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The OrthoPediatrics PediPlate™ system is used for adult and pediatric patients as indicated for pelvic, small and long bone fracture fixation of bones that have been surgically prepared (osteotomy) for correction of deformity or arthrodesis. Indications for use include fractures of the tibia, fibula, femur, pelvis, acetabulum, metacarpals, metatarsals, humerus, ulna, radius; middle hand and middle foot bones, treatment of the calcaneal; hip arthrodesis, and provisional hole fixation; as well as for redirecting the angle of growth of long bones. This is useful for gradually correcting angular deformities in growing children.

Specific pediatric conditions/diseases for which the devices will be indicated include:

• Valgus, varus, or flexion, extension deformities of the knee (femur and/or tibia) .
• Valgus, varus, or plantar flexion deformities of the ankle
• Valgus or varus deformities of the elbow (humerus)
• Radial or ulnar deviation, flexion or extension deformities of the wrist (radius)

The two and four-hole plates feature a contoured mid-section and low profile for pediatric use. There is an alignment mark or small provisional fixation hole in the center of the O. H and I-Plates to aid accurate placement of the device relative to the growth plate that is localized radiographically. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is transfixed to bone using two to four screws, depending on which plate is selected.

• Materials: The devices are manufactured from 316L stainless steel, which meet ASTM F138 or ASTM F139.
• Function: The system functions to provide immediate stability and temporary . fixation during the natural healing process.
  The OrthoPediatrics PediPlate TM System is intended for use in the treatment of pelvic, small and long bone fractures, as well as deformity corrections of pediatric patients' long bones, which includes osteotomies, and redirecting the angle of growth of children's long bones. The system includes cortical and cannulated screws, and specialty plates, referred to as O, 1, and H-Plates.

Based on the provided document, I cannot fulfill the request because the document is a 510(k) summary for the OrthoPediatrics PediPlates™ System, which is a medical device for bone fixation. This type of document establishes substantial equivalence to predicate devices and outlines the device description, indications for use, and materials.

However, it does not contain the information required to describe acceptance criteria and a study proving device performance against those criteria. Specifically, the document does not include:

• A table of acceptance criteria and reported device performance.
• Details about a specific study proving performance, sample sizes (test set, training set), data provenance, number or qualifications of experts, adjudication methods, MRMC studies, standalone algorithm performance, or how ground truth was established.

The document focuses on:

• Establishing substantial equivalence to predicate devices (K081407, K073344, K031493, K020221, K993106, K000684, K013248, K080522).
• Describing the device's design, materials (316L stainless steel), and function (immediate stability and temporary fixation during healing).
• Listing the indications for use for adult and pediatric patients for various bone fracture fixations and deformity corrections.

Therefore, since the document discusses a physical medical device (bone plates for fixation) and not an AI/software device, and lacks any clinical study data or performance metrics against specific acceptance criteria, I cannot extract the information requested related to "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of an AI/software device evaluation.

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