The OrthoPediatrics Titanium PediPlates® System is used for the express and sole purpose of redirecting the angle of growth of long bone(s). This is useful for gradually correcting angular 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), radial or ulnar deviation, flexion or extension deformities of the wrist (radius).

Device Description

The OrthoPediatrics Titanium PediPlates® System consists of two and four-hole plates featuring a contoured mid-section and a low profile for pediatric use. There is a small provisional fixation hole in the center of the O and I-Plates to aid in accurate placement of the device relative to the growth plate. The plates are available in various sizes to accommodate variations in bone size and geometry. The plate is affixed to the bone using two to four screws (solid and cannulated), depending on which plate is selected.

AI/ML Overview

This document is a 510(k) premarket notification for a medical device called the OrthoPediatrics Titanium PediPlates® System. It focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving performance against specific acceptance criteria for an AI/ML model. Therefore, much of the requested information regarding AI/ML device performance, such as test set sample size, expert ground truth establishment, MRMC studies, and training set details, is not applicable to this document.

However, I can extract the relevant information regarding the performance data provided:

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is a submission for a non-AI/ML medical device (bone fixation system) seeking substantial equivalence, there are no specific "acceptance criteria" in the sense of accuracy, sensitivity, or specificity for an AI model. Instead, the "acceptance" is based on demonstrating equivalence in performance to a predicate device.

The reported device performance is based on non-clinical tests comparing the subject device to the predicate. The "acceptance criteria" essentially boil down to performing equivalently to the predicate.

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Static Bend Testing	Performance equivalent to Orthofix Guided Growth System (K093442)	Concluded that the Titanium PediPlates® System will perform equivalently to the Orthofix Guided Growth System.
Torsional Testing	Performance equivalent to Orthofix Guided Growth System (K093442)	Concluded that the Titanium PediPlates® System will perform equivalently to the Orthofix Guided Growth System.
Four-Point Bend Testing	Performance equivalent to Orthofix Guided Growth System (K093442)	Concluded that the Titanium PediPlates® System will perform equivalently to the Orthofix Guided Growth System.
MR Environment Testing	MR Conditional	Determined to be MR Conditional.

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

Sample Size: Not explicitly stated, but typically for mechanical testing of this nature, a certain number of samples per test type would be used to establish statistical significance. The document states "Testing concluded that the Titanium PediPlates® System will performed equivalently...", implying sufficient samples were used to draw this conclusion for the non-clinical tests.
Data Provenance: Not specified, but likely from in-house testing or contracted testing laboratories. The data is retrospective in the sense that it was collected as part of the design verification and validation process prior to submission.

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

Not Applicable. This is a mechanical device, not an AI/ML device requiring expert interpretation for ground truth. The "ground truth" for mechanical testing is derived from the physical properties and behavior of the materials and designs under controlled conditions.

4. Adjudication method for the test set:

Not Applicable. As this is not an AI/ML device with human-in-the-loop assessment, there is no need for adjudication methods like 2+1 or 3+1.

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:

Not Applicable. This is not an AI/ML device. No MRMC study was performed.

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

Not Applicable. This is not an AI/ML device. No standalone algorithm performance was assessed.

7. The type of ground truth used:

The "ground truth" for this device's performance is based on engineering and biophysical principles applied during mechanical testing. This includes:
- Material properties: Conformance to ASTM F136 for Ti-6Al-4V.
- Mechanical performance: Comparison of static bend, torsional, and four-point bend characteristics.
- MR compatibility standards.

8. The sample size for the training set:

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. As no training set exists for this type of medical device, ground truth establishment for a training set is irrelevant.

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

OrthoPediatrics, Corp. Mr. Adam Cargill Regulatory Affairs Associate Manager 2850 Frontier Drive Warsaw, Indiana 46580

August 24, 2017

Re: K171173

Trade/Device Name: OrthoPediatrics Titanium PediPlates® 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, HWC Dated: June 23, 2017 Received: June 26, 2017

Dear Mr. Cargill:

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. 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 requirements, including, but not limited to: registration and listing (21 CFR

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K171173

Device Name

OrthoPediatrics Titanium PediPlates® System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
✖ Prescription Use (Part 21 CFR 801 Subpart D)	❏ Over-The-Counter Use (21 CFR 801 Subpart C)

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In accordance with 21 CFR §807.92 and the Safe Medical Devices Act of 1990, the following information is provided for the OrthoPediatrics' Titanium PediPlates® System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, 'Format for Traditional and Abbreviated 510(k)s', issued on August 12, 2005.

Sponsor:	OrthoPediatrics, Corp.2850 Frontier DriveWarsaw, IN 46582Establishment Registration Number: 9102640Phone: (574) 267-6379Fax: (574) 269-3692
Contact:	Adam CargillRegulatory Affairs Manager
Date:	August 24, 2017
Subject Device:	Trade Name: OrthoPediatrics Titanium PediPlates® SystemRegulation Number: 888.3030Regulation Name: Single/multiple component metallic bone fixation appliancesand accessoriesProduct Code: HRSRegulation Number: 888.3040Regulation Name: Smooth or threaded metallic bone fixation fastenerProduct Code: HWCCommon Name(s): Plate, Fixation, BoneScrew, Fixation, Bone

Legally marketed devices to which substantial equivalence is claimed:

K093442 - Orthofix Guided Growth System

Device Description

Materials: The plates and screws are manufactured from Ti-6Al-4V per ASTM F136. ●
Function: The system functions to provide immediate stability and temporary fixation during the natural healing process.

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Intended Use and Indications for Use

Summary of Technological Characteristics

The technological characteristics (materials, design, sizing, and indications) of the Titanium PediPlates® System are similar to the predicate Orthofix Guided Growth System (K093442).

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

Intended Use: The proposed Titanium PediPlates® System is used for the express and sole purpose of redirecting the angle of growth of long bones which is the same as the predicate K093442.

Indications for Use: Indications for Use are identical to the predicate.

Materials: The proposed Titanium PediPlates® System is manufactured from Ti-6Al-4V conforming to ASTM F136 which is the same material as the predicate.

Design Features: The proposed Titanium PediPlates® System incorporates similar design features as the predicate.

Sterilization: The proposed Titanium PediPlates® System is provided non-sterile and require sterilization prior to use which is the same sterilization method utilized for the predicate.

Summary of Performance Data (Nonclinical and/or Clinical)

. Non-Clinical Tests
Non-clinical substantial equivalence testing including static bend testing, torsional testing, and four-point bend testing were performed comparing the proposed Titanium PediPlates® System to the Orthofix Guided Growth System (K093442). Testing concluded that the Titanium PediPlates® System will performed equivalently to the Orthofix Guide Growth System.
. The proposed Titanium PediPlates® System was tested in an MR Environment and determined to be MR Conditional.
. Clinical Tests - None provided as a basis for substantial equivalence.

Substantial Equivalence Conclusion

OrthoPediatrics believes that the Titanium PediPlates® System is substantially equivalent to the legally marketed predicate, Orthofix Guide Growth Plate System (K093442) based on the similarities of design, intended use, materials, sizing, and the results of verification activities conducted. No new risks have been identified and it is expected that the Titanium PediPlates® System will perform substantially equivalent to the legally marketed predicate device.

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.