Procedure
Define authorised steps, anatomy, access, instruments and exclusions.
Real-work map · 09
Computer-assisted surgery
Evaluate surgeon-controlled instruments, imaging, navigation and room workflow as a procedure-specific system.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
09
FUURAA thesis
Robotic assistance usually changes how clinicians act; it does not remove clinical responsibility.
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.
Control
Trace clinician commands, system constraints, feedback and emergency release.
Outcome
Compare complications, conversion, recovery and patient-important benefit.
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 steps are robot-assisted?
- 02
What requires direct clinician judgement?
- 03
How is conversion performed?
- 04
What outcome justifies added complexity?
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
Procedure-specific labeling
- 02
Evidence package 2
Unedited workflow and conversion records
- 03
Evidence package 3
Comparative clinical outcomes
Scope boundary
State what this evidence still cannot be generalised to.
- 01
The phrase robotic surgery must not imply independent surgery when the system translates clinician control.
- 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.
U.S. FDA · Updated 2026-08-03
↗03Applying Human Factors and Usability Engineering to Medical Devices
Frames safe and effective use around intended users, uses, environments, interfaces, critical tasks and validation of use-related risk controls.
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.