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The Acuson P50 ™ Ultrasound System is intended for diagnostic ultrasound imaging or fluid flow analysis of the human body; specific indications for use are tabulated in Section 4.3 of this submission.

The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section.

The provided text is a 510(k) summary for the Siemens Medical Solutions Siemens P50™ Ultrasound System. This document focuses on establishing substantial equivalence to predicate devices rather than proving the device meets specific performance acceptance criteria through clinical studies of its own.

Therefore, the following information cannot be extracted from the provided text:

• A table of acceptance criteria and the reported device performance: The document does not define specific performance acceptance criteria for the P50 system itself, as it relies on the predicate devices.
• Sample size used for the test set and the data provenance: No new clinical test sets are described for performance evaluation.
• Number of experts used to establish the ground truth for the test set and their qualifications: Not applicable as no new test set is described.
• Adjudication method for the test set: Not applicable.
• If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable.
• If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable, as this is an ultrasound imaging system, not an AI algorithm in the traditional sense, and its primary function involves human operation.
• The type of ground truth used: Not applicable.
• The sample size for the training set: Not applicable, as this is not an AI/ML device requiring a training set in the context of this 510(k).
• How the ground truth for the training set was established: Not applicable.

Explanation of the Device's Approval Approach based on the provided text:

The Siemens P50™ Ultrasound System received 510(k) clearance based on demonstrating substantial equivalence to several legally marketed predicate devices (Teratech Model 2000 Imaging System, Teratech Model 8C4 Endocavity Smart Probe, etc.).

Key arguments for substantial equivalence:

• Identicality to predicate devices: "The Acuson P50 ™ Ultrasound System is identical to the Teratech 2000 and previous Teratech models as identified in the predicate device section." (Page 2)
• Modes of operation: "It is equivalent in modes of operation." (Page 2)
• Intended clinical applications: "and intended for the same clinical applications." (Page 2)
• Hardware and Software: The hardware and software are explicitly stated as "No change" compared to the Teratech 2000 specified in K051334. (Page 2)
• Transducers: The submission details specific transducers intended for use with the ACUSON P50, and their intended uses (clinical application and mode of operation) are largely marked as "P" (previously cleared by FDA) for the various modes (B, M, PWD, CWD, Color Doppler, Combination Modes, and Harmonic Imaging). For the 4V2 Phased Array transducer, K063085 is referenced; for the 7L3 Linear Array, K042055 is referenced; for the 12HL7 Hockeystick Linear Array and 12L5 Linear Array, K051334 is referenced; and for the AuxCW 2MHz Pedof, K063085 is referenced. This indicates that the performance of these transducers for their stated clinical applications has already been established and cleared by the FDA under their respective 510(k) numbers.

In essence, the device meets regulatory requirements by demonstrating that it is as safe and effective as existing legally marketed devices, primarily by being identical or having changes that do not raise new questions of safety or effectiveness. No new, independent performance study validating specific acceptance criteria for the P50 system itself is detailed in this 510(k) summary, as its performance is effectively "inherited" from its predicate devices.

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