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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 (< 24 hours). The silicone materials used passed the tests for Cytotoxicity, Sensitization, Irritation and Acute Systemic toxicity. The Titanium alloy has passed the Intracutaneous, Acute Systemic Toxicity and Sensitization test (Implant).

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)

Detailed breakdown of inapplicable/missing information for AI/diagnostic devices:

1. Sample sized used for the test set and the data provenance: Not applicable. This is a physical device; there's no "test set" of data in the diagnostic sense.
2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No diagnostic ground truth is being established.
3. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
4. 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: Not applicable. This device is not an AI-assisted diagnostic tool.
5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable for diagnostic purposes. The "ground truth" for this device relates to its physical properties (e.g., whether it can withstand 100g of force, whether it's sterile, whether it's biocompatible). These are verified through engineering tests, material certifications, and validated sterilization processes, not expert diagnostic consensus.
7. The sample size for the training set: Not applicable. This device does not have a "training set."
8. How the ground truth for the training set was established: Not applicable.

Summary of the "Study" (or rather, evidence of compliance) in the provided text:

The provided document describes a technical and manufacturing-focused compliance demonstration, not a clinical study in the typical sense of a comparative effectiveness or diagnostic accuracy study.

• Mechanical Strength: The device is designed to withstand a 100g force, implying engineering specifications were met, likely through design calculations and/or physical testing of prototypes. No detailed study protocol or results are presented beyond this statement.
• Sterilization: The sterilization method (100% Ethylene Oxide) is stated to be an "overkill method" and "validated to the terminal process endpoint probability of a non-sterile unit of 10⁻⁶." This refers to a validation study performed by the manufacturer on the sterilization process itself, which involves specific biological indicator tests and exposure cycles. The details of this validation study (e.g., number of runs, specific indicators) are not in this summary but are required documentation for regulatory submission.
• Pyrogenicity: "The Bacterial Endotoxin test is conducted as described in the USP Endotoxin Reference Standard." This indicates a laboratory test performed on samples of the device to ensure pyrogen levels are below the specified limit (2.4 Eu/device).
• Biocompatibility: The silicone gasket and titanium alloy materials underwent specific biocompatibility tests (Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Intracutaneous). These are standard in-vitro and in-vivo tests performed in specialized labs according to regulatory guidelines (e.g., ISO 10993 series, referenced in G95-1). The document states the materials "passed" these tests.
• Packaging: "The Tyvek pouch with the chevron design feature provides a 1-3 lb. pull apart strength." This alludes to packaging integrity testing conducted to ensure the sterile barrier is maintained.

In essence, the "study" demonstrating the device meets its acceptance criteria is a compilation of validation reports and test results from various engineering, material, sterilization, and packaging evaluations, all conducted in accordance with established medical device manufacturing and regulatory standards. It is not an AI validation study.

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