The aap LOQTEQ® Elbow System consists of bone plates and bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments of the distal humerus. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).

The aap LOQTEQ® Elbow System consists of:
LOQTEQ® Distal Dorsolateral Humerus Plate (left and right) LOQTEQ® Distal Medial Humerus Plate (left and right) LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping Cortical Screw 2.5, small head T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Elbow System

AI/ML Overview

Here's a breakdown of the requested information based on the provided text, focusing on the acceptance criteria and the study that proves the device meets those criteria:

Device: aap LOQTEQ® Elbow System (a bone fixation system)

Note: The provided document is a 510(k) summary for a medical device (aap LOQTEQ® Elbow System). For this type of device, "acceptance criteria" and "performance" primarily refer to the mechanical and physical properties of the implant, demonstrating its ability to function as intended and its substantial equivalence to a predicate device. It's not about an AI algorithm's diagnostic performance, but rather the device's structural integrity and biological compatibility. Therefore, some of the requested points related to AI algorithms (like MRMC studies, training sets, adjudication methods, and human reader improvement with AI) are not applicable to this document.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (What was measured)	Reported Device Performance (Result)
Mechanical Performance (Static and Dynamic System Tests): Comparing the mechanical performance of the aap LOQTEQ® Elbow System to the predicate device (Synthes (USA) 3.5 mm LCP Distal Humerus System). The acceptance criteria would be that the aap LOQTEQ® Elbow System demonstrates equivalent or superior mechanical properties under worst-case clinical scenarios, ensuring it can withstand the forces expected in vivo without failure, fracture, or loosening, and function effectively for internal fixation of bone fragments.	Substantial Equivalence: The assessment of test results stated, "Substantial equivalence with respect to the mechanical performance of the aap system could be stated due to the test results gained. The subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses." This indicates that the device met the mechanical performance standards necessary to be considered substantially equivalent to the predicate device. While specific quantitative results (e.g., stiffness values, fatigue cycles survived, load-to-failure data) are not provided in this summary, the conclusion confirms that the device's performance aligns with the established acceptance criteria for mechanical integrity and functionality.
Biocompatibility: The material (Ti6Al4V) used for the implants generally has established acceptance criteria for biocompatibility, ensuring it does not cause adverse biological reactions when implanted in the human body.	Material Selection: Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3). This material is a well-established and approved medical-grade alloy with a known history of biocompatibility. By using a standard material that meets these specifications, the device inherently meets established biocompatibility acceptance criteria. (No explicit test results are detailed in this summary, but reliance on standard materials is a common approach for biocompatibility in 510(k) submissions).
Functional Equivalence: The device's components (plates and screws) and their interaction should allow for internal fixation of distal humerus fractures as intended, similar to the predicate device.	Similar Design and Functionality: The summary states, "The Substantial Equivalence of the new device and the predicate device is based on similar intended use, design, functionality, components and materials in use." This indicates that the device's overall functional performance, including its ability to achieve internal fixation via bone plates and screws, was found to be equivalent to the predicate.

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

Sample Size for Test Set: The document mentions "Static and dynamic system tests, representing worst case scenario with respect to clinical use." It does not specify the exact number of samples (e.g., number of plates or screws) tested, but refers to "tests" in the plural, implying multiple tests were conducted. Standard practice for such mechanical testing involves a statistically relevant number of samples to ensure robust results.
Data Provenance: The tests are non-clinical (laboratory-based mechanical tests). The country of origin for the data is not explicitly stated, but the sponsor, aap Implantate AG, is based in Berlin, Germany. Therefore, it is highly probable the testing was conducted either in Germany or by an accredited testing facility that supports their regulatory submissions. The data is prospective in the sense that these specific tests were performed for this 510(k) submission to demonstrate equivalence.

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

Not applicable (N/A). This refers to bone fixation implants, not an AI diagnostic device. The "ground truth" for mechanical testing is established by engineering standards, validated testing protocols, and comparison to the predicate device's known performance. There isn't a concept of "experts establishing ground truth" in the same way as for medical imaging diagnosis. The evaluation and interpretation of the test results would be performed by qualified engineers or scientists.

