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Diagnostic ultrasound imaging or Doppler analysis of the human body as follows:
Clinical Applications listed for each transducer model include: Ophthalmic, Fetal, Abdominal, Intra-operative (Specify), Intra-operative Neurological, Pediatric, Small Organ (Breast, Thyroid, Testes), Neonatal Cephalic, Adult Cephalic, Cardiac Adult, Cardiac Pediatric, Trans-esophageal, Trans-rectal, Trans-vaginal, Intra-luminal, Trans-utethral, Peripheral vessel, Laparoscopic, Musculo-skeletal Conventional, Musculo-skeletal Superficial, Other (Specify).
Modes of Operation listed for each clinical application include: A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (Specify) (B/M mode), Other (Specify).

Diagnostic Ultrasound System SDU-450 with various transducer models (L070-075U, L040-100U, EL033-075UA, 1110-0350, VA13R-035U, VA13R-050U, VA15R-035U, VA15R-050U, VA40R-035U, VA57R-0375U, TV11R-055U, TV13R-050U, 1072-0500, UB10R-065U).

The provided text is a series of "Ultrasound Device Indications Statement" forms for various transducers used with the Shimasonic SDU-450 Linear/Convex Diagnostic Ultrasound System (Echo View). These forms detail the specific clinical applications for which each transducer is indicated, along with the approved modes of operation (A, B, M, PWD, CWD, Color Doppler, Power (Amplitude) Doppler, Color Velocity Imaging, Combined (B/M mode)).

However, this document does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, or multi-reader multi-case (MRMC) comparative effectiveness studies.

The document is a regulatory clearance letter from the FDA to Shimadzu Medical Systems, confirming that their device is "substantially equivalent" to predicate devices marketed before May 28, 1976. This means the device is considered safe and effective for its stated indications based on equivalence to existing technology, rather than requiring new clinical trials demonstrating its performance against specific acceptance criteria.

Therefore, I cannot fulfill your request for information regarding acceptance criteria and the study that proves the device meets them, as that information is not present in the provided text. The document focuses on regulatory approval based on substantial equivalence, not on a performance study against predefined criteria.

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