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The Expandable Knee offers a treatment option for patients requiring distal femoral replacement who have not yet achieved full skeletal maturity (open epiphysis) or patients who require surgery who have significant residual leg length discrepancy. Indication for use of this device is most commonly tumor resection but could also involve osteoarthritis; rheumatoid arthritis; correction of deformity; and correction or revision of unsuccessful osteotomy, arthrodesis or previous joint replacement. The devices are single use implants intended for implantation with bone cement.

The Expandable Knee is an additional component to Biomet's Oncology Salvage System that gives the surgeon the ability to expand the prosthesis as a patient grows. All expansion takes place where the natural bone has been removed. The device does not "lengthen" existing bones. The devices are available in two styles or expansion mechanisms: a clip-style and a screw-style. The clip-style is available as either a one-piece unit with an integrated distal femoral surface or as a diaphyseal segment for use with the distal femoral replacement component of Biomet's Oncology Salvage System constrained knee system. Clip-style devices are available in 7 initial replacement lengths of 13cm to 19cm providing an additional expansion from 3cm to 9cm. The screw-style expandable segment relies on movement of a screw for expansion. The device has an integrated distal femoral component. The screw-style Expandable Knee is available in 11 sizes providing a maximum expansion from 3cm to 13cm. A series of intramedullary stems form 9mm to 19mm in diameter are available for cemented fixation of the remaining femoral bone. In addition to a set number of sizes, Biomet will offer customized components designed to more closely match patient anatomy. These components will be designed within a predefined envelope. All types of expandable components are intended for use with components of Biomet's Oncology Salvage System.

The provided document describes a medical device, the "Expandable Knee" prosthesis, for which the manufacturer sought substantial equivalence with existing devices. It details the device, its intended use, and the testing performed. However, it does not describe an AI/ML powered device, nor does it contain information about acceptance criteria or studies related to AI/ML device performance.

Therefore, I cannot fulfill the request as the provided text lacks the necessary information regarding:

• Acceptance Criteria for AI/ML Device Performance: No such criteria are mentioned.
• Reported Device Performance for AI/ML: The document focuses on mechanical strength and fatigue of the physical prosthesis, not AI performance metrics like accuracy, sensitivity, or specificity.
• Sample sizes for test sets (AI): Not applicable.
• Data provenance (AI): Not applicable.
• Number of experts and qualifications (AI ground truth): Not applicable.
• Adjudication method (AI): Not applicable.
• MRMC comparative effectiveness study (AI): Not applicable.
• Standalone AI performance: Not applicable.
• Type of ground truth (AI): Not applicable.
• Sample size for training set (AI): Not applicable.
• Ground truth establishment for training set (AI): Not applicable.

The document states: "Clinical Testing: None provided". This indicates that no human clinical trials were conducted for this device to prove its effectiveness in patients, rather its substantial equivalence was based on mechanical testing and comparison to predicate devices.

Summary of what the document does provide regarding the device's acceptance verification:

The device's acceptance was based on non-clinical mechanical testing and a demonstration of substantial equivalence to legally marketed predicate devices.

Non-Clinical Testing:

• Mechanical analysis of both screw-type and clip-type Expandable Knee was conducted.
• Acceptance Criteria: The strength of the expandable devices must exceed that of the clinically successful predicate Finn® Knee device.
• Reported Device Performance: Analysis showed that the strength of the expandable devices exceeds that of the clinically successful predicate Finn® Knee device.
• Fatigue testing of the screw-type (worst-case) device was conducted.
• Acceptance Criteria: The screw mechanism should successfully withstand anatomic loading conditions at maximum expansion and remain functional after fatigue.
• Reported Device Performance: This testing showed that the screw mechanism could successfully withstand anatomic loading conditions at maximum expansion. The testing also demonstrated that the expansion mechanism remained functional after fatigue.

Predicate Devices for Substantial Equivalence:

• Biomet's Finn® Knee System (K945028)
• Oncology Salvage System (K002757)

This information is not related to AI/ML performance, but rather to the mechanical safety and efficacy of a physical knee prosthesis.

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