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The MIDASVu is indicated for use in diagnostic and operative arthroscopic and endoscopic procedures to provide illumination and visualization of interior cavity joints and other body cavities through a natural or surgical opening.

MIDASVu is an advanced imaging system comprised of sterile, single-use scopes (0° and 30° viewing angle) and a reusable tablet. The scopes include camera and image capture features with LED light source. The distal tip of the scopes contains the camera, illumination, and imaging optics. The scopes are available in three lengths: 60mm, 90mm, and 120mm. The scopes and tablet work in concert as a system to acquire, display and record an intra-articular image as well as store images and video taken during the procedure.

The provided text is a 510(k) summary for the MIDASVu device. It primarily discusses the device's substantial equivalence to a predicate device based on non-clinical testing. It does not include information about acceptance criteria for an AI/ML-based device, nor does it detail a study proving such a device meets acceptance criteria. The MIDASVu is described as an "advanced imaging system" and an "arthroscope," which implies a hardware device for visualization, not an AI/ML diagnostic or assistive tool.

Therefore, the requested information regarding acceptance criteria, performance studies of an AI/ML device, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, and training set details for an AI/ML device is not present in the provided document. The document focuses on demonstrating substantial equivalence to a predicate hardware device through non-clinical performance and safety testing (electrical safety, EMC, biocompatibility, software validation for functionality, and cybersecurity for the embedded software of the hardware device, not for an AI/ML component).

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