(27 days)
The TSolution One® Total Knee Application is intended for use as a device that uses 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 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:
- Aesculap Columbus Knee System
- Corin Unity Knee
- DJO Surgical EMPOWR 3D Knee
- DJO Surgical EMPOWR Knee System
- Ortho Development Balanced Knee
- Total Joint Orthopedics Klassic Knee System
- United U2 Knee
- Zimmer Biomet Persona
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 ioint 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 acceptance criteria and study proving the device meets them are described below:
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. This testing demonstrated that the TSolution One® Total Knee Application met all test criteria and specifications. Validation testing, with methods and acceptance criteria similar to that used for the predicate device, was conducted using simulated surgical testing in a cadaver model and all test criteria were met."
Therefore, the specific quantitative acceptance criteria are not explicitly detailed but are implied to be met based on the predicate device's standards.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Cutting Accuracy | Passed |
| Cadaver Lab Validation | Passed |
| Software Testing | Passed |
Study Details
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Sample Size for the Test Set and Data Provenance:
- Cutting Accuracy Verification: Not specified.
- Cadaver Lab Validation Testing: Not specified, but involved "simulated surgical testing in a cadaver model". The provenance of the cadaver models (e.g., country of origin, retrospective or prospective) is not mentioned.
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Number of Experts and Qualifications for Ground Truth: Not specified, as the testing focuses on device performance against established criteria rather than expert interpretation of outputs.
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Adjudication Method: Not applicable/specified for this type of performance testing.
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Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study: No, an MRMC comparative effectiveness study was not done. The document focuses on the device's technical performance and equivalence to a predicate device, not on comparing human reader performance with and without AI assistance.
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Standalone (Algorithm Only) Performance: Yes, the testing described appears to be a standalone performance evaluation of the TSolution One® Total Knee Application, specifically its cutting accuracy and functionality in a cadaver model, without human-in-the-loop performance measurement.
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Type of Ground Truth Used for Test Set:
- For "Cutting Accuracy Verification" and "Cadaver Lab Validation Testing," the ground truth would inherently be based on precise physical measurements of resections and implant positioning against the pre-surgical plan. While not explicitly stated, this implies highly accurate measurement tools and established anatomical references for assessment.
- For "Software Testing," the ground truth would be defined by the software's functional specifications and expected outputs.
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Sample Size for the Training Set: Not specified. The document describes performance testing and validation for a device modification (adding more compatible implant systems), not the development or training of an AI algorithm from scratch.
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How the Ground Truth for the Training Set Was Established: Not specified, as the document doesn't detail the development or training phase of the device's original algorithms.
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).