Airlock® Centrolock® osteosynthesis implant systems are single-use devices intended for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers and toes.

Examples include:

Mono or Bi-Cortical osteotomies in the foot or hand
Distal or Proximal metatarsal or metacarpal osteotomies
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
Calcaneus/cuboid arthrodesis
Talar/navicular arthrodesis

The system may be used in adult patients.

Device Description

Airlock® Centrolock® osteosynthesis implant systems are single-use bone fixation devices intended to be permanently implanted. implant systems are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 2mm cortical screws or 2,5mm locking screws. The drill holes are aligned to make sure there is no risk of conflict between the screws. The implant vary essentially through different curvatures and shapes.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Airlock® Centrolock® osteosynthesis implant system based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The provided document (K192356) is a 510(k) summary for a medical device. For such devices, "acceptance criteria" are typically met through performance testing that demonstrates substantial equivalence to a predicate device, rather than specific numerical performance metrics for an AI algorithm. The document emphasizes mechanical and material characteristics.

Acceptance Criterion (Established through substantially equivalent predicate)	Reported Device Performance (as demonstrated by testing and comparison)
Material Composition	Wrought Titanium 6-Aluminum 4-Vanadium Alloy (ISO 5832-3 Fourth edition 2016-10-15)
Mechanical Characteristics (Implants)	Similar static and dynamic bending resistance (tested per ASTM-F382-17) to predicate Novastep Airlock® osteosynthesis Plate System.
Mechanical Characteristics (Screws)	Similar pull-out strength and torsional resistance (tested per ASTMF543-17 sections A1 A3) to predicate Novastep Airlock® osteosynthesis Plate System.
Biocompatibility	Evaluation conducted in accordance with Blue Book Memorandum #G95-1 and ISO 10993-1.
Intended Use / Indications for Use	Same as predicate devices: Fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hands, feet, ankle, fingers, and toes in adult patients.
Design	Similar technological characteristics in terms of design to predicate devices.

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

This is not an AI/software device submission. The "test set" in this context refers to the samples used for mechanical and biocompatibility testing.

Sample Size: Not explicitly stated in terms of specific numbers of implants or screws tested for mechanical properties. Biocompatibility would involve various test samples, also not specified numerically.
Data Provenance: Not applicable in the context of clinical data. The tests are material and mechanical characterization tests conducted in a laboratory setting. No country of origin for clinical data is relevant here as no clinical studies were performed. The tests are prospective in the sense that they were designed and executed for this submission.

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

Not applicable. This is not an AI device where expert ground truth is typically established. The "ground truth" for mechanical testing is based on established engineering standards (ASTM, ISO).

4. Adjudication Method for the Test Set

Not applicable. This is not an AI device with human expert interpretation or 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

Not applicable. This is a medical implant, not an AI-powered diagnostic or assistive device. No MRMC study was performed.

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

Not applicable. This is a medical implant, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's acceptance is based on:

Engineering Standards: Established international standards for material composition (ISO 5832-3), mechanical testing (ASTM F382-17, ASTM F543-17), and biocompatibility (ISO 10993-1).
Substantial Equivalence: Comparison to legally marketed predicate devices in terms of intended use, indications for use, material, design, and function. The "truth" is that the new device is as safe and effective as the predicate.

8. The Sample Size for the Training Set

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

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

Not applicable.

Summary

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December 14, 2019

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left side of the logo is the Department of Health & Human Services USA seal. To the right of the seal is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Novastep Gilles Audic QA/RA Director Espace Performance III- Batiment P Saint-Gregoire, 35769 FR

Re: K192356

Trade/Device Name: Airlock Centrolock Osteosynthesis Implant System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances And Accessories Regulatory Class: Class II Product Code: HRS Dated: August 19, 2019 Received: August 29, 2019

Dear Gilles Audic:

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

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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) 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 (OS) 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,

Shumaya Ali, MPH Assistant Director DHT6C: Division of Restorative, Repair and Trauma 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 Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
	Form Approved: OMB No. 0910-0120
	Expiration Date: 06/30/2020
	See PRA Statement below.
510(k) Number (if known)	K192356
Device Name	Airlock® Centrolock® osteosynthesis implant system

Indications for Use (Describe)

Examples include:

Mono or Bi-Cortical osteotomies in the foot or hand
Distal or Proximal metatarsal or metacarpal osteotomies
Fixation of osteotomies for Hallux Valgus treatment (such as Scarf, Chevron, etc.)
Calcaneus/cuboid arthrodesis
Talar/navicular arthrodesis

The system may be used in adult patients.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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tep®

"510(k) Summary" as required by section 807.92(c)

Submitter	NOVASTEP
	Espace performance 3
	Bâtiment P
	35769 SAINT GREGOIRE CEDEX
	France
	Phone: +33 (0)2 99 33 86 50
	Fax: +33 (0)9 70 29 18 95
Contact person	Mister Gilles AUDIC
	QA / RA Director
	Cell phone:+33 (0)6 30 93 96 08
	e-mail: gilles.audic@novastep-ortho.com
Preparation date	December 13 2019

Trade name	Airlock® Centrolock® osteosynthesis implant system
Common Name	Plate, Fixation, Bone
Classification Name	Single / Multiple component metallic bone fixation appliances andaccessories (21CFR 888.3030, product code HRS)
Regulatory class	II

