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OrthoPediatrics PediFoot Deformity Correction System is intended for fixation of fractures, nonunions, replantations, and fusions of small bone fragments. Examples include, but are not limited to, the hand, wrist, foot, and ankle.

The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for the use in fracture fixation, osteotomies, and arthrodesis, primarily in the foot. The subject plates system will offer five different plate options – compression/neutral plates, reconstruction plates, wedge plates, clover plates and angle iron plates in various sizes to accommodate patient anatomy. All plates will be sized to allow their use in children and small statured adults. The plates are designed to accept the subject Ø2.7mm or Ø3.5mm cortical and/or variable angle locking screws. All subject plates and screws are manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139. All instruments are manufactured from stainless steel per ASTM F899, cobalt chrome per ASTM F562, silicone, propylux, polyphenylsulfone, or aluminum per ASTM B209, B211, or B221.

This document describes the premarket notification (510(k)) for the OrthoPediatrics PediFoot Deformity Correction System. The primary purpose of this 510(k) is to demonstrate substantial equivalence to legally marketed predicate devices, not to prove clinical superiority or specific performance metrics against a predefined acceptance criterion in the context of an AI/ML device.

Therefore, many of the requested elements for an AI/ML device's acceptance criteria and study design are not applicable to this traditional medical device submission. This submission focuses on engineering and material equivalence, along with mechanical testing.

Here's an attempt to address the prompts given the available information, highlighting what is missing or not applicable:

Overview of Device and Submission Type:

The OrthoPediatrics PediFoot Deformity Correction System is a plate and screw system intended for fracture fixation, osteotomies, nonunions, replantations, and fusions of small bone fragments, primarily in the foot, hand, wrist, and ankle. This is a traditional orthopedic implant device, not an Artificial Intelligence/Machine Learning (AI/ML) powered device. Its 510(k) submission focused on demonstrating substantial equivalence to predicate devices through technical characteristics (materials, design, function, sterilization) and non-clinical mechanical testing, rather than clinical efficacy or diagnostic accuracy.

1. Table of Acceptance Criteria and Reported Device Performance

• Torque to Failure (screws)
• Driving Torque (screws)
• Axial Pullout (screws)
• Bone Plate Bend Strength
• Variable Angle Screw/Plate Interface Performance (bending strength, push out strength) | Demonstrated Substantial Equivalence:
• Testing demonstrated the subject device's mechanical properties (torque to failure, driving torque, axial pullout, bone plate bend strength, variable angle screw/plate interface performance) are equivalent to or better than the predicate devices (Synthes Modular Foot System K001941 and Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System K100776). Specific numerical results for "acceptance" vs. "performance" are not provided in this summary but were likely part of the detailed submission. |
  | Material Compatibility:
• Biocompatibility
• ASTM standards compliance (for materials) | Demonstrated Compatibility:
• Plates and screws manufactured from medical grade 316L stainless steel per ASTM F138 or ASTM F139, identical to predicate materials.
• Biocompatibility assessment completed (details not in summary). |
  | MR Environment Compatibility:
• MRI safety (if applicable) | MR Conditional:
• Evaluated for use in an MR Environment and determined to be MR Conditional. |

Note: For this type of device (traditional orthopedic implant), "acceptance criteria" are typically rooted in demonstrating that the new device performs at least as safely and effectively as predicates with respect to mechanical properties, material properties, and intended use. Specific quantitative thresholds for "acceptance" are generally not disclosed in the 510(k) summary but are part of the full submission's engineering reports.

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

• Sample Size for Test Set: Not specified in the provided summary. Mechanical testing typically involves a number of samples (e.g., 5-10 per test condition) to establish statistical significance for engineering properties.
• Data Provenance: The data is from non-clinical (bench) testing performed by the manufacturer, OrthoPediatrics, Corp. This is not patient data; it's laboratory test data.

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

• Not Applicable: This is a mechanical device submission, not an AI/ML diagnostic or prognostic tool. "Ground truth" in the context of expert consensus on patient data (e.g., radiologists interpreting images) is not relevant to demonstrating substantial equivalence for an orthopedic implant. Ground truth for mechanical testing is established by the test methods and equipment calibration.

4. Adjudication Method for the Test Set

• Not Applicable: Adjudication methods (e.g., 2+1, 3+1) are used for reconciling expert opinions on clinical data, which is not relevant here. Mechanical test results are objective measurements.

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

• No: An MRMC study is relevant for evaluating the impact of AI on human reader performance for diagnostic tasks. This device is an orthopedic implant, not a diagnostic imaging tool.

6. If a Standalone (Algorithm Only) Performance Was Done

• Not Applicable: This is not an algorithm or AI device.

7. The Type of Ground Truth Used

• Engineering Specifications and Mechanical Test Standards: The "ground truth" for this device's performance demonstration lies in meeting established mechanical performance standards (e.g., ASTM F543, F382) and demonstrating comparable or superior performance to the predicate devices in these tests. The properties measured (e.g., torque, bend strength, pullout force) are the "ground truth" for the device's mechanical integrity.

8. The Sample Size for the Training Set

• Not Applicable: This device does not involve training data as it is not an AI/ML algorithm.

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

• Not Applicable: No training set or associated ground truth for an AI/ML algorithm development.

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