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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. It includes a handheld robotic device, an optical sensor navigation system and accessories, software system, surgical instruments and accessories.

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.

It includes a handheld robotic device, an optical sensor navigation system and accessories, surgical instruments and accessories.

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

The TMINI 1.1 like its predicate, the TMINI™ Miniature Robotic 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/surgeon 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, 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 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.

Here's a breakdown of the acceptance criteria and study information for the TMINI™ Miniature Robotic System (TMINI 1.1) based on the provided text, recognizing that specific numerical values for acceptance criteria and detailed study designs are often proprietary and not fully disclosed in 510(k) summaries.

Important Note: The provided text is a 510(k) summary for a modified device (TMINI 1.1), asserting substantial equivalence to a previously cleared predicate device (TMINI™ Miniature Robotic System, K232802). As such, it primarily refers to the testing methods and acceptance criteria being similar to those of the predicate, rather than detailing new, distinct acceptance criteria and studies for the TMINI 1.1 that would demonstrate its initial safety and effectiveness from scratch. The text emphasizes that the modifications did not alter indications for use or raise new safety/effectiveness questions, and thus, previous testing is largely considered sufficient by extension.

1. Table of Acceptance Criteria and Reported Device Performance

Given the nature of the 510(k) summary for a modified device, specific quantitative acceptance criteria are not explicitly stated for all tests. Instead, the document consistently states that the device "Passed" various tests, implying it met the established (but not detailed) criteria.

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify the exact sample sizes for each test set.

• For "Cadaver Lab Validation Testing," it implies that cadaver models were used, suggesting a prospective design for those specific tests.
• The data provenance (country of origin) is not mentioned.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

• Number of Experts: Not explicitly stated.
• Qualifications of Experts: For "System Gap Balance Accuracy," the text mentions "qualitative surgeon assessment testing." This implies that qualified surgeons were involved in assessing the device's performance, but their specific number and detailed qualifications (e.g., years of experience, specialization) are not provided.

4. Adjudication Method for the Test Set

The document does not describe any specific adjudication method (like 2+1 or 3+1 consensus) for establishing ground truth or evaluating test results. It states that tests "Passed" or "Met" criteria, implying a direct comparison against predefined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No, an MRMC comparative effectiveness study is not mentioned in the provided text. The document focuses on demonstrating substantial equivalence of a robotic surgical system (an instrumentation system) to a predicate, not on a human-reader performance comparison.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

• The TMINI™ Miniature Robotic System (TMINI 1.1) is described as an "instrumentation system" that "assists the surgeon." It includes "software-defined spatial boundaries" and a "robotically controlled hand-held tool."
• While software testing was performed ("Software Testing: Passed"), the overall device function inherently involves human interaction (the surgeon). Therefore, a purely standalone algorithm-only performance as a diagnostic or analytical tool (without any human in the loop for the critical surgical actions) seems unlikely and is not explicitly stated. The described functions (planning, robot guidance, navigation) are all in support of a human-performed surgery.

7. The Type of Ground Truth Used

• For "Cutting Accuracy - Pin & Block Placement Accuracy," "Cadaver Lab Validation Testing," and "System Gap Balance Accuracy," the ground truth implicitly refers to objective physical measurements and surgical assessments (e.g., accuracy of pin/block placement against a programmed plan, quantitative gap measurements, qualitative surgeon assessment of balance). These are proxies for optimal surgical outcomes and precise execution.
• The system uses "CT images... to create a 3D model of the bone for surgical planning," and "preoperatively determined landmarks are compared to intraoperatively identified landmarks to complete patient bone registration." This suggests that the ground truth for planning and navigation largely relies on preoperative imaging and anatomical landmarks.
• No mention of pathology or long-term outcomes data being used as ground truth for this particular submission.

8. The Sample Size for the Training Set

• The document does not provide information regarding a training set sample size. This submission is for a modification to an existing device, and the focus is on verification and validation testing, not typically on reiterating details of the initial development or training data for the core algorithms (which would have been part of the predicate device's clearance).

9. How the Ground Truth for the Training Set Was Established

• As the document does not discuss a training set for the current submission, there is no information on how ground truth for any potential training set was established. The existing (predicate) device's software and algorithms would have had their own development and training, but those details are not part of this modification summary.

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