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510(k) Data Aggregation
(267 days)
The Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemissheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid) are intended for temporary (< 30 days) use with recording, monitoring, and stimulation equipment for the recording, monitoring, and stimulation of electrical signals on the surface of the brain. The recording of electrical activity supports definition of epileptogenic foci and brain mapping.
The device under review is a family of Subdural Electrodes. These electrodes provide surface brain contact to support recording, monitoring and stimulation from user supplied equipment.
The family of Subdural Electrodes under review are used under the direction of neurosurgeons and other skilled physicians to support their clinical needs for subdural electrodes on the brain. Based upon the needs of their clinical practice and particular patients, various 2-dimensional geometric shapes (length and width) resulting in variations of Subdural Electrode body shapes and orientation configurations are necessary.
All variations of Subdural Electrodes under review consist of the same materials and fundamental design as the predicate Subdural Electrodes. Either round discs or rectangular electrode contact material are sandwiched between two layers of silicone substrate electrode body material. The brain contacting side of the silicone substrate body has material removed to expose an amount of electrode contact surface area. The subdural electrode wires between the electrode contact and connector contacts at the most distal end of the subdural electrode tail pass through a tube for interface with the user's equipment.
Here's a breakdown of the acceptance criteria and study information for the Ad-Tech Subdural Electrodes based on the provided document:
This document is a 510(k) summary for a medical device, which typically aims to demonstrate substantial equivalence to a predicate device rather than providing extensive clinical study data that would be found in a PMA (Premarket Approval) application. Therefore, you will find information related to design and performance verification rather than large-scale clinical trials.
1. Table of Acceptance Criteria and Reported Device Performance
Device: Ad-Tech Subdural Electrodes (Strip/Intraoperative Strip, Grid/Intraoperative Grid, Dual-Sided Interhemispheric, Multi-Strip and Split Grid, Intraoperative Mapping Grid)
| Acceptance Criteria / Performance Requirement | Reported Device Performance |
|---|---|
| Electrical Resistance: Measure electrical resistance from the electrode contact to connector. Verification of electrical resistance from electrode contact to connector meet specification, no electrical contact or connector cross connects to another electrode contact or connector. | Pass: Verification of electrical resistance from electrode contact to connector meet specification, no electrical contact or connector cross connects to another electrode contact or connector. (The specific resistance values/specifications are not provided in this summary but are implied to be met). |
| Dimensional Characteristics: Dimensional requirements are met by manufacturing. Verification of the dimensional characteristics, electrode contact placement is confirmed using the same manufacturing methods and processes as the predicate electrodes. | Pass: Verification of the dimensional characteristics, electrode contact placement is confirmed using the same manufacturing methods and processes as the predicate electrodes. (The specific dimensional requirements are not provided, but the document mentions modifications like range of contact spacing (1-20mm) and range of round electrode contact diameters (1.96-6.35mm), and exposed surface area (1.08-19.6 mm²), all confirmed through manufacturing methods.) |
| Stimulation Effect: Stimulation at 30 µC/cm² does not affect the electrodes. Verification that under the anticipated duration of electrical stimulation at the maximum limit does not affect the electrode resistance. | Pass: Verification that under the anticipated duration of electrical stimulation at the maximum limit does not affect the electrode resistance. (Confirmed that charge density limits of < 30 µC/cm² for the electrode contact exposed diameter surface area are discussed in the Directions for Use, and that no change in Subdural Electrode resistance was verified for durations of maximum stimulation charge density.) |
| Shelf Life: Confirmation of subdural electrode functional performance and sterile barrier pouch integrity (seal peel per ASTM F88 and bubble leak per ASTM F2096) after 2-year aging and simulated distribution per ASTM 4169-16 and bubble leak (ASTM F2096) after accelerated aging (ASTM F1980) and real-following time aging of two years and after simulated distribution by ASTM 4169-16. | Pass: Verified by application of referenced standards and conformance with specifications. (Specific test results are not detailed, but adherence to ASTM F88, F2096, F4169-16, and F1980 is claimed, demonstrating 2-year shelf life and barrier integrity.) |
| Sterility: EO sterilization of the subject device was validated according to ISO 11135:2014 to demonstrate that it is provided with a minimum sterility assumed level (SAL) of 10-6. | Pass: EO sterilization of the subject device was validated according to ISO 11135:2014 to demonstrate that it is provided with a minimum sterility assumed level (SAL) of 10-6. |
| Biocompatibility: (Not changed from predicate device, therefore no new testing required for this submission.) | N/A: Biocompatibility was not provided to support a determination of substantial equivalence for this submission because material and manufacturing processes have not been changed from those were cleared with the predicate device. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "test set" in the context of clinical data for algorithmic performance. Instead, it details performance tests conducted on the device hardware.
- Sample Size for Performance Tests: The document does not explicitly state the number of devices or samples used for each performance test (Electrical Resistance, Dimensional Characteristics, Stimulation Effect, Shelf Life, Sterility). It implies that sufficient samples were tested to demonstrate compliance.
- Data Provenance: The data provenance is laboratory testing and manufacturing verification of the device's physical and electrical characteristics, adhering to industry standards (e.g., ASTM, ISO). This is not retrospective or prospective clinical data from human subjects.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts
This information is not applicable as the submission is for a hardware device (electrodes) and focuses on engineering/performance verification rather than a diagnostic algorithm requiring ground truth established by medical experts. The "ground truth" for these tests would be the established engineering specifications and international standards.
4. Adjudication Method for the Test Set
The concept of an "adjudication method" (like 2+1 or 3+1) is relevant for clinical studies where multiple human readers assess cases and their disagreements are resolved. This is not applicable to the performance verification tests described for these physical electrodes. The "adjudication" in this context is the comparison of test results against predefined specifications and industry standards.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "Clinical data was not provided to support a determination of substantial equivalence." This type of study would be for evaluating the performance of a diagnostic or assistive AI algorithm, which is not the subject of this 510(k).
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Study was done
No, a standalone algorithm study was not done. This submission is for physical medical electrodes, not an algorithm.
7. The Type of Ground Truth Used
For the performance tests described, the "ground truth" is based on:
- Established engineering specifications for electrical resistance and dimensional characteristics.
- Recognized international standards (e.g., ISO 11135:2014 for sterilization, ASTM F88, F2096, F4169-16, F1980 for shelf life and packaging).
- Clinically established physiological limits (e.g., charge density limits of < 30 µC/cm² for brain tissue).
8. The Sample Size for the Training Set
This information is not applicable as this 510(k) submission is for a physical medical device (electrodes) and does not involve an AI algorithm with a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable as this 510(k) submission is for a physical medical device (electrodes) and does not involve an AI algorithm with a training set.
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