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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.

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.

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The ACUSON Sequoia 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: Fetal. Abdominal. Pediatric, Neonatal Cephalic, Small Parts, OB/GYN (useful for visualization of the ovaries, follicles, uterus and other pelvic structures), Cardiac, Pelvic, Vascular, Adult Cephalic, Musculoskeletal and Peripheral Vascular applications.

The system supports the Ultrasonically-Derived Fat Fraction (UDFF) measurement tool to report an index that can be useful as an aid to a physician managing adult patients with hepatic steatosis.

The system also provides the ability to measure anatomical structures for fetal, abdominal, pediatric, small organ, cardiac, transrectal, transvaginal, peripheral vessel, musculoskeletal and calculation packages that provide information to the clinician that may be used adjunctively with other medical data obtained by a physician for clinical diagnosis purposes.

The ACUSON Sequoia Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bio-effect mechanisms. Its function is to transmit and receive 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 Mode, Amplitude Doppler Mode, a combination of modes, Panoramic Imaging, Contrast agent Imaging, Virtual Touch Strain Imaging, Virtual Touch - pSWE Imaging, Virtual Touch - SWE Imaging, syngo Velocity Vector Imaging, Custom Tissue Imaging, 3D/4D Volume Imaging and Harmonic Imaging on a Display.

The provided text does not contain detailed acceptance criteria or a study proving that the device meets specific performance criteria through a rigorous clinical or standalone study. Instead, it is a 510(k) summary for a medical device (ACUSON Sequoia Diagnostic Ultrasound System) seeking substantial equivalence to previously cleared predicate devices.

The document primarily focuses on demonstrating that the new device shares the same intended use and technological characteristics as the predicate devices, with minor modifications (like new transducers and software features that were already cleared for other transducers/devices).

Therefore, I cannot extract the requested information (like a table of acceptance criteria, sample size for test/training sets, number of experts for ground truth, adjudication method, MRMC study results, or detailed standalone performance) because the document explicitly states:

• "Since the ACUSON Sequoia Diagnostic Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (Section 8)

This means the submission relies on the established safety and effectiveness of the predicate devices and general compliance with performance and safety standards, rather than new performance studies with specific acceptance criteria.

The information closest to what you requested, but not a direct answer, is the list of features where the submission device and its predicate are compared (Table in Section 6). This table shows that features are present (marked with '√') but does not specify quantitative acceptance criteria or performance metrics for those features.

If this were a submission for an AI/ML-driven device requiring performance validation, the content would be significantly different and would include the types of studies and criteria you've listed. As it stands, this is a traditional 510(k) for an ultrasound system primarily focused on demonstrating substantial equivalence to prior versions.

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The ACUSON P500 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: Fetal, Abdominal (including liver), Pediatric, Small Parts, Transcranial, Transesophageal, OB/GYN(useful for visualization of ovaries, follicles, uterus and other pelvic structures), Lung, Pelvic, Neonatal Cephalic, Cardiac, Vascular(including Peripheral Vessel), Musculoskeletal, Superficial Musculoskeletal and Urology applications.

The system also provides the ability to measure and calculation packages 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 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.

Note: 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 Society of Echocardiography Carotid Intima-Media Thickness Task Force. Endorsed by the Society for Vascular imaging."

The ACUSON P500 Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound system with an on-screen display of thermal and mechanical indices related to potential bioeffect mechanisms. Its function is to transmit and receive 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 Mode, Power(Amplitude) Doppler Mode, a combination of modes and Harmonic Imaging on a Display.

This document is a 510(k) summary for the ACUSON P500 Ultrasound System, seeking clearance for a modified device. It declares substantial equivalence to previously cleared predicate devices by the same company, the ACUSON P500 (K163396), ACUSON Juniper (K201130), and ACUSON Redwood (K210743).

Here's an analysis of the acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present specific quantitative acceptance criteria or corresponding reported device performance values in a table. Instead, it relies on demonstrating substantial equivalence to predicate devices, asserting that the modified ACUSON P500 Ultrasound System (this submission) operates in the same manner and has similar technological characteristics as the previously cleared devices.

The "Determination of Substantial Equivalence" section (page 6-8) lists the features and characteristics of the submitted device and compares them to the predicate and reference devices. The core argument for acceptance is that the added features (transducers, applications, software features) and expanded clinical applications were already cleared on the reference devices.

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

The document explicitly states: "Since the ACUSON P500 Ultrasound System uses the same technology and principles as existing devices, clinical studies were not required to support substantial equivalence." (page 11, Section 8).

Therefore, there is no specific test set or associated sample size for a clinical study to prove the device meets acceptance criteria. The data provenance for performance relies on the previous clearances of the predicate and reference devices.

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

As no new clinical study was conducted for this submission, there were no experts specifically engaged to establish ground truth for a new test set for this clearance. The ground truth for the predicate and reference devices would have been established during their respective clearance processes.

4. Adjudication Method for the Test Set:

Since no new clinical study testing performance was performed for this 510(k), no adjudication method was specified or used for a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

The document does not mention any MRMC comparative effectiveness study, nor does it discuss AI-assisted performance or its effect size on human readers. The ACUSON P500 is an ultrasound system with various imaging modes and measurement packages, not an AI-driven diagnostic assistance tool in the context of this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

The document does not report any standalone algorithm performance studies. The device is an ultrasound system intended for use by "appropriately trained healthcare professional in a clinical setting" (page 2, 5).

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

As per the answer to point 2, no new clinical study was conducted for this submission. The basis for clearance is substantial equivalence to existing devices. Therefore, no new ground truth was established for this specific submission. The original ground truth for the clearances of the predicate and reference devices would have been established through methods appropriate for diagnostic ultrasound systems (e.g., expert interpretation of images, correlation with other diagnostic modalities or clinical outcomes). The Arterial Health Package (AHP) software, a feature of the device, references "normative tables that have been validated in peer-reviewed studies," which implies a form of ground truth based on established medical knowledge and research.

8. The Sample Size for the Training Set:

Since no new clinical study or algorithm development (in the context of this clearance) requiring a training set is discussed, no training set sample size is reported.

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

As no training set is discussed for this submission, the method for establishing its ground truth is not applicable or provided.

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