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The WISE Cortical Strip is intended for intraoperative (≤24 hours) use with recording, monitoring and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain.
The WCS is indicated as an aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries.

The WISE Cortical Strip is medical device composed of:

• A strip containing 4 electrodes that is positioned during surgery on the exposed surface of the brain
• A cable composed of 4 conductive channels intended to transfer electrical signals to and from a commercial connecting cable.
  The device is intended to be used only for intraoperative monitoring during brain surgery and is not implanted.
  The WCS is a sterile, single-use device, individually packaged with a shelf life of 18 months.
  Manufacture of the device uses a WISE proprietary patented technology called "Supersonic Cluster Beam Implantation" (SCBI). This technology produces flexible conductors by enabling thin conducting metal layers to be deposited on a silicone substrate. This enables the strip to be flexible and conform to the brain's surface.
  The WCS is intended to be used with FDA-cleared IONM equipment and a reusable connecting cable. The device does not include (as an accessory or component) these separate devices.

The provided text describes a 510(k) premarket notification for the WISE Cortical Strip (WCS). However, it does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML medical device.

The document details:

• Device Description: The WISE Cortical Strip is a medical device composed of a strip with 4 electrodes and a cable for transferring electrical signals. It's intended for intraoperative use (≤24 hours) with recording, monitoring, and stimulation equipment.
• Intended Use: Aid to IntraOperative Neurophysiological Monitoring (IONM) during brain surgeries for recording, monitoring, and stimulation of electrical signals on the brain surface.
• Technological Characteristics Comparison: Compares the WCS to predicate devices (Ad-Tech Intraoperative Strip Electrode and Ad-Tech Intraoperative Subdural Electrode). Key similarities include intraoperative use, sterilization method, electrode configuration, and stimulation charge density. Differences include contact materials (Platinum only for WCS vs. Platinum:Iridium or stainless steel for predicate), non-pyrogenic labeling for WCS, and the unique Supersonic Cluster Beam Implantation (SCBI) manufacturing process for WCS.
• Non-Clinical Performance Data: A table of bench testing performed, including:
  • Labeling and packaging integrity verification
  • Label indelibility test
  • Dielectric strength test
  • Device integrity verification
  • AC impedance test (with a specific acceptance criterion of ≤ 10 kΩ @ 10 Hz)
  • Insulation test
  • Compatibility with recorders test
  • Compatibility with stimulators test
  • Stimulation and metal release test
  • Bias current tolerance test
    All tests passed.
• Biocompatibility Testing: Performed according to ISO 10993-1 for an externally communicating device with tissue and cerebrospinal contact (limited duration ≤ 24 hours). Tests included Cytotoxicity, Sensitization, Intracutaneous reactivity, Pyrogenicity, Acute Systemic Toxicity, and Indirect Hemolysis. All results indicated the device materials are safe.
• Sterilization and Shelf-Life Testing: Validated Ethylene Oxide sterilization (SAL of 10-6) and established an 18-month shelf-life via accelerated aging.

What is missing for the requested information regarding AI/ML device acceptance criteria and studies:

The provided text describes a hardware medical device (cortical strip electrode), not an AI/ML software device. Therefore, the concepts of "test set," "training set," "ground truth establishment," "number of experts," "adjudication methods," and "MRMC studies" as they apply to AI/ML performance evaluation are not applicable and are not present in this document.

The "acceptance criteria" presented are for the physical and electrical performance of the electrode itself (e.g., AC impedance ≤ 10 kΩ), mechanical integrity, biocompatibility, and sterility, which are standard for such devices.

Therefore, it is impossible to complete the requested table and answer the specific questions about AI/ML device performance from the provided document.

If the intent was to find information on a software component that uses AI/ML with the data from this cortical strip, that information is not in this FDA submission summary. This document focuses solely on the WISE Cortical Strip hardware.

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