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V5Ms Transesophageal Transducer and MPT7-4 Multiplane Transesophageal Transducer are intended for ultrasound imaging or fluid flow analysis of the human body.

MPT7-4 Multiplane Transesophageal Transducer for use with SONOLINE G60 S Ultrasound System: Trans-esophageal (Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined BMDC, Other Note 2,3,7)

V5Ms Transesophageal Transducer for use with ACUSON CV70 Cardiovascular System: Trans-esophageal (Mode of Operation: A, B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Combined BMDC, Other Note 2,3)

V5Ms Transesophageal Transducer for use with ACUSON Sequoia Diagnostic Ultrasound System: Trans-esophageal (Mode of Operation: M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Combined P*, Other: Harmonic Imaging, Other: 3D)

V5Ms Transesophageal Transducer for use with ACUSON Cypress Ultrasound System: Transesophageal (Mode of Operation: B, M, PWD, CWD, Color Doppler, Amplitude Doppler, Other Note 3,4)

Note 2: Ensemble tissue harmonic imaging
Note 3: 3D imaging
Note 4: Contrast agent imaging
Note 7: Contrast agent imaging

The V5M/MPT7-4 transducers consist of a gastroscope control housing where nosepiece articulation and transducer rotation are controlled. A flexible transesophageal guide tube with a nosepiece containing the acoustic array extends from one end of the control housing and the system cable/connector extends from the other end. The acoustic array has 64 elements and rotates 180 degrees to provide imaging planes from transverse view to inverse transverse view. Rotation is powered by a motor in the control housing and is controlled by the operator using a switch button on the control housing for clockwise and counterclockwise rotation. Nosepiece articulation is achieved by manipulating a vertebrae section adjacent to the nosepiece through a series of control wires attached to knobs on the control housing. The nosepiece can be articulated in both the anterior/posterior and left/right directions.

The provided document is a 510(k) premarket notification for Siemens Medical Solutions USA, Inc. Ultrasound Division regarding modifications to their V5M TEE and MPT7-4 TEE ultrasound transducers. It describes the devices, their intended uses, and compares them to predicate devices. However, this document does not contain information about acceptance criteria or a study proving that the device meets specific performance criteria.

The purpose of a 510(k) submission is to demonstrate substantial equivalence to a predicate device that has already been cleared for market. This typically involves showing that the new device has the same intended use and similar technological characteristics, or if there are differences, that those differences do not raise new questions of safety and effectiveness. It does not generally require a new clinical study to establish performance against pre-defined acceptance criteria in the same way a PMA (Premarket Approval) would.

Therefore, I cannot provide the requested information from this document.

To directly answer your numbered points based on the absence of such information in the provided text:

1. A table of acceptance criteria and the reported device performance: Not available in this document. The submission focuses on demonstrating substantial equivalence, not performance against specific acceptance criteria.
2. Sample sized used for the test set and the data provenance: Not applicable as a performance study against acceptance criteria is not detailed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
4. Adjudication method for the test set: Not applicable.
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 applicable. This document pertains to ultrasound transducers, not AI-assisted diagnostic tools.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
7. The type of ground truth used: Not applicable.
8. The sample size for the training set: Not applicable.
9. How the ground truth for the training set was established: Not applicable.

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