Precision AI Surgical Planning System (PAI-SPS)

K243955

Precision AI Pty Ltd · cleared 2025-01-21 · product code QHE · Orthopedic

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.7)
“The Precision Al Surgical Planning System Software will create a 3D construct/render of the patient's shoulder joint for the surgeon to plan the operation preoperatively then create a physical Patient Specific Instrument (or Guide), using 3D printing by selective laser sintering. The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm.”
Algorithmartificial intelligence algorithm for auto-segmentation
source quote (p.7)
“The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm.”
Adaptive (vs locked)No
source quote (p.7)
“The patient's CT scan images are the design input for this to be created and are auto segmented via a locked, or static, artificial intelligence algorithm.”
PCCPNo
Cybersecurity addressedNo

Validation studies (2)

Bench

sample size not stated

Bench

sample size not stated

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

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

1
recalls in product code, 24mo
1
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) K251558 (decision 2026-01-12) from Precision AI Pty, Ltd. for a matching device line ("Precision AI Surgical Planning System (PAI-SPS)") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251558

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 Orthopedic 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/K243955