Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric patients.

Device Description

Airlock® osteosynthesis plate systems are single-use bone fixation devices intended to be permanently implanted. Plates are designed with different shapes and are made of Titanium (Alloy Ti-6Al-4V ELI). The system uses either 3mm or 3,5mm locking and non-locking screws. The drill hole are aligned to make sure there is no risk of conflict between the screws. The plates vary essentially through different curvatures, lengths, number of holes and shape.

AI/ML Overview

This document is a 510(k) Premarket Notification for the Airlock® osteosynthesis plate system. It describes the device, its intended use, and demonstrates its substantial equivalence to a predicate device.

Here's an analysis of the provided text in relation to your request for acceptance criteria and study information:

Key Finding: This document is concerned with demonstrating substantial equivalence of a new medical device (Airlock® osteosynthesis plate system) to an existing legally marketed device (Anchorage® Bone Plate System) based on similar technological characteristics and performance data. It explicitly states that clinical studies and animal studies were not required for this submission. Therefore, it does not describe a clinical study of the device to meet specific performance acceptance criteria in the way you might expect for an AI algorithm or diagnostic tool.

Instead, the "acceptance criteria" and "study" are focused on demonstrating that the new device is as safe and effective as the predicate device through bench testing and material characterization to meet recognized standards.

1. Table of Acceptance Criteria and Reported Device Performance

Since this is a mechanical device submission, the "acceptance criteria" relate to material composition, mechanical properties, and biocompatibility, as established by recognized standards. The "performance" refers to the device meeting these standards.

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
Material Composition:
ISO 5832-3 Implants for surgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy	The Airlock® osteosynthesis plate systems are made of Titanium (Alloy Ti-6Al-4V ELI) and have similar technological characteristics in terms of material to the predicate device, which also complies with ISO 5832-3.
Mechanical Characteristics (Plates):
ASTM F382-99 Standard Specification and Test Methods for Metallic Bone plates	The Airlock® osteosynthesis plate systems have similar mechanical characteristics to the predicate device, which complies with ASTM F382-99.
Mechanical Characteristics (Screws):
ASTM F543-13 Standard Specification and Test Methods for Metallic Bone screws Part A1, A2 & A3	The Airlock® osteosynthesis plate systems screws have similar mechanical characteristics to the predicate device, which complies with ASTM F543-13.
Biocompatibility:
Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process"	Biocompatibility evaluation was conducted in accordance with these recognized standards.

Regarding items 2 through 9:

Due to the nature of this 510(k) submission for a mechanical implant and the explicit statement that "Clinical studies was not required for this submission" and "Animal Study was not required for this submission," the following points related to clinical or AI algorithm performance studies are not applicable (N/A) in this context:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): N/A (No clinical test set described)
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience): N/A (No clinical ground truth described)
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A (No clinical test set described)
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: N/A (This is a mechanical implant, not an AI or diagnostic tool)
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: N/A (This is a mechanical implant, not an AI algorithm)
The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (The "ground truth" here is compliance with engineering and material standards through laboratory testing, not medical diagnostic ground truth.)
The sample size for the training set: N/A (No AI training set described)
How the ground truth for the training set was established: N/A (No AI training set described)

In summary: This document is an FDA 510(k) premarket notification for a bone plate system. It demonstrates substantial equivalence to a predicate device through engineering tests (material, mechanical properties, biocompatibility) and compliance with established industry standards (ISO, ASTM), rather than through clinical trials or performance studies on a test set of patient data, which are typically required for diagnostic software or AI algorithms.

Summary

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

August 13, 2015

NOVASTEP Mr. Gilles Audic, QA/RA Director Espace performance Alphasis Batiment C1-C2 35769 SAINT GREGOIRE France

Re: K151277

Trade/Device Name: Airlock® osteosynthesis plate 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: May 21, 2015 Received: May 26, 2015

Dear Mr. 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. 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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Page 2 - Mr. Gilles Audic

(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 (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,

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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Section

4: Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICESFood and Drug Administration		Form Approved: OMB No. 0910-0120
Indications for Use		Expiration Date: January 31, 2017See PRA Statement below.
510(k) Number (if known)	K151277
Device Name	Airlock® osteosynthesis plate systems
Indications for Use (Describe)	Airlock® osteosynthesis plate systems are indicated for fixation and stabilization of fresh fractures, revision procedures, joint fusion and reconstruction of small bones of the hand, feet, wrist, ankles, fingers and toes. The system may be used in both adult and pediatric 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)

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)
This section applies only to requirements of the Paperwork Reduction Act of 1995.

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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Image /page/3/Picture/2 description: The image shows the logo for "novastep". The logo is in a pink color. To the left of the word "novastep" is a pink design that looks like two curved lines. To the right of the word "novastep" is a registered trademark symbol.

