The Phantom® Hindfoot TTC/TC Nail system is intended for tibiotalocalcaneal arthrodesis (fusion) and to provide stabilization of the hindfoot and ankle including the transverse tarsal joints coupling the mid-foot to the hindfoot. Examples of specific indications include:

Post-traumatic or degenerative arthritis
Previously infected arthrosis
Revision of failed ankle arthrodesis
Revision of failed total ankle arthroplasty
Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
Rheumatoid arthritis
Osteoarthritis
Nonunions or pseudarthrosis of hindfoot and distal tibia
Trauma (severe or malunited tibial pilon fracture)
Charcot foot (neuroarthropathy)
Severe end-stage degenerative arthritis
Instability and skeletal defects after tumor resection
Pantalar arthrodesis
Severe foot/ankle deformity

Device Description

The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

AI/ML Overview

This FDA 510(k) summary describes the Paragon 28 Phantom® Hindfoot TTC/TC Nail System, a medical device for tibiotalocalcaneal arthrodesis. It does not present acceptance criteria or a study that proves the device meets specific performance criteria in the context of an AI/ML device.

The provided text focuses on demonstrating substantial equivalence to a predicate device for regulatory clearance, not on validating the performance of an AI/ML algorithm.

Therefore, I cannot provide the requested information for an AI/ML device based on this document. The document describes a traditional medical device (intramedullary nail system) and its mechanical and biocompatibility testing.

Here's why the provided text does not contain the requested information about AI/ML device performance:

No mention of AI/ML: The document makes no reference to artificial intelligence, machine learning, algorithms, or any computational component that would require such performance evaluations.
Focus on mechanical and biological properties: The preclinical testing described (ASTM F1264 for static and dynamic mechanical testing, cadaveric implantation, biocompatibility per ISO 10993-1, bacterial endotoxins, and sterilization) are standard tests for orthopedic implants, not for software or AI/ML components.
"Substantial Equivalence" claim: The core of the 510(k) submission is to show that the new device is "substantially equivalent" to a legally marketed predicate device, meaning it has the same intended use and similar technological characteristics, and does not raise new questions of safety or effectiveness. This is a comparison to an existing device, not a performance validation against defined criteria for an AI/ML system.

To answer your request, if this were an AI/ML device, the document would need to include information such as:

Performance metrics: Sensitivity, specificity, AUC, F1 score, accuracy, precision, etc.
Ground truth: How the true positive/negative cases were established (e.g., expert consensus, pathology, follow-up data).
Test set details: Size, characteristics, provenance (e.g., retrospective/prospective, patient demographics).
Expert qualifications: If human experts were involved in ground truth establishment or reading studies.
AI vs. human performance: If comparative studies were conducted.
Training set details: Size, ground truth establishment.

Since the provided text is for a traditional orthopedic implant, none of the requested AI/ML specific information is present.

Summary

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June 28, 2021

Paragon 28, Inc. Haylie Hertz Regulatory Affairs Specialist 14445 Grasslands Dr. Englewood, Colorado 80112

Re: K210869

Trade/Device Name: Phantom® Hindfoot TTC/TC Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB, HWC Dated: May 28, 2021 Received: June 2, 2021

Dear Haylie Hertz:

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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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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 (QS) 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,

Michael Owens Assistant Director DHT6A: Division of Joint Arthroplasty 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)

K210869

Device Name Phantom® Hindfoot TTC/TC Nail System

Indications for Use (Describe)

· Post-traumatic or degenerative arthritis
· Previously infected arthrosis
Revision of failed ankle arthrodesis
· Revision of failed total ankle arthroplasty
· Talar deficiency conditions such as avascular necrosis of the talus (requiring tibiocalcaneal arthrodesis)
· Neuromuscular deformity or other neuromuscular disease with severe deformity or instability of the ankle
Rheumatoid arthritis
· Osteoarthritis
Nonunions or pseudarthrosis of hindfoot and distal tibia
· Trauma (severe or malunited tibial pilon fracture)
· Charcot foot (neuroarthropathy)
· Severe end-stage degenerative arthritis
Instability and skeletal defects after tumor resection
· Pantalar arthrodesis
· Severe foot/ankle deformity

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

510(k) Number:	K210869
Device Trade Name:	Phantom® Hindfoot TTC/TC Nail System
Manufacturer:	Paragon 28, Inc.14445 Grasslands Dr.Englewood, CO 80112
Contact:	Ms. Haylie HertzRegulatory Affairs SpecialistPhone: 303.720.0017hhertz@paragon28.com
Date Prepared:	May 28, 2021
Classification:	21 CFR §888.3020, Intramedullary Nail, Bone Screw21 CFR §888.3040, Screw, fixation, bone
Class:	II
Product Code:	HSB, HWC
Common Name:	Intramedullary Nail
Predicate Device:	Phantom® Hindfoot TTC/TC Nail System (K201227)
Reference Device:	Anatomic Ankle Arthrodesis Interlocking Nail (K130147)
Indications for Use:	The Phantom® Hindfoot TTC/TC Nail System is intended fortibiotalocalcaneal arthrodesis (fusion) and to provide stabilization ofthe hindfoot and ankle including the transverse tarsal joints couplingthe mid-foot to the hindfoot. Examples of specific indicationsinclude:• Post-traumatic or degenerative arthritis• Previously infected arthrosis• Revision of failed ankle arthrodesis• Revision of failed total ankle arthroplasty• Talar deficiency conditions such as avascular necrosis of thetalus (requiring tibiocalcaneal arthrodesis)• Neuromuscular deformity or other neuromuscular diseasewith severe deformity or instability of the ankle• Rheumatoid arthritis

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Osteoarthritis
Nonunions or pseudarthrosis of hindfoot and distal tibia ●
Trauma (severe or malunited tibial pilon fracture) ●
Charcot foot (neuroarthropathy) ●
Severe end-stage degenerative arthritis
Instability and skeletal defects after tumor resection
Pantalar arthrodesis
Severe foot/ankle deformity ●

Device Description: The Paragon 28® Phantom® Hindfoot TTC/TC Nail System is comprised of intramedullary nails, screws and accessory components. The Phantom® nails are offered in a variety of sizes lengths, and configurations to accommodate variations in patient anatomy. The Phantom® screws insert through the intramedullary nail to secure the construct. These are offered in varying lengths to accommodate the anatomical fixation required.

Substantial Equivalence:

The intended use of the subject device is the same as the predicate device. In addition, the subject device possesses the same technological characteristics as the predicate device, including performance, basic design, material, manufacturing, and sizes. Differences between the Phantom® nails and the predicate device (i.e. nail shape and screw diameter) were shown not to raise new questions of safety and effectiveness. Therefore, the Phantom® Hindfoot TTC/TC Nail System is substantially equivalent to the predicate device with respect to indications, design, function, and performance.

Preclinical Testing:

Static and dynamic mechanical testing per ASTM F1264 was conducted on the Phantom® Hindfoot Curved Nail. A cadaveric implantation study was also conducted. Biocompatibility was evaluated per ISO 10993-1 and CDRH's 2020 Biocompatibility Guidance Document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process". Additional testing includes bacterial endotoxins and sterilization.

Conclusion:

The Phantom® Hindfoot Curved Nail has the same intended use and equivalent technological characteristics as the predicate devices. Additionally, the preclinical testing supports the substantial equivalence of the Phantom® Hindfoot Curved Nail to the predicate. Therefore, the Phantom® Hindfoot TTC/TC Nail System is substantially equivalent for its intended use.

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.