Search Results

The Acuson Antares ultrasound imaging system is intended for the following applications: Abdominal, Intraoperative, Small Parts, Transcranial, OB/GYN, Cardiac, Intracardiac, Transesophageal, Pelvic, Neonatal/Adult Cephalic, Vascular, Intravascular, Musculoskeletal, Superficial Musculoskeletal, Great Vessel, 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 Siemens Acuson ANTARES MODIFICATION has been designed to meet the following product safety standards: UL 60601-1, Safety Requirements for Medical Equipment; IEC 60601-2-37 Diagnostic Ultrasound Safety Standards; CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment; AIUM/NEMA UD-3, 1998 Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment; AIUM/NEMA UD-2, 1998 Acoustic Output Measurement Standard for Diagnostic Ultrasound; 93/42/EEC Medical Devices Directive; Safety and EMC Requirements for Medical Equipment EN/IEC 60601-1, EN/IEC 60601-1-1, EN/IEC 60601-1-2; IEC 1157 Declaration of Acoustic Power; ISO 10993-1 Biocompatibility.

The provided document is a 510(k) summary for the Siemens Antares Ultrasound System. It details modifications to the system and various transducers. However, it does not contain information about specific acceptance criteria for device performance in terms of diagnostic accuracy or clinical outcomes, nor does it describe a study proving the device meets such criteria.

The document primarily focuses on:

• Safety and EMC Requirements: The device (Siemens Acuson ANTARES MODIFICATION) is designed to meet various product safety standards (UL, IEC, CSA, AIUM/NEMA, EEC, ISO 10993-1). These are technical standards for electrical safety, electromagnetic compatibility, acoustic output, and biocompatibility, rather than clinical performance metrics.
• Intended Use: It lists numerous clinical applications for the ultrasound system and its various transducers.
• Substantial Equivalence: The submission asserts that the device is substantially equivalent to legally marketed predicate devices in terms of intended use and technological characteristics.
• Performance Data (General Statement): It states, "The modifications to the Antares are verified and validated according to the company's design control process as certified in the 510(k) Notification." This is a general statement about their internal quality and design control processes, not a report of a specific clinical study with defined acceptance criteria and performance results.
• Transducer-Specific Indications: Detailed tables show the modes of operation and specific clinical applications for each transducer model, indicating which applications were "previously cleared by the FDA" ("P") and which were "added under Appendix E" ("E").

Therefore, I cannot provide the requested information in the table or answer the specific questions about sample size, data provenance, expert ground truth, adjudication methods, MRMC studies, standalone performance, training set, and how training set ground truth was established because this specific 510(k) summary does not contain that type of clinical performance study data or acceptance criteria.

The document is a regulatory submission demonstrating compliance with safety standards and substantial equivalence, not a clinical trial report.

Ask a specific question about this device