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The PRECICE System is indicated for limb lengthening, open and closed fracture fixation, pseudoarthrosis, malunions, non-unions, or bone transport of long bones.

The PRECICE System is composed of the PRECICE Nail, locking screws, end cap, surgical instruments and an external remote controller (ERC). The Nail is available in various diameters, lengths and screwhole configurations to accommodate a variety of patient anatomies. The locking screws are also available in a variety of diameters and lengths. The PRECICE Nail and end cap is supplied sterile by gamma radiation while the locking screws and reusable instruments are supplied non sterile and must be sterilized prior to use. The Nail contains an enclosed rare earth magnet, telescoping lead screw/nut assembly, and planetary gearing. The Nail is offered in pre-distracted and non-predistracted models. Pre-distracted models are supplied pre-distracted by 10 mm (femur and tibia models), 15 mm and 20 mm (humeral model), to allow for compression fracture reduction techniques

The provided text is a 510(k) premarket notification letter and summary for the PRECICE System, an intramedullary fixation rod. It describes the device, its indications for use, and argues for its substantial equivalence to a previously cleared version of the PRECICE System.

However, the document does not contain information about:

• Acceptance criteria for device performance (e.g., accuracy, precision, reliability metrics).
• Any specific test studies proving performance against acceptance criteria.
• Sample sizes used for test or training sets for an AI/algorithm-based device.
• The number or qualification of experts, or ground truth adjudication methods.
• Multi-reader multi-case (MRMC) comparative effectiveness studies.
• Standalone algorithm performance studies.
• The type of ground truth used.
• How ground truth for a training set was established.

This document focuses on regulatory approval, particularly emphasizing the substantial equivalence of a modified device (material change to stainless steel) to an already cleared predicate device. It highlights that no changes were made to the design, technological characteristics, or principles of operation, and that previous testing on the existing components remains applicable.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them, as this information is not present in the provided text. The device in question is a mechanical intramedullary fixation rod, not an AI or algorithm-based medical device that would typically involve the types of studies and criteria mentioned in your request (e.g., image analysis, diagnostic performance).

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