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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: Fetal, Abdominal, Intraoperative (abdominal, vascular), Intraoperative Neurological, Pediatric, Small Organ (breast, testes, thyroid, penis, prostate, etc.), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Intravascular, Peripheral vessel, Musculo-skeletal Conventional, Musculo-skeletal Superficial.

The Siemens Acuson X300 ultrasound system is a multi-purpose diagnostic ultrasound system with accessories and proprietary software.

Here's an analysis of the provided text regarding the acceptance criteria and study for the ACUSON X300™ Ultrasound System, based on your requested information:

This device is a diagnostic ultrasound system and as such, the submission primarily focuses on meeting regulatory safety and performance standards for ultrasound devices, not on diagnostic accuracy for specific conditions (which AI/ML devices typically address). Therefore, many of your requested items regarding AI/ML clinical study specifics are not applicable or explicitly stated in this type of submission.

Acceptance Criteria and Reported Device Performance

Study Information (as applicable to a conventional ultrasound device 510(k) submission):

1. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

   • This submission does not describe a clinical study in the sense of testing image interpretations or diagnostic accuracy on a patient data set. The performance data mentioned is related to engineering verification and validation against regulatory safety and performance standards. Therefore, an explicit "test set" sample size or data provenance for patient data is not provided. The testing would involve engineering and physics measurements on the device itself.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

   • Not applicable. This device is an ultrasound system, not an AI/ML diagnostic aid that relies on expert ground truth for image interpretation. The "ground truth" here would be established by validated engineering tests and compliance with recognized standards.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

   • Not applicable. There is no clinical test set requiring adjudication in this type of submission.

4. 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 study was done. This is not an AI/ML device, and no AI assistance is mentioned.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is not an algorithm-only device. It's a complete ultrasound system.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

   • The "ground truth" as described in the submission is compliance with established engineering, safety, and performance standards (e.g., UL, IEC, NEMA, ISO). These standards define acceptable acoustic output, electrical safety, EMC, and biocompatibility, as well as the system's ability to perform its intended imaging and measurement functions reliably.

7. The sample size for the training set:

   • Not applicable. This is not an AI/ML device that requires a training set in that context. The "training" here refers to the engineering design and development process that ensures the device meets its specifications.

8. How the ground truth for the training set was established:

   • Not applicable. As above, there is no AI/ML training set. The "ground truth" for the device's design and development comes from the aforementioned regulatory and engineering standards.

Summary of the K072676 Submission:

This 510(k) submission for the Siemens ACUSON X300™ Ultrasound System is a "Special 510(k) Submission," indicating it's for modifications to an already cleared device (K071036, K061946). The core of the submission is to demonstrate that the modified device remains substantially equivalent to its predicate device in terms of intended use and technological characteristics.

The "Performance Data" section explicitly states: "The Acuson X300 modifications are verified and validated according to the company's design control process." This indicates that the performance criteria are primarily engineering and regulatory compliance, ensuring the device continues to meet all relevant safety (e.g., electrical, acoustic output, biocompatibility) and functional standards for diagnostic ultrasound systems. The FDA's clearance letter also emphasizes compliance with general controls, and notably, requires a post-clearance special report for acoustic output measurements, which is a critical safety parameter for ultrasound devices.

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