Maestro System (REF100)

K242323

Moon Surgical · cleared 2025-03-14 · 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.”
AlgorithmImage processing algorithms using Machine Learning methodology
source quote (p.9)
“Image processing algorithms that enable the detection of all surgical tools within the displayed video image and when commanded by the surgeon, follow the movement of the chosen tool. ... Machine Learning methodology used to develop”
Adaptive (vs locked)No
source quote (p.10)
“Once developed, this software algorithm is fixed and static and added to the rest of the system software.”
PCCPNo
Cybersecurity addressedYes
source quote (p.12)
“Design verification testing included the following: ... • Cybersecurity”

Validation studies (5)

Bench

sample size not stated

endpoints: Payload Capacity; Malformed Input; Force Accuracy; Drape Integrity; Emergency Stop; Hold Position Accuracy; IFU Inspection; Positioning Guidance & Collision Detection; ScoPilot Motion Performance; System Positioning Accuracy; Bedside Joint Control Accuracy; End to End Workflow; Design Inspection; System Setup; System Latency; Electro-Cautery Compatibility; ScoPilot Latency; ScoPilot End to End; ScoPilot IFU Inspection; System Endurance; ScoPilot Vision Performance; ScoPilot Malformed Input; Cybersecurity; Coupler Performance; Electrical safety and electromagnetic compatibility (EMC)

Bench

sample size not stated

endpoints: detection and tracking of specified instrument tips; generation of motion trajectories; safety limits; detection of malformed inputs at a video and frame level

standards: FDA's Guidance for Industry and FDA Staff, “Content of Premarket Submissions for Device Software Functions”, “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions”

Standalone

sample size not stated

endpoints: model performance (lower bound of the 95%CI for AP and AR) is compliant with our specification

Bench

sample size not stated

Bench

sample size not stated

Reported performance (2 observations)

ppvas written: “Average Precision (AP)”stated without valueCI lower bound of the 95%CI
source quote (p.13)
“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.13)
“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
1
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K250984 (decision 2025-06-27) from Moon Surgical for a matching device line ("Maestro System (REF100)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K250984

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/K242323