Bone plates and screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Bone plates are fixed by the use of bone screws. Bone plates and bone screws are implants. If the plates are used in conjunction with locking screws, a so called internal fixator will be realized (internal fixation).
The aap Radius Set 2.5 consists of:
Extra-art. Radius Plate WSP 2.5, (left and right version)
Juxta-art. Radius Plate WSP 2.5, (left and right version)
L-Plate WSP 2.5, (left and right version)
Straight Plate WSP 2.5
T-Plate WSP 2.5
Cortical Screw WS 2.5, self-tapping (locking bone screw)
Cortical Screw 2.5, self-tapping
Set of Instruments, Radius Set 2.5

AI/ML Overview

The aap Radius Set 2.5 is a device indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

Here's an analysis of the provided information regarding its acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The submission primarily focuses on mechanical performance to establish substantial equivalence.

Acceptance Criteria	Reported Device Performance
Fatigue implant tests with progressive loadings: Represent worst-case clinical scenario.	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 its performance meets the requirements of its pre-defined acceptance criteria and intended uses.
Mechanical tests of Screws acc. to ASTM F543-07: Fulfil relevant requirements.	The Screws fulfil the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses.

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

The provided summary does not explicitly state the specific sample sizes for the mechanical tests (e.g., number of plates, screws, or test repetitions). It only mentions "fatigue implant tests with progressive loadings" and "Mechanical tests of Screws acc. to ASTM F543-07."

The data provenance is non-clinical testing, performed by the manufacturer, aap Implantate AG, in Germany. The study is prospective in the sense that these tests were conducted specifically for this submission to demonstrate substantial equivalence, rather than being a retrospective analysis of existing data.

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

This information is not applicable as the evaluation relies on non-clinical mechanical testing based on established engineering standards (ASTM F543-07), not on expert consensus for clinical image interpretation or diagnosis. The "ground truth" here is adherence to specified mechanical properties.

4. Adjudication Method for the Test Set

This information is not applicable as the evaluation is based on objective mechanical testing results against established standards, not on human adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No, an MRMC comparative effectiveness study was not done. This type of study is typical for diagnostic or screening devices where human interpretation is involved. For a bone fixation device, the primary evaluation is mechanical performance.

6. Standalone Performance Study

Yes, a standalone performance study was implicitly done. The "Summary of Non-clinical tests" describes mechanical tests performed on the device components (implants and screws) to demonstrate their effectiveness and safety against pre-defined acceptance criteria and established standards (ASTM F543-07). This is a standalone evaluation of the device's physical properties and performance.

7. Type of Ground Truth Used

The type of ground truth used is engineering specifications and established mechanical testing standards. Specifically:

Pre-defined acceptance criteria for fatigue implant tests.
ASTM F543-07 for mechanical tests of screws.

8. Sample Size for the Training Set

This information is not applicable. The device is a physical medical implant, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data-driven model development.

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

This information is not applicable as there is no training set for this type of device.

Summary

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oop Implantate AG aap Radius Set 2.5

K123875 Page 1 of 2

Summary of Safety and Effectiveness

MAR 1 1 2013

Sponsor:	aap Implantate AGLorenzweg 5D-12099 Berlin Germany
Company Contact:	Dr. Christian ZietschPhone:+49-30-750-19 -193Fax: +49-30-750-19 - 111
Date	December/13/2012
Trade Name:	aap Radius Set 2.5
Common Name:	Radius Set 2.5
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 fixation fas-tener - Class II
Device Product Code andPanel Code:	Orthopedics/87/ HRS: Plate, Fixation, BoneOrthopedics/87/ HWC: Screw, Fixation, Bone
Predicate device:	Synthes Locking Distal Radius Plating System, Synthes (USA)with premarket notification no. K012114 (SEP 28, 2001).
Device Description:	Bone plates and screws are used for fixation of bone fragments,i.e., for treatment of bone fractures and other bone injuries.Bone plates are fixed by the use of bone screws. Bone platesand bone screws are implants. If the plates are used in conjunc-tion with locking screws, a so called internal fixator will be real-ized (internal fixation).The aap Radius Set 2.5 consists of: Extra-art. Radius Plate WSP 2.5, (left and right version)Juxta-art. Radius Plate WSP 2.5, (left and right version)L-Plate WSP 2.5, (left and right version)Straight Plate WSP 2.5T-Plate WSP 2.5Cortical Screw WS 2.5, self-tapping (locking bone screw)Cortical Screw 2.5, self-tappingSet of Instruments, Radius Set 2.5
Material:	Plates are made of cp Titanium (ASTM F67 or ISO 5832-2).Screws are made of Ti6Al4V (ASTM F136 or ISO 5832-3)
Indications:	The aap Radius Set 2.5 is indicated for the fixation of intra- andextra-articular fractures and osteotomies of the distal radius.

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aap Implantate AG aop LOQTEQ® Distal Lateral Femur Plate 4.5 System

Page 2 of 2

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 and safety and effectiveness has been provided with this submission.

Performance Data (Non-Clinical and / or Clinical):

Non-clinical tests have been performed and show the effectiveness and safety of the device.

Summary of Non-clinical tests:

Type of test:

Fatigue implant tests with progressive loadings, representing worst case scenario with respect to clinical use. Mechanical tests of Screws acc. to ASTM F543-07

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 subject device is safe and effective, and whose performance meets the requirements of its pre-defined acceptance criteria and intended uses.

The Screws fulfil the relevant requirements of ASTM F543-07 and 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.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The text is in all caps and appears to be in a sans-serif font. The logo is black and white.

Public Health Service

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

March 11, 2013

aap Implantate AG % Dr. Christian Zietsch Manager Regulatory Affairs Lorenzweg 5 Berlin Germany 12099

Re: K123875

Trade/Device Name: aap 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: December 13, 2012 Received: December 17, 2012

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. Iisting 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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/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/Safetv/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,

Image /page/3/Picture/6 description: The image shows the name "Erin DKeith" in a stylized font. The letters "Erin" and "eith" are in a solid black font. The letters "D" and "K" are in a more decorative font with multiple lines.

Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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aap Implantate AG aap Radius Set 2.5

Indications for Use Statement

K123875 510(k) Number (if known):

Device Name: aap Radius Set 2.5

Indications for Use:

The aap Radius Set 2.5 is indicated for the fixation of intra- and extra-articular fractures and osteotomies of the distal radius.

. ..

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)

Page 1 of 1

Elizabeth L. Frank -S

Divison of Orthopedic Devices

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.