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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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The HALLU® -PLATES are intended to be implanted for fixation of fractures, osteotomies or arthrodesis of the first metatarso-phalangeal joint. Examples include:
-Hallux rigidus
-Severe hallux valgus (IM angle > 20° and HV angle > 40°)
-Deformity from rheumatoid arthritis
-Failed previous surgical procedure
-Traumatic arthritis
-Neuromuscular instability.

The HALLU® -PLATES are available in two different designs :

• the HALLU®-C PLATE -
• the HALLU®-S PLATE -
  The HALLU®-C PLATE and the HALLU® -S PLATE are low profile Titanium plates dedicated to first metatarso-phalangeal arthrodesis. Those implants are pre-bent for optimal anatomical adaptation (10° valgus and 10°dorsiflexion). Their fixation is provided by Titanium SNAP-OFF® screws available in a two diameters: 3.0 and 2.7 mm. They exist in different colors for size identification. The bone contact surface is sand blasted in order to maximize plate stability. The range of HALLU -C PLATE and HALLUS S PLATE include 6 sizes ( 31eft/3right) for optimal anatomic fit. Moreover, the HALLU®-S PLATE has an anatomical design providing optimal bone coverage.

The provided text describes a medical device, the HALLU®-PLATES, and its regulatory clearance based on substantial equivalence to predicate devices, rather than a study proving performance against specific acceptance criteria for a new AI/software device. Therefore, much of the requested information regarding AI/software device studies (e.g., sample sizes for test/training sets, expert adjudication methods, MRMC studies, standalone performance, ground truth for training) is not applicable.

However, I can extract the information related to the device's testing and the standards it met.

1. Table of Acceptance Criteria and Reported Device Performance

Detailed Breakdown of Applicable Information:

2. Sample size used for the test set and the data provenance:

• Sample Size: Not explicitly stated as this was a physical device test, not a data-driven software evaluation. The document mentions "Test 1" and "Test 2," implying multiple samples of the plate were tested for bending and fatigue.
• Data Provenance: The tests were conducted to comply with French Standard ISO 9585 and ASTM Standard F-382-99. This implies the tests were performed in a controlled laboratory setting, likely in the country of origin of the sponsor (France) or a qualified testing facility. The study type is experimental/bench testing, not retrospective or prospective human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• This question is not applicable as the "ground truth" for a physical device test like this is defined by established engineering standards (ISO 9585 and ASTM F-382-99) and the physical properties of the materials and design, not by expert human interpretation.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

• This question is not applicable for a physical device test. The compliance is determined by measurements against predefined standard thresholds.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

• No, a MRMC comparative effectiveness study was not done. This is a physical bone plate, not an AI or imaging device that would involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

• Yes, a standalone test was done. The device's performance (bending strength, stiffness, fatigue strength) was evaluated independently against established physical standards. This is analogous to a "standalone" test for a physical product.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

• The ground truth was based on established engineering standards for bone plates: French Standard ISO 9585 and ASTM Standard F-382-99.

8. The sample size for the training set:

• Not applicable. This device underwent physical bench testing, not a machine learning training process.

9. How the ground truth for the training set was established:

• Not applicable. As above, there was no training set for a machine learning model.

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