The subject device plate has an anatomical design appropriate for both the left and right wrist. The plate has a uniform thickness of 1.3 mm and has overall dimensions of approximately 35 mm x 13 mm, before bending to conform to the hand anatomy. The screw holes of the plate are designed to accommodate appropriately sized bone screws presently marketed as part of the APTUS® System and previously cleared under K051567. The subject device plate is compatible with 2.0 mm diameter screws, and is used with TriLock locking screws and cortical (nonlocking) screws. The subject device plate is made of unalloyed titanium conforming to ASTM F67.

AI/ML Overview

This document (K181009) is a 510(k) premarket notification for the Medartis AG APTUS® CMC-I Fusion Plate System. It focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not explicitly state "acceptance criteria" in a quantitative sense as might be found for software performance (e.g., specific sensitivity/specificity thresholds). Instead, the acceptance criteria are implicitly met by demonstrating substantial equivalence to predicate devices through various tests.

The performance data primarily focuses on mechanical equivalence.

Acceptance Criterion (Implicit)	Reported Device Performance
Biocompatibility: Device material is safe for implantation.	Referenced from K051567 (APTUS® Titanium System). The final finished subject device is manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared reference predicate device components cleared in K051567.
Mechanical Strength (Static): The plate can withstand loads.	Mechanical testing according to ASTM F382 (four-point bend testing) was performed. The document states "Performance data demonstrated the subject device plates to be substantially equivalent to K062498."
Mechanical Strength (Dynamic/Fatigue): The plate can withstand repetitive loads without failure.	Comparative dynamic testing in a simulated fracture model was performed. The document states "Performance data demonstrated the subject device plates to be substantially equivalent to K062498."
Equivalent Intended Use: The device is for the same purpose as predicates.	The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal. This is deemed similar to the predicate device's use for internal fixation of bones of hand and wrist, with a focus on specific fusion.
Equivalent Technological Characteristics: Similar materials, design, and screw compatibility.	The subject device and predicate devices are made of unalloyed titanium (ASTM F67 for subject, grade 2 for primary predicate). Similar design characteristics including screw holes for locking/non-locking screws. Subject device compatible with screws from reference predicate K051567.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Sample Size: The document does not specify the number of physical samples used for the mechanical tests (e.g., number of plates tested for four-point bend or dynamic testing). ASTM F382 and similar standards typically require a certain number of replicates, but this detail is not provided.
Data Provenance: The tests are non-clinical, laboratory-based mechanical and biocompatibility tests. Product development and potentially the testing itself occurred in Switzerland (Medartis AG is based in Basel, Switzerland). The document does not specify if the testing was performed retrospectively or prospectively, although in a verification/validation context they are typically conducted prospectively.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable as the submission is for a physical medical device (bone plate) and relies on non-clinical engineering and material science testing, not on clinical data, image interpretation, or expert consensus on patient outcomes.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

This information is not applicable for the reasons stated above (non-clinical, non-human-reader dependent testing).

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:

This information is not applicable. This is a submission for a physical medical implant, not an AI/software device that assists human readers.

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

This information is not applicable. This refers to AI/software performance.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

The "ground truth" in this context refers to the established standards and specifications for material properties and mechanical performance.

For Biocompatibility: The "ground truth" is that the material (unalloyed titanium, ASTM F67) and manufacturing processes are identical to a previously cleared device (K051567), and thus are known to be biocompatible.
For Mechanical Performance: The "ground truth" for mechanical testing is established by recognized standards such as ASTM F382 and by comparative performance against a legally marketed predicate device (K062498) known to be safe and effective for its intended use. The device's performance measurements (e.g., load to failure, fatigue life) are compared against the predicate's performance in similar test setups.

8. The sample size for the training set:

This information is not applicable. "Training set" refers to data used to train machine learning algorithms. This device is a physical implant.

9. How the ground truth for the training set was established:

This information is not applicable for the reasons stated above.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that 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.

August 24, 2018

Medartis AG % Kevin A. Thomas, Ph.D. Vice President and Director of Regulatory Affairs PaxMed International, LLC 12264 El Camino Real, Suite 400 San Diego, California 92130

Re: K181009

Trade/Device Name: APTUS CMC-I Fusion 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: July 23, 2018 Received: July 24, 2018

Dear Kevin A. Thomas, Ph.D .:

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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K181009

Device Name

APTUS® CMC-I Fusion Plate System

Indications for Use (Describe)

The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal.

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"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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510(k) Summary

Medartis AG

APTUS® CMC-I Fusion Plate System

April 17, 2018

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, PhD
	Floyd G. Larson, MS, MBA
	PaxMed International, LLC
	12264 El Camino Real, Suite 400
	San Diego, CA 92130
Telephone:	+1-858-792-1235
Fax:	+1-858-792-1236
Email:	kthomas@paxmed.com flarson@paxmed.com

DEVICE NAME AND CLASSIFICATION

Trade/Proprietary Name	APTUS® CMC-I Fusion Plate System
Common Name	Plate, fixation, bone
Classification Name	Single/multiple component metallic bone fixation applianceand accessories
Classification Regulation	21 CFR 888.3030
Product Code	HRS
Classification Panel	Orthopedic Products Panel
Reviewing Branch	Joint Fixation Devices Branch Two (JFDB2)

PREDICATE DEVICE INFORMATION

The primary predicate device is K062498, Profyle® System, Howmedica Osteonics Corporation. The reference predicate device is K051567, APTUS® Titanium System, Medartis, Inc.

