(113 days)
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.
The provided text is a 510(k) Premarket Notification summary for the ACUSON Juniper Diagnostic Ultrasound System and ACUSON Juniper Select Diagnostic Ultrasound System. It details the device's intended use, technological characteristics, and a comparison to predicate devices, but it explicitly states that no clinical studies were required or conducted to demonstrate substantial equivalence.
Therefore, I cannot fulfill your request to describe acceptance criteria and a study that proves the device meets those criteria, as the document explicitly states "The subject of this premarket submission, ACUSON Juniper and ACUSON Juniper Select, did not require clinical studies to support substantial equivalence." (Section 8).
The provided text does not contain information on:
- Acceptance Criteria and Reported Performance: No quantitative performance metrics or acceptance criteria based on clinical studies are mentioned.
- Sample Size and Data Provenance: No test set sample sizes or data provenance (country, retrospective/prospective) are mentioned as no clinical studies were performed.
- Expert Ground Truth Etablishment: No information on experts establishing ground truth is provided.
- Adjudication Method: Not applicable as no clinical studies were conducted.
- MRMC Comparative Effectiveness Study: No such study was conducted.
- Standalone Performance: No standalone algorithm performance is discussed as this is an ultrasound system, not an AI-based diagnostic algorithm.
- Type of Ground Truth: Not applicable as no clinical studies were conducted.
- Training Set Sample Size/Ground Truth: Not applicable, as this is for an ultrasound device, not an AI algorithmic device with a training set in the typical sense.
The document primarily relies on non-clinical tests to demonstrate safety and substantial equivalence to legally marketed predicate devices, focusing on:
- Acoustic output
- Biocompatibility
- Cleaning and disinfection effectiveness
- Thermal, electromagnetic, 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, the provided document does not contain the information needed to answer your questions regarding acceptance criteria and clinical study performance for this device, as no clinical studies were performed for its 510(k) clearance.
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.