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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.

Diagnostic imaging or fluid flow analysis of the human body as follows: (followed by tables detailing specific applications and modes of operation for various transducers).

The Siemens ACUSON X300 has been designed to meet the following product safety standards:

• UL 60601-1, Safety Requirements for Medical Equipment
• I IEC 60601-2-37 Diagnostic Ultrasound Safety Standards
• I CSA C22.2 No. 601-1, Safety Requirements for Medical Equipment
• AIUM/NEMA UD-3, Standard for Real Time Display of Thermal and Mechanical Acoustic Output Indices on Diagnostic Ultrasound Equipment
• 1 AIUM/NEMA UD-2, Acoustic Output Measurement Standard for Diagnostic Ultrasound
• 93/42/EEC Medical Devices Directive
• . Safety and EMC Requirements for Medical Equipment
  • 트 EN/IEC 60601-1
  • 요 EN/IEC 60601-1-1
  • 트 EN/IEC 60601-1-2
  • 트 EN/EC 60601-1-4
• 이 EN/EC 60601-1-6
• . EN/IEC 60601-2-18
• 피 EN/EC 60601-2-25
• I IEC 61157 Declaration of Acoustic Power
• ISO 10993-1 Biocompatibility

The provided document is a 510(k) summary for the ACUSON X300™ Ultrasound System. It describes the device, its intended use, and claims substantial equivalence to predicate devices. However, this document does not contain information regarding acceptance criteria, device performance studies (like test set sample size, provenance, expert qualifications, or adjudication methods), MRMC studies, standalone algorithm performance, or details about the training set.

The "Performance Data" section (Section E) simply states: "The ACUSON X300 modifications are verified and validated according to the company's design control process." This is a general statement and does not provide the specific details requested in your prompt.

Therefore, I cannot provide the requested information from the given text.

In summary:

• 1. A table of acceptance criteria and the reported device performance: Not provided in the document.
• 2. Sample sized used for the test set and the data provenance: Not provided in the document.
• 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not provided in the document.
• 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not provided in the document.
• 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 provided in the document. This is a diagnostic ultrasound system, not an AI-assisted device.
• 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not provided in the document. This is a diagnostic ultrasound system, not an algorithm.
• 7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not provided in the document.
• 8. The sample size for the training set: Not provided in the document. This is a diagnostic ultrasound system, not an AI/ML model that undergoes "training."
• 9. How the ground truth for the training set was established: Not provided in the document.

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