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The Acclarix LX9 Series/ Acclarix AX8 Diagnostic Ultrasound System is intended for use by a qualified physician or allied health professional for ultrasound evaluation in hospitals and clinics. Clinical applications include Abdominal, Gynecology, Obstetric, Cardiac, Small parts, Urology, Musculoskeletal, Peripheral vascular, Intra-operative, Pediatric, Neonatal and Adult Cephalic.

The Modes of Operation for Acclarix LX9 series include B mode, Doppler mode, Harmonic Imaging, Elastography Imaging, Contrast imaging and their combination modes.

The Modes of Operation for Acclarix AX8 include B mode, M mode, Harmonic Imaging, Elastography Imaging and their combination modes.

Acclarix AX8/ Acclarix LX9 Series is a software controlled Diagnostic Ultrasound System, which consists of a main unit along with associated transducers. It is intended for use by a qualified physician or allied health professional for ultrasound evaluations. This system is a Track 3 device to acquire and display ultrasound data in various imaging modes.

The provided FDA 510(k) summary for the Acclarix AX8/LX9 Series Diagnostic Ultrasound System does not contain information about studies proving the device meets acceptance criteria related to AI or machine learning algorithms, specific performance metrics for image interpretation (e.g., sensitivity, specificity), or comparative effectiveness studies with human readers.

The document states: "Clinical testing is not required." and emphasizes non-clinical testing for electrical safety, EMC, and compliance with general ultrasound standards. The submission primarily focuses on demonstrating substantial equivalence to predicate devices based on design features, intended use, and general performance (e.g., transducer additions, new imaging modes).

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them in the context of AI/ML performance, as such information is not present in the provided text.

Specifically, the following requested information is not available in the provided document:

1. A table of acceptance criteria and the reported device performance: No such table is present for AI/ML performance.
2. Sample sized used for the test set and the data provenance: Not applicable as no AI/ML performance testing is detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and the effect size: Not done or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not done or reported for AI/ML algorithms.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

The "Performance Data" section solely details non-clinical testing for electrical safety, electromagnetic compatibility (EMC), general ultrasound equipment standards, and biocompatibility. The "Conclusion" explicitly states that "Verification and validation testing has been conducted... This premarket notification submission demonstrates that Acclarix LX9 Series Diagnostic Ultrasound Systems are substantially equivalent to the predicate devices." This substantial equivalence is based on the technical characteristics and intended use, not on specific AI/ML diagnostic performance metrics.

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