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The PMT Depth Electrode Anchor Bolt is an accessory used in cases where it's necessary to minimize concerns about potential cerebrospinal fluid (CSF) leakage and infection of the subdural space while stabilizing the electrode during intraoperative electroclincal characterization. The PMT Depth Electrode Anchor Bolt is attached onto the skulls with the insertion of the Anchor Bolt Tapered Screw Threads into a pre-drilled burr hole, through a skin incision. Once installed on to the skull a PMT Depthalon® Depth Electrode (510(k) number K802151 and K802152) can be inserted into the Anchor Bolt Screw Cap Port Hole through the Silicone Gasket and into the cranium. The PMT Depth Electrode Anchor Bolt is made of Titanium alloy (Ti 6Al 4V) with a silicone gasket. The gasket is designed to accept the PMT Depthalon® Depth Electrode. The port hole of the PMT Depth Electrode Anchor Bolt is designed to accommodate depth electrodes with a diameter of 0.050 ± .005 inches. Additional designs will be made available to accommodate different manufactures and models of Depth Electrodes with various diameters. Once the Depth Electrode is at the intended foci, the Port Hole Screw Cap can be tightened to fixture the PMT Depthalon® Depth Electrode . The Device is designed to withstand a longitudinal ( push/ pull)100 gram force. The PMT Depth Electrode Anchor Bolt is available in 25mm, 30mm, 35mm and 40mm lengths to accommodate neurophysiologist preference. The PMT Depth Electrode Anchor Bolt is provided in a primary and secondary pouch. The pouch is a Tyvek and cellophane configuration. The Tyvek pouch with the chevron design feature provides a 1- 3 lb. pull apart strength. The PMT Depth Electrode Anchor Bolt is provided sterile or non-sterile. The type of sterilization used is 100% Ethylene Oxide. The sterilization method employed is the overkill method and validated to the terminal process endpoint probability of a non-sterile unit of 10°. The PMT Depth Electrode Anchor Bolt is provided pyrogen free. The method of determination is the Limulus Amebocyte Lysate Test. The Bacterial Endotoxin test is conducted as described in the USP Endotoxin Reference Standard. The pyrogen limit for the PMT Depth Electrode Anchor Bolt is 2.4 Eu/device. The PMT Depthalon® Electrode Anchor Bolt is tested for biocompatibility. The silicone gasket material has been tested per the General Program Memo # G95-1. the device is classified as an implant device, contacting tissue/ bone with an "A" class duration of contact (

Here's an analysis of the provided text in the context of acceptance criteria and a study demonstrating device performance.

Based on the provided text, there is no study described that directly proves the device meets specific acceptance criteria in the way typically expected for a diagnostic or AI-driven medical device. The document is a 510(k) Premarket Notification summary for a physical medical device (an anchor bolt), focusing on its design, materials, sterilization, and biocompatibility.

Therefore, many of the requested fields regarding AI/diagnostic device performance studies (like sample size, ground truth, experts, MRMC studies, effect size, standalone performance, training set details) are not applicable or derivable from this document.

However, I can extract the acceptance criteria related to its physical and material properties and how some of them are "met" by stating design specifications or testing methods.

Acceptance Criteria and Reported Device "Performance" (Based on Design and Material Testing)

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