Porous-titanium implant: separate bone ingrowth from revision rates
Real sources · Illustrative request · Sample version
Customer question
A fictional implant version and two comparators need a literature evaluation for the EU market.
How far do material or animal data support a claim, and which clinical claims still need human evidence?
The same “porous titanium” description does not establish equivalence. Check technical, biological and clinical differences together.
Claims versus evidence types
| Check / stage | Chart content |
|---|---|
| Material performance | Describes bench-measured performance; does not directly establish human benefit |
| Animal bone ingrowth | Mechanistic/nonclinical support with model limitations |
| Human osseointegration | Check version, anatomical site, population and measurement |
| Reduced revision rate | Needs relevant human outcomes and comparative evidence; no inference across types |
The matrix uses MDCG 2020-5 equivalence dimensions; it establishes no proven benefit for an implant.
Analysis excerpt
| Check | Finding / sample content | Use |
|---|---|---|
| Product differences | Separate porosity, surface, contact materials, site and patients | Record potential clinical impact and required materials |
| Proposed claim | Illustrative materials do not establish “reduced revision rates” | Prioritise the relevant human-outcome evidence gap |
Delivery manifest
| File | Format | Contents |
|---|---|---|
| claim-evidence-matrix.xlsx | XLSX | Proposed clinical claims, evidence types, source locations and extrapolation conditions. |
| comparator-differences.xlsx | XLSX | Technical, biological and clinical differences for one version and up to two comparators. |
| clinical-literature-brief.pdf | Literature support, unresolved questions and inputs for further testing or research. |
This is an illustrative formal delivery manifest. This pack supplies an HTML report, CSV tables and a source register. Agree formal formats, quantities and scope in the quote.
Acceptance criteria
- Material performance and human outcomes are labelled separately. Product differences, extrapolation conditions and sources are recorded for the company's further professional review.
Sources
- MDCG 2020-5: Clinical evaluation — equivalence
https://health.ec.europa.eu/system/files/2020-09/md_mdcg_2020_5_guidance_clinical_evaluation_equivalence_en_0.pdf