Double Engine Bone Plate and Screw Systems are provided non-sterile. Double Engine Bone Plate and Screw Systems are intended for fixation of various bone fracture, including large bone (clavicle, scapula, pelvis, humerus, ulna, radius, femur, tibia, and fibula), and small bone (metacarpals, metatarsals, and phalanges).

Device Description

Double Engine Bone Plate System consists of plates in various designs and size. Plates are provided in straight designs and various geometric configurations that are commonly used in traumatic and reconstructive surgery (Table 3.5.1). Plates are provided with screw holes to accommodate non-locking and locking screws. They are named according to both anatomical positions and biomechanical functions of the plates. The sets in size of Double Engine Bone Plate System are divided into four sets: large, small, mini, and reconstruction. The thickness of plates varies from 1.0 to 5.6mm, width from 3.8 to 43.6mm, length from 15.4 to 361mm, and hole number from 2 to 27 holes.

Double Engine Bone Screw System is used either to fasten plates or similar devices onto bones, or, as lag screws, to hold bone fragments together. The screws are differentiated by the manner in which they are inserted into bone, their size, and the type of bone they are intended for. There are three sets of style: cortex, cancellous, and cannulated sets. The screw recess is hexagon or star shaped to allow screw removal and insertion. The thread diameter of screw varies from 1.5 to 7.3mm, total length from 6 to 150mm.

The proposed devices are not provided sterile. It is required to be sterilized via autoclave method to reach a SAL of 10th by the hospital prior to surgery. The sterilization method is presented in the user manual, which was validated per 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.

AI/ML Overview

Here's a summary of the acceptance criteria and the study that proves the device meets them, based on the provided text.

Note: This document describes a traditional medical device (bone plates and screws), not an AI/ML-based device. Therefore, many of the typical questions for AI/ML validation (like expert adjudication, MRMC studies, training set details, etc.) are not applicable here. The evaluation focuses on physical characteristics and mechanical performance compared to predicate devices.

Acceptance Criteria and Device Performance for Double Engine Bone Plate and Bone Screw Systems

This submission evaluates the Double Engine Bone Plate and Screw Systems against predicate devices based on their mechanical and physical properties to demonstrate substantial equivalence, rather than using typical AI/ML performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria/Method	Acceptance Threshold (Implicit)	Reported Device Performance
Material Composition	Commercially pure titanium and titanium alloy	Meeting ASTM F67-06, F1472-08e1, and F163-02a standards.	Devices manufactured from materials meeting these ASTM standards.
Intended Use	Fixation of various bone fractures (large and small bones)	Substantially equivalent to predicate devices.	Stated intended use is identical to predicate devices.
Sterilization	Sterilizable via autoclave to SAL of 10⁻⁶	Validation per ISO 17665-1:2006.	Sterilization method validated per ISO 17665-1:2006.
Mechanical Properties	Bending strength, torsional strength, fatigue life, etc. (for plates and screws)	Performance equivalent to or better than predicate devices.	Mechanical tests completed demonstrated performances were equivalent to or better than the predicate devices.
Physical Characteristics / Geometric Design	Plate dimensions, screw thread diameters, etc.	Similar to predicate devices.	Similar physical characteristics and geometric designs compared to predicate devices.

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

Sample Size for Mechanical Testing:
- Bone Plates: Four representative types of bone plates were selected for testing: one from each of the large, small, mini, and reconstruction sets. These were chosen based on finite-element analyses indicating they had "poor mechanical properties" (implying they were the weakest and thus represented a critical test case).
- Bone Screws: Three representative types of bone screws were selected: cortex, cancellous, and cannulated. The size and type of the predicate screws were identical to the proposed screws.
Data Provenance: Not explicitly stated as retrospective or prospective in the context of clinical data. This is a non-clinical, laboratory-based study. The finite-element analyses and mechanical tests were presumably conducted internally or by a contracted lab. There is no mention of country of origin for test data, as it's not patient-related.

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

Not Applicable: For this type of medical device submission (bone plates and screws), "ground truth" typically refers to established engineering standards, material specifications (e.g., ASTM), and the mechanical performance of legally marketed predicate devices. It does not involve expert consensus on image interpretation or clinical outcomes in the way an AI/ML study would. The experts involved would be engineers, material scientists, and regulatory specialists.

4. Adjudication Method for the Test Set

Not Applicable: Adjudication methods like 2+1 or 3+1 are used for human expert disagreement on ground truth labeling in AI/ML studies. This submission relies on objective mechanical testing and finite-element analysis results, compared against engineering standards and predicate device performance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable: This device is a physical implant, not an AI-assisted diagnostic or therapeutic tool. Therefore, an MRMC study and evaluation of human reader improvement with AI assistance are irrelevant.

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

Not Applicable: As a physical medical device, the concept of "standalone algorithm performance" does not apply.

7. The type of ground truth used

Engineering Standards and Predicate Device Performance:
- Material Ground Truth: Adherence to ASTM F67-06, F1472-08e1, and F163-02a standards for titanium and titanium alloys.
- Mechanical Performance Ground Truth: The established mechanical properties and performance of legally marketed predicate devices (Synthes, Syntec Scientific). The acceptance criterion was that the proposed devices perform "equivalent to or better than" these predicates.
- Sterilization Ground Truth: Compliance with ISO 17665-1:2006 for sterilization validation.

8. The Sample Size for the Training Set

Not Applicable: There is no "training set" in the context of traditional medical device mechanical testing. Finite-element analyses (FEA) were likely used for design and optimization, which could be considered an initial "simulation phase," but this doesn't equate to a data-driven training set for an algorithm.

