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The OrthoPediatrics Pediatric Nailing Platform|Femur is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; prophylactionalling of impending pathologic fractures; nonunions; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening and shortening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The OrthoPediatrics Pediatric Nailing Platform|Femur is for single use only.

The proposed OrthoPediatrics Pediatric Nailing Platform|Femur seeks to add sterile packaged nails for distribution. All subject components have previously been cleared as non-sterile implants. All other components of the OrthoPediatrics Pediatric Nailing Platform|Femur will remain non-sterile to be sterilized by end-user.

The OrthoPediatrics Pediatric Nailing Platform|Femur nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design which with an advanced surgical technique. The smaller diameter of the nail allows it to be inserted in patients with a narrow medullary canal and allows for easier insertion without the need for excessive reaming.

The proposed nails are manufactured from stainless steel conforming to ASTM F138 and are available in child and adolescent configurations:

• The child nails are available in 7mm, 8mm, and 9mm diameters.
• The adolescent nails are available in 9mm, 10mm, 11mm, and 12mm diameters.
• These nails range in length from 20cm to 42cm, depending on the naildiameter.
• Surgeon preference dictates the appropriate nail size required to stabilize the fracture and allow for appropriate healing.

This document is a 510(k) premarket notification for a medical device called the "OrthoPediatrics Pediatric Nailing Platform|Femur". It is a submission to the FDA (Food and Drug Administration) for clearance to market the device.

The document discusses the device's indications for use, its technical characteristics, and compares it to a legally marketed predicate device (K172583 OrthoPediatrics' PediNail Intramedullary Nailing System).

However, this document does not contain information about acceptance criteria or a study proving the device meets those criteria, specifically in the context of an AI/algorithm-driven device or diagnostic.

The core of this submission is about demonstrating "substantial equivalence" to a predicate device, specifically regarding the addition of sterile packaged nails. It focuses on mechanical properties of the material after sterilization, not on software performance, diagnostic accuracy, or human-AI interaction.

Therefore, I cannot extract the requested information (acceptance criteria table, sample size for test set, data provenance, number of experts, adjudication method, MRMC study, standalone performance, type of ground truth, training set information) from the provided text because it describes a hardware medical device clearance, not an AI/algorithm-based diagnostic or treatment planning system that would typically have the kinds of performance studies you are asking about.

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