Legally marketedpredicate devices	Primary predicate device510(k) number: K120157Device name: Mini MaxLock Extreme® Plating SystemOriginal applicant: OrthoHelix Surgical Designs, Inc.
	Reference device
	510(k) number: K143523
	Device name: Airlock® Osteosynthesis Plate System
	Original applicant: NOVASTEP.
	Other predicate
	510(k) number: K162353
	Device name: MICA™ Screw System
	Original applicant: Wright Medical Technology, Inc..
Description	Airlock® Centrolock® osteosynthesis implant systems are single-use bonefixation devices intended to be permanently implanted. implant systemsare designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI).The system uses either 2mm cortical screws or 2,5mm locking screws.The drill holes are aligned to make sure there is no risk of conflict betweenthe screws.The implant vary essentially through different curvatures and shapes.
Intended use	Airlock® Centrolock® osteosynthesis implant systems are single-usedevices intended for fixation and stabilization of fresh fractures,revision procedures, joint fusion and reconstruction of small bones ofthe hands, feet, ankle, fingers and toes.Examples include:
	• Mono or Bi-Cortical osteotomies in the foot or hand
	• Distal or Proximal metatarsal or metacarpal osteotomies
	• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf,Chevron, etc.)
	• Calcaneus/cuboid arthrodesis
	• Talar/navicular arthrodesis
	The system may be used in adult patients.
Comparison of thetechnological	The new devices Airlock® Centrolock® osteosynthesis implant systemimplants have similar technological characteristics in terms of designand mechanical characteristics [Static and dynamic bending resistance
characteristics with thepredicate device	(ASTM-F382-17) and thus are believed to be substantially equivalent tothe predicate Novastep Airlock® osteosynthesis Plate System.The new devices Airlock® Centrolock® osteosynthesis implant systemscrews have similar technological characteristics in terms of design andmechanical characteristics (pull-out strength, torsional resistance(ASTMF543-17 sections A1 A3) and thus are believed to besubstantially equivalent to the predicate Novastep Airlock®osteosynthesis Plate System.
Performance data	The biocompatibility evaluation for new devices Airlock® Centrolock®osteosynthesis implant systems was conducted in accordance with BlueBook Memorandum #G95-1 "Use of International Standard ISO-10993,'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing'"and International Standard ISO 10993-1 "Biological Evaluation of MedicalDevices - Part 1: Evaluation and Testing Within a Risk ManagementProcess" as recognized by FDA.
	The new devices Airlock® Centrolock® osteosynthesis implant systemimplants have similar technological characteristics in terms of material(ISO 5832-3 Fourth edition 2016-10-15 Implants For Surgery - MetallicMaterials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)and thus are believed to be substantially equivalent to the primarypredicate legally marketed device OrthoHelix Surgical Designs MiniMaxLock Extreme® Plating System (K120157), and the reference devicemarketed Novastep Airlock® osteosynthesis Plate System (K143523).
	The new devices Airlock® Centrolock® osteosynthesis implant systemscrews have similar technological characteristics in terms of material (ISO5832-3 Fourth edition 2016-10-15 Implants For Surgery - MetallicMaterials - Part 3: Wrought Titanium 6-Aluminium 4-Vanadium Alloy)and thus are believed to be substantially equivalent to the primarypredicate legally marketed device OrthoHelix Surgical Designs MiniMaxLock Extreme® Plating System (K120157), and the reference devicemarketed Novastep Airlock® osteosynthesis Plate System (K143523).
Indication for use	Airlock® Centrolock® osteosynthesis implant systems are single-usedevices intended for fixation and stabilization of fresh fractures,revision procedures, joint fusion and reconstruction of small bones ofthe hands, feet, ankle, fingers and toes.Examples include:• Mono or Bi-Cortical osteotomies in the foot or hand• Distal or Proximal metatarsal or metacarpal osteotomies• Fixation of osteotomies for Hallux Valgus treatment (such as Scarf,Chevron, etc.)
	• Calcaneus/cuboid arthrodesis• Talar/navicular arthrodesisThe system may be used in adult patients.
Clinical studies	Clinical studies were not required for this submission
Animal Study	Animal Study was not required for this submission
Conclusion	The Airlock® Centrolock® osteosynthesis implant systems aresubstantially equivalent to the primary predicate device OrthoHelixsurgical designs Mini MaxLock Extreme® Plating System (K120157), to thereference Novastep Airlock® osteosynthesis plate systems (K143523), andto the other predicate Wright Medical Technology MICA™ Screw System(K162353) in terms of intended use and indications for use.The Airlock® Centrolock® osteosynthesis implant systems aresubstantially equivalent to the primary predicate device OrthoHelixsurgical designs Mini MaxLock Extreme® Plating System (K120157), to thereference Novastep Airlock® osteosynthesis plate systems (K143523) interms of material, design and function.
	Any minor differences between these devices do not raise new questionsof safety and effectiveness.

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nowatlep . S id / Service Class 100 5 Espace Performance Alphasis - Bliment P / 187119 SAINT-QRÉGORIE Cades - FRANCE Tel. +33 (0)2 99 33 86 50 - Fea : +20 (0)2 20 94 25 41 BAN au captal de T2V SE2 E - Claste A.P.C. | 30504 - Nº (SRECT : 750 201 : Nº (SREET : PSD 200 : (NO TVA. FICH SE BE BE ORT : LEL JERF TOL FO FOR

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.