Domain configuration template

Supplement S2

Complete domain configuration covering deployment context, datasets, thresholds, MLcps weights, drift detection, decision categories, gold standard, and regulatory pathway mapping.

Device information

Common header

Device name *

Include version number

Intended use *

Reference IEC 62304 or IFU documentation

Author name *

Author role *

Date *

Organisation *

Deployment context

Supplementary S2.1

Data modality *

Model architecture *

Primary performance metrics *

Clinical use case *

Dataset configuration

Supplementary S2.2

Golden dataset size (N) *

Golden dataset description *

Split strategy *

Split details *

Deduplication method *

Threshold specification

Supplementary S2.3

All thresholds must be derived from ISO 14971:2019 hazard analysis. Enter the hazard ID from your risk management file.

Parameter	Symbol	Value	Clinical justification	ISO 14971 hazard ID	Source

MLcps configuration

Supplementary S2.4

Define up to four metric-weight pairs for the composite performance score. Weights range from 0.5 (low priority) to 3.0 (critical).

Metric 1 name

Metric 1 weight

Metric 2 name

Metric 2 weight

Metric 3 name

Metric 3 weight

Metric 4 name

Metric 4 weight

Weight derivation method

Drift detection configuration

Supplementary S2.5

Drift detection method *

Number of features (K) *

Significance level (α) *

Corrected significance (α' = α/K)

Auto-calculated: α divided by K

Feature list for drift monitoring

Active decision categories

Supplementary S2.6

APPROVE and REJECT are always active. Optionally disable intermediate categories with clinical justification.

APPROVE

REJECT

CONDITIONAL APPROVAL

Justification for disabling CONDITIONAL APPROVAL

Required if CONDITIONAL APPROVAL is disabled

CLINICAL REVIEW

Justification for disabling CLINICAL REVIEW

Required if CLINICAL REVIEW is disabled

Gold standard baseline

Supplementary S2.7

Gold standard iteration

Gold standard metric values

Gold standard date

Gold standard dataset ID

Regulatory pathway mapping

Supplementary S2.8

Map AEGIS configuration to PCCP components. Pre-populated with template text — customise for your device.

Description of Modifications (PCCP Component 1)

Modification Protocol (PCCP Component 2)

Impact Assessment (PCCP Component 3)

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