Cannulated Screws are used for fixation of bone fragments, i.e., for treatment of bone fractures and other bone injuries. Cannulated Screws with a diameter of 2.0 mm are manly in use for foot and hand surgery.

The aap Cannulated Screw 2.0 consists of:
• Cannulated Screw 2.0, Long thread
• Cannulated Screw 2.0, Short thread
• Washer
• Set of Instruments Cannulated Screws

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "aap Cannulated Screw 2.0". This is a medical device application for orthopedic screws, and the "acceptance criteria" and "study" refer to mechanical and performance testing against established standards for such devices, rather than a clinical study with human or animal subjects or an AI/ML context.

Here's a breakdown of the requested information based on the provided text, focusing on the mechanical testing described:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria (Standard)	Reported Device Performance
ASTM F543-07 relevant requirements	The Screws fulfill the relevant requirements of ASTM F543-07 and pre-defined acceptance criteria and intended uses.

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

Sample Size: Not specified in the provided text. The document states "Non-clinical tests have been performed" and "mechanical testing to show the substantial equivalence," but does not detail the number of screws tested.
Data Provenance: The tests are non-clinical (mechanical tests) and were performed by the manufacturer, aap Implantate AG. The country of origin for the data would be Germany, where the sponsor is located, or a testing facility commissioned by them. The data is prospective in the sense that the tests were conducted 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 question is not applicable to this type of submission. "Ground truth" in this context refers to a standard of mechanical performance, not expert consensus on medical images or diagnoses. The "ground truth" is defined by the ASTM F543-07 standard.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical or imaging studies where expert consensus is needed. For mechanical testing against a standard, the results are objectively measured and compared to the standard's specifications.

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

This is not applicable. The device is a physical orthopedic screw, not an AI/ML algorithm or imaging device that would involve human readers or AI assistance in interpretation.

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

This is not applicable as the device is a physical medical implant, not an algorithm.

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

The "ground truth" for the non-clinical tests is the specified mechanical performance requirements outlined in the ASTM F543-07 standard.

8. The sample size for the training set

This is not applicable. There is no AI/ML algorithm involved, and therefore no training set.

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

This is not applicable as there is no AI/ML algorithm or training set.

Summary

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aap Implantate AG aap Cannulated Screw 2.0

K130590 page 1 of 2

SO (K) Summary of Safety and Effectiveness

APR 2 2 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	February/28/ 2013
Trade Name:	aap Cannulated Screw 2.0
Common Name:	Cannulated Screw 2.0
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/ HWC: Screw, Fixation, BoneOrthopedics/87/ HTN: Washer, Bolt Nut
Predicate device:	Asnis™ Micro Cannulated Screw Systemfrom Stryker (former Howmedica) under the premarket noti-fication K071092 (May 11, 2007)
Device Description:	Cannulated Screws are used for fixation of bone frag-ments, i.e., for treatment of bone fractures and other boneinjuries. Cannulated Screws with a diameter of 2.0 mm aremanly in use for foot and hand surgery.The aap Cannulated Screw 2.0 consists of:• Cannulated Screw 2.0, Long thread• Cannulated Screw 2.0, Short thread• Washer• Set of Instruments Cannulated Screws
Material:	Implants made of Ti6Al4V (ASTM F136 or ISO 5832-3) orImplants made of stainless steel (ASTM F138or ISO 5832-1)
Indications:	The aap Cannulated Screw 2.0 is intended for fracture fixa-tion of small and long bones and of the pelvis. The systemis not intended for spinal use.
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.

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oop Implantate AG aap Cannulated Screw 2.0

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: Mechanical tests of Screws acc. to ASTM F543-07

Assessment of test results: 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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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

April 22, 2013

aap Implantate AG % Dr. Christian Zietsch Manager RA Lorenzweg 5 D-12099 Berlin Germany

Re: K130590

Trade/Device Name: aap Cannulated Screw 2.0 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC, HTN Dated: February 28, 2013 Received: March 14, 2013

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 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 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/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 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.goy/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 "E", "r", "i", and "n" are in a simple, bold font. The letters "D", "K", "e", "i", "t", and "h" are in a more complex font with lines and shapes.

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 Cannulated Screw 2.0

Indications for Use Statement

510(k) Number (if known): K130590

Device Name: aap Cannulated Screw 2.0

Indications for Use:

The aap Cannulated Screw 2.0 is intended for fracture fixation of small and long bones and of the pelvis. The system is not intended for spinal use.

Prescription Use × (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

Elizabeth @ Frank -S

Division of Orthopedic Devices

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.