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STELLAR Knee is a stereotaxic system including an intraoperative software as a medical device and surgical instruments. STELLAR Knee is indicated for primary Total Knee Replacement, to assist the surgeon in determining reference alignment axes in relation to anatomical landmarks, in order to position the cutting guide regarding computed mechanical axis. The STELLAR Knee is installed on a Head Mounted Device (HMD) for displaying information to the user intraoperatively. The HMD should not be relied upon solely and should always be used in conjunction with traditional methods.

The main purpose of the STELLAR Knee is to assist the surgeon during the primary Total Knee Replacement (TKR) intervention. STELLAR Knee includes software and surgical instruments.

STELLAR Knee uses established surgical navigation techniques to provide information to help track patient bony landmarks in real time to assist the surgeon in determining resection angles and measurements as required in knee replacement surgery. STELLAR Knee allows the surgeon to adjust the cutting plane orientation and the resection level. This includes means for the surgeon to collect anatomical references during the TKR intervention using the surgical instruments. The software locates in a 3D reference frame the instruments which include marker arrays. All collected coordinates are treated by software algorithms to provide the surgeon with the relevant orientation of the tracked cutting quide. STELLAR Knee software is installed on a wearable Head Mounted Device (HMD) which includes an embedded camera and displays intraoperative information to the user. This near-eye display allows the surgeon to look at the HMD screen or the field of view when needed.

The provided text describes a 510(k) premarket notification for the STELLAR Knee device, which is a stereotaxic system for Total Knee Replacement. However, the document does not contain the detailed acceptance criteria or the study data that proves the device meets those criteria.

The "Non-clinical performance testing" section briefly mentions that "Bench testing was conducted in order to demonstrate that STELLAR Knee performs according to its requirements and specifications when installed on the Head Mounted Device. In particular, overall system repeatability and accuracy were tested." It also states, "The results demonstrated that the STELLAR Knee performs according to its specifications and functions as intended."

However, information regarding specific quantitative acceptance criteria (e.g., accuracy thresholds in mm or degrees), the reported device performance against these criteria, sample sizes used, data provenance, ground truth establishment, or any comparative effectiveness studies (MRMC) is not provided in this document.

Therefore, I cannot fulfill the request to provide a table of acceptance criteria and reported device performance, nor the details of any study that proves the device meets specific acceptance criteria based on the given input. The document focuses on establishing substantial equivalence with a predicate device based on similar indications for use, operating principles, and general performance testing, without detailing the results of those performance tests in a quantitative manner against predefined acceptance criteria.

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