DeepXray

K223621

Alpha Intelligence Manifolds, Inc. · cleared 2023-09-08 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.3)

“DeepXray is a radiological fully automated image processing software device of either computed (CR) or directly digital (DX) images intended to aid medical professionals in the measurement of minimum joint space width; the assessment of the presence or absence of sclerosis, joint space narrowing, and osteophytes based on OARSI criteria for these parameters; and, the presence or absence of radiographic knee OA based on Kellgren & Lawrence Grading of standing, fixed-flexion radiographs of the knee.”

Algorithmartificial intelligence (AI) and computer vision algorithms

source quote (p.4)

“DeepXray is a standalone software device that utilizes artificial intelligence (AI) and computer vision algorithms to assist clinical professionals in analyzing and measuring radiographic abnormalities of knee osteoarthritis (OA) during review of posterior-anterior or anterior-posterior knee radiographs.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=1,121 patients · 1 site(s)

endpoints: Kellgren-Lawrence Grade assessment; Joint Space Narrowing assessment; Osteophyte assessment; Sclerosis assessment; Medial mJSW measurement; Lateral mJSW measurement; Femoral-Tibial Angle measurement

Reported performance (8 observations)

sensitivity0.87CI 0.86/0.88

source quote (p.8)

“Sensitivity (KL Grade ≥2) 0.87 (0.86/0.88)”

specificity0.84CI 0.83/0.85

source quote (p.8)

“Specificity (KL Grade ≥2) 0.84 (0.83/0.85)”

sensitivityas written: “Sensitivity (OARSI Grade ≥1) for Joint Space Narrowing”0.88CI 0.87/0.89

source quote (p.8)

“Sensitivity (OARSI Grade ≥1) 0.88 (0.87/0.89)”

specificityas written: “Specificity (OARSI Grade ≥1) for Joint Space Narrowing”0.82CI 0.81/0.83

source quote (p.8)

“Specificity (OARSI Grade ≥1) 0.82 (0.81/0.83)”

sensitivityas written: “Sensitivity (OARSI Grade ≥1) for Osteophyte”0.86CI 0.85/0.87

source quote (p.8)

“Sensitivity (OARSI Grade ≥1) 0.86 (0.85/0.87)”

specificityas written: “Specificity (OARSI Grade ≥1) for Osteophyte”0.8CI 0.79/0.81

source quote (p.8)

“Specificity (OARSI Grade ≥1) 0.80 (0.79/0.81)”

sensitivityas written: “Sensitivity (Presence/Absence) for Sclerosis”0.84CI 0.83/0.85

source quote (p.8)

“Sensitivity (Presence/Absence) 0.84 (0.83/0.85)”

specificityas written: “Specificity (Presence/Absence) for Sclerosis”0.88CI 0.87/0.89

source quote (p.8)

“Specificity (Presence/Absence) 0.88 (0.87/0.89)”

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

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

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).