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SurgiCube® is a stand-alone device that creates a surgical operating environment with a directed, non-turbulent flow of air to the surgical site during ophthalmic surgery and to the sterile instruments used during surgery. The air flow from the device is HEPA-filtered to reduce the presence of particulate matter to reduce the microorganisms to a level of

The SurgiCube® is an apparatus that provides a localized, optimally HEPA filtered, surgical environment to carry out minimally invasive surgery for ophthalmic procedures. It supplies air around the operating surface using uni directional air flow technique. Possible sources of contamination are sidelined. The patient is physically positioned outside the surgical area; just the operating area is in the field. The surgical team can move around the operating surface without interfering with the air. The uni directional flow together with correct surgical draping create a compact and manageable surgical area that will eliminate airborne contamination risks for patients. The SurgiCube® is equipped with a multiple mechanical filter system, including a High Efficiency Particle Air (HEPA) filter with an efficiency of filtering 99,995% of all particles of 0.3um.

I am sorry, but the provided text describes a medical device, the SurgiCube, for creating a sterile surgical environment, and its regulatory clearance (510(k) submission) by the FDA. The information provided heavily pertains to engineering and performance specifications, and clinical validation for the device's ability to maintain a clean environment.

The request, however, asks for information typically associated with the evaluation of AI/ML-enabled medical devices, specifically:

• Acceptance criteria and device performance in a table format, often related to metrics like sensitivity, specificity, AUC, etc.
• Sample sizes for test sets and data provenance for an AI/ML model.
• Number and qualifications of experts for ground truth establishment.
• Adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies with AI assistance.
• Standalone algorithm performance.
• Type of ground truth used (e.g., pathology, outcomes data).
• Sample size for the training set and how its ground truth was established.

The provided document does NOT contain any of this information as the SurgiCube is not an AI/ML device. It is an air-handling apparatus designed to reduce microorganisms and particulate matter.

Therefore, I cannot fulfill your request based on the provided text.

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