INDICATIONS FOR USE

The APTUS® CMC-I Fusion Plate System is intended to be used for fusion of the trapezium with the first metacarpal.

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SUBJECT DEVICE DESCRIPTION

PERFORMANCE DATA

Non-clinical testing data submitted, referenced, or relied upon to demonstrate substantial equivalence include: biocompatibility (referenced from K051567), mechanical testing (according to ASTM F382), and comparative dynamic testing in a simulated fracture model. Clinical data were not provided in this submission.

EQUIVALENCE TO MARKETED DEVICE

Medartis AG submits the 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:

K062498, Profyle® System, Howmedica Osteonics Corporation; and

K051567, APTUS® Titanium System, Medartis, Inc.

A comparison of the technological characteristics of the subject device and the primary predicate device K062498 is provided in the following table.

	Subject Device	Primary Predicate Device
Comparison	APTUS® CMC-I Fusion Plate SystemMedartis AG	K062498Profyle® SystemHowmedica Osteonics Corporation
Indications for UseStatement	The APTUS® CMC-I Fusion Plate System is intended tobe used for fusion of the trapezium with the firstmetacarpal.	The Profyle® System is intended for use in internalfixation of the bones of hand and wrist. Examples ofthese procedures may include but are not limited toreplantation, lag screw techniques, joint fusions,corrective osteotomies, and the treatment of fractures.
Device Characteristics
Plate Designs	Anatomic plate designOne sizeSingle design for right and left hand-wrist;Screw holes accommodate conventional (cortex) andlocking screws	Anatomic plate designsMultiple sizesMultiple designsScrew holes accommodate conventional (cortex) andlocking screws
Plate Overall Dimensions(Approximate)	13 mm width x 35 mm length	Various
Plate Thickness	Uniform thickness, 1.3 mm	Uniform thickness, range from 0.55 mm – 1.5 mm
Plate Material	Unalloyed titanium, grade 4 (ASTM F67)	Unalloyed titanium, grade 2
Screw Designs	Previously cleared:Locking screws: cortical thread form, double thread,self-tapping, fully threadedNon-locking screws: cortical thread form, single thread,self-tapping, fully threadedCannulated screws: cortical thread form, single thread,self-tapping, partially threaded, cannulated	Cortical thread formSelf-tapping, fully threadedConventional (non-locking) and locking
Screw Diameter	Previously cleared:2.0 mm (locking and non-locking)3.0 mm (cannulated)	1.2 mm to 2.5 mm

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	Subject Device	Primary Predicate Device
Screw Length	Previously cleared:8 mm to 20 mm (conventional and locking)18 mm to 32 mm (cannulated)	6 mm to 26 mm
Screw Material	Previously cleared:Ti-6Al-4V alloy, ASTM F136	Ti-6Al-4V alloy

The subject device, the primary predicate device K062498, and reference predicate device K051567 have the same intended use for internal fixation of the bones of the hand and wrist, and have the same technological characteristics. The subject device and the plates from both predicate devices (K062498 and K051567) are fabricated from unalloyed titanium. The subject device and the reference predicate device K051567 have similar design characteristics, including the design of screw holes to accommodate locking and non-locking screws. The subject device and both predicate devices (plates) encompass a similar range of physical dimensions (overall width, length, and thickness). The subject device plates are compatible exclusively with screws from the reference predicate device K051567.

The differences between the subject device and primary predicate device K062498 are slight variations in the design of the plates and compatible screws. The differences between the subject device and reference predicate device K051567 plates are the specific design configurations and dimensions. These slight differences among the subject device and predicate devices do not raise of safety or efficacy.

The final finished subject device is manufactured in the same facilities using identical materials and identical manufacturing processes as used for the previously cleared reference predicate device components cleared in K051567, and therefore are substantially equivalent to the reference predicate device regarding biocompatibility. The subject device and reference predicate device K051567 components are packaged using the same materials, and are to be sterilized by the same methods.

The Indications for Use Statement for the subject device is similar to that of the primary predicate device K062498. The slight differences in wording do not affect the intended use for internal fixation of the hand and wrist.

Performance data provided to demonstrate substantial equivalence included four-point bend testing (according to ASTM F382), and comparative dynamic testing in a simulated fracture model.

CONCLUSION

The subject device plates and the primary predicate device plates have intended use, have similar technological characteristics, encompass a similar range of physical dimensions appropriate to the anatomy and are made of the same material. The subject device and reference predicate device K051567 are packaged in similar materials and are to be sterilized by the end-user using similar methods. Performance data demonstrated the subject device plates to be substantially equivalent to K062498.

The data included in this submission demonstrate substantial equivalence to the predicate devices K062498 and K051567.

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.