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ApolloKnee is indicated to aid the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee arthroplasty.

Apollo Robot and BalanceBot are optional accessories and are specifically indicated for use in total knee arthroplasty with the ApolloKnee system.

ApolloKnee is compatible with the following implant systems:

• · Apex Knee™ System.
• · Unity Knee™ System.

ApolloKnee is indicated for use in surgical knee procedures in which the use of stereotactic surgery may be appropriate.

ApolloKnee™ (formerly OMNBotics) is a robotic-assisted stereotaxic surgery system that aids the surgeon in locating anatomical structures and aligning endoprostheses with these anatomical structures during total knee replacement (TKR). ApolloKnee is composed of eight sub-systems that integrate to form the ApolloKnee system. Four of these sub-components (Station, Tracking System, Communication Module and Nonsurgical Application) form the main structure of Corin's core platform for robotic or computer assisted surgeries. This core platform is referred to as "Apollo". Future Corin technologies are intended to be developed on the basis of the Apollo core platform. ApolloKnee is one such technology built upon the Apollo common platform. ApolloKnee includes four system specific sub-components (Apollo Robot, BalanceBot, TKR Instruments and ApolloKnee Software),

ApolloKnee is an evolution of the former OMNIBotics Knee System. ApolloKnee is the first launched under Corin Ltd following acquisition of the OMNIBotics' prior manufacturer OMNIlife Science. ApolloKnee differs from OMNIBotics Knee System (as previously marketed under K200888) in branding (for commercial reasons), as well as redesigns of the station and software, and introduction of additional surgical instrumentation, namely the BalanceBot Pre-Resection Paddles, Tibial Cutting Guide and V-Array.

This document, a 510(k) Summary for the ApolloKnee device, details the premarket notification to the FDA. However, it does not contain the specific information required to answer your prompt about acceptance criteria and a study proving the device meets them.

The sections you've highlighted (Non-Clinical Testing, Conclusion) mention "Accuracy testing per custom protocols and ASTM F2554-22" and "surgeon user validation studies (cadaver evaluations)." While these indicate testing was performed, the document does not provide the acceptance criteria or detailed results of these studies.

Therefore, I cannot provide the requested information from this document. It lacks:

• A table of acceptance criteria and reported device performance.
• Sample sizes for test sets or data provenance.
• Number and qualifications of experts for ground truth.
• Adjudication methods.
• Information on MRMC studies or effect sizes.
• Standalone performance data.
• Specific type of ground truth used.
• Sample size for training sets.
• How ground truth for training was established.

This document primarily focuses on establishing substantial equivalence to a predicate device based on design, intended use, and general non-clinical testing categories, rather than presenting a detailed clinical or performance study report with specific acceptance criteria and detailed outcomes.

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CORI is indicated for use in surgical procedures, in which the use of stereotactic surgery may be appropriate, and where reference to rigid anatomical bony structures can be determined.

These procedures include unicondylar knee replacement (UKR), total knee arthroplasty (TKA), and total hip atthroplasty (THA).

The subject of this Traditional 510(k) is REAL INTELLIGENCE CORI (CORI), a robotic-assisted orthopedic surgical navigation and burring system. CORI uses established technologies of navigation via a passive infrared tracking camera. Based on intraoperatively-defined bone landmarks and known geometry of the surgical implant, the system aids the surgeon in establishing a bone surface model for the target surgery and planning the surgical implant location. For knee applications, CORI then aids the surgeon in executing the surgical plan by controlling the cutting engagement of the surgical bur.

CORI knee application software controls the cutting engagement of the surgical bur based on its proximity to the planned target surface. The cutting control is achieved with two modes:

• . Exposure control adjusts the bur's exposure with respect to a guard. If the surgeon encroaches on a portion of bone that is not to be cut, the robotic system retracts the bur inside the guard, disabling cutting.
• Speed control regulates the signal going to the tool control unit itself and limits the speed of the drill if the target surface is approached.

Alternatively, the surgeon can disable both controls and operate the robotic drill as a standard navigated surgical drill.

Here's a breakdown of the acceptance criteria and study information for the Real Intelligence Cori (Cori) device, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document primarily focuses on demonstrating substantial equivalence to a predicate device, rather than explicit numerical acceptance criteria for a new clinical study. The "acceptance criteria" are implied through various verification and validation activities.

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

The document does not explicitly mention a "test set" in the context of a clinical study with real patient data for the TENSIONER update. The testing described is primarily bench testing, software verification, and usability engineering validation.

• Bench Testing: No specific sample sizes for physical components are detailed, but "comprehensive performance testing" and "physical performance testing for all system components" are mentioned.
• Usability Engineering Validation: It involved "representative users" in a "simulated use environment." The exact number of users is not provided nor is the data provenance (e.g., country) specified. Given it's a simulated environment, it's not patient data.

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

This information is not provided in the document. The testing described does not seem to involve the establishment of "ground truth" by experts in the context of a diagnostic or predictive device study, but rather verification against design requirements and usability assessments.

4. Adjudication Method for the Test Set

This information is not provided as the document does not describe a study involving expert review for establishing ground truth in a clinical data set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not explicitly mentioned or described. The submission focuses on demonstrating substantial equivalence through non-clinical testing and usability, particularly regarding the addition of the TENSIONER accessory and associated software update. There is no information on how human readers (or surgeons, in this context) improve with or without AI assistance, as the device itself is a surgical navigation and robotic-assisted system, not an AI diagnostic tool that assists human readers in interpreting images.

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

This concept is not directly applicable in the terms of a diagnostic AI algorithm. The CORI system is a robotic-assisted surgical navigation and burring system. Its "performance" is inherently tied to its interaction with a human surgeon during a procedure (e.g., controlling bur engagement, providing navigation). The document describes rigorous software verification and validation, which would assess the algorithm's functionality in a standalone manner prior to human interaction, but not as an "algorithm only without human-in-the-loop performance" in the typical sense of a diagnostic AI system's clinical performance.

7. The Type of Ground Truth Used

For the software and system performance, the "ground truth" would be the design specifications and requirements that the device and its algorithms are designed to meet. For usability, the ground truth is the ability of users to safely and effectively operate the device as intended, which is assessed through usability engineering validation. There is no mention of pathology, outcomes data, or expert consensus on clinical cases.

8. The Sample Size for the Training Set

This submission is for an update to an existing system (CORI K220255) to integrate the TENSIONER accessory and software upgrade. The document does not describe the development or training of a new AI algorithm for which a "training set" would typically be referenced. Therefore, no sample size for a training set is provided. The "training" for this submission would involve the development of the software to manage the TENSIONER, which is verified against design requirements.

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

As no training set for a new AI algorithm is described, this information is not applicable/not provided. The software associated with the TENSIONER is verified against engineering and design specifications.

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