Input
Specify patient data, imaging, instruments and operator commands.
System anatomy · 05
Clinical function and claim
Translate robotic positioning, navigation, manipulation or assistance into a bounded clinical function and measurable output.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
05
FUURAA thesis
Architecture should follow the authorised clinical claim, not expand it by implication.
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.
Function
Separate sensing, recommendation, constraint, execution and monitoring.
Output
Define accuracy, uncertainty, timing and required clinician interpretation.
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
What function is medically necessary?
- 02
What does the robot not decide?
- 03
How is uncertainty shown?
- 04
Which failure changes care?
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
Function-and-claim specification
- 02
Evidence package 2
Input-output verification
- 03
Evidence package 3
Clinical interpretation protocol
Scope boundary
State what this evidence still cannot be generalised to.
- 01
More degrees of freedom or algorithmic sophistication does not establish a broader medical claim.
- 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.