Reference
Define image timing, coordinate frames, anatomy change and ground truth.
Real-work map · 11
Diagnostics, navigation and intervention
Trace imaging, registration, planning, targeting, instrument motion and clinician confirmation to the clinical result.
Evidence statusClinical evidence framework · intended use, jurisdiction and care-pathway validation requiredLast reviewed: 15 August 2026
11
FUURAA thesis
Precision claims are only meaningful when the full registration-to-action error chain is measured.
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.
Error chain
Combine sensing, registration, calibration, tracking, mechanics and user placement.
Decision
State how uncertainty changes planning, confirmation or abort.
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 is the end-to-end target error?
- 02
How is anatomy shift detected?
- 03
What independent confirmation exists?
- 04
Which error forces re-registration?
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
Coordinate and calibration trace
- 02
Evidence package 2
End-to-end accuracy distribution
- 03
Evidence package 3
Re-registration and abort ledger
Scope boundary
State what this evidence still cannot be generalised to.
- 01
Submillimetre component accuracy cannot be presented as patient-level clinical accuracy without the whole error chain.
- 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.
ISO · Published 2019-12 · current edition verified 2026-08-15
↗03ISO 14971:2019 — Medical-device risk management
Specifies a lifecycle process for identifying hazards, estimating and evaluating risk, controlling risk and monitoring control effectiveness.
Beijing Medical Products Administration · Published 2025-04-03
↗2025 inspection guide for surgical-robot manufacturing quality management
Details expectations spanning design, algorithms, assembly, software installation, inspection, supplier control, maintenance and after-sales capability.