Radiation Planning Assistant (RPA)

K222728

University of Texas, MD Anderson Cancer Center · cleared 2023-05-17 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“The Radiation Planning Assistant (RPA) is a web-based contouring and radiotherapy treatment planning software tool that incorporates the basic radiation planning functions from automated contouring, automated planning with dose optimization, and quality control checks.”
Algorithmdeep learning algorithms
source quote (p.7)
“The RPA uses deep learning algorithms which Eclipse does not.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (2)

Bench

sample size not stated

standards: IEC 62304 Medical device software - Software life cycle processes, IEC_62083 Requirements for the safety of radiotherapy treatment planning systems

Retrospective clinical

n=50 patients · 5 site(s)

endpoints: Difference in passing rates of dosimetric metrics for normal structures (RPA vs clinical contour) <= 5%; Difference in passing rates of dosimetric metrics for normal structures (RPA vs clinical plans) <= 5%; Difference in passing rates of dosimetric metrics for target structures (RPA vs clinical plans) <= 5%; 25th percentile of recall for RPA targets >= 0.7; Surface DSC (2mm) for body contouring > 0.8 for 95% of CT scans; Difference in automatically generated vs manually generated marked isocenters <= 3mm in all orthogonal directions

Reported performance (2 observations)

sensitivityas written: “25th percentile for recall for RPA targets”0.7
source quote (p.14)
“25th percentile for recall > 0.7”
diceas written: “Surface DSC (2mm) for body contouring”0.8
source quote (p.14)
“Surface DSC > 0.8 for 95% of CT scans”

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

35
recalls in product code, 24mo
17
MAUDE reports in code, 12mo
-50%
vs code's own 3-yr baseline
2
drift signals on this device
  • recall_reason_pattern

    Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-08-05): "Due to a software issue, there is a potential image error of the Region of Interest for expansion/contraction for HFP (Head First Prone), FFS (Feet First Supine) and FFP (Feet Firs" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97049

  • recall_reason_pattern

    Software/algorithm-related recall in product code MUJ (Philips Medical Systems (Cleveland) Inc, initiated 2025-07-17): "Due to software issue, Radiation Therapy Planning system may provide incorrect dataset calculations when performing the "Stopping Power Ratio" (SPR) ," Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97309

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 Radiology 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/K222728