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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

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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The Unity Total Knee System is intended for use in total knee arthroplasty in skeletally mature patients, to provide increased mobility and reduce pain by replacing the damaged knee joint articulation where there is evidence of sufficient sound bone to seat and support the components.

General total knee arthroplasty indications include:

• Painful, disabling joint disease of the knee resulting from: degenerative arthritis, rheumatoid arthritis or post-traumatic arthritis
• Post-traumatic loss of knee joint configuration and function
• Moderate varus, valgus, or flexion deformity in which the ligamentous structures can be returned to adequate function
• Revision of previous unsuccessful knee replacement or other procedure, where soft tissue stability is adequate
• Fracture of the distal femur and/or proximal tibia that cannot be stabilized by standard fracture management techniques
• The posterior stabilized variant is also indicated for PCL instability requiring implant bearing surface geometries with increased anterior-posterior constraint and absent or non-functioning posterior cruciate ligament

The Unity Total Knee System is indicated for cemented, single use only.

The Corin Unity Knee System is a fixed bearing total knee replacement system that consists of a femoral component, tibial insert, tibial tray and all-polyethylene patellar component for use in primary total knee arthroplasty. The Unity Knee System is provided in two variants, cruciate retaining (CR) and posterior stabilized (PS). The Unity CR Total Knee System is intended to accommodate the posterior cruciate ligament (PCL) if it is present. The Unity posterior stabilized variant is utilized when total knee replacement is indicated, and the posterior cruciate ligament is non-functioning or absent, resulting in joint instability. The Unity system patellar component is optional and is used in situations where replacement of the articular surface of the patella is required. The system also provides augments including femoral wedges, tibial wedges, a short keel extension and stem extensions.

The Unity Total Knee system was originally cleared in K113060. This submission is for the size of stem extension size to the range, a size 30mm in two available diameters 10mm and 14mm. Like the originally cleared stem extensions the 30mm has the same identical modular taper connection.

This document is a 510(k) summary for the Unity Total Knee System. It details the device's technical specifications and how it relates to predicate devices, but it does not contain information about the acceptance criteria or a study proving the device meets said criteria in the context of device performance metrics such as sensitivity, specificity, or accuracy.

The provided text describes a submission for an orthopedic implant (a knee replacement system), not a diagnostic or AI-driven medical device that would have performance metrics like those typically associated with acceptance criteria in the input request.

Therefore, I cannot extract the requested information from this document. The document primarily focuses on:

• Device Name: Unity Total Knee System
• Regulation Number: 21 CFR 888.3560
• Regulatory Class: Class II
• Product Code: JWH
• Indications for Use: Detailed for total knee arthroplasty in skeletally mature patients to increase mobility and reduce pain by replacing the damaged knee joint.
• Device Description: Discusses the components (femoral, tibial insert, tibial tray, patellar component), variants (cruciate retaining and posterior stabilized), and augments (femoral/tibial wedges, stem extensions).
• Substantial Equivalence: Claims equivalence to the predicate Corin Unity Total Knee System (K113060) based on identical intended use, indications, materials, and similar design for the new stem extension size.
• Non-Clinical Testing: Mentions fatigue endurance and fretting properties testing, concluding that the device is expected to be safe and effective.
• Clinical Testing: Explicitly states that clinical testing was not necessary to determine substantial equivalence.

In summary, the document does not contain the information required to answer your specific questions related to acceptance criteria and performance study details for an AI/diagnostic device.

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