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Alpha Omega NeuroProbes are intended to be used in neurosurgery for temporary stimulation of, or recording electrical signals of a small area in the brain.

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The provided text is a 510(k) Premarket Notification letter from the FDA to Alpha Omega Engineering, Ltd. regarding their device, the "NeuroProbe."

This document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

The 510(k) letter confirms that the FDA has reviewed the premarket notification and determined the device is substantially equivalent to legally marketed predicate devices. This means the device can be marketed, subject to general controls and potentially additional controls if classified as Class II or III.

Specifically, the document lacks:

• A table of acceptance criteria and reported device performance.
• Information about sample sizes for test or training sets.
• Details on data provenance.
• Information on experts used to establish ground truth or adjudication methods.
• Any mention of a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm performance study.
• Information about the type of ground truth used or how it was established.

The document's purpose is to grant market clearance based on substantial equivalence, not to detail performance studies or acceptance criteria met by the device.

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