HealthPPT
K211803Zebra Medical Vision Ltd. · cleared 2021-12-15 · product code QFM · Radiology
Premarket evidence — what FDA accepted
Device typesamd
source quote (p.3)
“The HealthPPT device is a software workflow tool designed to aid the clinical assessment of adult frontal Chest X-Ray cases with features suggestive of pneumoperitoneum in the medical care environment.”
Algorithmartificial intelligence algorithm
source quote (p.3)
“HealthPPT analyzes cases using an artificial intelligence algorithm to identify suspected findings.”
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=216 cases
endpoints: detection accuracy; AUC; sensitivity; specificity
Reported performance (5 observations)
sensitivity0.9252CI [85.94%;96.16%]
source quote (p.9)
“The first “balanced sensitivity and specificity” (default) operating point demonstrated a sensitivity of 92.52% (95% CI: [85.94%;96.16%])”
specificity0.9266CI [86.18%;96.23%]
source quote (p.9)
“and a specificity of 92.66% (95% CI: [86.18%;96.23%]).”
aurocas written: “auc”0.9675CI [94.28%, 99.21%]
source quote (p.9)
“Overall, the HealthPPT was able to demonstrate an area under the curve (AUC) of 96.75% (95% CI: [94.28%, 99.21%])”
sensitivityas written: “Sensitivity (high-specificity operating point)”0.8037CI [71.85%;86.79%]
source quote (p.9)
“The second “high-specificity” operating point reported a sensitivity of 80.37% (95% CI: [71.85%;86.79%])”
specificityas written: “Specificity (high-specificity operating point)”0.9725CI [92.22%;99.06%]
source quote (p.9)
“and a specificity of 97.25% (95% CI: [92.22%;99.06%]).”
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
0
recalls in product code, 24mo
0
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
0
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).