(139 days)
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 safe 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 Zimmer Persona™ Knee System.
The TSolution One® Total Knee Application is a three-dimensional, graphical, preoperative planner 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 surqical procedures.
Here's a breakdown of the acceptance criteria and the study proving the device meets them, based on the provided text:
Device Name: TSolution One® Total Knee Application
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Primary Safety Endpoint | Composite safety endpoint (7 relevant adverse events as defined by the Knee Society, each with expected incidence ≤2.7%, sum = 7.6%) | None of the seven adverse events identified were observed. 100% (115/115) of patients successfully completed the primary safety endpoint. |
| Primary Effectiveness Endpoint | Demonstrate a reduction in malalignment rate (coronal mechanical axis > ±3° from preoperative plan) by 50% compared to a historical 32% malalignment rate (i.e., achieve ≤ 16% malalignment). | ITT: 13.0% malalignment rate, a 59.2% reduction. |
| PP: 11.2% malalignment rate, a 65.0% reduction. |
2. Sample Sizes and Data Provenance
- Test Set (Clinical Trial): 115 patients were enrolled in the study (Intent-to-Treat group). 107 patients were in the Per-Protocol group for the effectiveness endpoint.
- Data Provenance: Multi-center, prospective, non-randomized clinical trial carried out at six investigational sites in the US.
3. Number of Experts and Qualifications for Ground Truth
The document does not explicitly state the number of experts used to establish ground truth for the test set beyond the involvement of "eight clinical investigators" in the study. Their specific qualifications (e.g., years of experience) are not detailed, but their role as clinical investigators implies medical expertise.
4. Adjudication Method for the Test Set
The document does not specify an adjudication method like "2+1" or "3+1" for assessing the primary endpoints. The outcomes (adverse events, malalignment rates) appear to be directly measured based on predefined criteria, rather than requiring expert consensus or adjudication of individual cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study was conducted to evaluate how human readers improve with AI vs. without AI assistance. This device is a robotic surgical tool, not an AI-assisted diagnostic imaging tool that human readers would interpret. The comparative effectiveness was against historical conventional manual TKA.
6. Standalone (Algorithm Only) Performance
The device is a robotic surgical tool that assists the surgeon, not a standalone algorithm for diagnosis or treatment decision-making without human intervention. Its performance is evaluated in the context of its use by a surgeon. The "cutting accuracy" and "software testing" results (table on page 6) refer to technical performance aspects of the system itself, which are a form of standalone testing for the specific functions of the device (e.g., how accurate are the cuts, does the software function as intended).
7. Type of Ground Truth Used
- For Safety: Clinical observation and reporting of predefined adverse events (composite safety endpoint).
- For Effectiveness: Direct measurement of coronal mechanical axis alignment from postoperative imaging at 3 months, compared to the preoperative plan and historical malalignment rates.
8. Sample Size for the Training Set
The document does not provide details on the sample size of any specific "training set" for the device's development or internal validation. It mentions the "library of FDA cleared components used to develop optimal implant size and location" for planning but doesn't quantify data used for algorithm training.
9. How Ground Truth for the Training Set Was Established
The document does not specify how ground truth for any potential training set was established. Given the nature of a surgical robotic system, its "training" might involve rigorous engineering validation, testing against known physical standards, and simulated surgical scenarios, rather than a traditional medical image dataset with expert-labeled ground truth like an AI diagnostic algorithm. The text focuses on the device's functionality rather than a machine learning model's training data.
§ 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).