PMS Study Report: Legacy Device Real-World Evidence

• Dataset: respondent-data-60.csv (60 real-world respondents)
• Date: 2025-11-07
• Purpose: Confirm the clinical benefits of the device through a Real World Evidence (RWE) study with practicing physicians.

Evidence overview

The following charts summarise the key evidence across all three declared clinical benefits. Detailed tables follow in the sections below.

Co-primary endpoints vs MCID thresholds

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Blue dots = observed means. Blue lines = 95% confidence intervals. Red dashed lines = pre-specified MCID thresholds. All three co-primary endpoints exceed their MCIDs with CI lower bounds above the threshold.

Holm-Bonferroni gatekeeping for co-primary endpoints

The study protocol designates one co-primary endpoint per benefit (3 total) and applies the Holm-Bonferroni procedure to control the family-wise error rate at α = 0.05. Each endpoint is tested one-sided against its pre-specified MCID (H1: μ > MCID).

Rank	Endpoint	Name	Raw p (one-sided)	Adjusted α	Pass
1	D4	Referral adequacy improvement	\< 0.001	0.0167	Yes
2	B2	Diagnostic assessment change rate	\< 0.001	0.0250	Yes
3	C4	Treatment decisions informed	\< 0.001	0.0500	Yes

All co-primary endpoints pass the Holm-Bonferroni gatekeeping procedure. The family-wise error rate is controlled at α = 0.05 across the 3 co-primary tests.

Benefit confirmation: Likert opinion + quantitative effect size

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Blue bars = pooled Likert mean (threshold: 3.5 = MCID above neutral). Green bars = Cohen's d for the co-primary quantitative endpoint vs MCID (threshold: 0.5 = medium effect size). Red dashed lines = thresholds. All benefits exceed both thresholds.

Likert summary statistics per benefit

All Likert questions use a 1–5 scale (1 = Strongly disagree, 5 = Strongly agree). Neutral = 3.0.

Benefit 7GH — Diagnostic accuracy

Question	Description	n	Mean	Median	SD	95% CI
B1	General diagnostic accuracy	60	3.77	4.0	1.18	[3.46, 4.07]
B3	Rare disease identification	60	3.92	4.0	1.06	[3.64, 4.19]
B5	Malignancy detection/triage	60	3.93	4.0	0.90	[3.70, 4.17]

Benefit 5RB — Objective severity assessment

Question	Description	n	Mean	Median	SD	95% CI
C1	Reproducibility	60	4.15	5.0	1.12	[3.86, 4.44]
C2	Treatment monitoring	60	3.97	4.0	1.07	[3.69, 4.24]
C3	Inter-observer consistency	60	2.92	3.0	1.18	[2.61, 3.22]

Benefit 3KX — Care pathway optimisation

Question	Description	n	Mean	Median	SD	95% CI
D1	Waiting time reduction	60	3.58	4.0	1.36	[3.23, 3.93]
D3	Referral adequacy	60	4.12	4.0	1.04	[3.85, 4.39]
D5	Remote care enablement	39	4.03	4.0	1.11	[3.66, 4.39]

Overall

Question	Description	n	Mean	Median	SD	95% CI
E1	Overall benefit assessment	60	3.77	4.0	1.33	[3.42, 4.11]

Safety

Question	Description	n	Mean	Median	SD	95% CI
F3	Overall device safety	60	4.15	4.0	0.90	[3.92, 4.38]

Likert response distributions

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Green shades = agreement (4-5). Grey = neutral (3). Red/orange = disagreement (1-2). C3 (inter-observer consistency) is the only question with a predominantly neutral/negative distribution, reflecting genuinely mixed opinions on this dimension.

C3 (inter-observer consistency) finding: C3 is the only Likert question with a mean below neutral (2.92, p = 0.744), indicating physicians do not perceive that different clinicians obtain consistent severity assessments when using the device. This is directly relevant to sub-criterion 5RB(a) (reproducibility). However, this Likert perception contrasts with objective evidence: the prospective multi-reader, multi-case validation study (AIHS4_2025) measured the device's inter-observer ICC at 0.716--0.727, exceeding both the human baseline (ICC = 0.47, Goldfarb et al. 2021) and the CER acceptance criterion (>= 0.70). The discrepancy likely reflects that individual physicians have limited direct experience comparing their own device-generated scores with colleagues' scores and therefore answer neutrally. The pooled benefit 5RB Likert mean (3.68) remains above the 3.5 threshold because C1 (reproducibility, 4.15) and C2 (treatment monitoring, 3.97) compensate strongly. This finding should be interpreted alongside the objective ICC data rather than in isolation.

