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510(k) Data Aggregation
(85 days)
The OMNIBotics Knee System is indicated for stereotaxic surgery to aid the surgeon in locating and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The BalanceBot™ is indicated as a tool for adjustment of soft tissue and the femoral implant to reduce instability from flexion gap asymmetry. The OMNIBotics Knee System supports OMNI Apex Knee™ implants and CORIN Unity Knee™ implants.
The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting quide that is used by surqeons and operating room (OR) staff to assist in performing stereotaxic total knee arthroplasty (TKA). The OMNIBotics® Knee System consists of the OMNIBotics® Station, ART Knee Application software, the OMNIBot cutting quide for quiding femoral bone resections, the BalanceBot defined as an active (motorized) knee spacer and ligament tensioning device, and the OMNIBotics™ Tracker Kit which is comprised of single-use reflective markers that are fixed onto the associated instruments that provide a frame of reference for tracking by the 3D optical optoelectronic localizer.
The OMNIBotics® Station includes the 3D optoelectronic localizer mounted on an articulated arm, a laptop hosting the ART Knee Software and equipped with a touchscreen, an external LCD monitor and a three-button footswitch as a means for the user to interact with the system. The power supply and communication hardware required for the camera, the laptop, the OMNIBot, and BalanceBot are contained within a single enclosure, the control box, located at the base of the OMNIBotics® Station.
The OMNIBotics® Knee System was originally cleared for use with OMNI Apex Knee™ System implants in K163338. This 510(k) notification demonstrates substantial equivalence of the OMNIBotics® Knee System for use with Corin Unity™ Total Knee System implants.
Acceptance Criteria and Study for OMNIBotics® Knee System
The OMNIBotics® Knee System, when used with Corin Unity knee implants, underwent performance testing and process validations to demonstrate substantial equivalence to its predicate device (OMNIBotics® Knee System, K163338).
1. Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| User Requirements & Usability | Device meets established user requirements and is usable. | "The results of the cadaver evaluation demonstrated that the subject device met the established criteria for user requirements, usability..." |
| Accuracy of Bone Resections | Bone resections performed using the device are accurate. | "...accuracy of bone resections..." (Met established criteria) |
| Accuracy of Implant Position | Implant positioning achieved with the device is accurate. | "...accuracy of implant position..." (Met established criteria) |
| Magnitude of Gaps | Achieves appropriate magnitudes of gaps. | "...magnitude of gaps..." (Met established criteria) |
| Joint Stability | Contributes to stable joint outcomes. | "...and joint stability." (Met established criteria) |
| Precision, Accuracy, Usability of Reflective Markers | Reflective markers/marker arrays demonstrate acceptable precision, accuracy, and usability. | Demonstrated through "Simulated use and validation testing". |
| Sterility | OMNIBotics® Tracker Kit is sterile. | Validated for a sterilization dose of 25 kGy of gamma radiation according to the VD max method NF EN ISO 11137-2: 2015. |
| Endotoxin Levels | Endotoxin levels of single-use reflective markers are within accepted limits. | "The endotoxin levels for the markers were determined to be well within the minimum acceptance criteria" (Tested per ANSI/AAMI ST72. 5.2). |
| Biocompatibility | Single-use reflective markers are non-cytotoxic. | "The single use markers were determined to be non-cytotoxic per ISO 10993-5." |
2. Sample Size for Test Set and Data Provenance
- Sample Size: Ten (10) cadaver surgeries.
- Data Provenance: Retrospective, using cadaveric subjects. The specific country of origin is not mentioned, but the manufacturer is based in the USA (Corin Ltd., Raynham, MA) and the submitter in Canada (BioVera, Inc., Quebec).
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Number of Experts: Four (4) surgeons.
- Qualifications: The document describes them as "Surgeon-user," implying they are practicing surgeons experienced in Total Knee Arthroplasty. No further specific details (e.g., years of experience, sub-specialty) are provided.
4. Adjudication Method for the Test Set
The document does not explicitly state an adjudication method (e.g., 2+1, 3+1). It reports that the evaluation "demonstrated that the subject device met the established criteria for user requirements, usability, accuracy...". This suggests a consensus or direct assessment against pre-defined criteria by the performing surgeons, rather than a separate adjudication process involving independent reviewers to resolve discrepancies.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No Multi-Reader Multi-Case (MRMC) comparative effectiveness study was mentioned where human readers' performance with and without AI assistance was evaluated. The study focused on validating the device's technical performance and usability, rather than comparing human reader performance.
6. Standalone Performance Study (Algorithm Only)
The study described is not a standalone (algorithm only) performance study. The evaluation involved "surgeon-user verification studies," meaning human surgeons interacted with and utilized the device during the cadaver surgeries. The OMNIBotics® Knee System is a computer-assisted navigation system and cutting guide designed to aid surgeons; therefore, its performance is inherently linked to human interaction.
7. Type of Ground Truth Used
The ground truth was established through direct measurement and assessment by the participating surgeons during the cadaver surgeries. This includes:
- Expert Assessment: Surgeons directly evaluated user requirements, usability, joint stability.
- Measurement-Based Assessment: Accuracy of bone resections, implant position, and magnitudes of gaps would have been determined through intraoperative measurements and post-resection/implantation evaluation, likely against predetermined surgical plans or anatomical landmarks.
- Laboratory Testing: For sterility, endotoxin levels, and biocompatibility of the reflective markers, specific laboratory tests (e.g., gamma radiation validation, ANSI/AAMI ST72. 5.2, ISO 10993-5) were used to establish ground truth.
8. Sample Size for the Training Set
The document does not mention a separate "training set" for the OMNIBotics® Knee System. This device is a navigation and cutting guide system (hardware and software), not an AI model that learns from data in the traditional sense of machine learning. The "ART Knee Application software" is part of the system, but the document does not describe it as having undergone an iterative training process with a dedicated training dataset in the context of this 510(k) submission. The validation primarily focused on the system's performance with the new implant system and revised components.
9. How the Ground Truth for the Training Set Was Established
As no dedicated training set is explicitly mentioned or seems applicable in the context of this device's validation described in the 510(k) summary, this question is not directly addressed by the provided text. The device's underlying algorithms and functionalities would have been developed and verified internally during its engineering and design phases, likely using various forms of testing and pre-clinical data, but these are not delineated as a "training set" in this regulatory submission.
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