Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

Device Description

The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.

The bone 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.

Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.

These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.

AI/ML Overview

The requested information is detailed below, based on the provided text:

Acceptance Criteria and Device Performance Study

The submission focuses on establishing substantial equivalence for medical implants (Locking Bone Plates and Screws) rather than a diagnostic AI device. Therefore, the "acceptance criteria" and "device performance" are related to mechanical and material specifications, and regulatory standards, rather than diagnostic metrics like accuracy, sensitivity, or specificity. The study confirming these criteria is a series of bench tests.

1. Table of Acceptance Criteria and Reported Device Performance

Item	Acceptance Criteria (Predicate Device K101400/K100721)	Reported Device Performance (Proposed Device)
General & Safety
Product Code	Plate: HRS, Screw: HWC	Same
Regulation No.	Plate: 21 CFR 888.3030, Screw: 21 CFR 888.3040	Same
Class	Class II	Same
Intended Use	Similar to predicate	Similar
Sterilization Method	Autoclave	Autoclave
Sterility Assurance Level (SAL)	10⁻⁶	10⁻⁶
Physical Specifications - Locking Bone Plates
Number of Holes	Similar to predicate	2-24
Length	Similar to predicate	26-312 mm
Thickness	Similar to predicate	3.3 / 3.6 / 4.2 mm
Width	Similar to predicate	11 / 12.5 / 13.5 mm
Material	Titanium conforms to ASTM F67-06	Titanium conforms to ASTM F67-06
Physical Specifications - Locking Bone Screws
Diameters	Similar to predicate	3.5, 4.5, 5.0
Lengths	Same as predicate	10~120mm
Material	Ti6Al4V ELI conforms to ASTM F136	Ti6Al4V ELI conforms to ASTM F136
Mechanical Performance (Bone Plates)
Test items	Static four point bending, Dynamic four point bending	Same
Test standard	ASTM F 382-99	ASTM F 382-99
Mechanical Performance (Bone Screws)
Test items	Torsional properties, Driving torque, Pull-out test	Same
Test standard	ASTM F543-07	ASTM F543-07

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

Sample Size: Not explicitly stated as a number of individual plates/screws, but rather through the scope of the specifications (e.g., bone plate lengths from 26-312mm). The testing was conducted on samples representative of the proposed device's various specifications.
Data Provenance: The tests were "Bench tests" conducted by the manufacturer, Weigao Orthopaedic Device Co., Ltd. in Weihai, Shandong, China. The data is retrospective in the sense that it's a pre-market submission based on completed testing, but it's not clinical data; it's engineering test data.

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

This section is not applicable as the submission describes a medical device (bone plates and screws), not an AI/diagnostic device that would require expert consensus for ground truth on disease states. The "ground truth" here is defined by established engineering and material standards (ASTM and ISO).

4. Adjudication Method for the Test Set

This is not applicable. Adjudication methods are typically for clinical or AI performance studies involving interpretations, not for engineering bench tests where outcomes are measured against predefined 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. No MRMC study was conducted as this is a submission for a medical implant, not an AI-assisted diagnostic tool.

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

This is not applicable. This submission is for a physical medical device, not a standalone AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device type is based on established industry standards and specifications:

ASTM 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.
ANSI/AAMI/ISO17665-1: 2006 for sterilization.
Material specifications: ASTM F67-06 for Titanium and ASTM F136 for Ti6Al4V ELI.

The performance of the proposed device was compared against the specifications and mechanical performance of the predicate devices, which are also compliant with these standards.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is a submission for a physical medical device, not an AI/machine learning model.

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

This is not applicable for the same reason as point 8.

Summary

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Section III 510(k) Summary Premarket Notification 510(k) Submission

Project #:M0042013Aa

Section Ill 510(k) Summary

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

K130340 The assigned 510(k) Number:

Date of Submission: 01/27/2013 1.
1. Sponsor

Weigao Orthopaedic Device Co., Ltd. No 26 Xiangjiang Road, Tourist Resorts, Weihai, Shandong, 264203, China

Establishment Registration Number: 3006639944

Contact Person: Han Wang Position: Quality & Technique Manager Tel: +86-631-5788966 Fax: +86-631-5660958 Email: wanghan@wegortho.com

3, Submission Correspondent

Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co., Ltd P.O. Box 237-023. Shanghai, 200237, China Tel: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

Proposed Device Identification

Proposed Device Name: Locking Bone Plates and Screws

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

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K130340 page 2 of 4

Premarket Notification 510(k) Submission

Section III 510(k) Summary

Project #:M0042013Aa

Review Panel: Orthopedic

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:

Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for . fixation of fractures, including ulna, radius, humerus, femur and tibia.

