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The PK High Tibial Osteotomy Correction System is an external fixation device, which is intended for use in the treatment of the following indications in the tibia:

• Temporary fracture fixation
• Correction of deformity
• Osteotomy
• Bone union
• Bone reconstruction
• Fracture fixation and other bone conditions amenable to treatment by use of the external fixation modality
• Leg lengthening

The PK High Tibial Osteotomy Correction System is a single-use external fixator which consisting of the following components: fixation plate, cortex pin and cancellous pin. Pins are available in various lengths and diameters according to practical requirements. These pins and other components are manufactured from 316L stainless steel (ASTM F138/ ISO 5832-1) and aluminum alloy. These devices are intended to be used in the tibia. Adjustment of the fixator is possible during the course of treatment. All components are provided sterile.

The provided document is a 510(k) premarket notification for a medical device called the "PK High Tibial Osteotomy Correction System." This document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing details of an AI/ML algorithm's performance.

Therefore, the information required to answer your questions regarding acceptance criteria, study data, sample sizes, expert ground truth, adjudication, MRMC studies, standalone performance, and training set details for an AI/ML device is NOT present in this submission.

This 510(k) submission confirms that:

• The device is a medical device (external fixator), not an AI/ML algorithm.
• The approval is based on substantial equivalence to predicate devices, not on a clinical performance study of an AI/ML algorithm.
• Non-clinical performance data (mechanical testing) was conducted, referring to ASTM F1541, to demonstrate substantial equivalence, but this is physical device testing, not AI/ML algorithm performance.
• "Clinical testing was not required for this submission." This explicitly states that no clinical performance data was gathered or submitted for this device, which would be crucial for evaluating an AI/ML algorithm.

In summary, the provided document does not contain the information requested in your prompt because it is about a physical medical device clearance, not an AI/ML algorithm's regulatory approval.

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