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

Submitter	NOVASTEPEspace performance AlphasisBatiment C1-C235769 SAINT GREGOIREFrancePhone : + 33 (0)2 99 33 86 50Fax : + 33 (0)9 70 29 18 95
Contact person	Mister Gilles AUDICQA / RA DirectorCell phone: +33 (0)6 30 93 96 08e-mail: gilles.audic@novastep-ortho.com
Preparation date	May 12th 2015

Trade name	Airlock® osteosynthesis plate 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	510(k) number: K083447Device name: Anchorage® Bone Plate SystemOriginal applicant: MEMOMETAL TECHNOLOGIES.This predicate has not been subject to a design-related recall.
Description	Airlock® osteosynthesis plate systems are single-use bone fixationdevices intended to be permanently implanted. Plates are designed withdifferent shapes and are made of Titanium (Alloy Ti-6Al-4V ELI).The system uses either 3mm or 3,5mm locking and non-locking screws.

vastep - Siège Social / Service Client

| n o v a s t e p - S iège Social / Service Client
Espace Performanoe Alphasis - Bâtiment C1-C2 - 35769 SAINT-GRÉGOIRE Cedex - FFRANCE
Tél. +33 (0)2 99 33 86 50 - Fa

Tél. +33 (0)2 99 33 86 50 - Fax: +33 (0)2 30 96 35 61

Code A.P.E.: 3250A - N° SIRET: 752 292 797 00020-N° TVA Intracommunautaire FR 64 752 292 797

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	The drill hole are aligned to make sure there is no risk of conflict betweenthe screws.The plates vary essentially through different curvatures, lengths, numberof holes and shape.
Intended use	Airlock® osteosynthesis plate systems are single use devices intended forfixation and stabilization of fresh fractures, revision procedures, jointfusion and reconstruction of small bones of the hand, feet, wrist, ankles,fingers and toes. The system may be used in both adult and pediatricpatients.
Comparison of thetechnologicalcharacteristics with thepredicate device	The new devices Airlock® osteosynthesis plate systems plates have similartechnological characteristics in terms of material (ISO5832-3 Implants forsurgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy) and mechanical characteristics (ASTM F382-99 StandardSpecification and Test Methods for Metallic Bone plates) and thus arebelieved to be substantially equivalent to the predicate MEMOMETALAnchorage® Bone Plate System plates (K083447).
	The new devices Airlock® osteosynthesis plate systems screws havesimilar technological characteristics in terms of material (ISO5832-3Implants for surgery - Metallic material - Part 3: Wrought titanium 6-aluminium 4-vanadium alloy) and mechanical characteristics (ASTM F543-13 Standard Specification and Test Methods for Metallic Bone screws PartA1, A2 & A3) and thus are believed to be substantially equivalent to thepredicate MEMOMETAL Anchorage® Bone Plate System screws(K083447).
Performance data	The biocompatibility evaluation for new devices Airlock® osteosynthesisplate systems was conducted in accordance with Blue BookMemorandum #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® osteosynthesis plate systems have similartechnological characteristics in terms of design and mechanicalcharacteristics and thus are believed to be substantially equivalent to thepredicate MEMOMETAL Anchorage® Bone Plate System (K083447).
Indication for use	The Airlock® osteosynthesis plate systems are single use devices indicatedfor fixation and stabilization of fresh fractures, revision procedures, jointfusion and reconstruction of small bones of the hand, feet, wrist, ankles,fingers and toes. The system may be used in both adult and pediatricpatients.
Clinical studies	Clinical studies was not required for this submission
Animal Study	Animal Study was not required for this submission1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1 - 1
Conclusion	The Airlock® osteosynthesis plate systems are substantially equivalent totheir predicate devices MEMOMETAL Anchorage® Bone Plate System(K083447), in terms of intended use and indications for use, material,design and function. Any minor differences between these two devicesdo not raise new questions of safety and effectiveness.

vastep - Siège Social / Service Client

| n o v a st e p - Siège Social / Service Client
| Espace Perbrimance Alphasis - Bâtiment C1-C2 - 35769 SAINT-GRÉGOIRE Cedex - FFRANCE
| Tél. +33 (0)2 99 33 86 50 - Fax

Code A.P.E.: 3250A-N° SIRET 752 292 797 00020 - N° TVA Intracommunautaire FR 64 752 292

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Traditional 510(k) premarket notification

step®

| n o v a s t e p - S iège Social / Service Client
| Espace Performance Alphasis - Bâtiment C1-C2 - 35769 SAINT-GRÉGOIFE Cedex - FFANCE
| Tél. +33 (0)2 99 33 86 50 - F

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.