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The GIRO™ Growth Modulation System is intended as a temporary implant to aid in the correction of the angle of growth of long bones by modulating growth of the physis in pediatric (child and adolescent) patients. It is indicated for the following conditions:

• [ Femur and tibia: varus, valgus, flexion, or extension deformities of the knee.
• □ Humerus: valgus or varus deformities of the elbow.
• □ Radius and ulna: flexion or extension deformities of the wrist.
• □ Ankle: varus, valgus or plantar flexion deformities of the ankle.
• □ Limb length discrepancy of the femur and tibia.

The GIRO™ Growth Modulation System is a tether device used for quided growth and deformity correction. It includes two couplings linked via a flexible cable and anchored to the bone via screws and bi-cortical posts. By tethering the growth plate, angular deformities can be corrected. The implants are manufactured in medical grade 316L stainless steel (ASTM F138) and offered in two sizes: 4.5 and 6.0.

The provided text describes a 510(k) premarket notification for a medical device called "The GIRO™ Growth Modulation System." It outlines the device's intended use, description, and the basis for claiming substantial equivalence to legally marketed predicate devices.

However, the text does not contain any information about acceptance criteria or a study that proves the device meets specific performance criteria related to an AI or algorithm-based system. The "Non-clinical Performance Data" section describes bench testing and mechanical property analyses comparing the GIRO™ System to predicate devices, focusing on the physical performance of the implant itself (e.g., tension, torque, bending, pullout). The "Clinical Performance Data" section explicitly states: "No clinical testing is provided as a basis for substantial equivalence."

Therefore, I cannot provide the requested information as it is not present in the given document. The document is for a mechanical orthopedic implant, not an AI/algorithm-based diagnostic or treatment device that would typically have the kind of acceptance criteria and study designs you're asking about (e.g., sample size for test/training sets, expert ground truth, MRMC studies, standalone performance, etc.).

If you have a document describing an AI/algorithm-based medical device, I would be happy to analyze it for the criteria you've outlined.

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