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The Smith & Nephew PiGalileo Total Hip Replacement (THR) V3.0 is intended to be used in computer assisted orthopedic surgery to aid the surgeon with bone cuts and implant positioning during joint replacement. It provides information to the surgeon that is used to place surgical instruments during surgery utilizing anatomical landmarks and other data specifically obtained intra-operatively (e.g. hip center, pelvic plane etc.). Examples of surgical procedures include but are not limited to: Primary total hip replacement, Revision hip surgery, Minimally invasive hip arthroplasty.

The PiGalileo Navigation System is a software-controlled electromechanical stereotaxic device for computer aided navigation of PiGalileo surgical instruments with the purpose of assisting the surgeon in optimally positioning knee and hip prostheses during total knee and hip arthroplasties. The PiGalleo THR V3.0 software application is a surgical technique for computer assisted navigation that leverages PiGalileo Total Hip Replacement (THR) instruments as well as a number of non-navigated hip instruments with the intent to optimally position hip prostheses during total joint arthroplasty.

The provided text describes a software application (PiGalileo Total Hip Replacement (THR) Software Application V3.0) for computer-assisted orthopedic surgery, specifically for total hip replacement procedures. However, the document does not contain specific acceptance criteria, performance metrics, or details of a study designed to prove the device meets such criteria.

The document is a summary of safety and effectiveness, indicating substantial equivalence to a previously cleared device (K070731, Plus Orthopedics AG THR V2.5 Software). It outlines the device description, classification, and indications for use. The FDA letter confirms that the device is substantially equivalent to a legally marketed predicate device, allowing it to proceed to market. This is a regulatory pathway, not a detailed performance study report against specific acceptance criteria.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving the device meets them because the source text does not contain this information.

Missing Information:

• Acceptance Criteria and Reported Device Performance: No specific performance metrics or thresholds are mentioned.
• Sample Size and Data Provenance for Test Set: No test set is described, nor its sample size or origin.
• Number of Experts and Qualifications for Ground Truth: No experts are mentioned in the context of establishing ground truth for a test set.
• Adjudication Method: Not applicable as no test set data is discussed.
• MRMC Comparative Effectiveness Study: No such study is mentioned or its results (effect size).
• Standalone Performance Study: No standalone performance study or its results are detailed.
• Type of Ground Truth Used (for Test Set): Not mentioned.
• Sample Size for Training Set: No training set is mentioned.
• Ground Truth Establishment for Training Set: Not mentioned.

The document primarily focuses on the regulatory clearance process through substantial equivalence, rather than a detailed technical performance evaluation against specific, quantified acceptance criteria.

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