4. Adjudication Method for the Test Set

Not applicable (N/A). Adjudication methods like 2+1 or 3+1 are used for expert consensus on diagnostic imaging. For mechanical testing, the results are quantitative and compared against predefined engineering specifications and the predicate device's performance. The outcome is typically based on whether the measured values fall within acceptable ranges and demonstrate equivalence.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This type of study (MRMC for human readers with/without AI assistance) is not applicable to a bone fixation system. MRMC studies are relevant for diagnostic devices that involve interpretation by human readers.

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

Not applicable (N/A). This product is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

Engineering Standards and Predicate Device Performance: For the mechanical tests, the "ground truth" is defined by:
- Applicable international and national standards for medical device materials and mechanical performance (e.g., ISO, ASTM standards for bone plates and screws).
- The established performance characteristics of the legally marketed predicate device (Synthes (USA) 3.5 mm LCP Distal Humerus System), which serves as the benchmark for substantial equivalence. "Worst case scenarios with respect to clinical use" also define the parameters against which the device's performance is measured.
- Biocompatibility "ground truth" is based on established material specifications (ASTM F136 or ISO 5832-3 for Ti6Al4V).

8. The Sample Size for the Training Set

Not applicable (N/A). This product is a physical implant, not a software algorithm that requires a training set.

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

Not applicable (N/A). No training set is involved for this type of device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo features a stylized image of three faces in profile, stacked on top of each other. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the image.

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

March 24, 2015

aap Implantate AG Dr. Christian Zietsch Manager, Regulatory Affairs Lorenzweg 5, D-12099 Berlin GERMANY

Re: K132787 Trade/Device Name: aap LOQTEQ® Elbow 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, HWC Dated: September 26, 2013 Received: October 7, 2013

Dear Dr. Zietsch:

This letter corrects our substantially equivalent letter of December 24, 2013.

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

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Page 2 - Dr. Christian Zietsch

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 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 vours.

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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Indications for Use Statement

510(k) Number (if known): K132787

Device Name: aap LOQTEQ® Elbow System

Indications for Use:

The aap LOQTEQ® Elbow System is indicated for:

intra-articular fractures of the distal Humerus .
supracondylar fractures of the distal Humerus .
osteotomies, and non-unions of the distal Humerus .

Prescription Use	X
(Part 21 CFR 801 Subpart D)	AND/OR
Over-The-Counter Use	(21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Laurence D. Coyne -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K132787

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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	March / 12 / 2015
Trade Name:	aap LOQTEQ® Elbow System
Common Name:	Distal Humerus System
Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallicbone fixation appliances and accessories – Class II and21 CFR 888.3040 Smooth or threaded metallic bone fixa-tion fastener - Class II
Device Product Code andPanel Code:	Orthopedics/87/ HRS: Plate, Fixation, BoneOrthopedics/87/ HWC: Screw, Fixation, Bone
Predicate device:	Synthes (USA) 3.5 mm LCP Distal Humerus System underthe premarket notification K033995 (Mar 1, 2004)
Device Description:	The aap LOQTEQ® Elbow System consists of bone platesand bone screws, to be implanted by a surgeon in order toachieve an internal fixation of bone fragments of the distalhumerus. If the plates are used in conjunction with lockingscrews, a so called internal fixator will be realized (internalfixation).The aap LOQTEQ® Elbow System consists of:LOQTEQ® Distal Dorsolateral Humerus Plate (left and right) LOQTEQ® Distal Medial Humerus Plate (left and right) LOQTEQ® Cortical Screw 2.7, small head T8, self-tapping Cortical Screw 2.5, small head T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Elbow System
Material:	Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
Indications:	The aap LOQTEQ® Elbow System is indicated for:- intra-articular fractures of the distal Humerus- supracondylar fractures of the distal Humerus

Substantial Equivalence	The Substantial Equivalence of the new device and thepredicate device is based on similar intended use, design,functionality, components and materials in use.
	Documentation including mechanical testing to show thesubstantial equivalence and safety and effectiveness hasbeen provided with this submission.
Performance Data(Non-Clinical and /or Clinical):	Non-clinical tests have been performed and showthe effectiveness and safety of the device.
	Summary of Non-clinical tests:
	Type of test:Static and dynamic system tests, representing worst casescenario with respect to clinical use.
	Assessment of test results:Substantial equivalence with respect to the mechanicalperformance of the aap system could be stated due to thetest results gained. The subject device is safe and effec-

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Documentation regarding the mechanical testing to show the substantial equivalence and safety and effectiveness has been provided with this submission.

tive, and whose performance meets the requirements of its

pre-defined acceptance criteria and intended uses.

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.