The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of the LOQTEQ® Elbow System (K132787 and K140607), to be implanted by a surgeon in order to achieve a repositioning of fragments and an internal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate-screw system guarantees an additional mechanical fixation and enables the application for osteopenic bones. aap already offers a system of two plates for treatment of distal Humerus fractures: these are the anatomical shaped Plates LOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® Distal Medial Humerus Plate. Typically these devices are used together for one fracture and are placed under 90° orientation. The devices are already registered under the premarket notification K132787. Depending on the surgeons education some doctors prefer to use a different placement of the two plates. Therefore aap wants to add a further plate for the use in the identical intended use: this is the LOQTEQ® Distal Lateral Humerus Plate which is also used together with the LOQTEQ® Distal Medial Humerus Plate (see surgical approach above). In some rare indications this new device might be used as a standalone The anatomically performed plates are available as right and left version and in different lengths and with several shaft holes. The tapered end of the plate enables tissue-conserving, submuscular insertion. The tip of the shaft is tapered to allow a minimally invasive surgical technique. The bottom of shaft area is structured and tunnelled by cross grooves to minimize bone contact. All shaft holes, with the exception of the elongated hole are compatible with unidirectional locking screws as well as cortical screws. The use of locking screws is state of the art and is particularly important in osteoporotic bones or for stabilizing comminuted fractures. The elongated hole can be used to adjust the height as well as the initial fixation of the plate. The round locking holes are suitable for locking screws as well as cortical screws. The locking screws allow evening catching very small fragments. The design of the so-called glide holes allows angle stable fixation and proximal compression of bone fragments at the same time if LOQTEQ® Cortical Screws are used. The use of standard cortical bone screws leads to a non-angle stable fixation. A compression of the bone fragments can be realised, if the screws are positioned eccentric inside the glide hole. If the screws are placed directly in the locking part of the gliding hole, no compression occurs. The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of: LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holes LOQTEQ® Cortical Screw 2.7, small head, T8, self-tapping LOQTEQ® Cortical Screw 3.5, T15, self-tapping Cortical Screw 2.5, small head, T8, self-tapping Cortical Screw 3.5, self-tapping Set of Instruments aap LOQTEQ® Distal Lateral Humerus Plate

AI/ML Overview

This is a 510(k) Premarket Notification for a medical device, specifically bone fixation plates, and does not involve AI or machine learning. Therefore, the requested information about acceptance criteria, study details for AI performance, sample sizes for test/training sets, ground truth establishment, expert adjudication, or MRMC studies is not applicable to this document.

The document discusses the substantial equivalence of the "aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5" to a legally marketed predicate device (Synthes (USA): 3.5 MM LCP Distal Humerus System). The acceptance criteria and "study" are engineering analyses focusing on mechanical performance.

Here's the relevant information extracted from the provided text regarding the device's acceptance criteria and the "study" proving it:

1. Table of acceptance criteria and the reported device performance:

Acceptance Criteria (Technological Characteristics for Substantial Equivalence)	Reported Device Performance (aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5)
Identical intended use	Identical to predicate device
Similar technological characteristics	Similar to predicate device
Known characteristics relevant for safety described and assessed	All relevant characteristics described and assessed
Indication for use statement: identical	Identical to predicate device
Functionality: identical	Identical to predicate device
Components, Materials, Dimensions of components: comparable	Comparable to predicate device
Mechanical properties (ensured by benchmark tests) at least comparable	Passed all defined criteria, performed as well or better than predicate device in bending strength, bending stiffness, bending structural stiffness, and fatigue strength.

2. Sample size used for the test set and the data provenance: Not applicable. This is an engineering analysis/mechanical testing, not a clinical study involving a test set of data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for mechanical testing is established through standardized engineering protocols and measurements, not expert consensus.

4. Adjudication method for the test set: Not applicable.

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 device is a bone plate, not an AI-powered diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used: For the mechanical performance data, the ground truth is based on physical scientific measurements and established engineering standards for bending strength, bending stiffness, bending structural stiffness, and fatigue strength.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

Summary of the "study" (Performance Data):
"An engineering analysis was used to show substantial equivalence of the subject device to the predicate device in terms mechanical performance, including bending strength, bending stiffness, bending structural stiffness, and fatigue strength. The LOQTEQ®Distal Humerus Plate has passed all defined criteria, has performed as well or better than the predicate device and therefore considered substantially equivalent to the cleared predicate device."

