The Apex Kirschner wires and Steinmann pins are indicated for use in fixation of bone fractures, for bone reconstructions, as guide pins for insertion of other implants or implantation through the skin so that traction may be applied to the skeletal system.

Device Description

Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

AI/ML Overview

The provided text describes the 510(k) summary for the Apex Kirschner Wires and Steinmann Pins. It does not contain information about specific acceptance criteria or a detailed study proving the device meets those criteria, as typically found in performance testing sections for AI/ML-driven devices. Instead, it focuses on substantial equivalence to predicate devices based on design and materials.

However, I can extract the relevant information that is present and explain where the requested details are absent.

A table of acceptance criteria and the reported device performance

This information is not provided in the document. The submission is a 510(k) for orthopedic fixation devices (Kirschner Wires and Steinmann Pins), which typically rely on material properties, mechanical strength, and biocompatibility rather than "performance" in the sense of an algorithm's output metrics like sensitivity or specificity.
The document states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This implies that the 'acceptance criteria' are implicitly met if these characteristics are equivalent to legally marketed predicate devices, which are presumed safe and effective.
Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

This information is not applicable/provided for this type of device submission. There is no 'test set' in the context of an algorithm or diagnostic device. The evaluation is based on engineering specifications and comparison to predicate devices, not data from a clinical trial or dataset.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

This information is not applicable/provided. There is no ground truth established by experts for a test set, as this is a medical device (orthopedic pins) and not a diagnostic or AI-based product.
Adjudication method (e.g., 2+1, 3+1, none) for the test set

This information is not applicable/provided. No adjudication method for a test set is mentioned because there is no such test set.
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 information is not applicable/provided. An MRMC study is relevant for AI-assisted diagnostic devices. This submission concerns orthopedic hardware, not an AI system.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done

This information is not applicable/provided. This device is a physical medical implant, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

This information is not applicable/provided. Ground truth, as defined for algorithm performance, is not relevant here. The "truth" for this device lies in its material properties, manufacturing quality, and successful physical fixation as per its intended use, established through engineering standards and comparison to predicate devices.
The sample size for the training set

This information is not applicable/provided. There is no 'training set' for this physical medical device.
How the ground truth for the training set was established

This information is not applicable/provided. There is no ground truth or training set for this device.

Summary of available information regarding the "study" proving device meets "acceptance criteria":

Based on the provided document, the "study" demonstrating the device meets "acceptance criteria" is a substantive equivalence comparison with legally marketed predicate devices.

Study Design: A comparison of physical dimensions, materials, and technological characteristics of the Apex Kirschner Wires and Steinmann Pins to identified predicate devices:
- Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215)
- DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385)
- OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555)
- Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912)
Acceptance Criteria (Implied): The device is considered to meet acceptance criteria if its physical dimensions, materials, and technological characteristics are "similar" or equivalent to the identified predicate devices, thereby establishing substantial equivalence in terms of safety and effectiveness for its intended use.
Reported Device Performance: The document explicitly states: "The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters." This statement serves as the 'reported performance' for the 510(k) process, indicating that the device design and materials are comparable to existing, approved devices.
Data Provenance/Sample Size: Not applicable in the context of an AI/ML study. The 'data' consists of the specifications and characteristics of the Apex device and the predicate devices.

The FDA's letter confirms that they "reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... to legally marketed predicate devices." This substantial equivalence determination serves as the "proof" that the device meets regulatory requirements based on the comparative assessment.

Summary

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K112254(1/2)

OCT | 1 2011

510(k) Summary 5.

Device Trade Name:	Apex Kirschner Wires and Steinmann Pins
Manufacturer:	Apex Tools & Orthopedics Co.
Contact:	Apex Tools & Orthopedics Co.25 Yonghua, Yonghe, GETDDGuangzhou, Guangdong,CN-511356CHINAPhone: 86 20 82986918Fax: 86 20 82986913
Prepared by:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	August 4, 2011
Classifications:	21 CFR 888.3040, Smooth or threaded metallic bonefixation fasteners.
Class:	II
Product Codes:	HTY and IDW

Indications For Use:

Device Description:

Apex Kirschner Wires and Steinmann Pins are available in several diameters and lengths, in both threaded and non-threaded designs with a variety of point geometries.

Substantial Equivalence

The Apex Kirschner Wires and Steinmann Pins are substantially equivalent to the following devices: Evergreen Orthopedics Research Lab, Kirschner wires and Steinmann Pins (K102215); DePuy Inc. Sterile Kirschner Wires and Steinmann Pins (K960385); OrthoPro, LLC OrthoPro Steinman Pins and Kirschner Wires (K070555); Treu-Instrumente GmbH Treu Bone Fixation Screws and Pins (K083912); with respect to indications, materials, and technological characteristics.

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K112254(z/z)

Preclinical Testing:

The Apex Kirschner Wires and Steinmann Pins have similar physical dimensions, materials and technological characteristics as the identified predicate devices, and Apex's substantial equivalence rationale is based on comparisons of these parameters.

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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 eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES U.S.A." is arranged in a circular pattern around the eagle.

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

Apex Tools & Orthopedies Co. % Mr. Scott Liang General Manager 25 Yonghua, Yonghe, GETDD Guangzhou, Guangdong CN-511356 CHINA

00T 1 1 2011

Re: K112254

Trade/Device Name: Apex Kirschner Wires and Steinmann Pins Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HTY, JDW Dated: August 4, 2011 · Received: August 5, 2011

Dear Mr. Liang:

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 markcted 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.

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 (11 he 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 not me 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

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Page 2 - Mr. Scott Liang

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/ReportalProblem/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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

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

Enclosure

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Indications for Use 4.

510(k) Number (if known): K112254

Device Name: Apex Kirschner Wires and Steinmann Pins

Prescription Use 1/ (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 IF NEEDED)

Concurrence of CDRH, Offige of Device Avaluation (ODE)

(Division Sign-Oft)
Division of Surgical, Orthopedic,
and Restorative Devices

510(k) Number K11225.4

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.