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The Siemens ACUSON X150 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.

Diagnostic imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Intraoperative (abdominal, vascular), Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Transurethral, Intravascular, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Siemens ACUSON X150 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

The provided text is a 510(k) premarket notification for the ACUSON X150 Diagnostic Ultrasound System. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting detailed performance studies with acceptance criteria, sample sizes, expert ground truth, or statistical analyses common for novel device performance claims.

Therefore, the document does not contain the requested information regarding specific acceptance criteria, a study proving the device meets them, sample sizes (test or training), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone performance details, or how ground truth was established for training data.

The document states:

• "The ACUSON X150 modifications are verified and validated according to the company's design control process." (Section 12, E. Performance Data) This is a general statement about their internal quality system processes rather than a summary of specific performance study results.
• The FDA's letter (K081121) confirms substantial equivalence to a predicate device, which inherently means that its performance is considered comparable and acceptable based on existing standards and the predicate's established safety and effectiveness.

The tables provided describe the intended use and available modes of operation for various transducers with the ACUSON X150 system, indicating which applications (e.g., Fetal, Abdominal, Cardiac) and modes (e.g., B-mode, M-mode, Color Doppler) were "previously cleared by K070576" (the predicate device) or are "new indications" (though for this submission, most are "P" indicating previously cleared). This is a functional description, not a performance evaluation against specific metrics.

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