FDA 510(k) 慢性疼痛设备许可趋势与安全结果数据集

数据集获取（Figshare）

• 源站标题：FDA 510(k) clearances for chronic pain devices: regulatory trends and safety outcomes from 1976–2025
• DOI：10.6084/m9.figshare.31359985.v2
• 发布日期：2026-02-20
• 文件数：2 个
• 文件总体积：67.55 KB
• 源站页面：https://tandf.figshare.com/articles/dataset/FDA_510_k_clearances_for_chronic_pain_devices_regulatory_trends_and_safety_outcomes_from_1976-2025/31359985

命令行下载

curl -L -o "ierd_a_2633305_sm9044.docx" "https://ndownloader.figshare.com/files/61966489"
curl -L -o "ierd_a_2633305_sm9043.docx" "https://ndownloader.figshare.com/files/61966495"

文件清单

• ierd_a_2633305_sm9044.docx（43.77 KB）
• ierd_a_2633305_sm9043.docx（23.78 KB）

文件总体积 67.55 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

We characterized regulatory and safety patterns of FDA 510(k)-cleared chronic pain devices over five decades.
We analyzed 1718 chronic pain devices cleared from 1976–2025, assessing device modality, review times, recalls (2002–2025), and market concentration (Herfindahl – Hirschman Index, HHI).
Most devices were noninvasive neuromodulation (1,486 [86.5%]), followed by invasive neuromodulation (162 [9.4%]), energy-based (67 [3.9%]), and digital therapeutics (3 [0.2%]). Median FDA review was 117 days (IQR, 69–220) – shorter for invasive (90 days; IQR, 42–156) than noninvasive neuromodulation (120 days; IQR, 70–222). US-origin devices declined from 97.6% (1976–1985) to 43.1% (2016–2025). Invasive devices declined 45% from peak (12.3%, 1996–2005) to 6.7% (2016–2025), while digital therapeutics emerged post-2016. Among 843 devices evaluated for safety, invasive devices had 14-fold higher recall rates than noninvasive (100 vs. 7.1 per 1000); median time to recall was 3.9 years (IQR, 2.9–4.7). Market concentration differed markedly: invasive devices highly concentrated (HHI, 3710; single manufacturer 58%) versus fragmented noninvasive markets (HHI, 43).
Despite shorter regulatory review, invasive chronic pain devices demonstrated substantially higher recall rates. The shift toward globally sourced noninvasive technologies reflects evolving regulatory-technological considerations.

许可

CC BY 4.0

引用

学术使用请引用 DOI 10.6084/m9.figshare.31359985.v2（source: https://tandf.figshare.com/articles/dataset/FDA_510_k_clearances_for_chronic_pain_devices_regulatory_trends_and_safety_outcomes_from_1976-2025/31359985）。