Data Characteristics
Cardiovascular intervention medical device registration documents primarily originate from regulations, standards, and guidelines published by the National Medical Products Administration (NMPA). They also include clinical research reports, device performance test reports, and biocompatibility evaluation reports from authoritative domestic and international journals. Data update frequency is relatively stable. New regulations or guidelines are typically released annually or quarterly, while clinical research data updates irregularly as studies progress. Document structures are mainly official PDF files and internal reports in Word and Excel formats, with highly specialized content. Fields involve material parameters (e.g., elastic modulus of Nitinol), biological indicators (e.g., hemolysis rate), and clinical efficacy and safety data (e.g., target lesion revascularization rate). Units strictly follow international standards, such as millimeters (mm), milligrams (mg), percentages (%), and Poise.
Constraints Imposed by These Characteristics on Citation and Traceability
The specialized nature of cardiovascular intervention data requires precise citation. Ambiguous or incorrect citations can lead to registration failure. The authoritative nature of regulatory documents dictates that their original text must be maintained completely and accurately when cited, without arbitrary summarization or deletion. Clinical research reports contain large amounts of data and complex structures, requiring the system to locate specific charts or paragraphs. The moderate update frequency means the knowledge base needs regular maintenance to incorporate the latest regulatory changes and clinical advancements, ensuring the timeliness of cited content. Diverse document formats and strict unit requirements demand higher standards for document parsing and information extraction, especially when processing tabular data in PDFs. This includes ensuring correct association between fields and units to prevent data misalignment during traceability.
Configuration Settings
| Configuration Item | Suggested Value | Rationale |
|---|---|---|
Chunk size | 500–800 characters | Ensures completeness of key information segments in regulatory articles and clinical reports, preventing semantic fragmentation. |
Recall count | Top 10 entries | Increases recall scope, covering more potentially relevant regulatory documents and research reports to improve citation accuracy. |
Similarity threshold | 0.75 | Guarantees professional relevance of recalled content, filtering out interference, especially for technical details. |
Rerank result count | Top 3 entries | Prioritizes the most relevant content through reranking based on high recall, reducing manual screening time for engineers. |
maxContext | 4096 tokens | Accommodates long sentences and complex descriptions in regulations and reports, ensuring the LLM has sufficient context to understand cited content. |
PARSE_FILE_TIMEOUT_SECONDS | 300 seconds | Handles parsing of large PDF files, preventing document processing failures due to timeouts, especially for scanned documents with charts. |
Common Pitfalls
- Citations display "no local knowledge base citation" or provide citations inconsistent with the original text. This may be due to the knowledge base index failing to correctly associate original document paths or metadata loss during document parsing.
- Conversations contain numerous duplicate or irrelevant citations. This typically occurs when the
Similarity threshold(similarity threshold) is set too low, leading to the recall of low-relevance content. - In mixed retrieval mode, some critical citations are filtered out. This may be due to overly strict custom filter configurations, mistakenly excluding highly relevant specialized terms in the cardiovascular intervention field.
Verification of Configuration
- For core regulatory provisions and technical parameters, verify the system's ability to accurately cite specific sections or page numbers in the original text by asking questions.
- Upload a new clinical research report and observe whether the system can complete parsing within a reasonable time and extract key data points for citation from the report.
- Test queries of varying complexity. Check if the returned citation sources include NMPA official documents and authoritative journals, and verify the consistency of the cited content with the original text.
The values provided are common starting points and should be measured against the reader's own samples.
Question material comes from public community discussions. Configuration values are common starting points and should be measured against your own samples. Verified on 2026-09-21.