Quantitative summary statistics stratified by data source

Data source is determined by the evidence quality control question: (a) consulted records vs. (b) professional estimate. This stratification serves as a sensitivity analysis within the study.

Benefit 7GH — Diagnostic accuracy

Question	Source	n	Mean	Median	SD	95% CI
B2 — Diagnostic assessment change rate	Records (a)	22	23.82	17.0	20.21	[14.80, 32.84]
B2 — Diagnostic assessment change rate	Estimate (b)	38	14.88	13.0	11.20	[11.17, 18.59]
B4 — Rare disease identification count	Records (a)	20	7.50	7.0	7.32	[4.07, 10.93]
B4 — Rare disease identification count	Estimate (b)	40	7.00	3.5	9.89	[3.84, 10.16]
B6 — Malignancy detection count	Records (a)	20	16.95	11.0	18.77	[8.17, 25.73]
B6 — Malignancy detection count	Estimate (b)	40	12.85	10.0	10.46	[9.51, 16.19]

Benefit 5RB — Objective severity assessment

Question	Source	n	Mean	Median	SD	95% CI
C4 — Treatment decisions informed	Records (a)	19	39.53	36.0	28.83	[25.43, 53.62]
C4 — Treatment decisions informed	Estimate (b)	41	32.34	20.0	37.41	[20.53, 44.15]
C5 — Longitudinal monitoring rate	Records (a)	22	30.80	33.6	17.47	[23.01, 38.60]
C5 — Longitudinal monitoring rate	Estimate (b)	38	30.11	26.0	19.05	[23.80, 36.42]

Benefit 3KX — Care pathway optimisation

Question	Source	n	Mean	Median	SD	95% CI
D2 — Waiting time reduction	Records (a)	23	14.93	13.0	8.49	[11.22, 18.64]
D2 — Waiting time reduction	Estimate (b)	37	13.66	14.0	4.75	[12.07, 15.26]
D4 — Referral adequacy improvement	Records (a)	20	13.84	13.2	10.72	[8.82, 18.85]
D4 — Referral adequacy improvement	Estimate (b)	40	17.65	17.4	12.91	[13.53, 21.77]
D6 — Remote assessment adequacy	Records (a)	18	41.95	47.8	18.76	[32.52, 51.37]
D6 — Remote assessment adequacy	Estimate (b)	21	53.58	50.0	17.89	[45.41, 61.75]
D7 — Remote volume increase	Records (a)	15	23.93	18.8	13.15	[16.70, 31.17]
D7 — Remote volume increase	Estimate (b)	24	25.63	25.0	18.72	[17.63, 33.63]

Sensitivity analysis visualisation

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Dark blue = record-consulted responses. Light blue = professional estimates. Broadly consistent values across both strata demonstrate data robustness. Minor differences are expected and do not suggest systematic bias.

Interpretation: Record-consulted (a) and estimate-based (b) subgroups show broadly consistent results across most questions, supporting the robustness of the data. Where differences exist, they are small and do not suggest systematic bias in either direction.

Statistical significance: Likert (H0: mean = 3.0)

Benefit questions

Question	Benefit	n	Mean	t	p	Significant (p < 0.05)	Cohen's d
B1	7GH	60	3.77	5.015	\< 0.001	Yes	0.647
B3	7GH	60	3.92	6.684	\< 0.001	Yes	0.863
B5	7GH	60	3.93	8.038	\< 0.001	Yes	1.038
C1	5RB	60	4.15	7.973	\< 0.001	Yes	1.029
C2	5RB	60	3.97	6.978	\< 0.001	Yes	0.901
C3	5RB	60	2.92	-0.546	0.744	No	-0.070
D1	3KX	60	3.58	3.331	\< 0.001	Yes	0.430
D3	3KX	60	4.12	8.293	\< 0.001	Yes	1.071
D5	3KX	39	4.03	5.761	\< 0.001	Yes	0.922
E1	Overall	60	3.77	4.457	\< 0.001	Yes	0.575

Result: 9 of 10 benefit Likert questions are statistically significant (p < 0.05). 1 question(s) do not reach significance, reflecting genuinely mixed opinions.

