(88 days)
The TMINI® Miniature Robotic System is indicated as a stereotaxic instrumentation system for total knee replacement (TKA) surgery. It is to assist the surgeon by providing software-defined spatial boundaries for orientation and reference information to identifiable anatomical structures for the accurate placement of knee implant components.
The robotic device placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a surgical plan determined preoperatively using CT based surgical planning tools.
The targeted population has the same characteristics as the population that is suitable for the implant(s) compatible with the TMINI® Miniature Robotic System.
The TMINI® Miniature Robotic System is to be used with the following knee replacement system(s) in accordance with the indications and contraindications:
- Enovis™ EMPOWR Knee System®
- Ortho Development BKS® and BKS TriMax® Knee System
- Total Joint Orthopedics Klassic® Knee System
- United U2™ Knee Total Knee System
- Medacta® GMK® Sphere / SpheriKA Knee Systems
- Zimmer Biomet Anterior & Posterior Referencing Persona® Knee
- b-ONE MOBIO® Total Knee System
- Maxx Orthopedics Freedom® Total & Titan Knee
- LINK® LinkSymphoKnee System
The TMINI® Miniature Robotic System consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station) including THINK Case Manager (TCM) the web-based method for surgeons to review, approve and download approved surgical plans, an Optical Tracking Navigation Console (TNav) and a robotically controlled hand-held tool (TMINI Robot) that assists the surgeon in preparing the bone for implantation of TKA components.
The TPLAN Planning Station uses preoperative CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes. The Planning Workstation contains a library of 510(k) cleared knee replacement implant(s) available for use with the system. The surgeon can select an implant model from this library. The planner/surgeon can manipulate the 3D representation of the implant in relation to the bone model to place the implant. The surgeon reviews and approves the case plan using either TPLAN or the TCM web-based application once the surgeon is satisfied with the implant selection, location and orientation. The data from the approved plan is written to a file that is used to guide the robotically controlled hand-held tool.
The hand-held robotic tool is optically tracked relative to optical markers placed in both the femur and tibia and articulates in two degrees-of-freedom, allowing the user to place bone pins in a planar manner in both bones. Mechanical guides are clamped to the bone pins, resulting in subsequent placement of cut slots and drill guide holes such that the distal femoral and proximal tibial cuts can be made in the pre-planned positions and orientations, and such that the implant manufacturer's multi-planer cutting block can be placed relative to drilled distal femoral pilot holes. If the surgeon needs to change the plan during surgery, it can be changed intraoperatively using TNav.
The provided FDA 510(k) clearance letter pertains to the TMINI Miniature Robotic System, a device used to assist surgeons in total knee replacement (TKA) surgery. The submission describes modifications to the system, primarily software enhancements to improve tibial registration performance, along with data logging updates, open-source software report updates, and cybersecurity updates. The application claims substantial equivalence to a previously cleared predicate device (K243481) and focuses on demonstrating that these modifications do not alter the intended use, safety, or effectiveness of the device.
Based on the provided document, here's a breakdown of the acceptance criteria and the study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly present a table of numerical acceptance criteria for performance metrics (e.g., specific thresholds for accuracy, precision). Instead, it states that "Testing to verify the function of the subject device was conducted following the same test methods and acceptance criteria as those used for the predicate device. The testing demonstrated that the TMINI® Miniature Robotic System met all test criteria and specifications."
The performance tests conducted and their qualitative results are summarized in Table 2: Substantial Equivalence, under the "Performance Testing" section.
| Performance Test Name | Acceptance Criteria (Implicit: Same as Predicate) | Reported Device Performance |
|---|---|---|
| Full System Run Through Testing | Passed for predicate | Passed |
| Pin & Block Placement Accuracy | Passed for predicate | Passed* |
| Cadaver Lab Validation Testing | Passed for predicate | Reanalyzed data passed |
| System Gap Balance Accuracy | Passed for predicate | Passed* |
| User Needs Validation Testing | Passed for predicate | Passed* |
| Usability Testing | Passed for predicate | Passed* |
| Software Testing | Passed for predicate | Passed |
* *Note: For Pin & Block Placement Accuracy, System Gap Balance Accuracy, User Needs Validation Testing, and Usability Testing, the document explicitly states "**Passed" and clarifies in a footnote, "These tests did not need to be repeated as a result of the changes to the software included in this submission." This implies that the acceptance criteria were met by the previous testing on the predicate device, and the current modifications did not necessitate re-testing these specific performance aspects.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the performance testing. For tests like "Cadaver Lab Validation Testing," while it mentions "Reanalyzed data passed," it does not specify the number of cadavers or cases.
The document does not provide information on the data provenance (e.g., country of origin, retrospective or prospective) for the test sets.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not provide information on the number of experts used or their qualifications for establishing ground truth for the test set. Given the nature of a robotic surgical system, ground truth would typically refer to highly accurate measurements obtained from advanced imaging or physical measurements in a controlled environment, likely assisted by surgical and engineering expertise.
4. Adjudication Method for the Test Set
The document does not specify any adjudication method (e.g., 2+1, 3+1, none) used for the test set.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study was not done or reported. This type of study is more common for diagnostic AI algorithms where human interpretation is a key component. The TMINI Miniature Robotic System is a surgical assistance robot, and the study focuses on its performance and accuracy rather than its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
The performance tests listed, such as "Pin & Block Placement Accuracy," "Cadaver Lab Validation Testing," and "System Gap Balance Accuracy," directly assess the standalone performance of the robotic system in achieving its intended surgical accuracies. While a surgeon operates the system, these accuracy measurements inherent to the robot's capabilities would constitute standalone performance in a sense, as they evaluate the robot's ability to execute pre-planned actions with precision. However, it's important to note that the system is intended to assist the surgeon, so "standalone" in the context of a robotic surgical system usually refers to the accuracy and precision of the robotic movements and tool positioning, which appear to have been tested.
7. The Type of Ground Truth Used
The document implicitly suggests that the ground truth for surgical accuracy tests (e.g., "Pin & Block Placement Accuracy," "System Gap Balance Accuracy") would be established through highly precise measurement techniques in a controlled lab or cadaveric setting, likely using CMM (Coordinate Measuring Machine) data, optical tracking references, or other metrology tools to determine the true positions and orientations relative to the planned surgical targets. For the "Cadaver Lab Validation Testing," the ground truth would be based on anatomical measurements in those cadavers after the robotic intervention.
8. The Sample Size for the Training Set
The document does not provide any information on the sample size for a training set. This submission is for modifications to a previously cleared device, and the focus is on verification and validation of those specific changes rather than the initial development and training of a new AI model for the core robotic functions. While "software enhancements to improve tibial registration performance" are mentioned, it's not specified if this involved a machine learning model that required a distinct training set.
9. How the Ground Truth for the Training Set was Established
As no training set information is provided, there is no information on how ground truth for a training set was established.
§ 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).