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Intended Use

CORIOGRAPH Pre-Op Planning and Modeling Services are intended to provide preoperative planning for surgical procedures based on patient imaging, provided that anatomic landmarks necessary for generating the plan are identifiable on patient imaging scans.

Indications for Use

The CORIOGRAPH Pre-op Planning and Modeling Services are indicated for use for the following procedures:

• Unicondylar Knee Replacement (UKR)
• Total Knee Arthroplasty (TKA)
• Primary Total Hip Arthroplasty (THA)
• Primary Anatomic Total Shoulder Arthroplasty (aTSA)
• Primary Reverse Total Shoulder Arthroplasty (rTSA)

Coriograph Pre-Op Planning and Modeling Services (CORIOGRAPH) are Software as a Medical Device (SaMD) that provide pre-operative planning for orthopedic surgical procedures based on patient imaging, surgeon preferences and implant geometry. CORIOGRAPH is comprised of several medical software systems (modules), and these modules share a set of non-medical function software applications called the Case Processing System.

CORIOGRAPH is a Software Medical Device System. The medical function modules share a graphic user interface where the surgeon provides their case preferences and patient imaging, retrieves PDF plans generated by the Pre-Op Plan modules, and launches the Modeler modules.

CORIOGRAPH Pre-Op Plan Modules

Using patient-specific information, patient imaging, and surgeon inputs, a pre-operative plan is generated by Smith+Nephew personnel. The plan provides initial alignment recommendations to the surgeon on implant placement based on the geometries of the implant and of the generated bone models.

CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler Modules

CORIOGRAPH Hip Modeler and CORIOGRAPH Shoulder Modeler are web-based software applications intended for surgeons to modify the patient-specific pre-operative plan and to evaluate the impact of the modifications through the impingement analysis tools such as Impingement-free Range-of Motion (ROM) and Activities of Daily Living (ADL) simulations.

The provided text is a 510(k) clearance letter and summary for a medical device called CORIOGRAPH Pre-Op Planning and Modeling Services. It details the device's intended use, indications for use, and a comparison to predicate devices, focusing on the addition of shoulder arthroplasty procedures.

However, the document does not contain the specific information requested regarding acceptance criteria and the detailed study proving the device meets these criteria. It mentions non-clinical bench testing, software verification testing (IEC 62304), credibility evaluation of kinematic models and ADL simulations, and summative usability validation testing (IEC 62366). It states that "Design verification and validation testing demonstrated that CORIOGRAPH Pre-Op Planning and Modeling Services (v 3.0) meets all design requirements and is as safe and effective as its primary and secondary predicate devices." and "The credibility evaluation demonstrated that the kinematic models and Activities of Daily Living (ADLs) simulations utilized in the subject device are clinically relevant."

Crucially, it does not provide:

• Specific acceptance criteria for accuracy, precision, or performance metrics.
• Quantifiable reported device performance against those criteria.
• Sample sizes for test sets used for performance evaluation (other than mentioning "representative users" for usability).
• Data provenance (country of origin, retrospective/prospective) for performance data.
• Details on expert ground truth establishment (number of experts, qualifications, adjudication method).
• Information on MRMC comparative effectiveness studies.
• Standalone (algorithm-only) performance.
• Type of ground truth used (e.g., pathology, outcomes data) for clinical performance, if any.
• Sample size for the training set or how its ground truth was established.

The document is a high-level summary confirming regulatory clearance based on substantial equivalence, implying that the detailed testing data would have been part of the full 510(k) submission, but is not included in this public-facing summary.

Therefore, based only on the provided text, I cannot complete the requested tables and details about acceptance criteria and study proof. The document confirms that testing was done and results met requirements, but does not provide the specifics of those results or the criteria themselves.

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