Which ONE of the following options contains the three MOST required aspects to be satisfied for the above scenario of certification of Al enabled medical devices?

Max. Score: 2

Al-enabled medical devices are used nowadays for automating certain parts of the medical diagnostic processes. Since these are life-critical process the relevant authorities are considenng bringing about suitable certifications for these Al enabled medical devices. This certification may involve several facets of Al testing (I – V).

I. Autonomy

II. Maintainability

III. Safety

IV. Transparency

V. Side Effects

Which ONE of the following options contains the three MOST required aspects to be satisfied for the above scenario of certification of Al enabled medical devices? SELECT ONE OPTION
A . Aspects II, III and IV
B . Aspects I, II, and III
C . Aspects III, IV, and V
D . Aspects I, IV, and V

View Answer

Answer: C

Explanation:

For AI-enabled medical devices, the most required aspects for certification are safety, transparency, and side effects. Here’s why:

Safety (Aspect III): Critical for ensuring that the AI system does not cause harm to patients.

Transparency (Aspect IV): Important for understanding and verifying the decisions made by the AI system.

Side Effects (Aspect V): Necessary to identify and mitigate any unintended consequences of the AI system.

Why Not Other Options:

Autonomy and Maintainability (Aspects I and II): While important, they are secondary to the immediate concerns of safety, transparency, and managing side effects in life-critical processes.

Reference: This explanation is aligned with the critical quality characteristics for AI-based systems as mentioned in the ISTQB CT-AI syllabus, focusing on the certification of medical devices​.