The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 10 mm nail available in 3 lengths (45 mm, 50 mm and 55 mm) for fracture repair. The system also includes a series of 5 mm cannulated screws for fixation available in 17 lengths (24 mm - 80 mm)

AI/ML Overview

This document is a 510(k) Summary for a medical device called the "CalcaNail Orthopedic Nail." The purpose of a 510(k) summary is to demonstrate that a new device is "substantially equivalent" to an existing, legally marketed device (a predicate device). Therefore, the information provided focuses on comparative performance rather than establishing absolute performance criteria for the new device in isolation.

Based on the provided information, the acceptance criteria and study details are as follows:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Primary Stability (biomechanical testing): The CalcaNail Orthopedic Screw should demonstrate at least comparable or better primary stability compared to the predicate Synthes calcaneal locking plate (K991407) in a standardized calcaneal fracture model.	Better Primary Stability: The results of published biomechanical testing showed that the primary stability at the chosen experimental set-up of a standardized calcaneal fracture was better with the CalcaNail than with the standard Synthes calcaneal locking plate.
Rigidity (engineering simulation): The CalcaNail nail should provide at least comparable or greater rigidity than the FHI cannulated screws (K070617) used routinely in rear foot deformity surgery, as demonstrated by moments of inertia of the smallest cross-sections.	Much Greater Rigidity: Engineering simulation demonstrated the CalcaNail provided much greater rigidity than the cannulated screws used routinely in rear foot deformity surgery, based on the moments of inertia of the smallest cross-sections.
Intended Use Equivalence: The CalcaNail must have the same intended use as the predicate devices (fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus).	The CalcaNail has the same intended use: fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus. The predicate devices (Synthes calcaneal locking plate K991407, FHI cannulated screws K070617, NewDeal Panta Nail K091788) are all indicated for use in the foot and ankle, including the calcaneus.
Material Equivalence: The CalcaNail must be manufactured from materials similar to the predicate devices (titanium and/or stainless steel).	The CalcaNail is made of titanium, which is consistent with the materials used in the predicate devices (titanium and/or stainless steel).
Design Equivalence: The CalcaNail's design (orthopedic nail with specific dimensions, cannulated screws) must be comparable to the predicate devices.	The CalcaNail is an orthopedic titanium 10 mm nail with 3 lengths (45, 50, 55 mm) and 5 mm cannulated screws of 17 lengths (24-80 mm). This design is compared to various predicate devices that are also nails, plates, and screws for similar indications.
Principles of Operation Equivalence: The CalcaNail must operate on principles similar to the predicate devices.	The CalcaNail operates on the principle of internal fixation for fracture repair, which is consistent with the predicate devices.
Safety and Effectiveness: No new issues of safety or effectiveness should be raised compared to the predicate devices.	The bench testing and device description confirms that the subject CalcaNail demonstrate no new issues of safety or effectiveness in treating calcaneal fractures.

2. Sample Size Used for the Test Set and Data Provenance

Biomechanical Testing (Primary Stability):
- Sample Size: Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones.
- Data Provenance: The document does not explicitly state the country of origin. The test used human calcaneal and talar bones, implying ex vivo or cadaveric testing. The document states it's a "published testing," suggesting it was conducted retrospectively to the 510(k) submission, but the study itself could have involved prospective data collection on the cadaveric specimens.
Engineering Simulation (Rigidity):
- Sample Size: The smallest cross-sections of the CalcaNail nail and the FHI cannulated screws (K070617). The exact number of cross-sections or unique components modeled is not specified.
- Data Provenance: This is an in silico (computer-based) study using engineering principles and likely based on design specifications of the devices. It is therefore retrospective in terms of the submission, but the data is generated via simulation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts

Biomechanics / Engineering: The document does not mention the use of human experts to establish "ground truth" for the biomechanical or engineering studies. These are objective measures (primary stability, moments of inertia) derived from physical testing and computational models, respectively, rather than subjective interpretation requiring expert consensus.

4. Adjudication Method for the Test Set

Not applicable. The studies described are objective measurements (biomechanical forces, rigidity calculations) rather than subjective assessments that would require adjudication.

