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The Guided Growth Plate System Plus is intended for redirecting the growth of long bones. It is indicated for gradually correcting angular growth deformities in growing children. Specific conditions/diseases for which the device 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), and radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183). The Subject device is a 3.5mm thread diameter screw, available in three lengths and manufactured by the same material (Ti6Al4V), as the 4.5mm diameter gamma screws, included in the predicate Guided Growth Plate System Plus (K172183).

The provided text describes a 510(k) premarket notification for the "Guided Growth Plate System Plus" and a new 3.5mm thread diameter screw, which is an extension of the existing screws for the system. The submission focuses on demonstrating substantial equivalence to a predicate device (K172183) rather than proving the device meets acceptance criteria through a clinical study in the traditional sense of a diagnostic AI device.

Therefore, many of the requested categories for AI/diagnostic device studies are not directly applicable. However, I can extract the relevant information regarding performance testing and how substantial equivalence was demonstrated.

Here's a breakdown based on the information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The submission is for a new screw size, so the "performance" is in demonstrating that this new size is as safe and effective as the existing screws within the Guided Growth Plate System Plus. The acceptance criteria relate to mechanical testing standards.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: Not explicitly stated regarding the number of screws or plates tested, but implies tests were conducted on the new 3.5mm thread diameter screws.
• Data Provenance: The testing was mechanical, performed by the manufacturer, Orthofix Srl, in Italy. This is laboratory/bench testing, not patient data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications

• This is not applicable as the "ground truth" for mechanical testing is adherence to engineering standards and robust physical properties, not expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

• Not applicable for mechanical testing. The results are quantitative measurements against defined standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

• No. This is a hardware device (bone plate system components), not an AI/diagnostic software, so an MRMC study is not relevant.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

• Not applicable. This is a hardware device.

7. The Type of Ground Truth Used

• Mechanical Testing Standards: The "ground truth" for the performance data in this submission is the fulfillment of established engineering and material standards (ASTM F564, ASTM F1264, ASTM F543) for bone fixation devices and screws.
• Clinical Literature Analysis: Supported by analysis of clinical literature to demonstrate clinical equivalence between the plate and screw system and staples (the reference devices).

8. The Sample Size for the Training Set

• Not applicable. This is a hardware device, not an AI model.

9. How the Ground Truth for the Training Set Was Established

• Not applicable. This is a hardware device.

Additional Information from the document:

• Device Description: The "Subject new 3.5mm thread diameter screw is a gamma extension of the existing screws (thread Ø4.5mm), components of the predicate Guided Growth Plate System Plus (K172183)." It is made of the same Ti6Al4V material.
• Technological Characteristics & Substantial Equivalence: The submission claims substantial equivalence based on:
  • Indications for use
  • Intended patient population
  • System composition
  • Implant material
  • Method of fixation
  • Packaging configuration
  • Sterilization method
  • Biocompatibility
  • MRI compatibility
  • The only change is a design dimensional specification for the new 3.5mm thread diameter screw.
• Biocompatibility Data: No additional assessment was required because the subject device is equivalent in material, manufacturing, sterilization, etc., to the predicate device (K172183).
• Conclusion: The analysis of performance data (mechanical testing and clinical literature review) supports the conclusion that the new 3.5mm thread diameter screw is safe and effective and substantially equivalent to the predicate (K172183).

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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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The Growth Control Plating System is designed for redirecting the angle of growth of long bone(s) in pediatric patients. This is useful for gradually correcting angular deformities in pediatric patients with an open physis. Specific conditions/diseases for which the device will be indicated include valgus, varus, or flexion extension deformities of the knee (femur and/or tibia); valqus, varus or plantar flexion deformities of the ankle, valgus or varus deformities of the elbow, as well as radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

The Growth Control Plating System consists of plates and screws, all of which are comprised of Ti-6Al-4V.

The provided text describes a 510(k) premarket notification for the "Growth Control Plating System." This document is focused on establishing substantial equivalence to a predicate device based on technological characteristics and non-clinical testing. It explicitly states that no clinical testing was performed or provided as a basis for substantial equivalence.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them, nor can I provide information on sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, specific types of ground truth, or training set details.

The document indicates:

• Clinical Testing: None provided as a basis for substantial equivalence.

This means that the information you are requesting regarding "acceptance criteria" based on clinical performance and a "study that proves the device meets the acceptance criteria" is not present in the provided 510(k) summary. The device's clearance was based on demonstrating "substantial equivalence" through non-clinical testing and technological comparisons to a legally marketed predicate device (Guided Growth Plate K031493 University of Utah School of Medicine).

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