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510(k) Data Aggregation
(206 days)
Spencer Probe Depth Electrodes
The AD-TECH Depth Electrodes (Spencer Probe Depth Electrodes) are intended for temporary (
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.
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 |
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(133 days)
Depth Electrodes, Foramen Ovale Depth Eletrodes, Marco-Micro Depth Electrodes, Spencer Probe Depth Electrodes
The Ad-Tech Depth Electrodes (Depth Electrodes, Foramen Ovale Depth Electrodes, Macro Micro Depth Electrodes, Spencer Probe Depth Electrodes, Wyler Sphenoidal Depth Electrodes) are intended for temporary (
The device under review is a family of Depth Electrodes. These electrodes provide sub-surface brain contact to support recording, monitoring and stimulation from user supplied equipment.
This document describes the Ad-Tech Medical Instrument Corporation's Depth Electrodes (K163355) and their substantial equivalence to predicate devices, rather than a study proving the device meets specific acceptance criteria in the context of an AI/ML medical device.
Therefore, most of the requested information regarding acceptance criteria, study design, expert involvement, and ground truth for an AI/ML device is not applicable to this 510(k) summary for a traditional medical device.
However, I can extract the acceptance criteria (defined as "Summary of Requirement" in the document) and the reported performance ("Result") for the physical device testing.
1. A table of acceptance criteria and the reported device performance
| Acceptance Criterion (Summary of Requirement) | Reported Device Performance (Result) |
|---|---|
| Measure electrical resistance from the electrode contact to connector. | Pass |
| Dimensional requirements are met by manufacturing. | Pass |
| Stimulation at 30 $\mu$ C/cm2 does not affect the electrodes. | Pass |
| The optional accessory Stay Flange supports adequate Depth Electrode retention. | Pass |
The following information is not applicable to this document as it pertains to an AI/ML software device, and this 510(k) is for a set of physical medical electrodes:
- Sample size used for the test set and the data provenance.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts.
- Adjudication method for the test set.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance.
- If a standalone (i.e. algorithm only without human-in-the loop performance) was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc).
- The sample size for the training set.
- How the ground truth for the training set was established.
Additional relevant information from the document:
- Intended Use: The Ad-Tech Depth Electrodes are intended for temporary (
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