KangLi® locking plate system contains locking plates with various specifications, metal bone and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery. The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6AI4V ELI that meets to ASTM F136. The materials of titanium and Ti6AI4V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

AI/ML Overview

The provided text describes the 510(k) submission for the KangLi® Locking Plate System, a medical device for bone fixation. However, it does not contain information about acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML device.

The document is a traditional 510(k) summary for a physical medical device (locking plates and screws), not a software or AI/ML device. Therefore, the questions related to AI/ML device evaluation (like sample size for test/training sets, experts for ground truth, adjudication methods, MRMC studies, or standalone algorithm performance) are not applicable to this submission.

Instead, this submission focuses on bench testing to demonstrate Substantial Equivalence (SE) to a predicate device. The "acceptance criteria" here are the performance requirements outlined in the referenced ASTM standards.

Here's a breakdown of the information that can be extracted from the provided text, modified to fit the context of device performance, and an explanation of why other requested information is not present:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
ASTM F 382-99 (Reapproved 2008): Standard Specification and Test Method for Metallic Bone Plates	The proposed device complies with and meets all design specifications. Verified through bench tests.
- Static four point bending	Test results demonstrated compliance.
- Dynamic four point bending	Test results demonstrated compliance.
ASTM F 543-07: Standard Specification and Test Methods for Metallic Medical Bone Screws	The proposed device complies with and meets all design specifications. Verified through bench tests.
- Torsional properties	Test results demonstrated compliance.
- Driving torque	Test results demonstrated compliance.
- Pull out test	Test results demonstrated compliance.

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

Sample Size: Not explicitly stated. For bench testing of physical orthopedic implants, sample sizes are typically determined by relevant ISO/ASTM standards or internal company protocols to ensure statistical significance for mechanical properties. These are usually small numbers (e.g., 5-10 samples per test arm) rather than large datasets.
Data Provenance: Not applicable in the context of "country of origin of data" or "retrospective/prospective" as this refers to mechanical bench testing, not clinical or image data. The testing was conducted by Suzhou Kangli Orthopaedics Instrument Co., Ltd., which is based in China.

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

Not applicable. "Ground truth" in this context refers to the measured physical properties of the device meeting the specified ASTM standards. This is determined by engineering measurements and quality control processes, not expert clinical interpretation.

4. Adjudication method for the test set:

Not applicable. Mechanical testing involves objective measurements against predefined thresholds, not subjective adjudication.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done:

No. This type of study is for evaluating the diagnostic performance of a device (often AI/ML systems) with human readers. The KangLi® Locking Plate System is a physical implant, not a diagnostic tool.

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

No. This relates to AI/ML algorithms. The KangLi® system is a physical implant. Its performance is inherent in its mechanical properties.

7. The type of ground truth used:

Engineering/Mechanical Specifications: The "ground truth" for this device's performance is adherence to the mechanical performance specifications defined by the ASTM standards (F 382-99 and F 543-07). This includes properties like static and dynamic bending strength for plates, and torsional properties, driving torque, and pull-out strength for screws.

8. The sample size for the training set:

Not applicable. There is no "training set" in the context of a physical medical device being evaluated through bench testing. The design of the device is based on engineering principles and knowledge of materials, not machine learning algorithms.

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

Not applicable, as there is no training set.

In summary: The provided text details the non-clinical bench testing conducted to demonstrate that the KangLi® Locking Plate System structurally performs in accordance with established ASTM standards for metallic bone plates and screws. This type of regulatory submission focuses on mechanical and material properties to prove "Substantial Equivalence" to a previously approved device, not on diagnostic accuracy or AI/ML performance. Therefore, most of the questions are not relevant to this specific document.

Summary

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Section 5 of Traditional 510(K) Submission:

JUL 2 9 2014

510 (K) Summary

This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92

Date of Submission: Dec. 11, 2013
Submitter / 510(K) Holder

Suzhou Kangli Orthopaedics Instrument Co., Ltd., Sha Zhou East Road, Zhangjiagang City, Jiangsu Province, China 215625

Contact Person: Miss Jin Hua Huang Tel: (86) 0512-58560562 Fax: (86) 0512-58358951 E-mail: hjh@kang-li.cn

Proposed Device Name

Trade name: KangLi® Common name: Locking Plate System

Classification Name: Plate, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HRS Regulation Number: 21 CFR 888.3030

Classification Name: Screw, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HWC Regulation Number: 21 CFR 888.3040

Predicate Devices

510 (k) Number: K130340 Product Name: Locking Bone Plates and Scews Submitter: Weigao Orthopaedic Device Co., Ltd.

Device Description

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The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The metal bone and locking screws are made of Ti6AI4V ELI that meets to ASTM F136. The materials of titanium and Ti6AI4V ELI are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

Indication for Use/Intended Use

KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.

Non-Clinical Testing

Bench tests were conducted to verify that proposed device meet all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:

ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items:

Static four point bending
Dynamic four point bending

ASTM F 543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws including the following item:

Torsional properties
Driving torque
Pull out test

8. Substantially Equivalent Conclusion

The KangLi® locking plate system has less intended use than the predicate device and similar technological characteristics as the predicate device. The proposed device, the KangLi® locking plate system, is determined to be Substantially Equivalent (SE) to the predicate device, K130340 locking bone plates and screws, in respect of safety and effectiveness.

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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

July 29, 2014

Suzhou Kangli Orthopaedics Instrument Co., Ltd. % Ms. Alice Gong Shanghai Yarui Consultant Co., Ltd. 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, Shanghai 200233 China

Re: K133840

Trade/Device Name: KangLi® Locking Plate System 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: June 12, 2014 Received: June 26, 2014

Dear Ms. Gong:

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

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Page 2 - Ms. Alice Gong

(21 CFR Part 807); labeling (21 CFR Part 801); medical device 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 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/Resourcesfor You/Industry/default.htm.

Sincerely yours, Lori A. Wigqins

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

Enclosure

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Section 4 of Traditional 510(K) Submission:

Indications for Use

510(k) Number: K133840

Device Name: KangLi® Locking Plate System

Indications For Use:

KangLi® locking plate system is intended for adult patients as indicated for fixation of fractures of tibia.

Prescription Use______________________________________________________________________________________________________________________________________________________________ AND/OR Over-The-Counter Use_ ________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of Center for Devices and Radiological Health (CDRH)

Elizabeth L. Frank -S

Division of Orthopedic Devices

KangLi®, Suzhou Kangli Orthopaedics Instrument Co., Ltd.,

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.