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The ACCUVIX V20 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, neonatal cephalic, trans-esophageal. and etc.

The ACCUVIX V20 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 mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The ACCUVIX V20 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) Premarket Notification for the ACCUVIX V20 Diagnostic Ultrasound System. It describes the device, its intended uses, and lists safety standards it meets. However, it does not contain any information about a study proving the device meets specific acceptance criteria in terms of diagnostic performance or accuracy, especially relating to AI or algorithmic performance.

Instead, this document focuses on confirming that the ACCUVIX V20 Diagnostic Ultrasound System is "substantially equivalent" to previously cleared predicate devices (K080800 and K052911). Substantial equivalence is primarily demonstrated through meeting safety standards, having similar technological characteristics, and having comparable intended uses, rather than through comparative clinical performance studies against specific quantitative acceptance criteria or ground truth.

Therefore, I cannot fulfill your request for:

1. A table of acceptance criteria and the reported device performance: This document does not specify quantitative acceptance criteria for diagnostic performance, nor does it report performance metrics against such criteria.
2. Sample size used for the test set and the data provenance: No clinical test set or data provenance details are provided for performance evaluation.
3. Number of experts used to establish the ground truth... and qualifications: No ground truth establishment is described for diagnostic performance.
4. Adjudication method: Not applicable as no diagnostic performance study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not applicable; no such study is mentioned.
6. Standalone (i.e. algorithm only without human-in-the-loop performance) study: Not applicable; the device is a diagnostic ultrasound system, not an AI algorithm being evaluated for standalone performance.
7. Type of ground truth used: Not applicable as no diagnostic performance study is described.
8. Sample size for the training set: Not applicable as this is not an AI/algorithm submission requiring a training set.
9. How the ground truth for the training set was established: Not applicable.

The document primarily demonstrates substantial equivalence by referencing existing cleared devices and compliance with recognized safety and performance standards for ultrasound equipment.

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The ACCUVIX V20 system and transducers are intended for diagnostic ultrasound imaging and fluid analysis of the human body. The clinical applications include: General, abdomen, obstetrics, gynecology, vascular, extremity, pediatric, cardiac, breast, urology, and etc.

The ACCUVIX V20 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 mode, Power Doppler mode, PW Spectral Doppler, CW Spectral Doppler mode, and Tissue Doppler Image mode on the LCD display. It also provides the 3D/4D imaging mode using the 3D/4D probe in the Mechanical scan mode. The ACCUVIX V20 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 of Safety and Effectiveness for the ACCUVIX V20 Diagnostic Ultrasound System. It primarily focuses on demonstrating substantial equivalence to predicate devices and outlining the intended uses of the system and its various transducers. Crucially, this document does not contain information about acceptance criteria for specific device performance metrics, nor does it describe any study (clinical or otherwise) that proves the device meets such criteria.

The document details the device's technological characteristics, intended uses, and lists the predicate devices. It also lists the specific transducers and their cleared indications for use, indicating which applications were "previously cleared" (P) under a predicate device, or "new indications" (N) for a particular transducer.

Therefore, it is not possible to provide the requested information based solely on the text provided, as it does not include:

1. A table of acceptance criteria and reported device performance: This document only outlines the intended uses and general technological characteristics, not specific performance metrics or acceptance thresholds.
2. Sample size used for the test set and data provenance: No performance studies are described.
3. Number of experts used to establish ground truth and their qualifications: No ground truth establishment process is mentioned.
4. Adjudication method for the test set: Not applicable as no test set or study is described.
5. Multi-reader multi-case (MRMC) comparative effectiveness study: Not mentioned in the document. The device is a diagnostic ultrasound system, not an AI-assisted diagnostic tool in the sense of image analysis software.
6. Standalone performance (algorithm only): Not applicable for a general-purpose ultrasound system.
7. Type of ground truth used: Not applicable as no performance studies are described.
8. Sample size for the training set: Not applicable as this is a hardware device, not an AI model requiring a training set in the conventional sense.
9. How ground truth for the training set was established: Not applicable.

The document's purpose is to satisfy regulatory requirements for a 510(k) submission, confirming that the new device is "substantially equivalent" to existing legally marketed devices, rather than presenting detailed performance data from a clinical trial or algorithm validation study. It relies on the equivalence of the device's technical specifications and intended uses to existing cleared devices.

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