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For ACUSON Juniper

The ACUSON Juniper ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Neonatal, Vascular, Urology, Echocardiography, Musculoskeletal, and Intraoperative applications using different ultrasound transducers for different applications.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic 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 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.

For ACUSON Juniper Select

The ACUSON Juniper Select ultrasound imaging system is intended to provide images of, or signals from, inside the body by an appropriately trained healthcare professional in a clinical setting for the following applications: Abdominal, Obstetrics, Gynecology, Small Parts, Pediatric, Vascular, Urology, Echocardiography and Musculoskeletal applications using different ultrasound transducers for different applications.

The system also provides the ability to measure anatomical structures and provides analysis packages that provide information used by a physician for clinical diagnostic 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 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.

The ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System are the multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Their function is to acquire harmonic ultrasound echo data and display it in B-Mode, M-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppler Mode, Color M mode, Doppler Tissue Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

This is a 510(k) premarket notification for an ultrasound system, which primarily focuses on demonstrating substantial equivalence to a predicate device rather than presenting novel clinical performance data that would typically require specific acceptance criteria and a detailed study report.

Therefore, the requested information regarding acceptance criteria and the study that proves the device meets the acceptance criteria in the context of device performance, human reader improvement, and ground truth establishment is not available in the provided text.

The document states: "The subject of this premarket submission, ACUSON Juniper and ACUSON Juniper Select, did not require clinical studies to support substantial equivalence." This means that no specific clinical performance study was conducted to establish new performance metrics against predefined acceptance criteria for clinical diagnostic accuracy or effectiveness.

Instead, the submission focuses on demonstrating substantial equivalence through:

• Comparison of Indications for Use and Technological Characteristics: The document includes tables comparing the new device's indications for use and features with those of the predicate device (K221190) and reference devices (K183575, K213487). The primary claim is that the new device is "substantially equivalent ... with regards to intended use, indications for use, technological characteristics (Transducers, accessories and software features) and safety and effectiveness."
• Nonclinical Tests: These tests focus on safety aspects like acoustic output, biocompatibility, cleaning/disinfection, thermal safety, electromagnetic compatibility, and mechanical safety, conforming to applicable medical device safety standards (e.g., IEC 62359, AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-18, IEC 60601-2-37, ISO 10993-1).

In summary, there were no specific acceptance criteria for diagnostic performance established in this submission, nor was there a clinical study designed to demonstrate performance against such criteria. The "proof" of meeting acceptance criteria is the demonstration of substantial equivalence to already cleared devices based on technological similarity and nonclinical safety testing.

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