(40 days)
The TSolution One® Cupl Surgical System is intended for use as a device that uses diagnostic images of the patient acquired specifically to assist the physician with presurgical planning and to provide orientation and reference information during intraoperative procedures. The robotic surgical tool, under the direction of the surqeon, precisely implements the presurgical software plan.
The preoperative planning software and robotic surgical tool is used as an alternative to manual planning and broaching/reaming/impacting techniques for femoral canal and acetabular cup preparation in primary cementless total hip arthroplasty (THA) using a posterior approach.
The TSolution One® Cup1 Surgical System is indicated for orthopedic procedures in which the broaching, reaming and impacting techniques used in primary cementless total hip arthroplasty (THA) using a posterior approach may be considered to be safe and effective and where references to rigid anatomical structures may be made.
The TSolution One® Cup1 Surgical System 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® Cupl Surgical System facilitates accurate positioning of THA implants, relative to these alignment axes.
The TSolution On® Cup1 Surgical System is a three-dimensional, graphical, preoperative planner and implementation tool for treatment of patients who require a total hip arthroplasty (THA) procedure. This device is intended as an alternative to manual template planning, broaching, reaming and impacting techniques for the preparation of femoral canal and acetabular cup for patients requiring a primary THA procedure. The system consists of the TPLAN™ Preoperative Planning Workstation and TCAT™, a robotic system composed of an electromechanical arm, arm base including control electronics and computer, display monitor, and miscellaneous accessories such as cutters, drapes, irrigation sets, probes, and markers. TPLAN™ and TCAT™ when used according to the instructions for use, make precision femoral canal and acetabular cup preparation possible before and during THA surgical procedures.
The provided text does not contain information about acceptance criteria and a study proving the device meets them in the format requested. The document is a 510(k) premarket notification for the TSolution One® Cup1 Surgical System, outlining its intended use, a comparison to a predicate device, and general performance data from verification/validation activities.
Specifically, the document does not include:
- A table of specific acceptance criteria (e.g., accuracy, precision metrics with numerical thresholds).
- Detailed results of a study designed to demonstrate adherence to such criteria.
- Information on sample sizes for test sets, data provenance, number or qualifications of experts, or adjudication methods for ground truth establishment.
- Details about a multi-reader, multi-case (MRMC) comparative effectiveness study or the effect size of AI assistance on human readers.
- Standalone algorithm performance.
- Type of ground truth used (e.g., pathology, outcomes data).
- Sample size for the training set or how ground truth was established for the training set.
Instead, it presents:
- Performance Data: "The TSolution One® Cup1 Surgical System has been evaluated with non-clinical performance testing for the following modifications and or improvements: TPLAN Bug Fixes, TCAT Bug Fixes, TCAT Instrument Changes, System User Manuals Changes."
- Verification/Validation Activities: A table (Table 2) lists "Software Testing" and "Support Surgical Instrument Testing" with the purpose to "Verify TPLAN presurgical planning and TCAT surgical system software function as intended to successfully complete THA procedure including Acetabular Cup Guidance" and "Verify TCAT surgical support instruments function as intended to successfully complete THA procedure including Acetabular Cup Guidance and meet user needs." Both activities report "PASS" as results.
The document concludes that "The results of performance testing indicated the device performed within the intended use and the differences between the predicate and the TSolution One® Cup1 Surgical System do not raise any new safety or efficacy issues." This implies that the device met internal verification and validation criteria, but those specific criteria and detailed study results are not provided in this regulatory summary.
§ 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).