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The AD-TECH Depth Electrodes (Spencer Probe 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.

Device Description

The Depth Electrodes (Spencer Probe Depth Electrode) are intended for recording, monitoring and stimulation at sub-surface levels of the brain. These electrodes are provided sterile, disposable and single patient use. The Depth Electrodes (Spencer Probe Depth Electrodes) provide the patient contact device. The Depth Electrodes (Spencer Probe Depth Electrodes) connect to an electrode cable that is applied to the user's equipment. The electrodes are used by physicians.

AI/ML Overview

Here's a breakdown of the acceptance criteria and the study information for the Spencer Probe Depth Electrodes, as extracted from the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Hazard Addressed	Test Method Used	Acceptance Criterion	Reported Device Performance (Summary of Test Results)
Image Artifact	ASTM F2119-13	No Criteria, Descriptive Statement	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: Image distortion of 19 mm from the edge of the device.
Magnetically Induced Displacement Force	ASTM F2052-15	<45° deflection	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: pass (meaning deflection was less than 45°).
Magnetically Induced Torque	ASTM F2213-17, Low friction surface method	<45° rotation	1.5T: Adoption from 3.0T tests since 3.0T is the worst-case. 3.0T: pass (meaning rotation was less than 45°).
RF Induced Heating	ASTM F2182-19e2	<6°C	1.5T & 3.0T: Under the conditions defined in the labeling, the MR induced heating will be less than <6°C.
Accessory Stay Flange Conductivity	N/A (Descriptive Test)	Negligible conductivity	Results showed that conductivity was negligible, and use of the optional accessory Stay Flange would not lead to any additional safety concerns in association with MRI.

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

Test Set Sample Size:
- Image Artifact, Magnetically Induced Displacement Force, Magnetically Induced Torque: "The device with the maximum mass/linear length" (for image artifact) and "The device with maximum mass" (for displacement force and torque) were tested. This implies a single representative model or a limited number of "worst-case" configurations. The exact number of individual devices or instances is not specified, but it's likely a small, controlled sample to demonstrate compliance with MR safety.
- RF Induced Heating: "devices with different lengths, different electrode designs, and different insertion depths were studied." Again, the exact number isn't quantified, but it indicates a range of device configurations were tested.
Data Provenance: The studies were conducted by "Ad-Tech, in conjunction with University of Houston." The data is thus likely laboratory-generated performance data specific to the device under controlled testing conditions, not derived from patient data (retrospective or prospective). The country of origin of the data would be the USA (University of Houston).

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

This type of information is not applicable to the provided document. The studies described are engineering performance tests related to MR safety, not clinical studies requiring expert ground truth for diagnostic or therapeutic accuracy. The acceptance criteria are based on established engineering standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This is not applicable as the studies are technical performance tests with objective, measurable criteria, not clinical assessments requiring adjudication of human readings or interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of AI Improvement

This is not applicable. The document describes the technical performance and safety testing of a medical device (depth electrodes) in the MR environment, not an AI-powered diagnostic or therapeutic tool that would typically undergo MRMC studies.

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

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for these tests are the objective measurements against established engineering and safety standards:

Physical properties: Measured displacement, rotation, and temperature changes in a controlled MR environment.
Standard compliance: The tests aim to demonstrate compliance with ASTM and ISO standards for MR safety. The "ground truth" is therefore adherence to these physical principles and regulatory standards.

8. Sample Size for the Training Set

This is not applicable. The device is a physical electrode, not a machine learning model, so there is no training set involved.

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

This is not applicable for the same reason as above.

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