Claim
Write the clinical purpose and output without promotional shorthand.
Reading method · 01
Define intended use first
Fix the jurisdiction, indication, patient population, procedure, operator, environment and accessories before discussing capability.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
01
FUURAA thesis
In medicine, the same mechanism can carry a different evidence burden when any element of intended use changes.
Engineering map
Turn the title into engineering objects that can be observed, measured and reviewed.
Each layer states the boundary to establish and the evidence needed for the next decision.
Population
Bound age, condition, anatomy, severity and exclusions.
Use system
Name operator, site, accessories, software version and required training.
Verification questions
Write the questions first, then decide whether a demo, test, pilot or operating record can answer them.
Each question needs an object, conditions, denominator, threshold and accountable decision owner.
- 01
Which regulator record supports this use?
- 02
Which patients and procedures are excluded?
- 03
Which accessories and versions are required?
- 04
Does the claim exceed the authorised wording?
Evidence to preserve
Enable the next reader to reconstruct conditions, results, failures and the decision.
A conclusion alone loses reviewability; raw records, configuration and exclusions matter too.
- 01
Evidence package 1
Primary authorisation and labeling
- 02
Evidence package 2
Intended-use and exclusion matrix
- 03
Evidence package 3
Configuration and training record
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Similarity to an authorised device or adjacent procedure does not extend the authorised use.
- 02
This is an engineering reading and decision framework; it does not replace application-specific risk assessment, conformity work, procurement acceptance or professional advice.
Sources and evidence status
Read standards scope, measurement evidence and application conclusions separately.
Source dates and review status remain visible; external sources open in a new tab.
01
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗02Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
European Commission MDCG · MDCG 2020-1 · March 2020
↗03Clinical evaluation and performance evaluation of medical device software
Connects valid clinical association, technical performance and clinical performance to a documented evaluation under the applicable regulation.
China NMPA · Published 2025-07-03
↗Lifecycle regulation measures supporting high-end medical devices
Calls for classification guidance for surgical and rehabilitation robots, naming consensus, standards work and lifecycle regulatory support.