(28 days)
TMIN® 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 TMIN® Miniature Robotic System. The TMIN® Miniature Robotic System is to be used with the following knee replacement systems 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™ 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
Like its predicate, the TMINI® Miniature Robotic System (Additional Knee System) consists of three primary components: a three-dimensional, graphical, Preoperative Planning Workstation (TPLAN® Planning Station), 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/surqeon can manipulate the 3D representation of the implant in relation to the bone model to optimally place the implant. The surgeon reviews and approves the case plan once the surgeon is satisfied with the implant selection 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 quides 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 document is a 510(k) summary for a medical device called the TMINI® Miniature Robotic System (Additional Knee System). This submission is for a modification to an already cleared predicate device (K242264) to add compatibility with three new knee implant systems.
Therefore, the primary focus of the acceptance criteria and study is to demonstrate that the modified device, when used with these new implants, performs equivalently to the predicate device and does not introduce new safety or effectiveness concerns.
Here's the breakdown of the information requested based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document states that "The verification and validation activities were successfully completed, and all pre-determined acceptance criteria were met." It doesn't explicitly list specific numerical acceptance criteria for each test in a table format but rather indicates overall success. The table below summarizes the types of performance testing conducted and implies that the results met the criteria of demonstrating substantial equivalence to the predicate.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Full System Run Through Testing | Passed |
| Cutting Accuracy | Passed |
| Pin & Block Placement Accuracy | Passed |
| Cadaver Lab Validation Testing | Passed |
| System Gap Balance Accuracy | Passed |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity) | Passed (No new testing required as no material changes) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample size for the test set (e.g., number of cadavers, number of simulated procedures) used in the performance testing. It also does not explicitly state the data provenance (country of origin, retrospective or prospective). It simply mentions "test samples were representative of the production product."
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)
The document does not provide information on the number of experts used or their qualifications for establishing ground truth in the performance testing. It mentions that surgical planning involves "Technician guided surgical planning with surgeon review and approval on a desktop planning station," implying expert input during surgical planning, but not specifically for establishing ground truth for the test set's performance evaluation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The document does not describe any specific adjudication method for the test set.
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
There is no mention of a multi-reader, multi-case (MRMC) comparative effectiveness study in the provided text. The device is a robotic system for surgical assistance, not an AI-assisted diagnostic tool that would typically involve "human readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The performance testing described ("Full System Run Through Testing," "Cutting Accuracy," "Pin & Block Placement Accuracy," "Cadaver Lab Validation Testing," "System Gap Balance Accuracy") implicitly involves the entire system, which includes the robotic component, navigation system, and software. The device's description highlights its role in "assisting the surgeon," indicating a human-in-the-loop system. Therefore, a standalone (algorithm only) performance assessment, separate from the integrated device, is not explicitly detailed or suggested by the nature of this robotic surgical tool.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The document implicitly refers to ground truth being established through "pre-planned positions and orientations" of bone cuts and drill guide holes, as determined by the CT-based surgical planning tools and approved by a surgeon. The performance tests ("Cutting Accuracy," "Pin & Block Placement Accuracy," "Cadaver Lab Validation Testing," "System Gap Balance Accuracy") likely compare the achieved surgical outcomes against these pre-planned, ideal targets.
8. The sample size for the training set
The document does not provide information on the sample size for the training set. The device uses "CT scans of the operative leg to create 3D surface models for case templating and intraoperative registration purposes" and contains a "library of 510(k) cleared knee replacement implant(s)," but it does not describe a machine learning training process with a distinct training set.
9. How the ground truth for the training set was established
As there is no explicit mention of a "training set" in the context of machine learning, the establishment of its ground truth is not described. The device's operation relies on pre-operative CT scans and surgeon-approved plans, which serve as the intended targets or "ground truth" for each specific surgical case.
§ 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).