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The SuperSonic Imagine AIXPLORER® Ultrasound System is indicated for use in the following applications: Abdominal, Small organs, Musculoskelatal, Superficial Musculoskeletal, Vascular, Intraoperative, OB-GYN, Pelvic, Pediatric, Urology, Trans-rectal, Trans-vaginal and Neonatal/adult Cephalic.

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

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 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, M-mode, Color Flow, Pulsed Wave Doppler, Harmonic Imaging, Amplitude Doppler, 3D imaging and for ShearWave™ elastography.

The provided text is a 510(k) Pre-market Notification for the SuperSonic Imagine Aixplorer® Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices for its intended uses and various transducers. Crucially, this document does not contain information about acceptance criteria or a study proving the device directly meets acceptance criteria in the context of diagnostic performance (e.g., accuracy, sensitivity, specificity).

Instead, the document asserts substantial equivalence based on technological characteristics and compliance with general safety and performance standards. It explicitly states that clinical data is not required because the device uses the same technology and principles as predicate devices.

Therefore, many of the requested sections about acceptance criteria and performance studies cannot be filled from this document. However, I can extract information regarding non-clinical tests and the general nature of the device's validation.

Here's a breakdown based on the available information:

1. A table of acceptance criteria and the reported device performance
   • Acceptance Criteria: The document implies that the acceptance criteria are adherence to various electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility standards. For instance, acoustic output must be "within FDA guidelines" as per NEMA UD-3.
   • Reported Device Performance: The document states that "All data fell within pre-determined product specifications and external standard requirements." However, specific numerical performance metrics (e.g., sensitivity, specificity, accuracy) are not provided as diagnostic performance studies were not conducted or submitted for this specific 510(k). The performance is described in terms of its ability to operate in various imaging modes (B-Mode, M-mode, Color Flow, Pulsed Wave Doppler, etc.) and for various clinical applications, which are identical or similar to predicate devices.

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

   • No information provided regarding a sample size for a test set related to diagnostic performance, as clinical studies were not submitted.
   • Non-clinical testing of the device and new transducers was performed, but no specific "test set" in terms of patient data is mentioned. The testing was likely conducted in a lab environment in France (where SuperSonic Imagine is based).

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 applicable, as no clinical studies with a test set requiring ground truth establishment by experts were submitted.

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

   • Not applicable, as no clinical studies with a test set requiring adjudication were submitted.

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 applicable. This is not an AI/CADe device. No MRMC study was mentioned.

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

   • Not applicable. This is not an AI/CADe device. No standalone algorithm performance was discussed.

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

   • Not applicable for diagnostic performance. For non-clinical tests, "ground truth" would be the specific requirements of the mentioned standards (IEC, UL, NEMA, ISO).

8. The sample size for the training set

   • Not applicable. This is not an AI/CADe device, and no training set is mentioned.

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

   • Not applicable. This is not an AI/CADe device, and no training set is mentioned.

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