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SkyWalker Total Knee System is intended to assist the surgeon to perform Total Knee Arthroplasty (TKA) procedures by providing software-defined spatial boundaries for orientation and reference information to anatomical structures for the accurate placement of compatible knee implant components.

It is indicated for use in TKA procedures in which the selection of stereotactic surgery is appropriate and the anatomical bony structures can be identified with a CT based model.

SkyWalker Total Knee System includes surgical console (a robotic arm platform), navigation console (an optical tracking navigation platform), software system (including preoperative planning software), cables, surgical instruments and accessories. The robotic arm placement is performed relative to anatomical landmarks as recorded using the system intraoperatively and based on a preoperative plan derived from imported CT images.

The targeted population as well as indications have the same characteristics as those suitable for the following implants compatible with SkyWalker Total Knee System: EVOLUTION® MP TOTAL KNEE SYSTEM, EVOLUTION® MP TOTAL KNEE SYSTEM, ADVANCE® STATURE FEMORAL COMPONENT, ADVANCE® TIBIAL COMPONENT, and ADVANCE® KNEE SYSTEM.

SkyWalker Total Knee System consists of a navigation console, a surgical console, cables, software system, surgical instruments and disposables. The navigation console includes a navigation trolley, an optical tracking device, a primary monitor and a surgeon monitor. The surgical console includes a robotic arm, a robotic arm trolley and a foot pedal.

The TKA surgery workflow under the guidance of SkyWalker Total Knee System can be divided into preoperative procedure and intraoperative procedure. The preoperative procedure is to assist the user with preoperative planning by using patient CT image data and providing reference information to anatomical structures to make a surgical plan for the TKA surgery. In the intraoperative procedure, Skywalker Total Knee System can provide stereotactic guidance for real-time orientation of the cutting block to a target position with a target pose. When the robotic arm reaches the target position, the cutting block is being held in an expected pose, then the surgeon could be able to accurately perform knee resection.

The provided text describes the MicroPort NaviBot International LLC's "SkyWalker Total Knee System" and its 510(k) summary for FDA clearance. However, it does NOT contain information about specific acceptance criteria for AI/ML performance, nor a study proving the device meets such criteria.

The document primarily focuses on:

• Indications for Use of the robotic surgical system.
• Comparison of its technological characteristics with a predicate device (ROSA Knee System).
• General performance data, including biocompatibility, electrical safety, device performance testing (bench, accelerated aging, reprocessing, human factor, cadaveric validation), and software verification.

Specifically, the document states:

• The subject device provides robot position repeatability ≤ 0.5mm, robot orientation repeatability ≤ 1.0°, navigation accuracy with mean of errors ≤ 0.5mm, and subsequently suffices for the system accuracy of cutting position accuracy ≤ 1.5mm and cutting orientation accuracy ≤ 2.0°.
• "Cadaveric Validation Test, to validate SkyWalker Total Knee System is safe and effective by orthopedic surgeons' simulated uses on cadaveric specimens, and provide evidence that the performances of SkyWalker Total Knee System satisfy the intended use."

This indicates that the focus of the performance testing was on the accuracy and repeatability of the robotic system itself for surgical procedures, rather than on an AI/ML algorithm's diagnostic or predictive performance that would require a test set, ground truth experts, and specific metrics like sensitivity, specificity, or AUC. The "software system" mentioned is for preoperative planning and real-time guidance, not for AI-driven image analysis or decision support in the context of an AI/ML device.

Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving an AI/ML device meets them, as this document does not describe such a device or study.

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The EVOLUTION® Revision CCK System is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis
2. Inflammatory degenerative joint disease, including rheumatoid arthritis;
3. Correction of functional deformity
4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.
   The EVOLUTION® Medial-Pivot Total Knee System Nonporous implants are for cemented use only.

EVOLUTION® Revision CCK (Constrained Condylar Knee) is being introduced to supplement MicroPort Orthopedics' knee product lines to provide options in the case of revision or complex primary total knee replacements. The design features are summarized below:

• Components manufactured from cobalt chrome alloy, titanium alloy, and UHMWPE conforming to ASTM F75, F136, and F648, respectively
• . Available in 8 standard sizes, left and right
• Available in 2 plus sizes, left and right
• . System includes femoral component, augments, stem offset adapters, tibial insert and stem cap

The provided text describes the MicroPort Orthopedics EVOLUTION® Revision CCK System, a knee joint prosthesis. However, it does not contain a study that establishes acceptance criteria and then proves the device meets those criteria in the typical format of a diagnostic or AI/software device.

Instead, this 510(k) summary focuses on demonstrating "substantial equivalence" to predicate devices based on design features, materials, and non-clinical performance testing. The information provided is primarily related to mechanical and material performance rather than diagnostic accuracy or human performance with or without AI.

Therefore, I cannot fulfill all parts of your request as posed because the document is not an "acceptance criteria study" in the sense you are asking for. It is a regulatory submission demonstrating substantial equivalence.

Based on the provided text, I can extract information relevant to non-clinical performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly state quantitative "acceptance criteria" for each test in a pass/fail format alongside numerical performance values. Instead, it describes comparative performance against a predicate device. The general "acceptance criteria" can be inferred as performing "as well as" or "greater than" the predicate device for various mechanical properties to demonstrate substantial equivalence.

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