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The Strata NSC Valve is a shunt component designed to provide continued The Utrain NOO Varve is a onal from the ventricles of the brain to the right atrium of the Ocrobroopinal Hall (Cavity. The design allows the physician to non-invasively adjust valve pressure/performance level pre- and post-implantation by using a special magnetic adjustment tool.

The PS Medical Strata NSC Valve is an adjustable non-siphon control Valve. The valve is manufactured of silicone elastomer and polypropylene (tissue contact materials). The valve is used as a shunt component. The adjustable valve is designed for non-invasive pressure-flow adjustment.

This 510(k) summary describes a medical device, the Medtronic PS Medical Strata NSC Valve, a shunt component. This document does NOT contain a study or data to establish acceptance criteria or demonstrate device performance based on a study.

Instead, this submission is a claim of substantial equivalence to a previously cleared predicate device (Medtronic PS Medical Strata Valve and Shunt Assemblies with and without BioGlide, K012052). The summary states:

"Medtronic Neurosurgery submits that the materials of fabrication, intended use, performance characteristics and design specifications... are the same as the previously reviewed and cleared Strata Valve and Shunt Assemblies with and without BioGlide. Based upon the summary above, Medtronic Neurosurgery determines substantial equivalence, safety, and efficacy of the Strata NSC products based upon the predicate and currently marketed devices."

Therefore, the requested information regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance studies, and training set details cannot be provided from the given document.

The document primarily focuses on:

• Device Description: The PS Medical Strata NSC Valve is an adjustable non-siphon control valve made of silicone elastomer and polypropylene, intended as a shunt component for non-invasive pressure-flow adjustment.
• Intended Use: To provide controlled CSF flow from the ventricles of the brain into the peritoneal cavity, with the ability to non-invasively adjust pressure/flow pre- and post-implantation.
• Technological Comparison: Directly states the new device is the "same" in materials, intended use, performance characteristics, and design specifications as the predicate device.
• FDA Clearance: The FDA's letter confirms substantial equivalence to legally marketed predicate devices, allowing the device to be marketed.

In summary, there is no performance study or acceptance criteria explicitly detailed in this document. The basis for clearance is substantial equivalence to a predicate device, implying that the performance and safety of the new device are considered equivalent to the already cleared predicate device, which would have undergone its own clearance process and likely associated testing.

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