(238 days)
The mBôs TKA system is indicated for use in surgical knee procedures on adults in which the stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be identified relative to a CT based model of the anatomy.
These procedures include:
Total Knee Arthroplasty (TKA)
The implant systems compatible with the system:
mPress™ Total Knee System: mPress™ TL: Cementless mPress™ TC: Cemented
Each Implant System includes the Cruciate Retaining (CR), Cruciate Substituting (CS), and Posterior Stabilized (PS) implant types.
The mBôs TKA system is a stereotactic planning and implementation device designed to assist orthopedic surgeons in treating patients requiring primary total knee arthroplasty (TKA) surgeries. It is an alternative to manual template planning for femur and tibia bone for surgical preparation for TKA procedures.
The device's hardware comprises a robotic arm mounted on a stabilized cart with an integrated sagittal saw-based cutting system. The robot cart houses the necessary electromechanical components. It provides power and communications to an infrared (IR) based optical tracker, a display screen, a foot pedal, a touchscreen, a sagittal saw cutting tool, and protective stops. Additionally, the system includes dedicated instrumentation, tools, accessories, and proprietary software for operating and case planning.
The mBôs TKA system proprietary software suite (mSuite™) is comprised of the following: mPower® Case Management Application (CMA) mPower® Embedded System Applications
The provided document is a 510(k) summary for the Monogram mBôs TKA System, indicating FDA clearance based on substantial equivalence to a predicate device (Mako TKA System™). While it mentions performance testing and validation studies, it does not contain the detailed results of these studies, nor does it explicitly list acceptance criteria or specific performance metrics in a way that allows for a comprehensive answer to your request.
The document states: "Design verification was confirmed by examining and providing objective evidence that specified requirements were fulfilled. Tests performed for assessing device performance are included in the Design Verification and Validation Report (DS-00230, Rev 02), which includes Performance Testing, Functional Testing, Electrical Safety Testing, Electromagnetic Compatibility (EMC) Testing, Reliability Testing, Accuracy Testing, Software and Cybersecurity Testing, Biocompatibility, Sterilization, Cleanability, Packaging, and more."
Therefore, I cannot provide the specific details about acceptance criteria and reported device performance, sample sizes, expert qualifications, ground truth establishment, or comparative effectiveness studies because this information is not present in the provided text. The document refers to an internal "Design Verification and Validation Report (DS-00230, Rev 02)" where such details would be found.
Based on the available text, here's what can be inferred or explicitly stated regarding performance testing, albeit without the requested granular details:
1. Table of Acceptance Criteria and Reported Device Performance:
- Cannot be provided. The document states that performance testing was done, but it does not list specific acceptance criteria or the numerical results of the device's performance against those criteria. It only lists the types of tests performed.
2. Sample Size Used for the Test Set and Data Provenance:
- Test Set Sample Size: Not explicitly stated for each test. For simulated use, human factors, and design validation studies, it mentions "synthetic and human cadaveric knees," implying a test set size related to these. The specific number of cadaveric knees or synthetic models, and the number of tests performed on each, are not provided.
- Data Provenance: The studies involved "synthetic and human cadaveric knees." This implies data was generated prospectively during these studies. The country of origin for the cadaveric data is not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
- Number of Experts: Not specified.
- Qualifications of Experts: The document states "All users (surgeons, sterile staff, and Monogram representation) successfully used the mBôs TKA System to perform Simulated Use, Human Factors Summative Validation, and Design Validation studies." This indicates surgeons were involved, who would typically be considered experts in surgical procedures. No other specific qualifications (e.g., years of experience, board certification) are provided here.
4. Adjudication Method for the Test Set:
- Not specified.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No evidence. The document describes the mBôs TKA System as a "stereotactic planning and implementation device intended to assist surgeons," and "an alternative to manual TKA template planning." It describes performance testing related to accuracy and system function but does not mention a comparative effectiveness study involving human readers (or surgeons) with and without AI assistance to quantify improvement.
6. Standalone (Algorithm Only) Performance:
- Not explicitly stated in terms of a separate study report with metrics. The device is a computer-assisted system with proprietary software (mSuite™), and "Accuracy Testing, Software and Cybersecurity Testing" were performed. However, these are general categories, and specific standalone performance metrics (e.g., precision of the planning algorithm alone) are not detailed. The system's function is inherently a human-in-the-loop system as it assists surgeons.
7. Type of Ground Truth Used:
- For "Cadaveric Cut Accuracy, System End-to-End Accuracy, Robot Arm Positional Accuracy, Cutting Tool Positional Accuracy, Registration Accuracy," the ground truth would typically be established through highly precise measurement instruments (e.g., coordinate measuring machines, optical tracking systems with sub-millimeter precision) relative to the planned surgical cuts or positions.
- For "Blade Cut-Path Verification" and "Soft Tissue Assessment Validation," ground truth would likely involve visual inspection, anatomical measurements, and potentially histological analysis for soft tissue impact after cuts.
- The document mentions using "patient specific information from a pre-operative CT scan" for surgical planning, which serves as a foundational "ground truth" for the virtual model.
8. Sample Size for the Training Set:
- Not applicable/Not provided. This document describes the clearance of a medical device, not specifically a machine learning model that would have a distinct training set. While the software within the device could utilize machine learning, the document does not specify its methodology as such, nor does it provide details on any "training set." The focus is on the device's performance and validation.
9. How Ground Truth for the Training Set Was Established:
- Not applicable/Not provided for the same reasons as point 8.
§ 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).