ను Predicate Device Identification
510(k) Number: K101400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd

510(k) Number: K100721 Product Name: Locking Bone Screw Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd

6. Device Description

The proposed products, Locking Bone Plates and Screws, contain (1) locking plats with various specifications, (2) locking screws with various specifications and (3) Various specific instruments.

The bone 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.

Locking Screws are available in two kinds, which are self-dapping and self-drilling. Both of them share the same dimensions and materials.

These devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10th by hospital prior to use.

7 Non-Clinical Test Conclusion

Bench 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:

III-2

. •

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ASTM 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. ANSI/AAMI/ISO17665-1: 2006 Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine control of a sterilization process for medical devices.

Substantially Equivalent Comparison and Conclusion જે.

ITEM	Proposed DeviceLocking Bone Plates and Screws	Predicate Device
		Locking Compression PlateK101400Locking Bone Screw K100721
Product Code	Plate: HRSScrew: HWC	Same
Regulation No.	Plate: 21 CFR 888.3030Screw: 21 CFR 888.3040	Same
Class	Class II	Same
Regulation No.	Plate: 21 CFR 888.3030	Same
Intended Use	Locking Bone Plates and Screws areintended for adult patients with age above21 as indicated for fixation of fractures,including ulna, radius, humerus, femur andtibia.	Similar
Sterilization	Method: AutoclaveSAL: 10⁻⁶	Same

Table III-1 General and Safety Comparison

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Premarket Notification 510(k) Submission

Section III 510(k) Summary

ITEM	Proposed DeviceLocking Bone Plates and Screws	Predicate DeviceLocking Compression PlateK101400Locking Bone Screw K100721
Physical Specifications - Locking Bone Plates
Number of Holes	2-24	Similar
Length	26-312 mm	Similar
Thickness	3.3 / 3.6 / 4.2 mm	Similar
Width	11 / 12.5 / 13.5 mm	Similar
Material	Titanium conforms to ASTM F67-06	Similar
Physical Specifications - Locking Bone Screws
Diameters	3.5. 4.5, 5.0	Similar
Lengths	10~120mm	Same
Material	Ti6Al4V ELI conforms to ASTMF136	Same
Mechanical Performance
Test items for boneplates	Static four point bendingDynamic four point bending	Same
Test standard for boneplates	ASTM F 382-99	Same
Test items for bonescrews	Torsional propertiesDriving torquePull-out test	Same
Test standard for bonescrews	ASTM F543-07	Same

Table III-2 Specifications and Performance Comparison

. Difference in intended use, and physical specifications between the proposed and predicate device are discussed in the 510(k) submission documents, it is concluded that these differences will not affect the effectiveness and safety of the proposed device.

The proposed device. Locking Bone Plates and Screws, is determined to be Substantially Equivalent (SE) to the predicate device, Locking Compression Plate (K101400), and Locking Bone Screw (K100721), 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 & Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

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

Weigao Orthopaedic Device Co., Ltd. % Mid-Link Consulting Co., Ltd Ms. Diana Hong General Manager P.O. Box 237-023, 200237 Shanghai China

Letter dated: April 5, 2013

Re: K130340 Trade/Device Name: Locking Bone Plates and Screws 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. 2013 Received: February 19, 2013

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 (21

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Page 2 - Ms. Diana Hong

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/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.

Mark N. Melkerson -S

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

Enclosure

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Section II Indications for Use

510(k) Number: K130340 Device Name: Locking Bone Plates and Screws

Indications for Use:

Locking Bone Plates and Screws are intended for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur and tibia.

ZPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

OOVER-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 பூர்ลีที่ -S

Division 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.