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized image of three human profiles facing to the right, stacked on top of each other. The profiles are connected and appear to be flowing or merging together. 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

November 23, 2016

aap Implantate AG Reni Schaller Manager Regulatory Affairs Lorenzweg 5 Berlin, D-12099 Germany

Re: K161696 Trade/Device Name: aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 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 16, 2016 Received: October 18, 2016

Dear Ms. Schaller:

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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Indications for Use

510(k) Number (if known)

K161696

Device Name

aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5

Indications for Use (Describe)

Intra-articular fractures, supracondylar fractures, osteotomies and non-unions of the distal humerus

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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510(K) Traditional Premarket Notification, K161696
aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
Section 5 510(k) Summary

5. 510(K) Summary

(as required by section 807.92)

(as required by section 807.92)
(1)
Sponsor	aap Implantate AGLorenzweg 5D-12099 Berlin, Germany
Company Contact	Reni SchallerPhone: +49-30-750-19 - 193Fax: +49-30-750-19 – 111Email: r.schaller@aap.de
Date	November/22/2016
(2)
Trade Name	aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5
Common Name	LOQTEQ® Distal Lateral Humerus Plate
Classification Name andReference	21 CFR 888.3030 Single/multiple component metallic bone fixationappliances and accessories – Class II21 CFR 888.3040: Smooth or threaded metallic bone fixationfastener – Class II
Device Product Code andPanel Code	Orthopedics/87/HRSOrthopedics/87/HWC
(3)
Predicate devices	Company Synthes (USA):3.5 MM LCP Distal Humerus System under the premarketnotification K033995
(4)
Device Description	The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 is part of theLOQTEQ® Elbow System (K132787 and K140607), to be implanted bya surgeon in order to achieve a repositioning of fragments and aninternal fixation of the bone after fractures, osteotomies or non-unions. By using locking screws the plate-screw system guaranteesan additional mechanical fixation and enables the application forosteopenic bones.aap already offers a system of two plates for treatment of distalHumerus fractures: these are the anatomical shaped PlatesLOQTEQ® Distal Dorsolateral Humerus Plate and LOQTEQ® DistalMedial Humerus Plate. Typically these devices are used together forone fracture and are placed under 90° orientation. The devices arealready registered under the premarket notification K132787.Depending on the surgeons education some doctors prefer to use adifferent placement of the two plates.Therefore aap wants to add a further plate for the use in theidentical intended use: this is the LOQTEQ® Distal Lateral HumerusPlate which is also used together with the LOQTEQ® Distal MedialHumerus Plate (see surgical approach above). In some rareindications this new device might be used as a standalone
	The anatomically performed plates are available as right and leftversion and in different lengths and with several shaft holes. Thetapered end of the plate enables tissue-conserving, submuscularinsertion. The tip of the shaft is tapered to allow a minimally invasivesurgical technique. The bottom of shaft area is structured andtunnelled by cross grooves to minimize bone contact.All shaft holes, with the exception of the elongated hole arecompatible with unidirectional locking screws as well as corticalscrews. The use of locking screws is state of the art and isparticularly important in osteoporotic bones or for stabilizingcomminuted fractures. The elongated hole can be used to adjust theheight as well as the initial fixation of the plate.The round locking holes are suitable for locking screws as well ascortical screws. The locking screws allow evening catching very smallfragments.The design of the so-called glide holes allows angle stable fixationand proximal compression of bone fragments at the same time ifLOQTEQ® Cortical Screws are used. The use of standard corticalbone screws leads to a non-angle stable fixation.A compression of the bone fragments can be realised, if the screwsare positioned eccentric inside the glide hole. If the screws areplaced directly in the locking part of the gliding hole, no compressionoccurs.
	The aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5 consists of:LOQTEQ® Distal Lateral Humerus Plate, right/left, 2/3/5/7/11 holesLOQTEQ® Cortical Screw 2.7, small head, T8, self-tappingLOQTEQ® Cortical Screw 3.5, T15, self-tappingCortical Screw 2.5, small head, T8, self-tappingCortical Screw 3.5, self-tappingSet of Instruments aap LOQTEQ® Distal Lateral Humerus Plate
Material	All implants are made of Ti6Al4V(according ISO 5832-3 or ASTM F136)
Surface	The surface of the plates is generated by an automatic slidefinishing, the so-called “KeramoFinish”. Those surfaces correspondto polished surfaces. The surface of the LOQTEQ® Cortical Screwsare slightly polished and anodised. The surface of the Cortical Screwsare fine blasted and anodised as well.
(5)
Indications	aap LOQTEQ® Distal Lateral Humerus Plate 2.7/3.5:Intra-articular fractures, supracondylar fractures, osteotomies andnon-unions of the distal humerus
(6a)
Technologicalcharacteristics	The LOQTEQ® Distal Lateral Humerus Plate and the legally marketedpredicated devices have similar indications, dimensions, geometryand materials.
Comparison	The LOQTEQ® Distal Lateral Humerus Plate is technologicallysubstantially equivalent to the predicate devices according to theDecision-Making Process for 510(k)s:Predicate device is legally marketed

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(6b)

1. The devices have the identical intended use
1. The devices have similar technological characteristics

All characteristics which are known and are relevant for the safety for both devices are described and assessed mainly:

1.Indication for use statement: identical
1. Functionality: identical
1. Components, Materials, Dimensions of components: comparable
1. Mechanical properties (ensured by benchmark tests) at least comparable

Documentation including mechanical testing to show the substantial equivalence has been provided with this submission.

Performance Data An engineering analysis was used to show substantial equivalence of the subject device to the predicate device in terms mechanical performance, including bending strength, bending stiffness, bending structural stiffness, and fatigue strength.

The LOQTEQ®Distal Humerus Plate has passed all defined criteria, has performed as well or better than the predicate device and therefore considered substantially equivalent to the cleared predicate device.

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.