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The ACCUVIX V10 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: Abdomen, OB, Gynecology, Contrast Agent, Small parts, Vascular, Muscular-skeletal, Pediatric Abdomen, Adult Cardiac, Pediatric Cardiology, TCD, Urology, Cardiac applications.

The ACCUVIX V10 is a general purpose, mobile, software controlled, diagnostic ultrasound system. Its function is to acquire ultrasound data and to display the data as 2D mode, M mode, Color Doppler imaging, Power Doppler imaging, Harmonic imaging, and PW Spectral Doppler mode on the LCD display. It also provides the 3D imaging mode using the 3D probe in the Mechanical scan mode. The ACCUVIX V10 has real time acoustic output display with two basic indices, a mechanical index and a thermal index, which are both automatically displayed. The system also provides for the measurement of anatomical structures and for analysis packages that provide information used for clinical diagnostic purposes by competent health care professionals.

The provided text is a 510(k) summary for the ACCUVIX V10 Diagnostic Ultrasound System and its associated transducers. The document describes the device, its intended uses, and lists safety standards it has been designed to meet. However, it does not contain information about specific acceptance criteria or performance studies in the context of clinical efficacy or accuracy for the device itself or any AI components.

The tables within the document (e.g., in {4}-{27}) are "INDICATIONS FOR USE" statements for the main device and its various transducers. These tables specify the clinical applications and mode of operation ("B" for B-mode, "M" for M-mode, "PWD" for Pulsed Wave Doppler, "CWD" for Continuous Wave Doppler, "Color Doppler*", "Combined*", and "Other (Spec.)") for which each transducer is intended. The "P" indicates "previously cleared by FDA" for that specific indication, mode, and transducer combination, while "N" indicates a "new indication" for the overall system or a specific transducer. This is not performance data, but rather a catalog of approved uses.

Therefore, I cannot fulfill the request to provide:

1. A table of acceptance criteria and the reported device performance: The document does not provide acceptance criteria in terms of numerical performance targets (e.g., sensitivity, specificity, accuracy) or reported performance against such criteria.
2. Sample size used for the test set and the data provenance: No clinical study data, sample sizes, or data provenance (country, retrospective/prospective) are mentioned.
3. Number of experts used to establish the ground truth... and their qualifications: Not applicable as no ground truth creation process is described.
4. Adjudication method: Not applicable.
5. Multi Reader Multi Case (MRMC) comparative effectiveness study: Not applicable.
6. Standalone performance (algorithm only): Not applicable as the document describes a diagnostic ultrasound system, not an AI algorithm with standalone performance.
7. Type of ground truth used: Not applicable.
8. Sample size for the training set: Not applicable as no training data for an AI algorithm is mentioned.
9. How the ground truth for the training set was established: Not applicable.

The document focuses on regulatory clearance by demonstrating substantial equivalence to predicate devices (K052911, K063580, K032329, K060087, K43455, K053530 depending on the specific transducer). This means the device is considered as safe and effective as a legally marketed device without necessarily requiring new clinical performance studies if the technological characteristics and intended uses are sufficiently similar. The "performance" mentioned in the document relates to meeting general product safety standards (UL, CSA, IEC, EN/IEC, NEMA, ISO), but these are not clinical performance acceptance criteria in the sense of accuracy, sensitivity, or specificity for diagnostic tasks.

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