

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 comparative effectiveness study was done. This 510(k) summary focuses on the technical performance and safety of the ultrasound system itself, not on the improvement of human readers with AI assistance. The "AI" component mentioned (ShearWave™ elastography, quantification tool) is integrated into the device's imaging and measurement capabilities rather than being a separate AI-based diagnostic aid for human review.

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

• Yes, the non-clinical performance data represents "standalone" algorithm performance in controlled bench tests. The tests assessed the device's ability to accurately measure shear wave speed and QBox values independently.

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

• The primary type of ground truth used was phantom-based nominal values (for shear wave speed) and computational standards (comparison to Matlab for QBox measurements).

8. The sample size for the training set

• This document describes non-clinical performance testing for a diagnostic ultrasound system. It does not mention any "training set" as it would for a machine learning or AI algorithm in the typical sense of needing data to learn from. The device's "AI" functionalities (ShearWave™ elastography) are inherent in its design and physics-based measurements rather than being trained on a dataset.

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

• As no training set is mentioned or implied for this device's submission, this question is not applicable based on the provided text.

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