Maestro System (REF100)

K250984

Moon Surgical · cleared 2025-06-27 · product code QZB · Gastroenterology-Urology

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.5)
“The Moon Maestro System is a 2-arm system which utilizes software and hardware to provide support to surgeons for manipulating and maintaining instrument position.”
AlgorithmML model
source quote (p.10)
“The ML model was trained and tuned through a K-fold cross-tuning process to optimize hyperparameters, until it reached our predefined performance requirements.”
Adaptive (vs locked)Yes
source quote (p.7)
“the PCCP in this submission intends to train the model on a new instrument class and on currently known classes (additional or currently known brands)”
PCCPYes
source quote (p.1)
“FDA's substantial equivalence determination also included the review and clearance of your Predetermined Change Control Plan (PCCP).”
Cybersecurity addressedYes
source quote (p.9)
“Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Content of Premarket Submissions for Device Software Functions" and "Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”.”

Validation studies (3)

Bench

sample size not stated

standards: IEC 60601-1:2005+A1+A2, IEC 60601-1-6:2010+A1+A2, IEC 60601-1-2:2014+A1, AIM 7351731 Rev. 3.00: 20201, IEEE/ANSI C63.27:2021

Bench

sample size not stated

endpoints: Payload Capacity; Malformed Input; Force Accuracy; Emergency Stop; Hold Position Accuracy; IFU Inspection; Positioning Guidance & Collision Detection; System Positioning Accuracy; Bedside Joint Control Accuracy; End to End Workflow; Design Inspection; System Setup; System Latency; Electro-Cautery Compatibility; System Endurance; Cybersecurity; System Data Logging; System Connectivity; System Cloud Data; OS; ScoPilot Motion Performance; ScoPilot Vision Performance

Standalone

sample size not stated

endpoints: model performance (lower bound of the 95%CI for AP and AR)

Reported performance (2 observations)

ppvas written: “Average Precision (AP)”stated without valueCI lower bound of the 95%CI
source quote (p.10)
“An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning.”
sensitivityas written: “Average Recall (AR)”stated without valueCI lower bound of the 95%CI
source quote (p.10)
“An independent testing dataset containing videos was used to verify that the model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification when using data including brands unseen during training/tuning.”

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 Gastroenterology-Urology 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/K250984