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The NRFit® cap is a sterile, single-use device intended to provide positive closure to prevent fluid loss and contamination in Neuraxial devices CADD Cassettes or Syringes utilizing NRFit® connections. The NRFit® cap is intended to be used for less than 24 hours on any single application.

The NRFit® Caps (abbreviated as "NRFit") are ISO 80369-6 compliant caps designed to prevent fluid loss in Neuraxial devices. The NRFit cap is made from medical grade polypropylene with yellow colorant. The NRFit cap is available with either a male neuraxial lock connection or a female neuraxial lock connection. The NRFit cap is made of materials appropriate for a limited exposure duration, externally communicating, tissue/bone/dentin contacting medical device.

The provided document describes the NRFit® Caps, Male and Female Neuraxial Tip Caps, and its substantial equivalence to a predicate device. It specifies performance testing but does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of AI/ML performance.

The document is purely about the 510(k) premarket notification for a physical medical device (caps for neuraxial devices) and its comparison to a similar predicate device. The performance data presented are for non-clinical, physical tests of the device (e.g., leakage, stress cracking, axial separation), not for AI/ML performance metrics.

Therefore, I cannot provide the requested information regarding AI/ML device performance, as the provided text does not pertain to an AI/ML powered medical device.

If you have a document describing an AI/ML medical device and its performance studies, please provide that.

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