Comminuted fractures of the calcaneus
Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae
Osteoarthritis of the posterior subtalar joint, or
Valgus flatfoot deformities

Device Description

The CalcaNail is orthopaedic nail for the repair of articular fractures of the calcaneus. The device consists of an orthopedic titanium 12 mm nail available in 3 lengths (65 mm, 75 mm and 85 mm) for subtalar arthrodesis. 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) premarket notification for the CalcaNail Orthopedic Arthrodesis Nail, a medical device for subtalar arthrodesis. The information provided outlines the device, its intended use, and its comparison to predicate devices, but it does not contain acceptance criteria for device performance in the typical sense of a clinical trial or performance study on a new AI/software device. Instead, the "study" described is a biomechanical bench test and an engineering simulation comparing the CalcaNail to existing predicate devices for substantial equivalence.

Here's an analysis of the provided text based on your request, with the understanding that this is a hardware device submission, not an AI/software performance study. Therefore, many of your requested points related to AI/software performance metrics, ground truth, and expert evaluation are not directly applicable.

Acceptance Criteria and Device Performance (Based on presented data)

Since this is a hardware device submission and not a software/AI performance study, there aren't "acceptance criteria" in terms of sensitivity, specificity, or AUC. Instead, the acceptance criteria are implicit in demonstrating substantial equivalence to predicate devices through mechanical performance. The "reported device performance" refers to the results of the biomechanical and engineering tests.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance
Biomechanical Stability	The CalcaNail showed better primary stability at the chosen experimental set-up of a standardized calcaneal fracture compared to the standard Synthes calcaneal locking plate (K991407).
Rigidity	The engineering simulation demonstrated that the CalcaNail provided much greater rigidity than the FHI cannulated screws (K070617) used routinely in rear foot deformity surgery, when comparing moments of inertia of the smallest cross-sections.
Material Equivalence	Manufactured from titanium, similar to predicate devices.
Intended Use Equivalence	Subtalar arthrodesis for comminuted calcaneus fractures, post-traumatic osteoarthritis, osteoarthritis of posterior subtalar joint, and valgus flatfoot deformities, which is similar to predicate devices (Synthes calcaneal locking plate K991407, FHI cannulated screws K070617, NewDeal Panta Nail K091788) all indicated for use in the foot, ankle, and calcaneus, including subtalar arthrodesis.
Safety and Effectiveness	Bench testing and device description confirm that the subject CalcaNail demonstrates no new issues of safety or effectiveness compared to predicate devices for treating old and recent fractures of the heel bone joint and hind foot deformity surgery.

Study Proving Device Meets Acceptance Criteria:

The study proving the device meets the implicit acceptance criteria for substantial equivalence consists of two parts:

Biomechanical Bench Testing: This involved a direct comparison of the CalcaNail to a predicate device in terms of mechanical stability.
Engineering Simulation: This involved a comparison of rigidity between the CalcaNail and another predicate device using engineering principles.

Detailed Information for Each Point (as far as extract allows):

Sample size used for the test set and the data provenance:
- Biomechanical Testing: "Seven pairs of (total of 14) enzymatically corroded human calcaneal and talar bones" were used.
- Data Provenance: The origin of the human bones is not specified (e.g., country of origin). The study appears to be prospective (bench test designed for this submission), not retrospective clinical data.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable as the "test set" consists of physical bones and engineering models, not data requiring expert interpretation for ground truth in the context of an AI/software device. The integrity of the bones and the setup of the biomechanical test would typically be managed by engineers and biomechanics experts, but these are not "ground truth experts" in the clinical sense.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This concept pertains to resolving discrepancies among expert readers in clinical data annotation, which is not relevant for a biomechanical bench test or engineering simulation.
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, a multi-reader multi-case comparative effectiveness study was not done. This is a hardware device, not an AI/software diagnostic tool.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This concept is for AI algorithms. The "standalone" performance here relates to the inherent mechanical properties of the nail itself.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the biomechanical test, the "ground truth" is the measured mechanical stability of the construct under simulated loading conditions.
- For the engineering simulation, the "ground truth" is the calculated moment of inertia and derived rigidity based on established engineering principles and material properties.
- Neither of these involves clinical expert consensus, pathology, or outcomes data.
The sample size for the training set:
- Not applicable. This is a medical device (hardware) submission, not an AI/machine learning model where a "training set" would be used. The design of the nail is based on engineering principles and knowledge, not data training.
How the ground truth for the training set was established:
- Not applicable, as there is no "training set" in the context of an AI/ML model for this hardware device. The device design is based on engineering and anatomical considerations.

Summary

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

June 12, 2015

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

Re: K150471

Trade/Device Name: CalcaNail Orthopedic Arthrodesis Nail Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 14, 2015 Received: February 23, 2015

Dear Ms. Donnard:

This letter corrects our substantially equivalent letter of May 22, 2015.

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. Ilisting 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

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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); 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 vours.

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) K150471

Device Name CalcaNail Orthopedic Arthrodesis Nail

Indications for Use (Describe)

The CalcaNail Orthopedic Arthrodesis Nail is intended for subtalar arthrodesis in the treatment of patients with:

Comminuted fractures of the calcaneus
Post-traumatic osteoarthritis and/or poor function resulting from calcaneal fracture sequelae
Osteoarthritis of the posterior subtalar joint, or
Valgus flatfoot deformities

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

2 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 Arthrodesis Nail K150471

May 20, 2015

1. Submitter

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

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

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 Arthrodesis Nail

Common Name: Orthopedic 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.

3. Predicate Devices

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

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Synthes Calcaneal Locking Plate K991407 o
o FHI Cannulated Screws K070617
o NewDeal Panta Nail K091788

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 Arthrodesis Nail is intended for subtalar arthrodesis in the treatment of patients with:

Comminuted fractures of the calcaneus -
Post-traumatic osteoarthritis and/or poor function resulting from calcaneal ﮯ fracture sequelae
Osteoarthritis of the posterior subtalar joint, or l
-Valgus flatfoot deformities

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, ankle and the calcaneus with the nails and screws including subtalar arthrodesis. 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 Arthrodesis 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 old and recent fractures of the heel bone joint, and hind foot deformity surgery such as arthrodesis.

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.