Second Opinion® Panoramic
K250525Pearl, Inc. · cleared 2025-11-14 · product code MYN · Radiology
Premarket evidence — what FDA accepted
source quote (p.10)
“The device is a software-only device, so most testable characteristics common to other device types, including Biocompatibility/Materials, Shelf Life/Sterility, Electromagnetic Compatibility and Electrical Safety, Magnetic Resonance (MR) Compatibility, are not applicable to this device.”
source quote (p.9)
“All devices use neural network-based computer vision algorithms for anatomical and pathological detection.”
source quote (p.9)
“Pearl developed Security controls and processes in accordance with FDA Guidance Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions dated September 2023.”
Validation studies (2)
Standalone
n=795 images
endpoints: Weighted Alternative Free-Response Receiver Operating Characteristic (wAFROC) paradigm; lesion-level sensitivity; false positives per image (FPPI); Dice/Jaccard indices
Reader study (MRMC)
sample size not stated
endpoints: wAFROC area under the curve (at both a lesion level and image level); lesion-level sensitivity; false positives per image (FPPI); specificity; Dice coefficient; Jaccard Index
Reported performance (3 observations)
source quote (p.12)
“Second Opinion® Panoramic achieved lesion-level sensitivities of 99%, 82%, and 77% across the three features, indicating strong detection ability even for small or low-contrast lesions.”
source quote (p.12)
“Second Opinion® Panoramic achieved lesion-level sensitivities of 99%, 82%, and 77% across the three features, indicating strong detection ability even for small or low-contrast lesions.”
source quote (p.12)
“Second Opinion® Panoramic achieved lesion-level sensitivities of 99%, 82%, and 77% across the three features, indicating strong detection ability even for small or low-contrast lesions.”
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).