(30 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 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
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 document, a 510(k) Premarket Notification for the THINK Surgical TSolution One Total Knee Application, does not contain the detailed information required to describe the acceptance criteria and the study that proves the device meets those criteria in the way requested by the user.
Here's a breakdown of why and what information is missing:
The document primarily focuses on establishing "substantial equivalence" of a modified device (adding a new compatible knee implant system) to previously cleared predicate devices. It states that performance testing, specifically "cutting accuracy verification" and "cadaver lab validation testing," was conducted and "passed" following "similar test methods and acceptance criteria to those used for the predicate device." However, it does not provide the specific numerical acceptance criteria or the detailed results of these studies.
Therefore, I cannot provide a comprehensive answer to most of your questions based solely on the provided text.
Here's what I can extract and what's missing, aligning with your numbered questions:
1. A table of acceptance criteria and the reported device performance
- Acceptance Criteria: Not explicitly stated in numerical form. The document only mentions that testing was done with "similar test methods and acceptance criteria to those used for the predicate device" and that the device "met all test criteria and specifications."
- Reported Device Performance: Only reported as "Passed" for "Cutting Accuracy Verification" and "Cadaver Lab Validation Testing." No specific data (e.g., accuracy values, precision, failure rates) is provided.
| Acceptance Criteria (Not Explicitly Stated) | Reported Device Performance |
|---|---|
| Cutting Accuracy Verification: | Passed |
| Specific metric 1: (e.g., +/- X mm) | Not provided |
| Specific metric 2: (e.g., % within spec) | Not provided |
| Cadaver Lab Validation Testing: | Passed |
| Specific metric 1: (e.g., post-cut accuracy) | Not provided |
| Specific metric 2: (e.g., ease of use ratings) | Not provided |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified.
- Data Provenance: Not specified (e.g., country of origin, retrospective/prospective). The testing involved "simulated surgical testing in a cadaver model," implying a laboratory setting, but details are not given.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not specified. The document refers to the surgeon's role in the "preoperative planning software" and "robotic surgical tool" but does not detail expert involvement in establishing ground truth for testing.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not specified.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Not applicable. This device is a robotic surgical tool, not an image interpretation AI tool. Therefore, a multi-reader multi-case (MRMC) comparative effectiveness study as typically understood for AI image analysis performance is not relevant here. The device assists the surgeon in implementing a surgical plan.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- The document implies that the "cutting accuracy verification" and parts of the "cadaver lab validation testing" would be representative of "algorithm only" performance (i.e., how accurately the robot cuts based on the plan). However, the results are only stated as "Passed" without numerical data. The system is described as operating "under the direction of the surgeon," so it's inherently a human-in-the-loop system for clinical use, but the underlying robotic precision can be tested standalone.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- For the "cutting accuracy verification," the ground truth would likely be the pre-surgical plan (the intended cut), measured against the actual cut made by the robotic arm. This would be a form of objective physical measurement.
- For the "cadaver lab validation testing," the ground truth would also be related to the planned vs. executed surgical steps and the resulting bone preparation accuracy, again measured objectively.
- The document does not detail how this ground truth was established or measured (e.g., through metrology, post-cut imaging comparisons).
8. The sample size for the training set
- Not applicable. This document describes a robotic surgical system, not a machine learning or AI model that requires a "training set" in the context of data-driven learning. While the robot's control algorithms are developed, they are based on engineering principles and precise physical models, not on being "trained" on a dataset in the way a diagnostic AI would be.
9. How the ground truth for the training set was established
- Not applicable for the same reason as point 8.
In summary, the provided FDA 510(k) document confirms that performance testing was performed and met acceptance criteria, but it does not disclose the specific numerical criteria, the detailed quantitative results, or the methodological specifics (like sample size, expert involvement, or ground truth establishment details) of these tests. This level of detail is typically found in the full submission, which is not publicly available in this FDA clearance letter.
§ 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).