Guide-linked quiz · Medium Level
Evaluating Medical AI Tools as a Clinician Quiz
Tests judging vendor validation data, why positive predictive value and calibration matter locally, and what FDA 510(k) clearance shows.
Question 1 of 8
A vendor reports an AUC of 0.85 for its deterioration model. What does the guide say this number fails to tell a hospital?
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- A vendor reports an AUC of 0.85 for its deterioration model. What does the guide say this number fails to tell a hospital?
- How well the model ranks cases in the vendor's own dataset
- Whether the model was built with machine learning
- How the tool will behave with the hospital's own patients, workflow and alert threshold
- Whether the model can be installed in an EHR
- What did the 2021 external validation of a proprietary sepsis model, published in JAMA Internal Medicine, find?
- Much weaker discrimination than the developer reported, with many missed cases and frequent alerts
- Performance identical to the developer's figures
- Better performance at the external site than at the development site
- That the FDA had revoked the model's clearance
- A model was validated where a condition affects 10 percent of patients. Why might it generate more false alarms on a unit where only 2 percent have the condition?
- Calibration always improves at lower prevalence
- AUC automatically falls when prevalence falls
- Sensitivity rises sharply at lower prevalence
- Positive predictive value depends on prevalence, so a larger share of alerts are false when the condition is rarer
- According to the guide, which pathway do most AI medical devices use to reach the US market?
- Premarket approval backed by randomized trials
- The 510(k) pathway, based on substantial equivalence to an existing device
- No FDA review of any kind
- Emergency use authorization
- What is a silent or shadow deployment of a clinical AI model?
- Muting the sound on alert notifications
- A vendor updating the model without telling the customer
- Letting the model score live patients without showing results to clinicians, so local performance can be measured
- Running the model only during overnight shifts
- A dermatology group learns that darker skin tones were rare in a classifier's training images. Which evaluation area does this concern?
- Post-deployment monitoring
- Bias, meaning performance across patient subgroups
- Regulatory status
- Alert threshold selection
- A model assigns 30 percent risk to a group of patients, but only 10 percent of them go on to have the outcome. What problem does this show?
- A low AUC, necessarily
- Substantial equivalence failure
- High positive predictive value
- Poor calibration
- After go-live, a hospital switches to a new lab assay and the values feeding the model shift. What does the guide call this, and how should it be handled?
- Input drift, which ongoing monitoring should detect
- Algorithm aversion, which training should fix
- Substantial equivalence, which the FDA handles
- Prevalence shift, which needs no action
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