Comparator
Use the care pathway patients would otherwise receive at comparable expertise.
Deployment evaluation · 14
Comparative benefit and harm
Compare the robotic pathway with relevant standard care using patient-important outcomes and complete resource use.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
14
FUURAA thesis
Technical improvement is clinically valuable only when net benefit survives a fair comparison.
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.
Outcomes
Include harm, recovery, function, reintervention and quality of life where relevant.
Resources
Count setup, staff, consumables, conversion, maintenance and length of stay.
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
Is the comparator contemporary and relevant?
- 02
Are patient-important harms captured?
- 03
How does experience affect results?
- 04
Are missing outcomes explained?
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
Prespecified comparative protocol
- 02
Evidence package 2
Complete benefit-harm outcome table
- 03
Evidence package 3
Sensitivity and subgroup analysis
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Shorter incision, higher accuracy or shorter console time alone cannot establish better overall care.
- 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
European Commission MDCG · MDCG 2020-1 · March 2020
↗02Clinical 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.
U.S. FDA · Updated 2022-06-21 · verified 2026-08-15
↗03Computer-Assisted Surgical Systems
Explains authorised uses, clinician control, training, credentialing, facility responsibilities and adverse-event reporting for computer-assisted surgery.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.