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

No, an MRMC comparative effectiveness study was not done. This device is an orthopedic intramedullary nail, not an AI-powered diagnostic imaging tool, so such a study would not be relevant.

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

Not applicable. This is a physical, implantable medical device, not a software algorithm.

7. The Type of Ground Truth Used

Biomechanical Testing: The "ground truth" here is the objective, measured mechanical performance (primary stability) obtained from physical testing on human cadaveric bones.
Engineering Simulation: The "ground truth" here is the mathematically calculated and simulated rigidity (moments of inertia) based on the physical properties and geometries of the devices.

8. The Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that requires a training set.

9. How the Ground Truth for the Training Set was Established

Not applicable. As above, this device does not involve a training set or ground truth establishment in the context of machine learning.

Summary

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

May 22, 2015

Fournitures Hospitalieres Industrie Ms. Patricia Donnard Regulatory Affairs Manager 6 rue Nobel- ZI de Kernevez 29000 Quimper France

Re: K150463

Trade/Device Name: CalcaNail Orthopedic Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 11, 2015 Received: February 23, 2015

Dear Ms. Donnard:

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

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(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours,

Lori A. Wiggins -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) K150463

Device Name CalcaNail Orthopedic Nail

Indications for Use (Describe)

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

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 CalcaNail Orthopedic Nail K150463

May 20, 2015

1. Submitter

Fournitures Hospitalieres Industrie (FHI) ZI de Kernevez – 6 rue Nobel 29000 QUIMPER – FranceFH Orthopedics Establishment Registration # 3003898228 Owner/Operator # 9025586

Contacts: Patricia Donnard Regulatory Affairs Manager Email: p.donnard@fh-industrie.com

Or

Naoual RAHIMI Regulatory Affairs Representative Email: n.rahimi@fh-industrie.com

Tel number: +33.2.98.55.68.95 Fax: +33.2.98.53.42.13

2. Name of Device

Proprietary Name: CalcaNail Orthopedic Nail

Common Name: Orrthopedic Nail

Device Classification: Intramedullary Fixation Rod

Product Code: 87 HSB (Rod, Fixation, Intramedullary and Accessories)

These devices have been placed in Class II as per 21 CFR Regulation Number 888.3020 and assigned the Product Code 87 HSB.

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3. Predicate Devices

The components of the CalcaNail Orthopedic Nail are substantially equivalent to the following legally marketed devices:

Synthes calcaneal locking plate K991407 O
FHI cannulated screws K070617 O
NewDeal Panta Nail K091788 O

This statement is based on the similarity of the subject device to the predicate devices in one or more of intended use, materials, design and principles of operation.

4. Device Description

5. Intended Use

The CalcaNail Orthopedic Nail is intended for fracture fixation in the treatment of patients with displaced articular fractures of the calcaneus.

6. Comparison to Predicate Devices

The CalcaNail System has been carefully compared to legally marketed devices with respect to intended use and safety and effectiveness. The Synthes calcaneal locking plate K991407, FHI cannulated screws K070617, NewDeal Panta Nail K091788 are all indicated for use in the foot and ankle including the calcaneous. All devices are manufactured from titanium and/or stainless steel and are available with delivery instruments for proper use.

Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones were fixed either by the CalcaNail Orthopedic Screw or Synthes locking plate (K991407) for biomechanical testing. The results of this published testing showed that the primary stability at the chosen experimental set-up of a standardized calcaneal fracture was better with the CalcaNail than with the standard Synthes calcaneal locking plate.

Engineering simulation was used to compare the moments of inertia of the smallest crosssections of the CalcaNail nail comparing this to the currently marketed FHI cannulated screws (K070617). The analysis performed demonstrated the CalcaNail provided much greater rigidity than the cannulated screws used routinely in rear foot deformity surgery.

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7. Summary of Substantial Equivalence

Based on the descriptive information and analysis provided FH Industrie has determined that the CalcaNail Calcaneal Nail is substantially equivalent to the predicate devices presented. The bench testing and device description confirms that the subject CalcaNail demonstrate no new issues of safety or effectiveness in treating calcaneal fractures.

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.