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The TSolution One® Total Knee Application is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with preoperative planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surgeon, precisely implements the presurgical software plan.

The preoperative planning software and robotic surgical tool are used as an alternative to manual planning and resecting techniques for the distal femur and proximal tibia preparation in primary total knee arthroplasty (TKA).

The TSolution One® Total Knee Application is indicated for orthopedic procedures in which resecting techniques used for the distal femur and proximal tibia may be considered to be as safe and effective and where references to rigid anatomical structures may be made.

The TSolution One® Total Knee Application is also intended to assist the surgeon in determining reference alignment axes in relation to anatomical and instrumentation structures during stereotactic orthopedic surgical procedures. The TSolution One® Total Knee Application facilitates accurate positioning of TKA implants, relative to these alignment axes.

The TSolution One® Total Knee Application is compatible with the following Knee Implant Systems:

• . Zimmer Persona™ Knee System
• . Corin Unity Knee System
• . Aesculap Columbus Knee System
• . DJO Surgical® EMPOWR 3D Knee® System
• . United U2 Knee System

Like its predicate, the TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planning workstation and implementation tool for treatment of patients who require total joint arthroplasty. The device is intended as an alternative to manual template planning and preparation of the bone with patients requiring primary total knee arthroplasty (TKA).

The TSolution One® Total Knee Application consists of TPLAN and TCAT. TPLAN is a three-dimensional (3D) preoperative planning workstation that aids a surgeon in planning the position and orientation of the implant components relative to 3D models of the patient's anatomy. TCAT consists of an electromechanical arm, an arm base including control electronics and computer, a display monitor, operating software, pendant control, and tools and accessories, for the implementation of the preoperative plan. TCAT and TPLAN when used according to the instructions for use, make submillimeter precision bone preparation possible before and during TKA surgical procedures.

The provided text describes the TSolution One® Total Knee Application, a robotic surgical tool for total knee arthroplasty (TKA). The document is a 510(k) summary demonstrating substantial equivalence to a predicate device (K201255).

Here's a breakdown of the acceptance criteria and study information, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document states that "Performance testing to verify the cutting accuracy of the subject device was conducted following similar test methods and acceptance criteria to those used for the predicate device." And "All of this testing demonstrated that the TSolution One® Total Knee Application met the test criteria and specifications of the predicate device."

2. Sample Size for Test Set and Data Provenance:

The document mentions "simulated surgical testing in a cadaver model" for validation testing but does not specify the sample size for this test set (e.g., number of cadavers or knees).
Data provenance: The cadaver model suggests human anatomical data, likely from a biospecimen provider, but does not specify the country of origin. The study was prospective simulation.

3. Number of Experts and Qualifications for Ground Truth:

The document does not provide information on the number of experts or their qualifications used to establish ground truth for the test set.

4. Adjudication Method:

The document does not specify any adjudication method (e.g., 2+1, 3+1, none) for the test set.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

An MRMC comparative effectiveness study was not explicitly mentioned or described in the provided text. The document focuses on the device's technical performance and substantial equivalence to a predicate, rather than human reader improvement with or without AI assistance.

6. Standalone (Algorithm Only) Performance:

The testing described appears to be for the standalone device, as it focuses on verifying cutting accuracy, software performance, and other technical aspects of the TSolution One® Total Knee Application. While it operates "under the direction of the surgeon," the described performance tests (cutting accuracy, software, EMC) are inherently standalone assessments of the system's capabilities. There is no explicit mention of human-in-the-loop performance measurement in the reported tests.

7. Type of Ground Truth Used:

For cutting accuracy and cadaver lab validation, the ground truth would likely be based on direct measurements of the resected bone surfaces against the pre-surgical plan, using high-precision metrology tools. This is implied by the nature of "cutting accuracy verification" and "cadaver model validation."

8. Sample Size for Training Set:

The document does not provide any information about the sample size used for the training set. It describes the device's technological characteristics and performance testing but not its development or training data.

9. How Ground Truth for Training Set Was Established:

The document does not provide any information on how the ground truth for the training set was established.

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