NeuroRPM

K221772

New Touch Digital Inc. · cleared 2023-03-17 · product code GYD · Neurology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“NeuroRPM is a software application for the Apple Watch that is prescribed by a health professional to quantify motor symptoms of Parkinson's disease including bradykinesia, dyskinesia, and tremor.”
Algorithmmachine learning model
source quote (p.4)
“The motion data are transmitted to cloud servers and analyzed using machine learning models developed to generate binary symptom classifications.”
Adaptive (vs locked)No
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

endpoints: verify that the motion data from the Apple Watch reflected the subject's activities within the expected signal patterns and range of values, and that there were no outliers

Retrospective clinical

n=36 patients · 1 site(s)

endpoints: sensitivity; specificity

Reported performance (6 observations)

sensitivity0.7176CI [0.6081, 0.8172]
source quote (p.7)
“Tremor Sensitivity [95% CI] 0.7176 [0.6081, 0.8172]”
specificity0.9508CI [0.9119, 0.9802]
source quote (p.7)
“Tremor Specificity [95% CI] 0.9508 [0.9119, 0.9802]”
sensitivityas written: “Bradykinesia Sensitivity”0.7143CI [0.5894, 0.8332]
source quote (p.7)
“Bradykinesia Sensitivity [95% CI] 0.7143 [0.5894, 0.8332]”
specificityas written: “Bradykinesia Specificity”0.774CI [0.6787, 0.8597]
source quote (p.7)
“Bradykinesia Specificity [95% CI] 0.7740 [0.6787, 0.8597]”
sensitivityas written: “Dyskinesia Sensitivity”0.7123CI [0.5323, 0.8652]
source quote (p.7)
“Dyskinesia Sensitivity [95% CI] 0.7123 [0.5323, 0.8652]”
specificityas written: “Dyskinesia Specificity”0.9466CI [0.9069, 0.9741]
source quote (p.7)
“Dyskinesia Specificity [95% CI] 0.9466 [0.9069, 0.9741]”

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); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Neurology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K221772