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The AD-TECH Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Maero Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (< 30 days) use with recording, monitoring and stimulation equipment for the recording, monitoring and stimulation of electrical signals at the subsurface level of the brain. The recording of electrical activity supports definition of the location of epileptogenic foci and brain mapping.

Depth electrodes described in this application are single patient use, disposable, sterile and non-sterile devices. The electrodes are invasive as they are placed in contact with nerve tissue (brain). The electrodes provide the patient contact device. The electrodes connect to the user's recording, monitoring and stimulation/response equipment. The electrodes are used under the supervision of a physician.

The provided text describes a 510(k) premarket notification for AD-TECH Depth Electrodes. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a standalone study. Therefore, most of the requested information regarding acceptance criteria, sample sizes, ground truth, experts, and comparative effectiveness studies is not applicable to this type of submission.

Here's a breakdown of the relevant and non-applicable points based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable. This submission is for demonstrating substantial equivalence based on technological characteristics and intended use, not for reporting performance against predefined acceptance criteria from a specific study for a novel device. The conclusion states: "The characteristics of the Depth Electrodes are substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised."

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

Not Applicable. There is no specified "test set" or data from a performance study mentioned in this 510(k) summary. The submission relies on demonstrating similarity to existing, legally marketed predicate devices.

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

Not Applicable. No ground truth establishment for a test set is discussed.

4. Adjudication Method for the Test Set

Not Applicable. No adjudication method for a test set is discussed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

Not Applicable. No MRMC study was conducted or mentioned. The submission is not focused on demonstrating improved human reader performance with or without AI assistance, as it pertains to medical devices (depth electrodes) rather than AI-driven diagnostic tools.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not Applicable. This device is hardware (depth electrodes), not an algorithm or software. Therefore, a standalone algorithm performance study is irrelevant.

7. The Type of Ground Truth Used

Not Applicable. No ground truth is discussed as this is not a diagnostic device requiring comparison to a definitive truth. The "ground truth" in 510(k) submissions for devices like this typically relates to established clinical use and safety of predicate devices.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" as this is not a machine learning or AI device.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary of what the submission does present:

The submission focuses on establishing substantial equivalence to predicate depth electrodes by comparing their intended use and technological characteristics.

• Intended Use: The AD-TECH Depth Electrodes are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for recording, monitoring, and stimulating electrical signals at the subsurface level of the brain, aiding in defining epileptogenic foci and brain mapping. This intended use is compared to the predicate devices.
• Technological Characteristics: The submission explicitly states, "The technical characteristics of the depth electrodes are not affected this submission," implying that the characteristics of the new electrodes are sufficiently similar to the predicate devices and thus do not raise new questions of safety or effectiveness. From the context, this suggests the new electrodes inherit similar design, materials, and function as the specified predicate devices.

The "study" proving the device meets the acceptance criteria (in this context, substantial equivalence criteria) is the 510(k) premarket notification process itself, where the manufacturer provides documentation to the FDA demonstrating that the new device is as safe and effective as a legally marketed predicate device. The FDA's review and subsequent letter of substantial equivalence (K053358) serve as the "proof" that the device meets the regulatory requirements for market entry.

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