Table 7 Clinical trial device performance vs. real world performance.

From: An analysis of the real world performance of an artificial intelligence based autism diagnostic

Metric

Demographic

Clinical trial

performance

Real world

performance

Fisher’s Exact Test

p value

PPV

All Demographics

80.8%

(n = 78)

92.4%

(n = 119)

0.024*

(n = 197)

Female

60.0%

(n = 20)

85.7%

(n = 35)

0.048*

(n = 55)

Male

87.9%

(n = 58)

95.2%

(n = 85)

0.12

(n = 142)

Under 48 months

of age

81.5%

(n = 65)

96.3%

(n = 82)

0.005*

(n = 147)

Over 48 months

of age

76.9%

(n = 13)

83.8%

(n = 37)

0.68

(n = 50)

NPV

All Demographics

98.2%

(n = 57)

97.6%

(n = 41)

1.0

(n = 98)

Female

96.0%

(n = 25)

100.0%

(n = 13)

1.0

(n = 38)

Male

100.0%

(n = 32)

96.4%

(n = 28)

0.47

(n = 60)

Under 48 months

of age

97.8%

(n = 45)

96.6%

(n = 29)

1.0

(n = 74)

Over 48 months

of age

100.0%

(n = 12)

100.0%

(n = 12)

1.0

(n = 24)

Determinate rate

All Demographics

31.8%

(n = 425)

63.0%

(n = 254)

< 0.001*

(n = 679)

Female

29.2%

(n = 154)

64.9%

(n = 74)

< 0.001*

(n = 228)

Male

33.2%

(n = 451)

62.2%

(n = 180)

< 0.001*

(n = 451)

Under 48 months

of age

38.1%

(n = 289)

66.1%

(n = 168)

< 0.001*

(n = 457)

Over 48 months

of age

18.4%

(n = 136)

57.0%

(n = 86)

< 0.001*

(n = 222)

  1. *Significant difference.