Oncospace

K242748

Oncospace, Inc. · cleared 2025-04-11 · product code MUJ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“The Oncospace subject device is a software-only medical device that performs the same functions as the Oncospace predicate device. The software includes locked machine learning algorithms.”
AlgorithmThe Oncospace software includes locked machine learning algorithms. The Oncospace software includes an algorithm for transforming non-standardized OAR names used by treatment planners to standardized names defined by AAPM Task Group 263. This matching process primarily uses a table of synonyms that is updated as matches are made during use of the product, as well as a Natural Language Processing (NLP) model that attempts to match plan names not already in the synonym table. The thoracic, abdominal, and gynecological regions have been added using the same machine learning methods as in the predicate device.
source quote (p.5)
“The Oncospace software includes locked machine learning algorithms. The Oncospace software includes an algorithm for transforming non-standardized OAR names used by treatment planners to standardized names defined by AAPM Task Group 263. This matching process primarily uses a table of synonyms that is updated as matches are made during use of the product, as well as a Natural Language Processing (NLP) model that attempts to match plan names not already in the synonym table. The thoracic, abdominal, and gynecological regions have been added using the same machine learning methods as in the predicate device.”
Adaptive (vs locked)No
source quote (p.5)
“The software includes locked machine learning algorithms. Note: The subject device algorithms, and any future algorithm updates, are locked prior to clinical use.”
PCCPFDA source did not state this
Cybersecurity addressedYes
source quote (p.10)
“The verification tests met all system requirements and acceptance criteria which address clinical, standard user interface, and cybersecurity requirements for the Oncospace device.”

Validation studies (5)

Retrospective clinical

n=18 patients · 1 site(s)

endpoints: mean OAR dose sparing; target coverage

Retrospective clinical

n=20 patients · 1 site(s)

endpoints: mean OAR dose sparing; target coverage

Retrospective clinical

n=17 patients · 1 site(s)

endpoints: mean OAR dose sparing; target coverage

Retrospective clinical

n=17 patients · 1 site(s)

endpoints: mean OAR dose sparing; target coverage

Bench

n=221 other

endpoints: macro-averaged F1 score; accuracy; correct match rate

Reported performance (2 observations)

f1as written: “NLP model validation macro-averaged F1 score”stated without valueCI >0.92
source quote (p.13)
“During 5-fold cross-validation all models achieved a validation macro-averaged F1 score above 0.92 and accuracy above 96% for classifying previously unseen terms.”
accuracyas written: “NLP model validation accuracy”stated without valueCI >0.96
source quote (p.13)
“During 5-fold cross-validation all models achieved a validation macro-averaged F1 score above 0.92 and accuracy above 96% for classifying previously unseen terms.”

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/K242748