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The Solution Delivery System Local and Solution Delivery System Remote are intended to be used in a hemodialysis facility for mixing and distribution of sodium bicarbonate (bicarb) and the distribution of acid concentrates to remote points of use where they are mixed with purified water to create the dialysate solutions used in hemodialysis. The Acid Delivery System is intended to be used in a hemodialysis facility for the distribution of acid concentrates to remote points of use where they are mixed with bicarb and purified water to create the dialysate solution used in hemodialysis.

The Osmonics Solution Distribution System (SDS) provides semi-automatic mixing of bicarb concentrate and the distribution of bicarb and acid concentrates from storage to hemodialysis patient stations. The mixed bicarb solution is automatically transferred to an elevated reservoir (head tank). The SDS, depending on the model purchased, can transfer up to three different acid concentrates to elevated head tanks from 55-gallon drums or larger bulk acid storage tanks. Bicarb and acid then flow via gravity from the head tanks to the dispensing stations.

The provided document describes the Osmonics Medical Systems Solution Delivery System (SDS) and its 510(k) premarket notification (K023011). However, the document does not contain information regarding acceptance criteria, device performance metrics, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or specific study designs (like MRMC or standalone performance evaluations) as typically found in detailed performance studies.

Instead, the document states:

• Performance: "The Solution Delivery Systems have been manufactured and tested to meet the safety requirements of CSA and UL. The SDS systems comply with CAN/CSA C22.2 no. 601-1-M90: Safety of Medical Electrical Equipment, Part I, General Requirements for Safety and UL std No. 2601-1: Safety of Medical Electrical Equipment, Part I: General Requirements for Safety as certified by Canadian Standards Association."

This indicates that the device's performance was evaluated against safety standards for electrical and medical equipment, rather than clinical performance metrics or accuracy in specific measurements (which would be more relevant for an AI/CAD device). The document focuses on regulatory compliance based on safety and substantial equivalence to a predicate device, not on diagnostic performance or AI model evaluation.

Therefore, I cannot populate the requested table or answer the detailed questions about acceptance criteria, study design, and performance metrics as they are not present in the provided text. The document pertains to a medical device's safety compliance and regulatory clearance, not the performance evaluation of an AI-driven, diagnostic, or image analysis device.

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