(206 days)
The Ad-Tech Anchor Bolts are optional accessories for use with Depth Electrodes. The Anchor Bolts may be applied when it is desired to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode. Anchor Bolts are secured in the skull to provide an access point for Depth Electrodes.
The device under review is a family of Anchor Bolts. Anchor Bolts are optional accessories to Depth Electrodes. These Anchor Bolts provide an optional access point through the skull and stabilization support for Depth Electrodes.
The furnished document is an FDA 510(k) Premarket Notification stating substantial equivalence for the "Anchor Bolts as Accessories to Depth Electrodes" device. It outlines the device description, intended use, comparison with a predicate device, and performance data related to its safety in the Magnetic Resonance (MR) environment.
However, the information provided does not describe an AI medical device or a study involving human readers or AI assistance. The performance data is solely for the physical device's safety in an MR environment, not for an AI algorithm's diagnostic or assistive performance.
Therefore, I cannot fulfill your request as it pertains to acceptance criteria and studies for an AI medical device, multi-reader multi-case studies, or AI algorithm performance.
The document discusses the following acceptance criteria and performance for the physical device:
1. Table of Acceptance Criteria and Reported Device Performance
| Hazard Addressed | Test Method Used | Acceptance Criterion | Medical Device Configuration Tested | Summary of Test Results and pass/fail (if Appropriate) |
|---|---|---|---|---|
| Image Artifact (1.5T) | ASTM F2119-13 | No Criteria, Descriptive Statement | Device with the maximum mass/linear length | Adoption from 3.0T tests since 3.0T is the worst-case. |
| Magnetically Induced Displacement Force (1.5T) | ASTM F2052-15 |
§ 882.1330 Depth electrode.
(a)
Identification. A depth electrode is an electrode used for temporary stimulation of, or recording electrical signals at, subsurface levels of the brain.(b)
Classification. Class II (performance standards).