Precision AI Surgical Planning System (PAI-SPS)
Precision AI Pty LtdThe Precision AI Surgical Planning System (PAI-SPS) is an AI-enhanced medical device that assists surgeons in planning and performing shoulder joint replacements. It uses CT scan images to create a 3D model of the patient's shoulder, helps surgeons simulate and optimize implant positioning, and can produce custom surgical guides for use during the procedure. This system helps improve surgical accuracy and outcomes for shoulder arthroplasty patients.
Intended Use
The Precision AI Planning Software is intended to be used as a pre-surgical planner for simulation of surgical interventions for shoulder joint arthroplasty, assisting positioning of shoulder components by creating 3D bone constructs and leading to surgery reports and data for patient-specific guides and biomodels.
Technology
The system includes AI-powered software that auto segments CT images to generate a 3D shoulder joint model. Surgeons use this 3D render for virtual planning of implant positioning. Patient-specific surgical guides and biomodels are manufactured via 3D printing using selective laser sintering based on the approved plan to assist intraoperative implant positioning.
Performance
Performance testing included software verification and validation per FDA guidance, user needs validation, and previous applicable hardware biocompatibility and cadaver testing. Testing demonstrated the device meets all design requirements and is as safe and effective as its predicate device (K233992).
Predicate Devices
No predicate devices specified
Device Timeline
- 1
Submission
12/23/2024
29 days - 2
FDA Approval
1/21/2025
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