The Phantom™ Small Bone Intramedullary Nail System is indication and fixation of the small bones of the feet and ankle for the treatment of fractures, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

The PhantomTM Small Bone Intramedullary Nail System is indicated for use in stabilization and fixation of the small bones of the feet and ankle for the treatment of fractures, osteotomies, nonunions, pseudarthroses and malunions by revision, joint fusion or reconstruction procedures.

Device Description

The PhantomTM Small Bone Intramedullary Nail System is comprised of small bone intramedullary nails, locking screws and threaded pegs. The PhantomTM nails are offered in a variety of lengths to accommodate variations in patient anatomy. The PhantomTM threaded pegs and locking screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required. The system includes instruments for implantation.

AI/ML Overview

This document is a 510(k) summary for the Phantom™ Small Bone Intramedullary Nail System, a medical device. It does not describe an AI/ML powered device, therefore the information requested regarding acceptance criteria and a study proving the device meets those criteria, particularly with respect to AI/ML specific aspects (like sample size for test/training set, expert ground truth, MRMC studies, standalone performance), is not present in the provided text.

However, I can extract information regarding the device's mechanical performance testing and its acceptance criteria as implied by the comparison to a predicate device.

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

The document does not explicitly state numerical acceptance criteria, but it describes the type of testing performed and the conclusion drawn from it. The acceptance is implied by the "substantially equivalent" determination.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical performance comparable to predicate device	Worst-case Phantom™ nail: Static and dynamic bending performed according to ASTM F382.
	Worst-case Phantom™ locking screw and threaded peg: Torsion, insertion/removal, and pullout performed according to ASTM F543.
	Conclusion: The mechanical test results and predicate comparisons demonstrated that the mechanical performance of the Small Bone Intramedullary Nail System is substantially equivalent to the predicate. This implies the device met the performance standards demonstrated by the predicate device for these tests.
Similar technological characteristics to predicate device	The Phantom™ Small Bone Intramedullary Nail System possesses similar technological characteristics compared to the predicate device, including performance, basic design, material, manufacturing, and sizes/dimensions. The difference in stabilization method (combination nail/plate vs. plate) did not raise new questions of safety or effectiveness.

Regarding the other requested information, the document does not contain:

Sample size used for the test set and the data provenance: Not applicable as this is a mechanical device, not an AI/ML system tested on data sets.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: For mechanical testing, the "ground truth" is measured physical properties and performance under specific conditions as defined by ASTM standards.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

Summary based on available information:

The study proving the device meets acceptance criteria was a series of mechanical tests on the worst-case configurations of the Phantom™ nail, locking screws, and threaded pegs. These tests were conducted according to ASTM F382 (for static and dynamic bending of the nail) and ASTM F543 (for torsion, insertion/removal, and pullout of the screws/pegs). The acceptance criteria were met by demonstrating substantial equivalence in mechanical performance and technological characteristics to the predicate device, the ParaLock Plating System™ (K140397). The document does not specify the exact number of units tested for mechanical properties, or the numerical thresholds for passing, but rather states that the comparison demonstrated substantial equivalence.

Summary

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Image /page/0/Picture/2 description: The image shows the address for the Food and Drug Administration. The address is 10903 New Hampshire Avenue, Document Control Center - WO66-G609, Silver Spring, MD 20993-0002. The image is a simple text block with the address information.

June 19, 2017

Paragon 28, Inc. % Karen Warden Representative/Consultant BackRoads Consulting. Inc PO Box 566 Chesterland, Ohio 44026-0566

Re: K170693

Trade/Device Name: Phantom Small Bone Intramedullary Nail System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: KTW, HWC Dated: March 6, 2017 Received: March 7, 2017

Dear Karen Warden:

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

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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 (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 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 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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement on last page.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K170693

Device Name Phantom™ Small Bone Intramedullary Nail System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

区 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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510(k) Summary
Date:	6 March 2017
Sponsor:	Paragon 28, Inc.4B Inverness Ct. E., STE 280Englewood, Colorado 80112Phone: (888) 728-1888, Facsimile: (888) 728-1220
Sponsor Contact:	Frank S. Bono, Chief Technology Officer
510(k) Contact:	Karen E. Warden, PhDBackRoads ConsultingPO Box 566Chesterland, OH 44026Office: 440.729.8457
Trade Names:	PhantomTM Small Bone Intramedullary Nail System
Common Name:	Combination nail/plate
Regulatory Class:	Class II
Classification Name,Regulation, ProductCode:	Appliance, fixation, nail/blade/plate combination, single component,888.3030, KTWScrew, Fixation, Bone, 888.3040, HWC
Device Description:	The PhantomTM Small Bone Intramedullary Nail System is comprised ofsmall bone intramedullary nails, locking screws and threaded pegs. ThePhantomTM nails are offered in a variety of lengths to accommodatevariations in patient anatomy. The PhantomTM threaded pegs and lockingscrews insert through the intramedullary nail to secure the construct.These are offered in varying lengths to accommodate the anatomicalfixation required. The system includes instruments for implantation.
Indications for Use:	The PhantomTM Small Bone Intramedullary Nail System is indicated foruse in stabilization and fixation of the small bones of the feet and anklefor the treatment of fractures, osteotomies, nonunions, pseudarthrosesand malunions by revision, joint fusion or reconstruction procedures.
Materials:	The PhantomTM Small Bone Intramedullary Nail System implants aremanufactured from medical grade titanium alloy (per ASTM F136).
Primary Predicate:	ParaLock Plating SystemTM (Paragon 28, Inc. – K140397)
Performance Data:	Mechanical testing of the worst case PhantomTM nail included static anddynamic bending performed according to ASTM F382. Mechanical testingof the worst case PhantomTM locking screw and threaded peg includedtorsion, insertion/removal and pullout performed according to ASTMF543. The mechanical test results and predicate comparisonsdemonstrated that the mechanical performance of the Small BoneIntramedullary Nail System is substantially equivalent to the predicate.
TechnologicalCharacteristics:	The PhantomTM Small Bone Intramedullary Nail System possessessimilar technological characteristics compared to the predicate device.These include:performance,basic design,material, manufacturing andsizes (dimensions are comparable to those offered by thepredicate systems).The difference in the stabilization method between the subject andpredicate devices, i.e., combination nail/plate versus plate, did not raise
	new questions of safety or effectiveness. Therefore the fundamentalscientific technology of the Phantom™ Small Bone Intramedullary NailSystem is substantially equivalent to previously cleared devices.
Conclusion:	The Phantom™ Small Bone Intramedullary Nail System possessesindications for use and technological characteristics the same as andsimilar to the predicate devices. Therefore the Phantom™ Small BoneIntramedullary Nail System is substantially equivalent to the predicates.

510(k) Summary

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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.