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The PediFlex (Flexible) Nail System is intended for fixation of diaphyseal fractures of long bones where the medullary canal is narrow or flexibility of the implant is required. This includes upper extremity fractures in all patients and lower extremity fractures in pediatric or small stature patients. In pediatric patients, the flexibility of the nail allows it to be inserted at a point that does not disturb or disrupt the growth plate.

The nail is available in 2.0, 2.5, 3.0, 3.5, and 4.0 mm diameters, each 440 mm long, which can be cut to length intra-operatively. The PediFlex has a curved, tapered tip to facilitate insertion. This is a single use device intended for temporary implantation. It is intended to be removed once the bone has healed.
Materials: The devices are manufactured from Ti-6Al-4V which meets ASTM F136, and ISO-5832 standards.
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

The provided text does not contain information regarding acceptance criteria or the study that proves the device meets specific acceptance criteria in the context of a performance study like an AI/ML device.

This document describes a 510(k) premarket notification for a medical device called the OrthoPediatrics PediFlex™ Flexible Nail System, which is an intramedullary elastic nail. The focus of this submission is to demonstrate substantial equivalence to existing legally marketed predicate devices, rather than presenting a performance study with defined acceptance criteria for a new clinical efficacy or diagnostic accuracy claim.

The "Basis for Substantial Equivalence" section explicitly states: "OrthoPediatrics believes that this system is substantially equivalent to the legally marketed predicate devices based on similarities in design, materials, and indications."

Therefore, I cannot provide the requested information, such as a table of acceptance criteria and reported device performance, sample sizes for test sets, expert qualifications, or details about MRMC studies or standalone algorithm performance. These types of studies are typically associated with devices that have a new clinical function or AI/ML components requiring validation against specific performance metrics, which is not the case for this 510(k) submission.

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The OrthoPediatrics Plating System is intended for use in the treatment of pelvic, small and long bone fractures.

The OrthoPediatrics Pediatric Plating system is a system of bone plates and screws to provide the pediatric and general orthopedic surgeon with necessary devices to achieve optimal bone fixation when treating fractures, osteotomies, mal-unions, and mal-alignments.

• Materials: The devices are manufactured from 316L stainless steel, which . meet ASTM F138 and F139, and ISO-5832 standards.
• Eunction: The system functions to provide immediate stability and . temporary fixation during the natural healing process.
  The system includes cortical and cannulated screws, and specialty plates. The specialty plates will include three distinct shapes and each shape will be offered in multiple sizes to accommodate the individual requirements of the patient anatomy to aid the surgeon in achieving optimal fixation. The three specialty plates' shapes resemble the letters H and I, and the infinity symbol (similar to the number 8, lying on its side).

The provided text is related to a 510(k) premarket notification for a medical device (OrthoPediatrics Plating System). It primarily focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and indications for use.

Crucially, it does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert adjudication, or comparative effectiveness studies (MRMC or standalone AI performance tests). These types of studies and their results are typically required for AI/ML-driven devices to demonstrate their clinical validity and utility.

Therefore, I cannot populate the requested table and answer the study-related questions based on the provided text.

The document is a standard 510(k) clearance letter for a traditional medical device (bone plates and screws), where substantial equivalence is typically established through comparisons of material properties, design specifications, and intended use with already marketed devices, rather than through performance metrics of an AI algorithm.

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