表1：首个FDA批准的颅内刺激薄膜电极生物相容性测试（第1部分）

数据集获取（Figshare）

• 源站标题：Table_1_First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity—Part 1: Biocompatibility Testing.docx
• DOI：10.3389/fnins.2022.876877.s001
• 发布日期：2022-04-29
• 文件数：1 个
• 文件总体积：725.51 KB
• 源站页面：https://frontiersin.figshare.com/articles/dataset/Table_1_First_Food_and_Drug_Administration_Cleared_Thin-Film_Electrode_for_Intracranial_Stimulation_Recording_and_Monitoring_of_Brain_Activity_Part_1_Biocompatibility_Testing_docx/19681314

命令行下载

curl -L -o "Table_1_First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity—Part .docx" "https://ndownloader.figshare.com/files/34956393"

文件清单

• Table_1_First Food and Drug Administration Cleared Thin-Film Electrode for Intracranial Stimulation, Recording, and Monitoring of Brain Activity—Part .docx（725.51 KB）

文件总体积 725.51 KB（源站 API 实测）。

数据加载示例（图像类）

from PIL import Image
import glob, os

files = (glob.glob(os.path.join(path, "**", "*.png"), recursive=True)
       + glob.glob(os.path.join(path, "**", "*.jpg"), recursive=True)
       + glob.glob(os.path.join(path, "**", "*.tif"), recursive=True))
print("图像文件数:", len(files))
img = Image.open(files[0]); print("尺寸/模式:", img.size, img.mode)

# torchvision Dataset 方式:
# from torchvision import datasets
# ds = datasets.ImageFolder(path)  # 要求 子目录=类别

目录组织与标注格式以源站说明和下载后实际文件为准。

数据说明

Subdural strip and grid invasive electroencephalography electrodes are routinely used for surgical evaluation of patients with drug-resistant epilepsy (DRE). Although these electrodes have been in the United States market for decades (first FDA clearance 1985), their fabrication, materials, and properties have hardly changed. Existing commercially available electrodes are made of silicone, are thick (>0.5 mm), and do not optimally conform to brain convolutions. New thin-film polyimide electrodes (0.08 mm) have been manufactured to address these issues. While different thin-film electrodes are available for research use, to date, only one electrode is cleared by Food and Drug Administration (FDA) for use in clinical practice. This study describes the biocompatibility tests that led to this clearance. Biocompatibility was tested using standard methods according to International Organization for Standardization (ISO) 10993. Electrodes and appropriate control materials were bent, folded, and placed in the appropriate extraction vehicles, or implanted. The extracts were used for in vitro and in vivo tests, to assess the effects of any potential extractable and leachable materials that may be toxic to the body. In vitro studies included cytotoxicity tested in L929 cell line, genotoxicity tested using mouse lymphoma assay (MLA) and Ames assay, and hemolysis tested in rabbit whole blood samples. The results indicated that the electrodes were non-cytotoxic, non-mutagenic, non-clastogenic, and non-hemolytic. In vivo studies included sensitization tested in guinea pigs, irritation tested in rabbits, acute systemic toxicity testing in mice, pyrogenicity tested in rabbits, and a prolonged 28-day subdural implant in sheep. The results indicated that the electrodes induced no sensitization and irritation, no weight loss, and no temperature increase. Histological examination of the sheep brain tissue showed no or minimal immune cell accumulation, necrosis, neovascularization, fibrosis, and astrocyte infiltration, with no differences from the control material. In summary, biocompatibility studies indicated that these new thin-film electrodes are appropriate for human use. As a r

许可

CC BY 4.0

引用

学术使用请引用 DOI 10.3389/fnins.2022.876877.s001（source: https://frontiersin.figshare.com/articles/dataset/Table_1_First_Food_and_Drug_Administration_Cleared_Thin-Film_Electrode_for_Intracranial_Stimulation_Recording_and_Monitoring_of_Brain_Activity_Part_1_Biocompatibility_Testing_docx/19681314）。