BaiDe" 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 Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V 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

This document is a 510(k) premarket notification for a medical device called the "BaiDe® locking plate system," which is intended for orthopedic fixation. It does not describe an AI/ML powered medical device, therefore, the requested information about acceptance criteria for AI performance is not applicable.

The document discusses non-clinical bench testing to demonstrate substantial equivalence to predicate devices, focusing on mechanical properties rather than algorithm performance.

Here's a breakdown of the relevant information present:

Device Type: Medical device for orthopedic fixation (locking plate system).

Acceptance Criteria and Device Performance (Based on non-clinical bench testing):

Acceptance Criteria (Measured item)	Reported Device Performance (Compliance)
ASTM F 382-99 (Reapproved 2008) Metallic Bone Plates: Static four-point bending	Complies with standard
ASTM F 382-99 (Reapproved 2008) Metallic Bone Plates: Dynamic four-point bending	Complies with standard
ASTM F 543-07 Metallic Medical Bone Screws: Torsional properties	Complies with standard
ASTM F 543-07 Metallic Medical Bone Screws: Driving torque	Complies with standard
ASTM F 543-07 Metallic Medical Bone Screws: Pull out test	Complies with standard

Study Details (for non-clinical bench testing):

Sample size used for the test set and the data provenance: Not explicitly stated as a number of samples, but "Bench tests were conducted." The provenance is internal to the manufacturer's testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. These are physical bench tests against engineering standards, not clinical evaluations requiring expert interpretation.
Adjudication method for the test set: Not applicable for engineering bench tests.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this is not an MRMC study.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable, as this is a physical medical device, not an algorithm.
The type of ground truth used: Established by engineering standards (ASTM F 382-99, ASTM F 543-07).
The sample size for the training set: Not applicable. There is no concept of a "training set" for physical device bench testing in this context.
How the ground truth for the training set was established: Not applicable.

Summary in relation to your request:

This document describes the regulatory submission for a physical medical implant. Therefore, the questions related to AI/ML device performance, such as sample size for test/training sets, data provenance, expert ground truth, adjudication methods, MRMC studies, and standalone algorithm performance, are not relevant to this specific filing. The "acceptance criteria" here refer to conformance with established mechanical testing standards for bone plates and screws.

Summary

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

Jiangsu BaiDe Medical Instrument Co., Ltd. % Ms. Alice Gong Shanghai Yarui Consultant Co., Ltd. 503 Room, 8 Building, 600 Liu Zhou Road Shanghai, Shanghai 200233 China

February 25, 2015

Re: K150009 Trade/Device Name: Baide® 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: November 18, 2014 Received: January 2, 2015

Dear Ms. Alice 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 (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/Resourcesfor You/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 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 yours,

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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K150009

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

Device Name

Trade name: BaiDe®

Common name: Locking Plate System

Indications for Use (Describe)

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

Type of Use (Select one or both, as applicable)

2 Prescription 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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Section 5 of Traditional 510(K) Submission:

510 (K) Summary

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

1. Date of Submission: Nov. 18, 2014
1. Submitter / 510(K) Holder

Jiangsu BaiDe Medical Instrument Co.,Ltd. South Side of Dongqi Road, Donglai Village, YangShe Town Zhangjiagang City Jiangsu Province China

Contact Person: Mr. Kang Shui Tel: (86) 0512-56987731 Fax: (86) 0512-56987279 E-mail: yvigmm@126.com

3. Proposed Device Namet

Trade name: BaiDe® 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

4. Predicate Devices

Predicate Devices #1:

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Predicate Devices #2:

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

5. Device Description

6. Indication for Use/Intended Use

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

7. 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

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The BaiDe® locking plate system has same intended use as the predicate device and similar technological characteristics as the predicate device. The proposed device, the BaiDe® locking plate system, is determined to be Substantially Equivalent (SE) to the predicate device, K133840 Kangli® locking plate system and K130340 locking bone plates and screws, in respect of safety and effectiveness.

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.