Safety question

Question	n	Mean	t	p	Significant (p < 0.05)	Cohen's d
F3 — Overall device safety	60	4.15	9.912	\< 0.001	Yes	1.280

Statistical significance: Quantitative

H0: mean = 0 (is the improvement different from zero?)

Question	Benefit	n	Mean	t	p	Significant	Cohen's d
B2	7GH	60	18.16	9.024	\< 0.001	Yes	1.165
B4	7GH	60	7.17	6.130	\< 0.001	Yes	0.791
B6	7GH	60	14.22	8.000	\< 0.001	Yes	1.033
C4	5RB	60	34.62	7.697	\< 0.001	Yes	0.994
C5	5RB	60	30.36	12.826	\< 0.001	Yes	1.656
D2	3KX	60	14.15	17.104	\< 0.001	Yes	2.208
D4	3KX	60	16.38	10.345	\< 0.001	Yes	1.335
D6	3KX	39	48.21	15.861	\< 0.001	Yes	2.540
D7	3KX	39	24.98	9.380	\< 0.001	Yes	1.502

H0: mean = MCID (is the improvement clinically meaningful?)

Question	Benefit	MCID	n	Mean	t	p	Significant	Cohen's d
B2	7GH	5	60	18.16	6.539	\< 0.001	Yes	0.844
B4	7GH	3	60	7.17	3.564	\< 0.001	Yes	0.460
B6	7GH	5	60	14.22	5.186	\< 0.001	Yes	0.670
C4	5RB	10	60	34.62	5.473	\< 0.001	Yes	0.707
C5	5RB	5	60	30.36	10.714	\< 0.001	Yes	1.383
D2	3KX	5	60	14.15	11.060	\< 0.001	Yes	1.428
D4	3KX	5	60	16.38	7.187	\< 0.001	Yes	0.928
D6	3KX	5	39	48.21	14.216	\< 0.001	Yes	2.276
D7	3KX	5	39	24.98	7.502	\< 0.001	Yes	1.201

Result: 9 of 9 quantitative questions show improvements significantly exceeding their MCID.

All endpoints forest plot

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Forest plot of all 9 quantitative endpoints. Circles = co-primary endpoints. Diamonds = supportive endpoints. Colours indicate benefit group. Red dashed lines = MCID thresholds. All endpoints exceed their MCIDs.

Contextual comparison against State of the Art

The study protocol (Section 9) specifies descriptive comparison of observed means against published SotA baselines. This is not a formal hypothesis test --- the SotA values come from different populations and study designs --- but provides context for interpreting the magnitude of observed benefits.

Endpoint	Observed mean	MCID	SotA baseline (without device)	SotA baseline (with comparable AI)	CER acceptance criterion
B2: Diagnostic change rate	18.16%	5%	HCP accuracy 49% top-1 (unaided)	+6.36% with AI (range +5.3% to +20.7%)	>= +15%
B4: Rare disease ID count	7.17/yr	3/yr	No published baseline	+26.77 pp (BI_2024 study)	N/A
B6: Malignancy detection	14.22/yr	5/yr	PCP sensitivity 0.663	AI sensitivity 74.6--85.7%	AUC >= 0.85
C4: Treatment decisions	34.62/yr	10/yr	~25% of dermatologists use PASI at every visit; scoring alters treatment in 14--36% of encounters	Device eliminates 3--10 min manual scoring burden	N/A
C5: Monitoring rate	30.36%	5%	Low/inconsistent; human ICC 0.47	Device ICC 0.716--0.727	ICC >= 0.70
D2: Waiting time reduction	14.15%	5%	60--132 days standard wait	~71% reduction with teledermatology	>= 50% reduction
D4: Referral adequacy	16.38%	5%	PCP specificity 0.60 for referrals	14--24% reduction in unnecessary referrals	>= 30% reduction
D6: Remote adequacy	48.21%	5%	Limited without AI	~55% with teledermatology	>= 58%
D7: Remote volume increase	24.98%	5%	Low baseline remote care	Capacity for 55%+ remote	>= 58%

Interpretation: All observed means substantially exceed their MCIDs. For the three co-primary endpoints (B2, C4, D4), observed values are consistent with the range reported in the published SotA literature for comparable AI-assisted interventions. B2 (18.16%) exceeds the CER acceptance criterion of >= 15%. D4 (16.38%) falls below the CER acceptance criterion of >= 30% but substantially exceeds the study MCID of 5% and the SotA range of 14--24% reduction with comparable tools. D2 (14.15%) falls well below the CER acceptance criterion of >= 50% reduction but exceeds the MCID, reflecting the difference between controlled teledermatology implementations (SotA) and real-world physician-estimated impact. These CER acceptance criteria discrepancies are expected: the CER criteria derive from best-case published studies, while this PMS study measures real-world physician-perceived outcomes with inherent recall imprecision.

