Holtzman 2010.

Study characteristics
Patient Sampling	Method of sampling: selected Included conditions: sound, early/enamel lesions, no cavitation Teeth: not reported Sealants: results taken for no sealant (also reports results after sealing all teeth) Surface: not reported
Patient characteristics and setting	Age: not reported Sex: not reported Ethnicity: not reported Country: USA Setting: extracted teeth Number of participants/teeth/sites: 40 teeth, 40 sites Prevalence: enamel 0.65, dentine (no data)
Index tests	Category of test: spectral domain ‐ OCT Sequence of test(s): 1) visual, 2) OCT, 3) radiography, 4) histology (examiners blinded to different tests) Examiner training and calibration: 2 pre‐standardised scorers separate from the initial selection of the tooth samples (dentists, each with > 10 years clinical experience) Threshold applied: healthy/not healthy Device specifics: "Five hundred twelve sequential 2D‐OCT images of each tooth at a wavelength of 1350 nm were taken with SD‐OCT. The SD‐OCT system had a stationary reference arm with the tooth sample set on a stage for imaging"
Target condition and reference standard(s)	Category: histology Sequence of index test and reference standard: reference standard last Training of examiner: not reported Blinding to index test: yes (states "blinded" and "not aware of the previous diagnostic test results") Multiple tests: no Site selection: serial photomicrographs (10x) were taken of the region of interest of each section Target condition: presence or absence of pathology (demineralisation (very early stages in the caries process which may be reversible)/caries (more progressed non‐reversible lesions)) extending into enamel or dentine
Flow and timing	Participants with index test but no reference standard: 0 Participants with reference standard but no index test: 0 Time interval between tests: minimal Participants receiving both tests but excluded from results: 0
Comparative
Notes	Results were reported pre‐ and post‐sealant application but we have used the pre‐sealant data in this review
Methodological quality
Item	Authors' judgement	Risk of bias	Applicability concerns
DOMAIN 1: Patient Selection
Was a consecutive or random sample of patients enrolled?	No
Was a case‐control design avoided?	Yes
Did the study avoid inappropriate exclusions?	Unclear
Could the selection of patients have introduced bias?		High risk
Are there concerns that the included patients and setting do not match the review question?			High
DOMAIN 2: Index Test (All tests)
Were the index test results interpreted without knowledge of the results of the reference standard?	Yes
If a threshold was used, was it pre‐specified?	Yes
If multiple tests were applied were different examiners used for each (in vivo)?
Could the conduct or interpretation of the index test have introduced bias?		Low risk
Are there concerns that the index test, its conduct, or interpretation differ from the review question?			Low concern
DOMAIN 3: Reference Standard
Is the reference standards likely to correctly classify the target condition?	Yes
Were the reference standard results interpreted without knowledge of the results of the index tests?	Yes
Could the reference standard, its conduct, or its interpretation have introduced bias?		Low risk
Are there concerns that the target condition as defined by the reference standard does not match the question?			Low concern
DOMAIN 4: Flow and Timing
Was there an appropriate interval between index test and reference standard?	Yes
Did all patients receive the same reference standard?	Yes
Were all patients included in the analysis?	Yes
Could the patient flow have introduced bias?		Low risk