Precision AI Surgical Planning System (PAI-SPS)

K233992

Precision AI Pty Ltd · cleared 2024-08-05 · product code QHE · Orthopedic

Premarket evidence — what FDA accepted

Device typehardware with ml
source quote (p.6)
“Precision Al Surgical Planning System (PAI-SPS) is a patient-specific medical device that is designed to be used to assist the surgeon in the placement of shoulder components during total anatomic and reverse shoulder replacement surgery. This can be done by generating a pre-surgical shoulder plan and, if requested by the surgeon, by manufacturing a patient-specific guide and models to transfer the surgical plan to surgery. The device is a system composed of the following: a software component, Precision Al Surgical Planning Software which will create a 3D construct of the patient's joint for the surgeon to plan the operation preoperatively. Precision Al Surgical Planning Software incorporates non-adaptive machine or deep learning algorithms trained for the purpose of semi-automatic segmentation and landmark identification of image scans similar to the listed reference devices.”
Algorithmnon-adaptive machine or deep learning algorithms
source quote (p.6)
“Precision Al Surgical Planning Software incorporates non-adaptive machine or deep learning algorithms trained for the purpose of semi-automatic segmentation and landmark identification of image scans similar to the listed reference devices.”
Adaptive (vs locked)No
source quote (p.6)
“Precision Al Surgical Planning Software incorporates non-adaptive machine or deep learning algorithms trained for the purpose of semi-automatic segmentation and landmark identification of image scans similar to the listed reference devices.”
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Bench

sample size not stated

Bench

sample size not stated

Retrospective clinical

n=35 patients

endpoints: measurement accuracy

standards: ethics committee approval, GCP

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
2
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K243955 (decision 2025-01-21) 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:K243955

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/K233992