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The ACUSON NX2 and ACUSON NX2 Elite ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Parts (Small Organ), Adult Cephalic, Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

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 and published in peer-reviewed studies. The information is intended to provide the physician with an easily understood tool for communicating with patients regarding the state of their cardiovascular system.

Note: This feature can 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 Medicine."

The ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound Systems are 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 functions are 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, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging and 3D Imaging, or Harmonic Imaging and 4D imaqing on a Flat Panel Display.

This is a 510(k) premarket notification for a diagnostic ultrasound system, not an AI/ML device. Therefore, the typical acceptance criteria and study components related to software performance (such as sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and training set information) are not applicable or provided in this document.

The document primarily focuses on demonstrating substantial equivalence to a predicate device (ACUSON NX2 / ACUSON NX2 Elite Diagnostic Ultrasound System (K172374)) by comparing intended use, technological characteristics, and compliance with safety standards.

Here's a breakdown of the requested information based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

Since this is not an AI/ML device with specific performance metrics like sensitivity/specificity, the 'acceptance criteria' are primarily related to safety, operational modes, and clinical applications, demonstrating equivalence to the predicate device. The performance is implied by its equivalence to a previously cleared device and compliance with established safety and performance standards.

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

Not applicable. This is a submission for a diagnostic ultrasound system, not a software algorithm requiring a test set of patient data to evaluate performance metrics. The evaluation focuses on engineering, safety, and functional equivalence.

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. Ground truth for diagnostic performance evaluation is not relevant for this type of device submission.

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

Not applicable. No test set requiring adjudication of ground truth is mentioned.

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/ML device, and no MRMC study is mentioned.

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

Not applicable. This is not an algorithm-only device. It's a diagnostic ultrasound system.

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

Not applicable. Clinical performance data is not provided as part of this 510(k) submission, as it relies on substantial equivalence to an existing device.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. This is not an AI/ML device that requires a training set.

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The ACUSON NX2 and NX2 Elite diagnostic ultrasound imaging systems are intended for the following applications: Cardiac, Fetal, Abdominal (including liver), Pediatric, Small Organ), Transcranial, OB/GYN, Pelvic, Urology, Vascular (including Peripheral Vessel) and Musculoskeletal applications.

The systems also provide for the measurement of anatomical structures and for analysis packages that provide information that is used for clinical diagnosis purposes.

Ultrasound is used as an imaging aid, but may have further restrictions specific to in-vitro fertilization (IVF), chorionic villus sampling (CVS), and percutaneous umbilical cord blood sampling (PUBS) procedures. Observe local laws and regulations.

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 the state of their cardiovascular system.

Note: This feature can 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 Medicine."

The ACUSON NX2 Elite Diagnostic Ultrasound System is a multi-purpose mobile, software controlled, diagnostic ultrasound systems with an on-screen display for thermal and mechanical indices related to potential bio-effect mechanisms. Its 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, Tissue Doppler Image, Amplitude Doppler Mode, a combination of modes, or Harmonic Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

ACUSON NX2 Diagnostic Ultrasound System is exactly same as K161787.

This document describes a 510(k) premarket notification for the "ACUSON NX2 Diagnostic Ultrasound System" and the "ACUSON NX2 Elite Diagnostic Ultrasound System." The submission aims to demonstrate substantial equivalence to previously cleared devices rather than providing a study proving performance against defined acceptance criteria.

The core of this submission is the claim of substantial equivalence to existing legally marketed predicate devices, specifically the ACUSON NX2 (K161787) and features from the ACUSON S-family Diagnostic Ultrasound System (K163635). This means that the manufacturer is asserting the new device is as safe and effective as the predicate devices, and therefore, extensive new clinical studies with defined acceptance criteria are generally not required by the FDA.

Here's an breakdown of the information based on your request, noting that many items are not applicable in a 510(k) substantial equivalence submission:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission based on substantial equivalence, there isn't a specific table of acceptance criteria with reported device performance in the way one would see for a novel device undergoing a performance study. Instead, the "performance" is implicitly demonstrated through the claim of equivalence to already cleared devices. The document does list safety standards the device complies with, which could be considered a form of acceptance criteria (see point 5).

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

Not applicable. The document explicitly states: "A summary discussion of the clinical tests submitted, referenced, or relied on for a determination of substantial equivalence. Since the ACUSON NX2 Elite Diagnostic Ultrasound Systems uses the same technology and principles as existing devices, clinical data is not required." This indicates no new clinical test set was required for this particular submission.

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 new clinical test set was required for this substantial equivalence submission.

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

Not applicable, as no new clinical test set was required for this substantial equivalence submission.

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-assisted device and no MRMC study was conducted or required for this substantial equivalence submission.

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

Not applicable. This is a diagnostic ultrasound system, not an algorithm-only device. Its performance is tied to the human operator interpreting the images.

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

Not applicable, as no new clinical test set with explicit ground truth determination was required for this substantial equivalence submission. The "ground truth" for the predicate devices would have been established through their own clearance processes.

8. The sample size for the training set

Not applicable. This document is for a diagnostic ultrasound system based on existing technology and principles, not an AI/machine learning device that would require explicit training sets.

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

Not applicable, as no training set was used for this type of submission.

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