The OrthoPediatrics PediNail Intramedullary Platform is used for pediatric and stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; psilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondy|ar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The OrthoPediatrics PediNail Intramedullary Platform is for single use only.

Device Description

The OrthoPediatrics PediNail Intramedullary Nailing System (K083726) consists of a rigid stainless steel nail and stainless steel screws. The proposed OrthoPediatrics PediNail Intramedullary Platform seeks to broaden the reach of the PediNail brand by offering additional nail diameters, screws, nails designed specifically for child and adolescent, and improved instrumentation. The proposed device is composed of the intramedullary fixation rods (nails) with screw holes at either end for fixation to bone, screws, interlocking pegs, and end caps coupled with device-specific instruments including the Modular Necks, the Targeting Guides, the Attachment Bolts, the Derotation Dial Targeting Guide Attachment, the AP Nail Positioning Jig, the AP Position Templates, the Impactors, and the Nail Extractor Adaptor.

The OrthoPediatrics PediNail Intramedulary Platform nails have a complex 3-dimensional geometry resulting in an anatomically appropriate design. The smaller diameter of the nail allows it to be inserted in patients with a narrow medullary canal and allows for easier insertion without the need for excessive reaming.

AI/ML Overview

The provided text describes the OrthoPediatrics PediNail Intramedullary Platform, a medical device, and its 510(k) premarket notification. The document focuses on demonstrating substantial equivalence to a predicate device (OrthoPediatrics PediNail Intramedullary Nailing System K083726) rather than a study validating a specific acceptance criterion for an AI/CADe system.

Therefore, the requested information regarding acceptance criteria, device performance, sample sizes, ground truth establishment, expert involvement, and MRMC studies for an AI/CADe device is not applicable to the provided text. The submission is for a physical medical device (intramedullary fixation rod), not an AI algorithm.

However, I can extract the information that is present regarding the non-clinical performance testing of the device:

1. A table of acceptance criteria and the reported device performance:

Test Method	Acceptance Criteria (Implied by equivalence)	Reported Device Performance
Static Four-Point Bend Testing	Equivalent to predicate (K083726)	Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System.
Static Torsion Testing	Equivalent to predicate (K083726)	Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System.
Torsional Yield Strength Testing	Equivalent to predicate (K083726)	Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System.
Driving Torque Testing	Equivalent to predicate (K083726)	Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System.
Full Construct Testing (Fatigue)	Survival of 150,000 cycles at 75kg (165lbs)	"Three such constructs survived 150,000 cycles at a load of 75kg (165lbs)." This demonstrates "no additional risk is conferred to the device from the presence or use of the dynamic slot."
MR Environment (MR Conditional)	MR Conditional Status	The OrthoPediatrics PediNail Intramedullary Platform was evaluated in an MR Environment and was determined to be MR Conditional.

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

Sample Size for Full Construct Testing: 3 constructs (described as "system worst case" with a 7mm nail locked distally and a specific fracture/osteotomy).
Data Provenance: The tests were non-clinical, performed by the manufacturer (OrthoPediatrics). Country of origin is not specified, but the company is based in Warsaw, Indiana, USA. The data is non-retrospective as it describes custom-built test setups.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience):

Not applicable. This is not an AI/CADe device that requires expert ground truth establishment for diagnostic performance. The ground truth for mechanical testing is based on physical scientific principles and engineering standards.

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

Not applicable, as this is mechanical performance testing, not diagnostic assessment.

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/CADe device.

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

Not applicable. This is not an AI algorithm. The performance described is the standalone mechanical performance of the device itself.

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

For the non-clinical tests, the "ground truth" is defined by the physical properties of the materials, the mechanical stress and strain limits, and the ability to withstand simulated physiological loads based on established engineering principles and standards (e.g., ASTM F138 for material). For the fatigue testing, the "ground truth" for survival was reaching 150,000 cycles at a specific load without failure.

8. The sample size for the training set:

Not applicable. There is no training set as this is not an AI/CADe device.

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

Not applicable. There is no training set as this is not an AI/CADe device.

Summary

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May 10, 2018

OrthoPediatrics, Inc. James L. Crumley II Vice President Quality Assurance and Regulatory Affairs 2850 Frontier Drive Warsaw, Indiana 46582

Re: K172583

Trade/Device Name: OrthoPediatrics PediNail Intramedullary Platform Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: May 4, 2018 Received: May 7, 2018

Dear James Crumley:

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 Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Katherine D. Kavlock -S

for 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)

K172583

Device Name OrthoPediatrics PediNail Intramedullary Platform

Indications for Use (Describe)

The OrthoPediatrics PediNail Intramedullary Platform is for single use only.