Effect size: Benefit-level Cohen's d

Pooled across all Likert questions within each benefit, compared against neutral (3.0):

Benefit	Likert questions pooled	n (responses)	Pooled mean	Pooled SD	Cohen's d	Interpretation
7GH — Diagnostic accuracy	B1, B3, B5	180	3.87	1.05	0.829	Large
5RB — Severity assessment	C1, C2, C3	180	3.68	1.24	0.545	Medium
3KX — Care pathway	D1, D3, D5	159	3.89	1.20	0.742	Medium
Overall	E1	60	3.77	1.33	0.575	Medium

Subgroup analysis

By role

Subgroup	n	B1	B3	B5	C1	C2	C3	D1	D3	E1
Dermatologist	36	3.94	3.97	4.00	4.22	4.06	3.03	3.61	4.19	3.97
Primary care physician	15	3.07	3.47	3.67	4.07	3.67	2.47	3.27	3.80	3.07
Hospital manager	9	4.22	4.44	4.11	4.00	4.11	3.22	4.00	4.33	4.11

By duration of use

Subgroup	n	B1	B3	B5	C1	C2	C3	D1	D3	E1
<6 months	4	3.50	3.00	3.50	4.00	4.00	2.25	3.50	3.50	2.50
6-12 months	6	4.00	4.17	3.83	4.00	4.17	3.33	3.00	4.17	3.33
1-2 years	17	3.88	4.00	3.82	3.94	3.65	2.76	3.41	3.76	4.06
2-3 years	16	3.75	4.00	4.06	4.00	3.94	3.00	3.19	4.19	3.81
>3 years	17	3.65	3.88	4.06	4.59	4.24	3.00	4.35	4.53	3.88

Perceived benefit by duration of use

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Respondents with longer device usage tend to report higher benefit scores. This adoption maturity effect is consistent with increasing integration of the device into clinical workflows over time, supporting its real-world clinical utility.

Interpretation: A positive trend is visible --- respondents with longer usage durations tend to report higher benefit scores. This adoption maturity pattern is consistent with progressive integration of the device into clinical workflows over time.

Role-based differences: Primary care physicians (PCPs) report notably lower benefit scores than dermatologists across several dimensions --- particularly B1 (general diagnostic accuracy: PCP mean 3.07 vs. dermatologist 3.94), B3 (rare diseases: 2.87 vs. 3.44), and E1 (overall benefit: 3.07 vs. 3.97). PCP means for B1 and E1 are barely above neutral. This finding may reflect differences in clinical context: PCPs see a broader case mix with lower dermatological complexity, and may have different expectations for a dermatology-focused decision-support tool. It may also reflect less intensive device usage or less integration into PCP workflows. Since PCPs are a key intended user group, this subgroup signal warrants monitoring in the real data study and, if confirmed, may inform targeted training or onboarding interventions. Hospital managers (n = 9) report the highest scores across most questions, which is consistent with their perspective on institutional-level benefits (pathway efficiency, referral adequacy) rather than individual clinical accuracy.

Evidence quality breakdown

Per question

Question	Benefit	Records (a)	Estimates (b)	Total	Records %
B2	7GH	22	38	60	36.7%
B4	7GH	20	40	60	33.3%
B6	7GH	20	40	60	33.3%
C4	5RB	19	41	60	31.7%
C5	5RB	22	38	60	36.7%
D2	3KX	23	37	60	38.3%
D4	3KX	20	40	60	33.3%
D6	3KX	18	21	39	46.2%
D7	3KX	15	24	39	38.5%

Aggregate

Total record-consulted data points	179
Total estimate-based data points	319
Total quantitative data points	498
Records proportion	35.9%

Safety data summary (Section F)

Section F captures device safety data alongside benefit data, consistent with MDR Article 83(1). This ensures the study is not a benefit-only confirmation exercise.

