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The OMNIBotics® Knee System is indicated for stereotaxic surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during Total Knee Arthroplasty. The Active Spacer 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™ System implants.

The OMNIBotics® Knee system is a computer-assisted navigation system with a motorized bone cutting guide that is used by surgeons and 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 iBlock® cutting guide for guiding femoral bone resections, and the Active Spacer, an active (motorized) knee spacer and ligament tensioning device for knee ligament balancing.

The OMNIBotics® Station includes a 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 iBlock® and the Active Spacer are contained within a single enclosure, the control box, located at the base of the Station.

The provided text describes the OMNIBotics® Knee System, a computer-assisted navigation system for Total Knee Arthroplasty (TKA), and argues for its substantial equivalence to predicate devices, but it does not provide a detailed report of acceptance criteria and a study proving the device meets those criteria with specific performance metrics.

Instead, the document focuses on demonstrating that the OMNIBotics® Knee System is substantially equivalent to existing predicate devices (TOTAL KNEE SURGETICS Navigation System with iBlock®, VERASENSE Knee System, and eLibra® Soft Tissue Force Sensor) based on similar technological characteristics and intended use.

Therefore, much of the requested information regarding specific acceptance criteria, reported performance, sample sizes, ground truth establishment, and details of clinical studies (like MRMC or standalone performance) is not present in the provided document.

However, based on the available information, here's what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance

This information is not provided in the document. The document states that "Analyses demonstrate that system accuracy and performance are adequate for the established intended use," but it does not specify what those accuracy and performance criteria are, nor does it quantify the reported device performance against them.

2. Sample size used for the test set and the data provenance

The document mentions "cadaver testing" and "verification and validation performance testing" but does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective/prospective).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This information is not provided.

4. Adjudication method

This information is not provided.

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

A multi-reader, multi-case (MRMC) comparative effectiveness study is not mentioned in the document. The device is a surgical navigation system, not an AI-based diagnostic tool for human readers. Therefore, the concept of "human readers improve with AI vs without AI assistance" as typically applied to imaging analysis is not directly relevant here. The system is designed to assist surgeons in locating anatomical structures and aligning endoprostheses during TKA.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

The document describes the OMNIBotics® Knee System as a "computer-assisted navigation system with a motorized bone cutting guide that is used by surgeons and OR staff to assist in performing stereotaxic total knee arthroplasty." This implies a human-in-the-loop system. A standalone (algorithm-only) performance study is not mentioned, and given the nature of a surgical navigation system, it is unlikely to be applicable in that sense.

7. The type of ground truth used

The document mentions "cadaver testing." For a surgical navigation system, ground truth would typically involve precise measurements of anatomical landmarks and implant placement, potentially validated by imaging (e.g., CT scans with fiducials) or highly accurate mechanical measurement systems. However, the exact type of ground truth and how it was established (e.g., expert consensus, pathology, precise physical measurements) is not explicitly stated.

8. The sample size for the training set

The document does not mention a training set. Surgical navigation systems like this typically rely on pre-programmed anatomical models and algorithms rather than machine learning models that require a "training set" in the conventional sense.

9. How the ground truth for the training set was established

As no training set is mentioned, this information is not applicable/provided.

Summary of available information from the document:

• Device Type: Computer-assisted navigation system for Total Knee Arthroplasty (TKA), including a motorized bone cutting guide and an active knee spacer/ligament tensioning device.
• Purpose of Study/Testing: To demonstrate substantial equivalence to predicate devices and ensure accuracy and performance are adequate for the established intended use.
• Testing Mentioned: Cadaver testing, verification and validation performance testing.
• Conclusion of Testing: System accuracy and performance are adequate, and no new safety and efficacy issues are raised. The device is substantially equivalent to predicate devices.
• Key Components of the System: OMNIBotics® Station (3D optoelectronic localizer, laptop with ART Knee Application software, touchscreen, external LCD monitor, footswitch, control box), iBlock® cutting guide, and Active Spacer.
• Ground Truth (implied): Implied through "cadaver testing" and "verification and validation performance testing" as physical measurements against known anatomical structures and precise instrument references, but not detailed.

In essence, the provided text is a 510(k) summary focused on establishing substantial equivalence to predicate devices rather than a detailed report of a performance study against specific, quantified acceptance criteria.

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