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.

Device Description

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.

AI/ML Overview

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

Acceptance Criteria (Not Explicitly Stated, Inferred from Predicate Equivalence)	Reported Device Performance (Summary of Non-Clinical Testing)
Mechanical 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.

Summary

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August 6, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a symbol representing the Department of Health & Human Services - USA. To the right of the symbol, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" stacked above the word "ADMINISTRATION".

OrthoPediatrics, Corp Jen Gregory Regulatory Affairs Manager 2850 Frontier Drive Warsaw, Indiana 46582

Re: K190992

Trade/Device Name: OrthoPediatrics PediFoot Deformity Corrections System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: July 1, 2019 Received: July 5, 2019

Dear Jen Gregory:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K190992

Device Name

OrthoPediatrics PediFoot Deformity Correction System

Indications for Use (Describe)

OrthoPediatics 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.

Type of Use (Select one or both, as applicable)
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the OrthoPediatrics PediFoot Deformity Correction System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'The New 510(k) Paradigm – Alternate Approaches to Demonstration Substantial Equivalence in Premarket Notifications – Final Guidance', issued on March 20, 1998.

Sponsor:	OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, IN 46582Establishment Registration Number: 9102640Phone: (574) 267-0880Fax: (574) 269-3692
Contact:	Jen GregoryRegulatory Affairs Manager
Date:	June 26, 2019
Subject Device:	Trade Name: OrthoPediatrics PediFoot Deformity Correction SystemRegulation Number: 888.3030Regulation Name: Single/Multiple Component Metallic Bone FixationAppliances and AccessoriesProduct Code: HRSCommon Name: Plate, Fixation, Bone

Legally marketed devices to which substantial equivalence is claimed:

Primary Predicate:

K050110 – Synthes LCP Modular Foot Plates

Secondary Predicates:

K063049 - Synthes Modular Mini Fragment LCP System
K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System
. K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/Hindfoot
K001941 – Synthes Modular Foot System

Device Description

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

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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.

Intended Use and Indications for Use

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

Summary of Technological Characteristics

The technological characteristics (materials, design, sizing) of the subject OrthoPediatrics PediFoot Deformity Correction System are similar to the following predicate devices:

Primary Predicate:

K050110 Synthes LCP Modular Foot Plates ●
Secondary Predicates:
K063049 - Synthes Modular Mini Fragment LCP System
K100776 – Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System
K131186 – Synthes 2.7/3.5 Variable Angle LCP Midfoot/Hindfoot
K001941—Synthes Modular Foot System

The rationale for substantial equivalence is based on consideration of the following characteristics:

. Intended Use: The OrthoPediatrics PediFoot Deformity Correction System has the same intended use as the predicate Synthes LCP Modular Foot Plates (K050110), Modular Mini Fragment LCP System (K063049) and Synthes Modular Foot System (K001941).
. Indications for Use: Indications for Use are similar to the predicate Synthes LCP Modular Foot Plates (K050110), Modular Mini Fragment LCP System (K063049) and Synthes Modular Foot System (K001941).
. Materials: The proposed OrthoPediatrics PediFoot Deformity Correction System plates and screws are manufactured from 316L stainless steel conforming to ASTM F138 or ASTM F139 which is identical to the material of the predicates Synthes Modular Plates and Screws.
Design Features: The proposed OrthoPediatrics PediFoot Deformity Correction System incorporates similar design features and size ranges as the predicate devices.
Function: The OrthoPediatrics PediFoot Deformity Correction System is intended for use in small bones and small bone fragments, identical to the predicate devices.

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. Sterilization: The proposed OrthoPediatrics PediFoot Deformity Correction System is provided non-sterile and requires sterilization prior to use which is the same sterilization method utilized for the predicate devices, which are provided both sterile and non-sterile.

Performance Data

Non-Clinical Tests
- Torque to Failure per ASTM F543
- . Driving Torque per ASTM F54
- Axial Pullout per ASTM F543
- Bone Plate Bend Testing per ASTM F382
- Variable Angle Screw/Plate Interface Testing, including bending strength and push out strength

Testing demonstrated the subject device to be substantially equivalent to predicate Synthes Modular Foot System (K001941) and Synthes 2.4mm/2.7mm Variable Angle (VA)-LCP Forefoot/Midfoot System (K100776).

. The OrthoPediatrics PediFoot Deformity Correction System was evaluated for use in an MR Environment and were determined to be MR Conditional.
Clinical Tests None provided as a basis for substantial equivalence.

Substantial Equivalence Conclusion

OrthoPediatrics believes that the subject device is substantially equivalent to the legally marketed predicate device based on intended use, technology, materials, as well as the mechanical testing and biocompatibility assessment.

Regulation Number and Section

§ 888.3030 Single/multiple component metallic bone fixation appliances and accessories.

(a)
Identification. Single/multiple component metallic bone fixation appliances and accessories are devices intended to be implanted consisting of one or more metallic components and their metallic fasteners. The devices contain a plate, a nail/plate combination, or a blade/plate combination that are made of alloys, such as cobalt-chromium-molybdenum, stainless steel, and titanium, that are intended to be held in position with fasteners, such as screws and nails, or bolts, nuts, and washers. These devices are used for fixation of fractures of the proximal or distal end of long bones, such as intracapsular, intertrochanteric, intercervical, supracondylar, or condylar fractures of the femur; for fusion of a joint; or for surgical procedures that involve cutting a bone. The devices may be implanted or attached through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.