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The Accuro 3000 ultrasound scanner is intended for diagnostic ultrasound imaging of the human body in the following clinical applications: Abdominal, Musculoskeletal (Conventional and superficial), Cardiac, Peripheral vascular. A typical examination using the Accuro 3000 is guidance of neuraxial anesthesia.

The Accuro 3000 Ultrasound Imaging Device is a hand-held device that features real-time B-mode ultrasound imaging only. Additional features include a compact size and a simple user interface.

The provided text describes specific details regarding the Accuro 3000 Ultrasound System, but it does not contain information about acceptance criteria or a study that specifically proves the device meets acceptance criteria.

The document does state: "Verification and Validation activities were designed and performed to demonstrate that the Accuro 3000 met pre-determined performance specifications." However, it does not provide details of these specifications, the study design, or the results.

Therefore, I cannot fulfill your request for a table of acceptance criteria and reported device performance or information about sample sizes, ground truth establishment, or multi-reader multi-case studies based solely on the provided text.

The document primarily focuses on:

• Administrative details (submitter, contact, dates, trade names).
• Device classification and comparison to predicate devices.
• Device description (hand-held, real-time B-mode ultrasound).
• Indications for use (Abdominal, Musculoskeletal, Cardiac, Peripheral vascular, with typical use being guidance of neuraxial anesthesia).
• Technological characteristics (equivalent to predicate devices).
• Safety & Performance Tests: A list of IEC, UL, and NEMA standards that were used, implying the device met these standards for safety and acoustic output, but no specific performance metrics are given.

In summary, the provided text confirms that verification and validation activities were performed using specific standards, but it does not detail the acceptance criteria or report performance data against those criteria.

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