The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.

Device Description

The proposed product, Locking Compression Bone Plates and Screws System, contains (1) locking compression plates (LCPs) with various specifications, (2) locking screws with various specifications and (3) various specific instruments. The locking compression plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device (Locking Compression Bone Plates and Screws System). This type of submission focuses on demonstrating substantial equivalence to a predicate device based on non-clinical testing and comparison of characteristics. It does not contain information about clinical studies with human participants, expert review, or AI algorithms.

Therefore, most of the requested information (regarding acceptance criteria for a study, sample sizes for test/training sets, experts, adjudication methods, MRMC studies, standalone performance, and ground truth establishment for clinical data) is not present in the provided document. The device in question is a physical orthopedic implant, not an AI/software device.

However, I can extract information related to the acceptance criteria for the non-clinical tests and the device performance as reported in the summary.

1. Table of Acceptance Criteria and Reported Device Performance

Test Parameter	Acceptance Criteria (based on standards)	Reported Device Performance
Bone Plates (ASTM F382-99)
Static Performance	Complies with ASTM F382	Tested per ASTM F382
Dynamic Performance	Complies with ASTM F382	Tested per ASTM F382
Bone Screws (ASTM F543-07)
Torsional Strength	Complies with ASTM F543	Tested per ASTM F543
Driving Torque	Complies with ASTM F543	Tested per ASTM F543
Pull-out Strength	Complies with ASTM F543	Tested per ASTM F543

Explanation: The "acceptance criteria" here are that the device 'complies' or 'meets' the requirements of the specified ASTM standards (ASTM F382-99 for metallic bone plates and ASTM F543-07 for metallic medical bone screws). The "reported device performance" indicates that the tests were conducted according to these standards and the device met all design specifications to demonstrate substantial equivalence to the predicate. The summary states: "The test results demonstrated that the proposed device complies with the following standards." and "Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device."

Regarding the other requested information:

2. Sample sizes used for the test set and the data provenance: Not applicable. This document describes non-clinical, in-vitro mechanical testing of orthopedic implants, not a study involving human data or a "test set" in the context of an AI algorithm.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. The ground truth for mechanical testing is established by the defined parameters and methods within the ASTM standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for non-clinical mechanical testing.
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 device is a physical bone plate and screw system, not an AI diagnostic or assistance tool.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): The "ground truth" for this device's evaluation is adherence to established mechanical testing standards (ASTM F382-99 and ASTM F543-07) for metallic bone plates and screws.
8. The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device mechanical testing.
9. How the ground truth for the training set was established: Not applicable.

Summary

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K133525

Section 3 510 Summary

Section 3 510(k) Summary

This 510(k) Summary of 510(k) information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: _

l . Date of Submission: 11/04/2013

Sponsor Identification

Changzhou Dean Medical Instrument Co., Ltd. No. 10, Jinshajiang Road, Xinbei District, Changzhou, Jiangsu, 213125, China

Establishment Registration Number: Not yet registered

Contact Person: Xiaoqing Liu Position: Quality System Specialist Tel: +86-519-85195058 Fax: +86-519-85195058 Email: 717181584@qq.com

Submission Correspondent

Ms. Diana Hong& Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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4. Proposed Device Identification

Common Name: Locking Bone Plates and Locking Bone Screws Proposed Device Name: Locking Compression Bone Plates and Screws System

Plate:

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

Screw

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

Intended Use Statement:

The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.

Predicate Device Identification 5.
510(k) Number: K131759 Product Name: Metallic Locking Compression Bone Plates and Screws System Manufacturer: Tianjin Walkman Biomaterial Co., Ltd

ર. Device Description

The locking compression plates are used for internal fixation of bones, screws are used for fix the plates on the bones, and instruments are used for completing the surgery.

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7. Non-Clinical Test Conclusion

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

A STM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates; ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws

Substantially Equivalent (SE) Conclusion 8.
The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device	Predicate Device
		K131759
Product Code	HRSHWC	HRSHWC
Regulation Number	21 CFR 888.303021 CFR 888.3040	21 CFR 888.303021 CFR 888.3040
Intended Use	Locking Compression Bone Platesand Screw System is intended foradult patients with age above 21 asindicated for fixation of fractures,including ulna, radius and tibia.	Metallic Locking CompressionBone Plate and Screw System isintended for adult patients with ageabove 21 as indicated for fixationof fractures, including ulna, radius,humerus, femur and tibia.
Material	Bone Plate: TitaniumLocking Screw: Titanium alloy	Bone Plate: TitaniumLocking Screw: Titanium alloy
How supplied	Non-Sterile	Non-Sterile
Single Use	Yes	Yes
Sterile	Subject to steam sterilized prior touse.	Subject to steam sterilized prior touse.
Performance	Static and Dynamic Performancetested per ASTM F382Torsional, Driving Torque and Pullout strength tested per ASTM F543	Static and Dynamic Performancetested per ASTM F382Torsional, Driving Torque and Pullout strength tested per ASTM F543.

Table 3-1 Comnarison of Technology Characteristics

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Differences in physical specification and performance between the proposed and predicate device have been discussed and address. The proposed device is determined to be Substantially Equivalent (SE) to the predicate device, in respect of safety and effectiveness.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus. The logo is black and white.

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

March 4, 2014

Changzhou Dean Medical Instrument Co., Ltd. % Ms. Diana Hong General Manager Mid-Link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120, China

Re: K133525

Trade/Device Name: Locking Compression Bone Plates and Screws 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: February 7, 2014 Received: February 10, 2014

Dear Ms. Hong:

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. Diana Hong

(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 Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Vincent同比evlin -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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Premarket Notification 510(k) Submission Section 2 Indications for Use Project #: M0292013

Section 2 Indications for Use

K133525 510(k) Number: Device Name: Locking Compression Bone Plates and Screws System

Indications for Use:

The Locking Compression Bone Plates and Screws System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius and tibia.

APRESCRIPTION USE (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)

Elizabeth Warank -S

(Division Sign-Off) Division of Orthopedic Devices 510(k) Number: K133525
2-1

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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.