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The S12X Cortical Stimulator is intended for Intraoperative cortical stimulation mapping to aid in cortical resections in the vicinity of essential cortex. The device is intended for use only by medically trained and qualified personnel, within a hospital or medical environment. The ESAx option is intended for use with the S12X for facilitating the switching of the patient electrodes.

The S12X Stimulator supplies a bi-phasic, constant current electrical pulse sequence that is suitable for cortical stimulation. Currents can be applied to the surface of the cortex either with a Manual Probe or through a Set of Electrodes (using the ESAx) option. Electrodes, either the Manual Probe or the Set of Electrodes are not considered part of the S12X.

The S12X is intended to replace and discontinued S12 Stimulator in the product line of Grass Instruments, Inc. (now Grass-Technologies, an Astro-Med, Inc. Product Group), marketed prior to May 28. 1976 and sold as a research device thereafter. The essential functions of the S12 have been retained, but appropriate isolation and insulation features have been added to meet modern requlatory requirements for use with human patients. In order to provide for applications and expansions of function compatible with modern medical data systems, hardware timing circuits have been replaced with an embedded controller whose crystal controlled counters replace the hardware timing functions, and the panel controls have been largely replaced with a touch screen graphical user interface (GUI).

The S12X device consists of an external medical grade power supply, the S12X Stimulator Unit, and the optional ESAx electrode selector adapter. The S12X front panel consists of hardware switches for controlling the "Stimulate" and "All Stop" functions, and a color LCD touch screen display with instrumentstyle controls for setting up the stimulation parameters, calibrating the stimulation log file contents, and for selecting electrodes for stimulation. User input is via a stylus (for touch panel use) or via a standard mouse. The optional ESAx unit connects to a multi-pin connector on the side panel of the S12X.

The S12X accumulates a log of stimulation events, their time-of-day, and their parameters. The log file can be easily transferred to a USB flash drive or equivalent for electronically filing or printing of the stimulation log.

No transient voltage can exceed 34 volts on the patient electrodes (limited by a Zener diode across the patient leads). Further, if after two pulses the internal voltage monitor detects pulse voltages greater than 30 volts, the pulse train will terminate.

No sustained direct current can pass through the patient leads since the output stimulus is entirely transformer coupled. The unit is powered by an external regulated 12 volt DC medical-grade supply powered by standard mains voltage of 120V or 250V AC, and meets U.S. and European requlatory standards: IEC 60601-1-1, and IEC 60601-1-2.

ESAx Electrode Switch Array:

The ESAx is an optional accessory to the S12X which facilitates rapid functional brain mapping during presurgical workups and during surgery. The ESAx is an array of optically coupled relays that can select electrodes from an electrode grid array when more than one electrode pair is in contact with the cerebral cortex, usually in the form of strips or grids. Note that the cortical electrode strips or grids are not part of the device, and they are purchased by the user from other vendors. The ESAx connects the desired electrode pair to the stimulator and simultaneously disconnects the corresponding EEG amplifier leads from the amplifier. The choice of electrodes to be stimulated is controlled from a touch screen display on the S12X,

The ESAx has no buttons or switches, and consists of multi pin connectors for connecting to the S12X and for connecting EEG electrode iack boxes and EEG amplifier unit(s). Note that the EEG jack boxes and the multi-channel EEG amplifiers which can connect to the ESAx are not part of the S12X device, and therefore are not part of this 510(k) submission.

Here's a breakdown of the acceptance criteria and study information for the S12X with ESAx Option device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a particular sample size for a "test set" in the context of clinical or human subject testing. The "test data" mentioned refers to in-house engineering and functional testing of the S12X device itself.

• Sample Size: Not applicable for a human-subjects test set. The testing was on the device's functional performance.
• Data Provenance: The data comes from "in-house testing" performed by Chatten Associates, Inc. This indicates it's internal engineering and verification testing. It does not refer to clinical trial data or data collected from human subjects.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

Not applicable. The "ground truth" for this device's performance is based on its technical specifications and functional output as designed, and comparison to the technical specifications of predicate devices. There is no mention of experts establishing a ground truth for a clinical "test set" or a labeled dataset for an AI algorithm.

4. Adjudication Method for the Test Set

Not applicable. There's no mention of an adjudication method as no expert-labeled test set was used in the described testing.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No. The document describes technical verification and validation against the device's design and a comparison of its specifications to predicate devices. It does not mention any MRMC study involving human readers or AI assistance.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

The device itself is a piece of hardware (a cortical stimulator and an electrode switch array), not an AI algorithm. Therefore, the concept of a "standalone" algorithm performance study is not applicable here. The device's performance was assessed based on its functional output against its design specifications.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on:

• Design and Performance Functional Requirements: The device's ability to meet its own internal hardware and software design specifications.
• Technical Specifications of Predicate Devices: Comparison of parameters like maximum current, charge per pulse, and maximum power output to the Ojemann Cortical Stimulator (K924226).
• Regulatory Standards: Compliance with standards like IEC 60601-1-1 and IEC 60601-1-2.

8. The Sample Size for the Training Set

Not applicable. This device is hardware and does not employ AI or machine learning algorithms that would require a "training set."

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no training set mentioned for this hardware device.

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