Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

Device Description

The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments. The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401). The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

AI/ML Overview

The provided text describes a 510(k) submission for a Locking Plate System. This is a medical device for bone fixation, and the documentation focuses on demonstrating its substantial equivalence to previously cleared devices through non-clinical testing. No acceptance criteria for device performance in the context of diagnostic accuracy, image quality, or clinical effectiveness (as would be applicable to AI/ML software or imaging devices) are provided.

Instead, the "acceptance criteria" here refer to the device's ability to meet established ASTM standards for metallic bone plates and screws, as well as material specifications. The "study that proves the device meets the acceptance criteria" refers to non-clinical bench testing performed according to these ASTM standards.

Here's the information extracted from the document, framed in the context of device performance in a non-clinical setting:

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

Acceptance Criteria (Standard Met)	Reported Device Performance
ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates	Static and Dynamic Performance were tested per ASTM F 382
ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws	Torsional, Driving Torque, and Pull-out Strength performance were tested per ASTM F543
ASTM F67-13,Standard Specification for Unalloyed Titanium for Surgical Implant Applications (Materials)	Conforms to standard (Titanium)
ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI Alloy for Surgical Implant Applications (Materials)	Conforms to standard (Titanium alloy)
ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.	Device is provided un-sterilized, but sterilizable via autoclave to achieve SAL of 10-6 prior to use. (This is a process requirement for users, implying the device can withstand this process based on its material properties and design).

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not explicitly state the sample sizes (e.g., number of plates or screws tested) for the non-clinical bench tests.
The data provenance is from non-clinical (bench) testing performed by the manufacturer, Beijing Keyi Medical Device Technology Co., Ltd., based in China.

3. 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 is not applicable to this type of submission. Performance is judged against engineering standards, not expert interpretation of clinical data.

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

This is not applicable as there is no human interpretation or adjudication involved for the non-clinical bench tests against specified engineering standards.

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

No MRMC or studies involving human readers or AI assistance were performed. This device is a passive metallic implant, not an AI/ML diagnostic or imaging device.

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

Not applicable. This is a physical medical device, 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 defined by the specifications and methodologies outlined in the referenced ASTM international standards. These standards set physical and mechanical requirements (e.g., strength, torque, pull-out force) that the device must meet.

8. The sample size for the training set

Not applicable. There is no "training set" as this is not an AI/ML device.

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

Not applicable as there is no training set.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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

Beijing Keyi Medical Device Technology Co., Ltd. % Diana Hong General Manager Mid-link Consulting Co., Ltd P.O. Box 120-119 Shanghai, 200120 CN

May 2, 2017

Re: K162380 Trade/Device Name: 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: April 1, 2017 Received: April 3, 2017

Dear Ms. Diana 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 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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Indications for Use

510(k) Number (if known) K162380

Device Name Locking Plate System

Indications for Use (Describe)

Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

Type of Use ( Select one or both, as applicable )
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X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

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

The assigned 510(k) Number: K162380

1. Date of Preparation: 04/25/2017
1. Sponsor Identification

Beijing KeYi Medical Device Technology Co., Ltd.

Building 1, No. 11, 3rd Jinghai Street, Economic and Technological Development Area, Beijing, 100176, China

Establishment Registration Number: Not yet registered

Contact Person: Hongxin Nie Position: Vice President Tel: +86-10-67853877 Fax: +86-10-67853877 ext 817 Email: gm(@keyibangen.com

1. Designated Submission Correspondent
  Ms. Diana Hong (Primary Contact Person) Mr. Jing Cheng (Alternative Contact Person)

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. Identification of Proposed Device

Trade Name: Locking Plate System Common Name: Metallic Bone Plates and Bone Screws

Regulatory Information Plate Classification Name: Plate, Fixation, Bone Classification: II Product Code: HRS Regulation Number: 21 CFR part 888.3030 Review Panel: Orthopedic

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

Indications for Use:

Locking Plate System can be used for adult patients with age above 21 as indicated for fixation of fractures, including ulna, radius, humerus, femur, tibia and fibula.

Device Description

The proposed product, Locking Plate System, contains (1) Locking Plates, (2) Locking screws and (3) various specific instruments.

The raw material of the plate, titanium, conforms to ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700). The bone screws are made of titanium alloy (TI-6AL-4V ELI), which complies with ASTM F136-13, Standard Specification for Wrought Titanium-6 Aluminum-4 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401).

The devices are provided un-sterilized, but shall be sterilized via autoclave method to achieve Sterility Assurance Level of 10-6 by hospital prior to use.

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ર : Identification of Predicate Devices
Primary Predicate 510(k) Number: K101400 Product Name: Locking Compression Plate Manufacturer: Changzhou Orthmed Medical Instrument Co., Ltd.

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

Additional Predicate 510(k) Number: K130340 Product Name: Locking Bone Plates and Screws Manufacturer: Weigao Orthopaedic Device Co., Ltd.

1. 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 ASTM F382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates
A ASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone Screws
ASTM F67-13, Standard Specification for Unalloyed Titanium for Surgical Implant Applications (UNS R50250, UNS R50400, UNSR50550, UNS R50700).
ASTM F136-13: Standard Specification for Wrought Titanium-6Aluminum-4Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNSR56401).
A ASTM F138-13, Standard Specification for Wrought 18Chromium-14Nickel-2.5Molybdenum Stainless Steel Bar and Wire for Surgical Implants (UNS S31673).
A ISO 17665-1:2006, Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices.
1. Clinical Test Conclusion

No clinical study is included in this submission.

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Substantially Equivalent (SE) Comparison 8.

ITEM		Proposed Device	Primary Predicate,K101400
		Locking Plate System	Locking Compression Plate
Product Code		Plate: HRS	Plate: HRS
		Screw: HWC	N.A.
Regulation No.		Plate: 21 CFR 888.3030	Plate: 21 CFR 888.3030
		Screw: 21 CFR 888.3040	N.A.
Class		Class II	Class II
Intended Use		Locking Plate System can be used for adult patients	Locking Compression Plate can be used for adult
		with age above 21 as indicated for fixation of	patients with age above 21 as indicated for fixation
		fractures, including ulna, radius, humerus, femur,	of features, including ulna,radius, humerus, femur
		tibia and fibula.	and tibia.
Features of		Slots-Limited Contact Area	Slots-Limited Contact Area
Locking Plates		Combi-Holes	Combi-Holes
Features of		Self-tapping locking screws and Self-tapping-drilling	N.A.
Locking Screws		locking screws
Material		Locking Plates: Titanium	Locking Plate: Titanium alloy
		Locking Screws: Titanium alloy	N.A.
How supplied		Non-Sterile,	Non-Sterile,
		Subject to steam sterilized prior to use.	Subject to steam sterilized prior to use.
Performance	Plate	Static and Dynamic Performance were tested per	Static and Dynamic Performance were tested per
		ASTM F 382	ASTM F 382
	Locking screw	Torsional, Driving Torque and Pull- out Strength	Torsional, Driving Torque, Pull- out strength
		performance were tested per	performance was evaluated per
		ASTM F543	ASTM F543 for screws cleared in K100721

Table 1 Comparison of Technology Characteristics

9. Substantially Equivalent (SE) Conclusion

Based on the comparison and analysis above, the proposed devices are determined to be Substantially Equivalent (SE) to the predicate 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.