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The Siemens ACUSON X700™ ultrasound imaging system is intended for the following applications: Cardiac (Adult, Pediatric), Transesphageal (Cardiac), Intracardiac, Cerebrovascular, Peripheral Vessel, Abdominal, Retal, Abdominal, Intra-operative, Pediatric, Small Organ, Neonatal Cepahalic, Adult Cephalic, Orthopedics, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Pelvic, Obstetrical, Gynecological and Urological applications.

The system also provides for the measurement of anatomical structures and for analysis packages that provide information that is used 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 and published 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. 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 Association of Echocardiography; Carotid Intima-Media Thickness Task Force, Endorsed by the Society for Vascular Imaging".

The Acuson Acunav Ultrasound Catheter is intended for intra-cardiac and intra-luminal visualization of cardiac and great vessel anatomy and physiology, as well as visualization of other devices in the heart of adult and pediatric patients

Device Description

The Siemens ACUSON X700™ is a multi-purpose mobile, software controlled, diagnostic ultrasound system 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 and 3D Imaging, or Harmonic Imaging and 4D imaging on a Flat Panel Display.

AI/ML Overview

The Siemens ACUSON X700™ Ultrasound System is a multi-purpose diagnostic ultrasound system. Its 510(k) submission (K123001) primarily relies on demonstrating substantial equivalence to previously cleared predicate devices (Siemens ACUSON X300 (K121699), ACUSON S2000 (K112596), and Ultrasonix SonixTABLET (K113663, K102997)).

This means that the acceptance criteria are largely based on meeting established safety and performance standards for diagnostic ultrasound systems, rather than specific performance metrics against a defined dataset in a clinical study for this particular submission. The submission explicitly states that "Since the X700 uses the same technology and principles as existing devices, clinical data is not required." Therefore, there is no direct study detailed within this document that "proves the device meets the acceptance criteria" in terms of clinical performance data for this submission.

However, based on the provided text, we can infer the acceptance criteria and performance as implied by the FDA's "substantial equivalence" determination and the non-clinical tests conducted.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with medical device safety standards (electrical, thermal, mechanical, electromagnetic, acoustic output, biocompatibility).	The device has been evaluated for acoustic output, biocompatibility, cleaning and disinfection effectiveness, as well as thermal, electrical, electromagnetic, and mechanical safety, and has been found to conform with applicable medical device safety standards, including UL 60601-1, IEC 60601-2-37, CSA C22.2 No. 601-1, AIUM/NEMA UD-3, AIUM/NEMA UD-2, 93/42/EEC Medical Devices Directive, EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2, EN/IEC 60601-1-4, EN/IEC 60601-1-6, EN/IEC 60601-2-18, EN/IEC 60601-2-25, IEC 1157, ISO 10993-1.
Substantial equivalence to predicate devices regarding intended use and technological characteristics.	The Siemens ACUSON X700™ Ultrasound System is "substantially equivalent to our current product, the Siemens ACUSON X300 ultrasound system (K121699), ACUSON S2000 ultrasound system (K112596) and Ultrasonix SonixTABLET ultrasound scanner (K113663, K102997)." The submission device is substantially equivalent to the predicate with regard to both intended use and technological characteristics.
Performance of each transducer model for its specified clinical applications and modes of operation.	Each listed transducer (4C1, VF10-5, VF12-4, EC9-4w, 6C2, CW2, CW5, AcuNav 8F, AcuNav 10F, V5Ms TEE, 4V1c, C7F2, EV9F4, SoundStar 10F, SoundStar eco 10F) has its intended clinical applications and modes of operation (B, M, PWD, CWD, Color Doppler, Power Doppler, Combined) specified. For many, performance is indicated as "P" (previously cleared) in comparison to predicate devices, or "N" (new indication) for new applications with the VF12-4, EC9-4w and SoundStar eco 10F transducers, implying they meet the established performance characteristics for these new applications by virtue of being part of this new system that is found substantially equivalent.
Compliance with Quality System Regulations.	"The design and development process of the manufacturer conforms with 21 CFR 820 Quality System Regulation and ISO 13485:2003 quality system standards." "The Acuson X700 is verified and validated according to the company's design control process."

2. Sample Sizes Used for the Test Set and Data Provenance

The submission explicitly states: "Since the X700 uses the same technology and principles as existing devices, clinical data is not required." Therefore, there is no specific test set or clinical performance data provided or referenced in this 510(k) submission for the ACUSON X700 system itself that would require a sample size for a test set or information on data provenance (country of origin, retrospective/prospective). The primary "test" was the demonstration of conformance to safety standards and substantial equivalence to existing devices.

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

As clinical data was not required for this submission, there was no test set for which ground truth was established by experts.

4. Adjudication Method for the Test Set

Not applicable, as no dedicated clinical test set for performance evaluation was required or conducted for this 510(k) 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

No MRMC comparative effectiveness study was done. The device is a diagnostic ultrasound system (imaging hardware and software), not an AI-assisted diagnostic tool that would typically be evaluated with MRMC studies comparing human reader performance with and without AI assistance. The "Arterial Health Package (AHP) software" mentioned provides measurement capability and references normative tables, but it is described as a "tool for communicating with patients" and does not appear to be an AI-driven interpretive aid requiring a comparative effectiveness study in this context.

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

Not applicable. The device is a diagnostic ultrasound system, which inherently involves human operation and interpretation. There is no standalone algorithm without human-in-the-loop performance described in this submission that would require such testing.

7. The Type of Ground Truth Used

Not applicable to this 510(k) submission, as it relied on substantial equivalence to predicate devices and conformance to safety standards, rather than new clinical performance data requiring ground truth establishment.

8. The Sample Size for the Training Set

Not applicable. As clinical data was not required, there is no mention of a training set for an algorithm within this submission.

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

Not applicable, as no training set or clinical data requiring ground truth for training was used for this submission.

In summary, the detailed clinical performance studies, test sets, ground truth establishment, and expert involvement typically required for demonstrating efficacy of novel AI/CAD systems were not part of this 510(k) submission for the ACUSON X700 Ultrasound System due to its reliance on substantial equivalence to existing cleared devices and adherence to recognized safety standards.

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