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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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 PediNail Intramedullary Platform 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:	Jim CrumleyVP of Regulatory Affairs
Date:	May 9, 2018
Subject Device:	Trade Name: OrthoPediatrics PediNail Intramedullary Platform
	Regulation Number: 888.3020
	Regulation Name: Intramedullary fixation rod
	Product Code: HSB
	Common Name: Rod, Fixation, Intramedullary and Accessories

Legally marketed devices to which substantial equivalence is claimed:

K083726 – OrthoPediatrics PediNail Intramedullary NailingSystem

Device Description

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Intended Use and Indications for Use

The OrthoPediatrics PediNail Intramedullary Platform is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunions and malunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity.

Additional indications includes simple long bone fractures; severely comminuted spiral, large oblique and segmental fractures; polytrauma and multiple fractures; reconstruction, following tumor resection and grafting; supracondylar fractures; bone lengthening; fixation of fractures that occur in and between the proximal and distal third of the long bones being treated.

The OrthoPediatrics PediNail Intramedullary Platform is for single use only.

Summary of Technological Characteristics

The technological characteristics (materials, design, sizing) of the OrthoPediatrics PediNail Intramedullary Platform are similar to the predicate OrthoPediatrics PediNail Intramedullary Nailing System (K083726).

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

Intended Use: The proposed OrthoPediatrics PediNail Intermedullary Platform is used for pediatric and small stature adult patients as indicated to stabilize fractures of the femoral shaft; subtrochanteric fractures; ipsilateral neck/shaft fractures; prophylactic nailing of impending pathologic fractures; nonunion and malunion; fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity which is identical to the predicate (K083726).
Indications for Use: Indications for Use are identical to the predicate(K083726).
Materials: The proposed OrthoPediatrics PediNail Intramedullary Platform nails, screws, end caps, and pegs are manufactured from 316L stainless steel conforming to ASTM F138 which is identical to the material of the predicate (K083726).
Design Features: The proposed OrthoPediatrics PediNail Intramedullary Platform incorporate similar design features as the predicate (K083726).
Function: OrthoPediatrics PediNail Intramedullary Platform is used to address femoral shaft fractures, subtrochanteric femur fractures, ipsilateral neck/shaft fractures, prophylactic nailing of impending pathologic fractures, nonunions, malunions, and fixation of femurs that have been surgically prepared (osteotomy) for correction of deformity. This is identical to the predicate (K083726).
Sterilization: The proposed OrthoPediatrics PediNail Intramedullary Platform is provided nonsterile and requires sterilization prior to use which is the same sterilization method utilized for the predicate (K083726).

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Summary of Performance Data (Nonclinical and/or Clinical)

Non-Clinical Tests
Non-clinical, Static Four-Point Bend Testing, Static Torsion Testing, Torsional Yield Strength Testing, and Driving Torque Testing was performed comparing the proposed OrthoPediatrics PediNail Intramedullary Platform to the predicate OrthoPediatrics PediNail Intramedullary Nailing System (K083726). Testing concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform will perform equivalently to the predicate OrthoPediatrics PediNail Intramedullary Nailing System.

Full construct testing was performed. The construct consisted of a 7mm nail (system worst case), locked distally with a single screw in the dynamic position of the slot (i.e. not at the top of the slot) and a length-stable transverse fracture/osteotomy located 3cm above the superiormost distal screw hole. 4th generation composite femur sawbones were used and load was applied through the femoral head to allow for all possible loads—axial compression, bending, and torsion.

Three such constructs survived 150,000 cycles at a load of 75kg (165lbs).

The survival of three constructs subjected to the above conditions demonstrates no additional risk is conferred to the device from the presence or use of the dynamic slot.

Based on the results of this testing, it is concluded that the proposed OrthoPediatrics PediNail Intramedullary Platform does not raise any new issues of safety and effectiveness and is substantially equivalent to the predicate OrthoPediatrics PediNail Intramedullary Nailing System (K083726).

. The OrthoPediatrics PediNail Intramedullary Platform was evaluated in an MR Environment and was determined to be MR Conditional.
Clinical Tests None provided as a basis for substantial equivalence.

Substantial Equivalence Conclusion

OrthoPediatrics believes that the proposed PediNail Intramedullary Platform is substantially equivalent to the legally marketed predicate, OrthoPediatrics PediNail Intramedullary Nailing System (K083726) 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 proposed OrthoPediatrics PediNail Intramedullary Platform will perform substantially equivalent to the legally marketed predicate device.

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.

Katherine D. Kavlock -S

Indications for Use

K172583

Indications for Use (Describe)

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510(k) Summary

Legally marketed devices to which substantial equivalence is claimed:

Device Description

Intended Use and Indications for Use

Summary of Technological Characteristics

Summary of Performance Data (Nonclinical and/or Clinical)

Substantial Equivalence Conclusion

§ 888.3020 Intramedullary fixation rod.

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