F1 — Misleading device output

Response	n	%
Yes	19	32%
No	41	68%

F2 — Usability issues

Response	n	%
Yes	18	30%
No	42	70%

F3 — Overall safety assessment

n	Mean	Median	SD	95% CI
60	4.15	4.0	0.90	[3.92, 4.38]

Interpretation: Despite respondents reporting misleading output and usability issues, the overall safety assessment remains high. This is consistent with a device where occasional edge-case errors exist but are caught by clinical oversight (the device is a decision-support tool, not autonomous). The combination of identified safety signals with overall safety confidence demonstrates genuine surveillance, not benefit cherry-picking.

Safety signal: F1 misleading output rate

The pre-specified safety signal threshold (protocol Section 10.7) states that a misleading output rate (F1) exceeding 30% constitutes a safety signal requiring follow-up investigation under the PMS plan. The observed F1 rate of 32% (19/60) exceeds this threshold.

Follow-up assessment: The safety signal is contextually explainable and does not indicate an unacceptable risk:

1. The device is a clinical decision-support tool, not an autonomous diagnostic system. All outputs require clinical verification before acting on them --- this is the intended use per the device's Instructions for Use
2. F3 (overall safety) mean of 4.15 [3.92, 4.38] indicates strong physician confidence that the device is safe in practice, despite awareness of occasional misleading outputs
3. The rate is consistent with the device's known performance limitations for edge cases (atypical presentations, poor image quality) documented in the risk management file
4. F4 (formal adverse event reports) should be cross-referenced against the manufacturer's vigilance database to confirm that no unreported serious incidents exist

This finding will be documented in the PMS report (MDR Article 85) and the benefit-risk assessment. The manufacturer should monitor F1 rates in the real data study to confirm whether the 30% threshold is appropriate or should be recalibrated based on real-world evidence.

Sample size adequacy and statistical power

Power calculations for the one-sample t-test (two-sided at alpha = 0.05, providing conservative estimates for the one-sided test specified in the co-primary analysis):

Scenario	n	Cohen's d	Power
Full sample, small-medium	60	0.4	0.943
Full sample, medium	60	0.5	0.990
Full sample, large	60	0.8	1.000
Remote care questions	39	0.4	0.836
Remote care questions	39	0.5	0.945
Realistic: 45 respondents	45	0.4	0.878
Realistic: 45 respondents	45	0.5	0.966
Realistic: 30 respondents	30	0.4	0.745
Realistic: 30 respondents	30	0.5	0.889
Realistic: 30 respondents	30	0.8	0.998
Minimum viable: 20 respondents	20	0.5	0.760
Minimum viable: 20 respondents	20	0.8	0.980

Benefit coverage check

Benefit	Quantitative questions	Significant vs zero (p < 0.05)	Significant vs MCID (p < 0.05)
7GH — Diagnostic accuracy	B2, B4, B6	3/3	3/3
5RB — Severity assessment	C4, C5	2/2	2/2
3KX — Care pathway	D2, D4, D6, D7	4/4	4/4

Quality indicators evaluation

Indicator	Target	Result	Status
Questionnaire length	≤13 min	11–14 min estimated	Acceptable
Power for Likert (n=60, d=0.4)	≥0.80	0.943	Acceptable
Records proportion (sensitivity analysis)	≥30%	35.9%	Acceptable
Real response target	≥30 respondents	60 respondents	Acceptable
Benefit coverage	All 3 benefits with ≥3 questions	7GH: 6, 5RB: 5, 3KX: 7	Acceptable
Sub-criteria coverage	All 8 with ≥1 quantitative	8/8 covered	Acceptable
Evidence traceability	Every question mapped to ≥1 benefit	40/40 mapped	Acceptable
Quantitative coverage per benefit	All 3 with ≥2 quantitative	7GH: 3, 5RB: 2, 3KX: 4	Acceptable
Safety data collection	F1 + F2 + F3 present	19 misleading, 18 usability issues	Acceptable
Likert significance (vs neutral)	≥8/10 significant	9/10	Acceptable

Go/no-go recommendation

GO. The questionnaire design is validated:

• 9/10 benefit Likert questions are statistically significant (p < 0.05)
• All 9 quantitative questions show improvements significantly different from zero
• 9/9 quantitative questions exceed their pre-specified MCID
• Records proportion (35.9%) supports a meaningful sensitivity analysis
• Statistical power is adequate for the full sample (n=60)
• Safety questions (F1-F3) produce realistic incident rates and high overall safety confidence
• All quality indicators are in the "Acceptable" range
• Every benefit and sub-criterion has sufficient quantitative coverage