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The Strata NSC Lumboperitoneal Shunt System provides continued cerebrospinal fluid (CSF) flow from the subarachnoid space into the peritoneal cavity. The Strata NSC Lumboperitoneal Valve allows the physician to non-invasively adjust the pressure/flow performance level pre- and post-implantation without the need for radiographic confirmation in order to address changing patient needs. The Strata NSC Lumboperitoneal Shunt System is designed for management of communicating hydrocephalus.

PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System are designed for diversion of cerebrospinal fluid (CSF) from the lumbar subarachnoid space into the peritoneal cavity.

The shunt's implantable components include:

• Strata NSC Lumboperitoneal Valve ●
• Lumbar Catheter, Closed Tip, Barium Impregnated .
• Lumbar Catheter, Open Tip, Barium Impregnated .
• Peritoneal Catheter, Small Lumen, Open End, Barium Impregnated .
• Strain Relief .
• Fixation Tabs .

The provided text is a 510(k) summary for the PS Medical® Strata® NSC Lumboperitoneal Valve and Shunt System. It describes the device, its intended use, and its substantial equivalence to predicate devices. However, it does not contain the detailed information requested regarding acceptance criteria, specific device performance, study designs (sample sizes, provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone performance), or training set details relevant to AI/ML device studies.

The text states: "Testing performed on the Strata NSC LP Valve and Shunt System verified that the system met the required specifications and acceptance criteria." but does not provide details about these specifications or the reported performance relative to them.

Therefore, I cannot populate the table or answer the specific questions about acceptance criteria and study details. This document is a regulatory submission for a traditional medical device, not an AI/ML powered device, and thus the requested information (e.g., number of experts, adjudication methods, training sets, MRMC studies, standalone performance) is not applicable or present in this type of submission.

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