Management of the fractures of the distal, middle and proximal phalanges and metacarpals
Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
DIP and PIP arthrodoses .

APTUS® Radius 2.5 group:

. Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
. Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

Device Description

The APTUS 1.5 TriLock consists of titanium TriLock plates and titanium TriLock screws with locking function. The system is intended to be used for internal fixation of small bones. The 1.5 TriLock plates may also be used with existing standard 1.2 mm (thread diameter) and 1.5 mm (thread diameter) cortical bone screws cleared under APTUS® Titanium Fixation System. K051567. The only modifications being made in this submission are the addition of eight (8) plates, all 0.8 mm in thickness, having various screw hole and design configurations, and the addition of ten (10) screws, all having a major thread diameter of 1.5 mm, all with a locking head design, provided in lengths ranging from 4 mm to 13 mm in 1 mm increments. The technological differences between the subject device and the predicate include a change in the thickness of the plates and the change in plate configurations and the change in screw head design to allow locking to the plates.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (APTUS® 1.5 TriLock) and does not describe an AI/ML study. It details the device's intended use, description, and claims of substantial equivalence to a predicate device based on performance data that includes dimensional analysis, insertion, shear, and pullout testing of screws, and fatigue testing of plates.

Therefore, I cannot provide the requested information about acceptance criteria and a study proving device performance in the context of an AI/ML study, as the document pertains to a traditional medical device submission.

Here's why and what information is available:

No AI/ML Component: The document does not mention any artificial intelligence, machine learning, software algorithm, or diagnostic aid. It describes a physical orthopedic fixation system (plates and screws).
Performance Data Type: The "performance data" referred to is related to the mechanical properties of the implants (e.g., screw insertion/pullout strength, plate fatigue life), not diagnostic accuracy or AI model performance.
Substantial Equivalence: The submission focuses on demonstrating "substantial equivalence" to a previously cleared predicate device (APTUS® Titanium Fixation System, K051567), a common pathway for medical device clearance. This involves showing similar intended use, technological characteristics, materials, and mechanical performance.

Therefore, all requested points related to AI/ML study components (test set size, data provenance, expert ground truth, adjudication, MRMC, standalone algorithm, training set, etc.) are NOT applicable to this document.

The "acceptance criteria" for this device would be the demonstration of substantial equivalence through meeting comparable mechanical performance benchmarks to the predicate device, which are implicitly accepted by the FDA clearance. The "study" proving this involves the specific mechanical tests mentioned:

Detailed dimensional analysis of subject and predicate screw designs.
Insertion, shear, and pullout testing of subject and predicate screws.
Fatigue testing of subject and predicate plate designs.

Without the actual reports for these mechanical tests, specific numerical acceptance criteria and performance results cannot be extracted. The summary only states that these tests were "provided to demonstrate substantial equivalence."

Summary

{0}------------------------------------------------

K102537 p.10f 3

510(k) Summary

DEC 1 0 2010

APTUS® 1.5 TriLock Special 510(k): Device Modification

October 5, 2010

ADMINISTRATIVE INFORMATION

Manufacturer Name:

Medartis AG Hochbergerstrasse 60E CH-4057 Basel, Switzerland Telephone: +41 61 633 34 34 Fax: +41 61 633 34 00

Official Contact:

Ulrike Jehle Regulatory Affairs Manager

Representative/Consultant:

Kevin A. Thomas, PhD Floyd G. Larson PaxMed International, LLC 11234 El Camino Real, Suite 200 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: Common Name: Classification Regulations: APTUS® 1.5 TriLock Plate, fixation, bone Single/multiple component metallic bone fixation appliances and accessories 21 CFR 888.3030 Class II HRS Orthopedic Products Panel Orthopedic Devices Branch

Product Code Classification Panel: Reviewing Branch:

{1}------------------------------------------------

INTENDED USE

The APTUS® 1.5 TriLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

Management of the fractures of the distal, middle and proximal phalanges and ● metacarpals
. Management of all types of transversal fractures, spiral fractures, fractures near joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
DIP and PIP arthrodoses .

APTUS® Radius 2.5 group:

Management via radio volar approach of extra-articular extension and flexion . fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
. Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

DEVICE DESCRIPTION

EQUIVALENCE TO MARKETED PRODUCT

Medartis AG demonstrated that, for the purposes of FDA's regulation of medical devices, the APTUS 1.5 TriLock is substantially equivalent in indications and design principles to the following predicate device, which has been determined by FDA to be substantially equivalent to preamendment devices:

APTUS® Titanium Fixation System, K051567

The subject device has the same intended use as the predicate device and has the same Indications for Use Statement as the predicate cleared under K051567.

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The subject device has the same technological characteristics as the predicate device. The subject and predicate devices are all fabricated from the same materials (commercially pure titanium and titanium alloy) and share similar design characteristics. The subject and predicate devices are packaged using the same materials and are to be sterilized by the same methods.

Performance data provided to demonstrate substantial equivalence included: detailed dimensional analysis of the subject and predicate screw designs; insertion, shear, and pullout testing of the subject and predicate screws; and fatigue testing of the subject and predicate plate designs.

In summary, the APTUS 1.5 TriLock has the following similarities to the predicate device:

has the same intended use, .
. uses the same operating principle,
. incorporates the same basic design,
. incorporates the same materials, and
. is packaged and sterilized using the same materials and processes.

{3}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle-like symbol with three curved lines representing its body and wings. The symbol is positioned to the right of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".

Public Health Service

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

Medartis AG c/o Mr. Kevin A. Thomas Regulatory Consultant Hochbergerstrasse 60E CH-4057 Basel, Switzerland

DEC 1 0 2010

Trade/Device Name: APTUS 1.5 TriLock 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: November 5, 2010

Received: November 11, 2010

Dear Mr. Thomas:

Re: K102537

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 such 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

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Page 2 - Mr. Kevin Thomas

comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

DEC 1 0 2010

K102537 510(k) Number (if known):

APTUS® 1.5 TriLock Device Name:

The APTUS® 1.5 TriLock is intended for use in hand and forearm fractures, osteotomies and arthrodeses.

APTUS® Hand group:

Management of the fractures of the distal, middle and proximal phalanges and metacarpals
Management of all types of transversal fractures, spiral fractures, fractures near . joints with or without joint involvement, shaft factures, comminuted fractures, dislocation fractures, avulsion fractures
DIP and PIP arthrodoses .

APTUS® Radius 2.5 group:

. Management via radio volar approach of extra-articular extension and flexion fractures, articular extension and flexion fractures, correction osteotomies for badly healed radius fractures
. Management via dorsal approach of rare extension fractures that cannot be adequately reduced via volar approach, procedures for which the soft tissue conditions make a volar approach very difficult or impossible, correction osteotomies requiring stabilization from the dorsal side, carporadial fusions.

Prescription Use X (Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 801 Subpart.C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

	M. Melkerson
(Division Sign-Off)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number	K102537
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	Page 1 of ____
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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.