The aap LOQTEQ® VA Volar Distal Radius Plate 2.5, LO- QTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5 are intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius . The aap LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5 are intended for fractures and osteotomies of the distal ulna .

Device Description

The aap LOQTEQ® VA Radius Set 2.5 consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures, osteotomies. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

AI/ML Overview

This document is a 510(k) premarket notification for a medical device: "aap LOQTEQ® VA Radius Set 2.5," which includes plates and screws for fixing fractures and osteotomies of the distal radius and ulna. The FDA determined the device to be substantially equivalent to legally marketed predicate devices.

Here's an analysis of the provided information concerning acceptance criteria and studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Mechanical Performance: - Static and dynamic system tests - Screws meet relevant demands of ASTM F543-13	Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The screws fulfill the relevant demands of ASTM F543-13.
Safety and Effectiveness: - Meets requirements of pre-defined acceptance criteria - Meets intended uses	The subject device is safe and effective, and its performance meets the requirements of its pre-defined acceptance criteria and intended uses.

2. Sample size used for the test set and the data provenance

The document does not specify a "test set" in the context of clinical data for algorithmic performance. The studies mentioned are non-clinical (mechanical tests) and thus do not involve patient data or data provenance (country of origin, retrospective/prospective). The studies involve device components and system performance.

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

Not applicable. The studies are non-clinical mechanical tests, not dependent on expert interpretation of clinical data.

4. Adjudication method for the test set

Not applicable. The studies are non-clinical mechanical tests.

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 notification for a hardware device (bone plates and screws), not an AI-powered diagnostic or assistive tool for human readers.

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

Not applicable. This device does not involve an algorithm.

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

For the non-clinical mechanical tests, the "ground truth" would be established by:

Engineering specifications and design requirements.
Industry standards (e.g., ASTM F543-13 for screws).
Comparative performance data against predicate devices.

8. The sample size for the training set

Not applicable. The studies are non-clinical mechanical tests and do not involve a training set as understood in AI/machine learning contexts.

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

Not applicable. There is no training set mentioned in the context of this device and its studies.

Summary

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

January 21, 2016

aap Implantate Ag Dr. Christian Zietsch Director Quality Assurance and Regulatory Affairs Lorenzweg 5 Berlin, D-12099 GERMANY

Re: K153034 Trade/Device Name: aap LOQTEQ® VA Radius Set 2.5 Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: HRS, HWC Dated: October 20, 2015 Received: October 23, 2015

Dear Dr. Zietsch:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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forth in the quality systems (QS) 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" (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,

Lori A. Wiggins -S

for

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) K153034

Device Name aap LOOTEO® VA Radius Set 2.5

Indications for Use (Describe)

LOQTEQ® VA Volar Distal Radius Plate 2.5, LOQTEQ® VA Distal Radius Straight Plate 2.5,

LOQTEQ® VA Distal Radius L-Plate 2.5

· Fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius

LOQTEQ® VA Distal Ulna Plate 2.5,

LOQTEQ® VA Distal Ulna Hook Plate 2.5

• Fractures and osteotomies of the distal ulna

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)

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5. Summary of Safety and Effectiveness

Sponsor:	aap Implantate AGLorenzweg 5D-12099 Berlin, Germany
Company Contact:	Dr. Christian ZietschPhone:+49-30-750-19 - 193Fax: +49-30-750-19 – 111
Date	Jan/21/2016
Trade Name:	aap LOQTEQ® VA Radius Set 2.5
Common Name:	Variable Angle Distal Radius/Ulna Plates and Screws 2.5
Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessories - Class II21 CFR 888.3040 Smooth or threaded metallic bone fixa-tion fastener - Class II
Device ProductCodeand Panel Code:	Orthopedics/87/HRSOrthopedics/87/HWC
Predicate devices	Synthes (USA) Variable Angle LCP Dorsal Distal RadiusSystem under the premarket notification K102694 (Dec 09,2010)Synthes (USA) LCP Diaphyeal-Metaphyseal (Dia-Meta)Volar Distal Radius Plate under the premarket notificationK070946 (Jun 06, 2007)Synthes (USA) VA LCP Two-Column Volar Distal RadiusPlates under the premarket notification K083694 (MAR 06,2009)Medartis AG APTUS Ulna Plates under the premarket noti-fication K103332 (Jan 24, 2011).
Device Description:	The aap LOQTEQ® VA Radius Set 2.5 consists of boneplates and bone screws, to be implanted by a surgeon inorder to achieve an internal fixation of bone fragments typi-cally after fractures, osteotomies. If the plates are used inconjunction with locking screws, a so called internal fixatorwill be realized (internal fixation).

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The aap LOQTEQ® VA Radius Set 2.5 incorporates:

	LOQTEQ® VA Volar Distal Radius Plate 2.5, narrow/broad, right/leftLOQTEQ® VA Volar Distal Radius Plate 2.5, narrow, XL, right/leftLOQTEQ® VA Distal Radius Straight Plate 2.5LOQTEQ® VA Distal Radius L-Plate 2.5, right/leftLOQTEQ® VA Distal Ulna Plate 2.5LOQTEQ® VA Distal Ulna Hook Plate 2.5LOQTEQ® VA Cortical Screw 2.5, T8Cortical Screw 2.5, small head, T8, self-tappingSet of Instruments LOQTEQ® VA Distal Radius Set 2.5
Material:	Ti6Al4V (ASTM F136 or ISO 5832-3) unalloyed Titanium (ASTM F67 or ISO 5832-2)
Indications:	The aap LOQTEQ® VA Volar Distal Radius Plate 2.5, LO- QTEQ® VA Distal Radius Straight Plate 2.5, LOQTEQ® VA Distal Radius L-Plate 2.5 are intended for fixation of complex intra-articular and extra-articular fractures and osteotomies of the distal radius . The aap LOQTEQ® VA Distal Ulna Plate 2.5, LOQTEQ® VA Distal Ulna Hook Plate 2.5 are intended for fractures and osteotomies of the distal ulna .
Substantial Equivalence	The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use. Documentation including mechanical testing to show the substantial equivalence has been provided with this submission.
Performance Data (Non-Clinical and/or Clinical):	Non-clinical tests have been performed and show the substantial equivalence of the device. Summary of Non-clinical tests : Type of test : Static and dynamic system tests, representing worst case scenario with respect to clinical use. Screw tests according to ASTM F543 – 13. Assessment of test results : Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The screws fulfil the relevant demands of ASTM F543-13. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses. Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.

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.