The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management).

All aap bone screws are for single use only and are not intended for any spinal fixation procedures.

Device Description

The aap Cortical Screws 3.5, 4.5 are bone screws, to be implanted by a surgeon in order to achieve an internal fixation of bone fragments typically after fractures or osteotomies. The screws can be used as non locking screws along with the aap LOQTEQ® System as well as lag screws, to hold together fragments of bone. The devices are made of Titanium alloy.

Variations of the aap Cortical Screw 3.5, 4.5:
• Cortical Screw 3.5, T15, self-tapping, Titanium
• Cortical Screw 4.5, T25, self-tapping, Titanium

Material:
Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the aap Cortical Screws 3.5, 4.5.

The document describes a 510(k) premarket notification for a medical device. This type of submission relies on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness de novo through extensive clinical trials. Therefore, the "study" described is primarily focused on non-clinical mechanical testing to demonstrate that the new device performs similarly to established standards and the predicate device.

Description of Acceptance Criteria and the Study

1. Table of Acceptance Criteria and Reported Device Performance

Performance Metric	Acceptance Criteria (ASTM F543 Annex A5)	Reported Device Performance
"Summary of Non-clinical tests:"
Torsional Yield Strength	(Values not explicitly stated here)	Determined according to ASTM F543 (Annex A1). Substantial equivalence with respect to mechanical performance was stated due to test results.
Maximum Torque	Minimum acceptable values (ASTM F543 Annex A5)	Reached the minimum acceptable values as given in Annex A5 of ASTM F543. Substantial equivalence with respect to mechanical performance was stated due to test results.
Breaking Angle	Minimum acceptable values (ASTM F543 Annex A5)	Reached the minimum acceptable values as given in Annex A5 of ASTM F543. Substantial equivalence with respect to mechanical performance was stated due to test results.
Insertion Torque (Driving Torque)	(Values not explicitly stated here)	Determined according to ASTM F543 (Annex A2). Substantial equivalence with respect to mechanical performance was stated due to test results.
Removal Torque (Driving Torque)	(Values not explicitly stated here)	Determined according to ASTM F543 (Annex A2). Substantial equivalence with respect to mechanical performance was stated due to test results.
Axial Pullout Strength	(Values not explicitly stated here)	Determined according to ASTM F543 (Annex A3). Substantial equivalence with respect to mechanical performance was stated due to test results.

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

Sample Size: Not explicitly stated. The document mentions "Tests performed" and "test results gained" for the mechanical properties of the screws, implying multiple samples were tested for each metric. However, specific numbers are not provided.
Data Provenance: The tests are non-clinical, mechanical tests performed according to ASTM F543. The specific lab or country where these tests were conducted is not mentioned but would typically be part of the full submission, likely in Germany where aap Implantate AG is located. The data is thus prospective, as it was generated specifically for this submission.

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

This is a non-clinical, mechanical testing study. The "ground truth" is established by the specified industry standard, ASTM F543. Therefore, no human experts were used to establish the "ground truth" for the test set in the way one would for clinical imaging interpretation. The experts involved would be those who developed and maintain the ASTM F543 standard, and the engineers/technicians performing the tests.

4. Adjudication method for the test set

Not applicable as this is a non-clinical mechanical testing study. The results are quantitative measurements compared directly against the requirements of ASTM F543.

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 medical device (bone screw) and not an AI-powered diagnostic or assistive tool.

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

Not applicable. This is a medical device (bone screw) and not an AI algorithm.

7. The type of ground truth used

The ground truth for the performance assessment is based on established engineering and material science standards, specifically the requirements and methodologies outlined in ASTM F543 Standard Specification for Metallic Medical Bone Screws. The "acceptance criteria" are derived directly from this standard (e.g., minimum acceptable values for Maximum Torque and Breaking Angle as given in Annex A5 of ASTM F543).

8. The sample size for the training set

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

Not applicable. (See #8)

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle are three stylized human profiles facing to the right, stacked on top of each other. The profiles are rendered in a simple, flowing line style.

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

September 12, 2014

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

Re: K141949

Trade/Device Name: aap Cortical Screws 3.5, 4.5 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: August 8, 2014 Received: August 11, 2014

Dear Dr. Christian 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 Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Dr. Christian Zietsch

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/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): K141949

Device Name: aap Cortical Screws 3.5, 4.5

Indications for Use:

All aap bone screws are for single use only and are not intended for any spinal fixation procedures.

AND/OR

Prescription Use	X
(Part 21 CFR 801 Subpart D)

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)

Page 1 of 1_

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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	August/08/ 2014
Trade Name:	aap Cortical Screws 3.5, 4.5
Common Name:	Cortical Screws 3.5, 4.5Clavicle
Classification Name andReference:	21 CFR 888.3040 Smooth or threaded metallicbone fixation fastener — Class II
Device Product Code andPanel Code:	Orthopedics/87/ HWC
Predicate device:	The aap Cortical Screw 3.5, 4.5 are substantially equiva-lent to aap Screw Implants (Cortical Screw 3.5, self-tapping, Titanium and Cortical Screw 4.5, self-tapping, Ti-tanium) under the premarket notification K072411 (Mar 20,2008), aap Cortical Screw 3.5, small head , self-tapping, Ti-tanium under the premarket notification K113652 (Aug 30,2012) and Cortical Screw 4.5, small head, self-tapping, Ti-tanium under the premarket notification K113648 (Sep. 6,2012).
Device Description:	The aap Cortical Screws 3.5, 4.5 are bone screws, to beimplanted by a surgeon in order to achieve an internal fixa-tion of bone fragments typically after fractures or osteoto-mies. The screws can be used as non locking screws alongwith the aap LOQTEQ® System as well as lag screws, tohold together fragments of bone. The devices are made ofTitanium alloy.
	Variations of the aap Cortical Screw 3.5, 4.5:
	• Cortical Screw 3.5, T15, self-tapping, Titanium• Cortical Screw 4.5, T25, self-tapping, Titanium
Material:	Implants are made of Ti6Al4V (ASTM F136 or ISO 5832-3)

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Indications:	The devices are intended to treat fractures of various bones, including the clavicle, scapula, pelvis, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals, and phalanges) according to the standard of the AO Foundation (AO Principles of Fracture Management). All aap bone screws are for single use only and are not intended for any spinal fixation procedures.
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 and engineering analysis (dimensions and material) 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: Mechanical properties of metallic bone screws in accordance with ASTM F543
	Tests performed: The Torsional Properties of Metallic Bone Screws, here Torsional Yield Strength, Maximum Torque, and Breaking Angle, the Driving Torque Properties, here Insertion and Removal Torque as well as the Axial Pullout strength of the screws have been determined according to ASTM F543 (Annex A1, A2 and A3).
	Assessment of test results: Substantial equivalence with respect to the mechanical performance of the aap screws could be stated due to the test results gained. The minimum acceptable values for Maximum Torque and Breaking Angle as given in Annex A5 of ASTM F543 have been reached. The subject device is substantial equivalent, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.
	Documentation regarding the mechanical testing and technological characteristics to show the substantial equivalence has been provided with this submission.

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.