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The Siemens Acuson X300 ultrasound imaging system is intended for the following applications: General Radiology, Fetal, Abdominal, Intraoperative, Pediatric, Small Parts, Neonatal/Adult Cephalic, Cardiac, Transesophageal, Pelvic, Transcranial, OB/GYN, Urology, Vascular, Musculoskeletal, Superficial Musculoskeletal, and Peripheral Vascular 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".

Device Description

The Siemens ACUSON X300 Diagnostic Ultrasound System 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 primary or secondary harmonic ultrasound echo data and display it in B-Mode, Pulsed (PW) Doppler Mode, Continuous (CW) Doppler Mode, Color Doppier Mode, 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 provided text describes a Special 510(k) Submission for the ACUSON X300 Diagnostic Ultrasound System. This submission is for modifications to a previously cleared device, not for a new device requiring extensive clinical studies to establish safety and effectiveness from scratch. Therefore, the information typically found in such a study (like detailed acceptance criteria with performance values, sample sizes, ground truth establishment methods, or multi-reader multi-case studies) is not present in this document.

Instead, the submission focuses on substantial equivalence to predicate devices. This means the manufacturer demonstrates that the modified device performs as safely and effectively as a legally marketed device and does not raise new questions of safety or effectiveness. The performance data presented indicates nonclinical tests were performed.

Here's a breakdown of the available information regarding acceptance criteria and the "study" (nonclinical tests) that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document explicitly states that "The modifications to the Siemens ACUSON X300 Diagnostic Ultrasound System are verified and validated according to the company's design control process." It then lists the following voluntary standards that the system complies with. These standards implicitly serve as the acceptance criteria for the nonclinical performance of the device. The "reported device performance" is the statement of compliance with these standards.

Acceptance Criteria (Voluntary Standards)	Reported Device Performance
UL 60601-1, Safety Requirements for Medical Equipment	Conforms with applicable medical device safety standards
IEC 60601-2-37 Diagnostic Ultrasound Safety Standards	Conforms with applicable medical device safety standards
CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment	Conforms with applicable medical device safety standards
AIUM/NEMA UD-3, Standard for Real-Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment	Conforms with applicable medical device safety standards; evaluated for acoustic output and thermal safety
AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound	Conforms with applicable medical device safety standards; evaluated for acoustic output
93/42/EEC Medical Devices Directive	Conforms with applicable medical device safety standards
EN/IEC 60601-1 (Safety and EMC Requirements for Medical Equipment)	Conforms with applicable medical device safety standards; evaluated for electrical and electromagnetic safety
EN/IEC 60601-1-1	Conforms with applicable medical device safety standards
EN/IEC 60601-1-2	Conforms with applicable medical device safety standards
IEC 1157 Declaration of Acoustic Power	Conforms with applicable medical device safety standards
ISO 10993-1 Biocompatibility	Conforms with applicable medical device safety standards; evaluated for biocompatibility; cleared patient contact materials are unchanged

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

The document does not describe a clinical test set with a specific sample size. The "tests" mentioned are nonclinical evaluations for safety and performance against established standards. There is no information provided about data provenance (e.g., country of origin, retrospective/prospective) because this submission relies on engineering verification and validation, and compliance with recognized standards, rather than new clinical data.

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

This information is not applicable to the type of submission presented. The "ground truth" for nonclinical tests would be the specifications and requirements of the voluntary standards themselves, not expert consensus on medical images.

4. Adjudication Method for the Test Set:

Not applicable. This is not a study involving human interpretation of medical results requiring adjudication. The compliance is determined by engineering testing and verification.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:

No, an MRMC comparative effectiveness study was not done. This type of study is typically performed to demonstrate the clinical effectiveness of a new device or software feature, especially when involving AI, by comparing human reader performance with and without the aid of the device. This submission is for modifications to an existing ultrasound system, focusing on nonclinical performance relative to predicate devices.

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

Not explicitly stated as a "standalone" algorithm-only study in the context of AI performance. The document describes a diagnostic ultrasound system with various imaging modes and measurement packages. While these involve algorithms, the "performance data" mentioned refers to the system's compliance with safety and acoustic output standards, not a standalone evaluation of an AI algorithm's diagnostic accuracy. The Arterial Health Package (AHP) software is mentioned with its capability to measure Intima Media Thickness and reference normative tables, but no details of a standalone performance study for this software are provided in this summary.

7. The Type of Ground Truth Used:

For the nonclinical tests conducted, the "ground truth" is adherence to the specified voluntary standards (e.g., UL, IEC, AIUM/NEMA, ISO) for aspects like acoustic output, biocompatibility, electrical safety, etc. This is a form of standard-based ground truth rather than expert consensus, pathology, or outcomes data from patients.

8. The Sample Size for the Training Set:

Not applicable. The document does not describe any machine learning or AI models with training sets in the context of this 510(k) summary. The submission is for an ultrasound system, not for a new AI-based diagnostic algorithm requiring a specific training dataset.

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

Not applicable, as no training set for an AI model is described in this submission.

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