Search Results

Pediatric Nailing Platform | Femur is used for pediatric and small stature as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications include 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; 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.

Pediatric Nailing Platform | Femur includes 316L stainless steel nails which are intended to be inserted into the medullary canal of the femur for fixation of fractures by aligning and stabilizing the bone fragments in small statue adults and pediatric populations. The nails are provided as child nails and adolescent nails. The child nails are available in diameters of 7, 8 and 9 mm with a length of 200 to 420 mm depending on the diameter. The adolescent nails are available in diameters of 9, 10, 11, 12 mm with a length of 280 to 500 mm depending on the diameter. The nails have holes at each end which allow 316L stainless steel transverse screws to be installed to achieve greater stabilization. The screws are available in 3.8, 4.0, 4.5 and 5.0 mm in diameter and 15-120 mm in length depending on the diameter. The end caps are used to cap the head of the nail to prevent bony ingrowth and ease removal of the nail. The Pediatric Nailing Platform | Femur was evaluated for use in an MR Environment and were determined to be MR Conditional. The Pediatric Nailing Platform | Femur system is implanted using class I exempt instruments.

The subject implants under this submission in the Pediatric Nailing Platform | Femur are for single use only and will be provided non-sterile. The class II and class I exempt instruments can be single use or reusable and they are also provided non-sterile. All class II instruments have been cleared under K172583. The devices must be sterilized by the end user before use.

The provided text is a 510(k) summary for a medical device (Pediatric Nailing Platform | Femur) submitted to the FDA. It does not contain any information about acceptance criteria, device performance in a clinical study, sample sizes for test or training sets, expert qualifications, or ground truth establishment relevant to an AI/ML device.

The document describes a traditional 510(k) submission for an intramedullary fixation rod, which is a physical implant, not a software or AI/ML device. The "Performance Data" section refers to verification testing (e.g., Torsional Performance & Driving Torque, Axial Pullout, Bending Strength, Full Construct) conducted to demonstrate that new physical components (longer adolescent nails, longer screws, new end caps) meet design input requirements and are substantially equivalent to a previously cleared predicate device. It also mentions an evaluation for use in an MR Environment.

Therefore, based solely on the provided text, I cannot answer the questions regarding acceptance criteria, device performance metrics (like accuracy, sensitivity, specificity), sample sizes for AI/ML testing, expert ground truth establishment, or MRMC studies because this type of information is not relevant to the review of a physical implant device like the one described here.

To answer your prompt, I would need a document related to the FDA clearance of an AI/ML-based medical device.

Ask a specific question about this device