The subject device APTUS Coronoid 2.0 plates have an anatomical design and are provided for the left and right ulna. The plates have a uniform thickness of 1.6 mm. The subject device plates are compatible with 2.0 mm diameter screws, and are used with TriLock locking screws and cortical (nonlocking) screws. The compatible screws have cortical threads, are presently marketed as part of the APTUS System, and were cleared under K051567 and K090053. The subject device plates also are compatible with K-wires cleared under K092038. The subject device plates are made of commercially pure titanium, Grade 4, conforming to ASTM F67 Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNS R50550, UNS R50700).

AI/ML Overview

The provided text describes the 510(k) premarket notification for the Medartis AG APTUS® Coronoid 2.0 device. The document primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than presenting a standalone study with acceptance criteria and device performance metrics in the typical sense of a clinical trial or AI device validation.

Instead, the "acceptance criteria" here are focused on demonstrating mechanical performance of the device itself (a bone plate and screw system) and showing it is equivalent to or better than predicate devices. The "study" is a series of non-clinical mechanical tests.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility (referenced from K142906)	Substantially equivalent (all subject device final finished components are manufactured in the same facilities using identical materials and manufacturing processes as for the reference predicate cleared in K142906). Material is Unalloyed titanium ASTM F67.
Dimensional Analysis	Subject device plates have a uniform thickness of 1.6 mm. Overall dimensions (approximate) are 28 mm x 34 mm (before bending). These dimensions are within a similar range of physical dimensions appropriate to the coronoid anatomy compared to the predicate (20-21 mm x 31-35 mm).
Single Cycle Bending (according to ASTM F382)	Performance of the subject device constructs was superior to that of the primary predicate device constructs.
Bending Fatigue Testing (according to ASTM F382)	Performance of the subject device constructs was superior to that of the primary predicate device constructs.
Dynamic Compression Testing in a Simulated Coronoid Fracture Model	Performance of the subject device constructs was superior to that of the primary predicate device constructs.
Equivalence in Intended Use	ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna. This is deemed to have the same intended use as the primary predicate which provides fixation for fractures, fusions, or osteotomies for various bones including the ulna.
Equivalence in Technological Characteristics (Material, Design)	Subject device uses Unalloyed titanium ASTM F67, anodized blue. Designs are anatomical for left/right ulna.

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

The document does not specify exact sample sizes (e.g., number of plates or constructs) used for the mechanical tests. It refers to these as non-clinical testing data.

Sample Size (Test Set): Not specified in the provided text. The tests involve "subject device constructs" and "predicate device constructs," suggesting multiple samples were tested for each.
Data Provenance: Non-clinical testing results. No geographical location or retrospective/prospective nature is mentioned for these lab tests, which is typical for mechanical performance data.

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

Not applicable. This is a non-clinical mechanical performance study for a physical implant, not a study evaluating human interpretation or an AI algorithm that requires expert ground truth.

4. Adjudication Method for the Test Set

Not applicable. This is a non-clinical mechanical performance study.

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. This is a non-clinical mechanical performance study for a physical implant. It does not involve human readers or AI.

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

No. This is a non-clinical mechanical performance study for a physical implant. It does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" here is established by the specified mechanical testing standards (ASTM F382) and a simulated coronoid fracture model. The performance is objectively measured against these predefined physical and mechanical properties.

8. The Sample Size for the Training Set

Not applicable. This is a non-clinical mechanical performance study for a physical implant. There is no concept of a "training set" as there is no algorithm being trained.

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

Not applicable, as there is no training set mentioned or implied.

Summary

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Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized image of three human profiles facing right, with flowing lines extending from the profiles.

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

February 9, 2017

Medartis AG Kevin Thomas Paxmed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K161861 Trade/Device Name: APTUS® Coronoid 2.0 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: January 11, 2017 Received: January 12, 2017

Dear Mr. Thomas:

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 (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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/ResourcesforYou/Industry/default.htm. 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

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,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K161861

Device Name

APTUS® Coronoid 2.0

Indications for Use (Describe)

ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

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 Medartis AG APTUS® Coronoid 2.0

January 11, 2017

ADMINISTRATIVE INFORMATION

Manufacturer Name	Medartis AGHochbergerstrasse 60ECH-4057 Basel, Switzerland
	Telephone: +41 61 633 34 34Fax: +41 61 633 34 00
Official Contact	Andrea SchweizerHead of Quality Management
Representative/Consultant	Kevin A. Thomas, PhDFloyd G. Larson, MS, MBAPaxMed International, LLC12264 El Camino Real, Suite 400San Diego, CA 92130
	Telephone: +1 858-792-1235Fax: +1 858-792-1236Email: kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	APTUS® Coronoid 2.0
Common Name	Plate, fixation, bone
Classification Names	Single/multiple component metallic bone fixation appliancesand accessories
Classification Regulations	21 CFR 888.3030
Product Codes	HRS
Classification PanelReviewing Branch	Orthopedic Products PanelJoint Fixation Devices Branch Two (JFDB2)

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PREDICATE DEVICE INFORMATION

Primary predicate device: K071715, Acumed Congruent Bone Plate System, Acumed LLC

Reference predicate device: K142906, APTUS® Wrist 2.5 System, Medartis AG

INDICATIONS FOR USE

ATPUS Ulna Plates are indicated for fractures and osteotomies, in particular for the ulna.

DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K142906), dimensional analysis, single cycle bending and bending fatigue testing of the subject device plates and the primary predicate device plates (according to ASTM F382), and dynamic compression testing of the subject device plates and the primary predicate device plates in a simulated coronoid fracture model. No clinical data were included in this submission.

EQUIVALENCE TO MARKETED DEVICE

Medartis AG submits the following information in this Premarket Notification to demonstrate that, for the purposes of FDA's regulation of medical devices, the subject device is substantially equivalent in indications and design principles to the following legally marketed predicate devices:

K071715, Acumed Congruent Bone Plate System, Acumed LLC; and

K142906, APTUS® Wrist 2.5 System, Medartis AG.

A comparison of the technological characteristics of the subject device and the primary predicate device K071715 is provided in the following table.

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Comparison	Subject Device	Primary Predicate Device
Comparison	Medartis AGAPTUS® Coronoid 2.0	AcumedCongruent Bone Plate SystemK071715
Indications for Use	ATPUS Ulna Plates are indicated for fractures andosteotomies, in particular for the ulna.	The Acumed Congruent Bone Plate System providesfixation for fractures, fusions, or osteotomies for theclavicle, humerus, radius, ulna, metacarpal,metatarsal, malleolus, tibia and fibula.
Plates		Information below for predicate coronoid plates
Design	Anatomical plate designs for left and right ulna	Anatomical plate designs for left and right ulna
Thickness	1.6 mm	1.6 mm
Overall Dimensions(approximate)	28 mm x 34 mm (before bending)	(20-21 mm) x (31-35 mm)
Material	Unalloyed titanium ASTM F67, anodized blue	Unalloyed titanium ASTM F67; anodized blue, green
Screws	Information below for previously cleared compatiblescrews
Design	Self-tapping cortical (nonlocking) screwsSelf-tapping TriLock locking screws	Self-tapping cortical screwsSelf-tapping locking screws
Diameter	2.0 mm	2.7 mm
Length	Cortical screws 4 to 24 mmTriLock screws 6 to 30 mm	8 to 32 mm
Material	Ti-6Al-4V alloy, ASTM F136	Ti-6Al-4V alloy, ASTM F136

The subject device coronoid plates and the primary predicate device coronoid plates have the same intended use and have the same technological characteristics. The subject and primary predicate device plates are fabricated from the same materials and share similar design characteristics, including plate screw holes to accommodate locking and non-locking screws. The subject and primary predicate device plates also are provided in pre-contoured designs for the left and right ulna, and encompass a similar range of physical dimensions appropriate to the coronoid anatomy. Any minor differences in the technological characteristics between the subject device and the primary predicate device do not raise new issues of safety or efficacy.

The subject and primary predicate device plates are provided nonsterile and are to be sterilized by the end-user. The subject devices are packaged using the same materials and are to be sterilized by the same methods as the reference predicate device.

All of the subject device final finished components are manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared reference predicate devices in K142906, and therefore are substantially equivalent to the reference predicate with regard to biocompatibility.

The wording of the Indications for Use for the subject device is slightly different than that of the primary predicate device; however, the slight differences in wording do not change the intended use of the subject device as compared to the primary predicate device.

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Performance data provided to demonstrate substantial equivalence included single cycle bending and bending fatigue testing of the subject device and predicate device plate and screw constructs. In both single cycle bending and bending fatigue testing, the performance of the subject device constructs was superior to that of the predicate device constructs. In addition, in a simulated coronoid fracture model, the performance of the subject device constructs also was superior to that of the predicate device constructs.

Differences between the subject device and the primary predicate K071715 include differently shaped anatomic designs for the coronoid, and the use of 2.0 mm diameter screws (subject device) versus 2.7 mm diameter screws (primary predicate device). Substantial equivalence is supported by the single cycle and dynamic mechanical testing of the subject device and predicate device plate and screw constructs.

CONCLUSION

The subject device and the predicate devices have intended use, have similar technological characteristics, and are made of similar materials. The subject and primary predicate device plates also are provided in pre-contoured designs for the left and right ulna, and encompass a similar range of physical dimensions appropriate to the coronoid anatomy. The subject and predicate devices are packaged in similar materials and are sterilized by the end-user using similar methods.

The data included in this submission demonstrate substantial equivalence to the predicate devices listed above.

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.