Performance Data
This review framework separates a catalog value from evidence that can be reproduced in a specific ophthalmic, laboratory, or remote-care workflow.
Structured evidence
Values are example protocol targets for review planning, not declared specifications for every Topcon model.
| Metric | Example requirement | Test condition | Evidence to retain | Decision limitation |
|---|---|---|---|---|
| OCT axial resolution | 3–7 μm in tissue (class-dependent) | Declared scan protocol, phantom, software build, operator | Phantom series, raw B-scans, version log | Brochure maximum may omit media opacity and motion |
| Fundus field / image quality | Site-defined FOV and gradeability rate | Pupil size, fixation, illumination, media clarity | Capture log, reject rate, grader notes | One healthy-eye cohort does not prove pathology capture |
| Visual-field reliability | Predefined false-positive / fixation loss limits | Strategy, stimulus, monitoring method | Raw threshold files, reliability indices | Algorithm change invalidates prior baselines |
| Analyzer precision (IVD adjacency) | Site-defined CV threshold | At least two concentration levels across repeated runs | Raw results, mean, SD, CV, lot, date | One matrix or level does not establish full-range precision |
| DICOM / EMR interface | 100% pass for approved cases | Normal, amended, rejected, and outage scenarios | Message capture, expected vs actual, approval | Lab success does not cover every production exception |
Reproducibility checklist
A higher-throughput imaging lane can improve booking density but may increase dependency on photographer staffing, network uptime, and centralized reading queues. A distributed clinic model may improve access yet require more instruments, competency records, QC events, and DICOM endpoints. Compare both paths against the same volume and failure scenarios. Single-use consumable paths can simplify sterility assurance yet raise packaging waste versus reusable pathways with validated reprocessing.