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

Not Applicable: As there is no training set for this type of device validation, this question is not relevant. The "ground truth" in the design and development phase (e.g., for FEA) would be based on engineering principles, material properties, and clinical requirements for bone fixation.

Summary

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Section 3 510(k) Summary

APR 1 9 2013

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.

The assigned 510(k) Number: _K130108

3.1 Date of Submission

January 14, 2013

3.2 Submission Correspondent

Mr. Da Zeng

Xiamen Double Engine Medical Material Co., Ltd. ·

No.218, Houxiang Road, Haicang District, Xiamen, 361022, China

Tel: 86-0592-6087078

Fax: 86-0592-6587093

Email: RD_Analysis2@Double-Engine.com; da52827@gmail.com

3.3 Proposed Device

Device Name: Double Engine Bone Plate and Bone Screw Systems Classification: Il Product Code: HRS, HWC Regulation Number: 21 CF 888.3030, 21 CF 888.3040 Review Panel: Orthopedic Material:

Double Engine Bone Plate and Screw Systems are manufactured from commercially pure titanium and titanium alloy that meet ASTM F67-06, F1472-08e1, and F163-02a.

Intended Use Statement:

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3.4 Devices Description

Plate Name	Geometric Shape
DCP	Narrow, Broad, Lengthening-narrow, Lengthening-broad, Straight
Tubular	Semi-tubular, One third, Quarter
Special	T-shaped, T-buttress, T-oblique, L-shaped, L-buttress, Cobra head, Lateral tibial head, Condylar, Condylar buttress, Spoon, Reconstruction, Reconstruction-curved, Hook, H-shaped, W-shaped cloverleaf, Calcaneal, Y-calcaneal, Adaption

Table 3.5.1 Plate name and geometric shape of Double Engine Bone Plate System

3.5 Predicate Device Information

There are two types of predicate devices used as the control groups to evaluate the performance of proposed devices, including bone plate and bone screw.

Prior to selecting the predicate plates, the finite-element analyses were employed to evaluate the mechanical properties of various bone plates. The analysis results showed that

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K130108 page 3 of 4

Premarket Notification 510(k)

four types of bone plates have poor mechanical properties and used as the testing representatives of the large, small, mini, and reconstruction sets (Appendix 6). Consequently, these four types of bone plates were used as representative specimens to set the criterion for selecting the predicate plates. The information of the predicate plates is shown in Table 3.6.1.

There are three types of bone screws used as the representatives of Double Engine Bone Screw System, including cortex, cancellous, and cannulated screws. The size and type of the predicate devices are identical to the proposed screws. The information of the predicate screws is shown in Table 3.6.2.

Predicate Set	K No.	Company Name	Device Name
Large	K010766	Synthes (USA)	Synthes (USA)Large FragmentLocking Compression Plate (LCP)System-T Plate
Small	K041860	Synthes (USA)	Synthes (USA)LCP ProximalHumerus Plate, Long
Mini	K063049	Synthes (USA)	Synthes (USA)Modular MiniFragment LCP System
Reconstruction	K092889	Syntec ScientificCorporation	Syntec Osteo Plate and ScrewFixation

Table 3.6.1 Information of the predicate plates used in this submission

Table 3.6.2 Information of the predicate screws used in this submission

Predicate Set	K No.	Company Name	Device Name
Cortex	K043185	Synthes (USA)	Synthes 3.5mm Cortex Screws
Cancellous	K061621	Synthes (USA)	Synthes (USA) 6.5 mm CancellousScrews
Cannulated	K963192	Synthes (USA)	Synthes Sterile 3.5mm and 4.0 mmCannulated Screws

3.6 Non-Clinical Tests Conclusion

Non-clinical tests included finite-element analyses and mechanical tests. Finite-element analyses were made to support that the four selected bone plates were the representative of proposed device. Mechanical tests were completed to demonstrate that performances of four selected bone plates and three bone screws were subsequently equivalent to or better than the predicate devices. The results of non-clinical tests demonstrate the Double Engine Bone Plate and Screw Systems are safe and effective for its intended use and substantially equivalent to

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Premarket Notification 510(k)

3-4

the predicate devices.

3.7 Substantially Equivalent Conclusion

As compared with predicate devices, equivalence for Double Engine Bone Plate and Screw Systems are based on similarities of intended use, material, physical characteristics, geometric design, and mechanical strength. Therefore, Double Engine believes that there are sufficient evidences to conclude that the Double Engine Bone Plate and Screw Systems are substantially equivalent to existing legally marketed devices.

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Image /page/4/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged around the perimeter. Inside the circle is a stylized graphic of an eagle or other bird-like figure, depicted with flowing lines to suggest movement or flight.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Letter dated: April 19, 2013

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

Xiamen Double Engine Medical Material Co., Ltd. % Mr. Da Zeng No.218, Houxiang Road, Haicang District Xiamen, 361022 China

Re: K130108

Trade/Device Name: Double Engine Bone Plate and Bone Screw Systems 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: January 14, 2013 Received: April 15, 2013

Dear Mr. Da Zeng:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Da Zeng

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,

Mark Nighterson -S

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

Enclosure

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Section 2 Statement of Intended Use

K130108 510(k) Number:

Device Name: Double Engine Bone Plate and Bone Screw Systems

Intend Use Statement:

× PRESCRIPTION USE

OVER-THE-COUNTER USE

(Part 21 CFR 801 Subpart D) (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 L. Frank 2013.04.19 10:36:47=04'00

Division of Orthopedic Devices

Regulation Number and Section

N/A