iStone 腎結石風險評估系統

什麼是 iStone？

iStone 腎結石風險評估系統，利用AI與健檢常規數據，無需額外檢查，即可快速精準預測腎結石風險，協助早期發現高風險族群。

服務優勢

  • 利用AI人工智慧與健檢常規數據，快速精準預測腎結石風險
  • 準確率高達92.7%，遠超傳統影像診斷(X光50-60%、超音波40-50%)
  • 無需額外侵入性檢查，僅需輸入基本臨床資訊即可完成評估
  • 已完成多中心臨床驗證，並申請多國專利

檢測流程

  1. 受檢者授權健檢臨床資訊(性別、年齡、BMI、尿液檢驗、病史等)
  2. 通路線上輸入數據至iStone系統
  3. 系統即時運算並回傳腎結石風險結果(低風險<0.5，高風險≥0.5)
  4. 列印機率報告，提供受檢者參考
  5. 醫師判讀結果並給予後續建議(高風險者建議轉介泌尿科複檢)

臨床數據與專業驗證

  • 2019-2021臨床測試：AUC 96.7%，準確率92.7%，敏感性87.3%，特異性94.5%，陽性預測率85.3%，陰性預測率95.4%
  • 合作醫院：高醫附設醫院、小港醫院
  • 多篇國際期刊發表，台灣專利已獲准，美國、中國、歐洲申請中

常見問題

Q: 誰適合做iStone評估？
A: 有腎結石家族史、過去曾有結石、健檢異常者等。
Q: 多久可以知道結果？
A: 數據輸入後，數秒內即可取得結果。

諮詢與預約

歡迎聯絡我們了解更多或預約檢查。

醫材委託開發

服務內容

  • 醫療器材軟體設計與開發(符合IEC 62304標準)
  • 醫療器材風險管理系統導入(ISO 14971)
  • 醫材品質管理系統建置與輔導(QMS、ISO 13485)
  • 協助產品專利佈局、臨床驗證與法規諮詢

服務對象

  • 醫療器材新創公司
  • 醫療院所
  • 傳產轉型與醫療產業升級企業

服務優勢

  • 跨領域專業團隊，從需求分析到量產全程協助
  • 熟悉國際醫材法規，協助產品順利上市
  • 加速開發時程，降低法規與品質風險

各式軟硬體開發

服務內容

  • 網頁、APP及系統軟體開發
  • 伺服器架設及維護─NAS、FTP、網頁、資料庫
  • 各式API(Application Programming Interface)開發及串接服務

iStone Kidney Stone Risk Assessment System

What is iStone?

The iStone Kidney Stone Risk Assessment System uses AI and routine health check data to quickly and accurately predict the risk of kidney stones without additional examinations, helping to identify high-risk individuals early.

Service Advantages

  • Utilizes AI and routine health check data for fast and accurate kidney stone risk prediction
  • Accuracy up to 92.7%, far surpassing traditional imaging diagnosis (X-ray 50-60%, ultrasound 40-50%)
  • No additional invasive exams required; only basic clinical information is needed for assessment
  • Multi-center clinical validation completed and multiple international patents applied

Assessment Process

  1. Patient authorizes use of clinical health check data (gender, age, BMI, urinalysis, medical history, etc.)
  2. Data is entered online into the iStone system
  3. The system instantly calculates and returns the kidney stone risk result (low risk <0.5, high risk ≥0.5)
  4. Probability report is printed for the patient’s reference
  5. The physician interprets the result and provides further recommendations (high-risk individuals are advised to consult urology)

Clinical Data & Professional Validation

  • 2019-2021 Clinical Test: AUC 96.7%, Accuracy 92.7%, Sensitivity 87.3%, Specificity 94.5%, PPV 85.3%, NPV 95.4%
  • Partner Hospitals: Kaohsiung Medical University Hospital, Siaogang Hospital
  • Multiple international journal publications; Taiwan patent granted; US, China, and Europe applications in progress

Frequently Asked Questions

Q: Who should consider iStone assessment?
A: Those with a family history of kidney stones, previous stone episodes, or abnormal health check results.
Q: How soon are the results available?
A: Results are available within seconds after data entry.

Consultation & Appointment

Contact us for more information or to book an assessment.

Medical Device Contract Development

Service Content

  • Medical device software design and development (compliant with IEC 62304)
  • Implementation of medical device risk management systems (ISO 14971)
  • Establishment and guidance of medical device quality management systems (QMS, ISO 13485)
  • Support for patent strategy, clinical validation, and regulatory consulting

Target Clients

  • Medical device startups
  • Medical institutions
  • Traditional industries transforming or upgrading to the medical sector

Service Advantages

  • Cross-disciplinary professional team providing full support from requirement analysis to mass production
  • Familiar with international medical device regulations, assisting products to market smoothly
  • Accelerated development timeline, reduced regulatory and quality risks

Various software and hardware development

Service Content

  • Web, APP and system software development
  • Server installation and maintenance─NAS, FTP, web, database
  • Various API (Application Programming Interface) development and connection services