The Advanced Bone Plate (AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is internal fixation. Specific indications for the plates included in the system as follows:

The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is inticated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.

The ITVAL Foot & Ankle VAL System is internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.

The Distal Fibular VAL Plate is indicated for internal fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.

Device Description

Advanced Bone Plate is mainly used for internal fixation of hand, wrist, foot, ankle and distal fibular fractures. According to the anatomical characteristics of human bones, locking plates of different shapes and locking screws of different diameters are designed. In clinical practice, locking bone plate and locking bone screw are used in combination to play the role of temporary internal stent, providing a stable local environment for fracture ends and creating conditions for the healing of fracture ends.

Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Advanced Bone Plate is provided as non-sterile. The implants are intended for single-use only, while the instruments are reusable.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them:

Disclaimer: This document is a 510(k) summary for a medical device (Advanced Bone Plate) and primarily focuses on demonstrating "substantial equivalence" to predicate devices, rather than establishing de novo efficacy or setting new acceptance criteria. Therefore, the information provided will reflect this context.

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

The provided 510(k) summary does not explicitly define quantitative "acceptance criteria" in the traditional sense of a performance study with numerical targets. Instead, it aims to demonstrate "substantial equivalence" in terms of characteristics and performance to legally marketed predicate devices. The "reported device performance" is described through the successful completion of various non-clinical tests that show the device functions similarly to the predicate devices.

Acceptance Criteria (Implicit from Substantial Equivalence Goal)	Reported Device Performance
Biocompatibility: Device materials are safe for biological contact.	Evaluation conducted in accordance with ISO 10993-1, indicating compliance.
Mechanical Performance (Plates): Bending stiffness, bending strength of plates consistent with predicate devices.	Performed mechanical tests per ASTM F382-17 (Standard Specification and Test Methods for Metallic bone plate and Three-point Bending Test Method) to determine Bending Stiffness, Bending Strength, and Bending Structural Stiffness, demonstrating substantial equivalence.
Mechanical Performance (Screws): Torsion, insertion/removal, and pullout strength of screws consistent with predicate devices.	Performed mechanical tests per ASTM F543-17 (Standard Specification and Test Methods for Metallic Medical Bone Screws) to determine Torsion Test, Insertion/removal Test, and Pullout Test, demonstrating substantial equivalence.
Sterilization: Device can be effectively sterilized by the user to a sterility assurance level (SAL) of 10^-6.	Sterilization via Overkill Approach (Half-Cycle method) validated per ISO 17665-1:2006. (Device is non-sterile).
Reprocessing (Cleaning): Reusable instruments and implants can be effectively cleaned.	Cleaning instructions validated per FDA guidance AAMI TIR30:2003.
Technological Characteristics: Similar design features, materials, and indications for use as predicate devices.	Design Features: Variable angle locking technology, limited contact profiles, anatomic contours, and similar size ranges. Materials: Titanium alloy (plates per ASTM F1472, screws per ASTM F136). Both found to be substantially equivalent.

2. Sample sized used for the test set and the data provenance

Sample Size for Test Set: The document does not specify exact sample sizes for each mechanical test (e.g., number of plates or screws tested). It refers to standard ASTM methods (F382-17, F543-17) which would prescribe sample sizes.
Data Provenance: The tests are non-clinical, conducted in a laboratory setting by the manufacturer (Double Medical Technology Inc.) or a contracted lab. The data is thus prospective experimental data generated for the purpose of this submission.
- Country of Origin: Likely China, given the submitter's address.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This section is not applicable in the context of this 510(k) submission. The "ground truth" for non-clinical mechanical testing is established by the specifications in the relevant ASTM standards (e.g., ASTM F382-17, ASTM F543-17) and successful execution according to those methods, rather than expert consensus on medical images or patient outcomes.

4. Adjudication method for the test set

This section is not applicable. Adjudication methods (like 2+1, 3+1) are typically used in clinical studies or studies involving human readers where there's a need to resolve discrepancies in expert interpretations of data (e.g., imaging scans). For mechanical testing, the results are quantitative and objective, based on physical measurements and adherence to standard protocols.

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, a multi-reader, multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI-assisted diagnostic tools, not for a passive internal fixation device like a bone plate. The document explicitly states: "No clinical performance data was provided to demonstrate substantially equivalence."

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

No, a standalone performance study in the context of an algorithm or AI device was not done. This device is a physical implant, not a software algorithm.

7. The type of ground truth used

The "ground truth" for this device, within the scope of this 510(k), is established by:

Accepted Industry Standards: Primarily ASTM F382-17 and ASTM F543-17 for mechanical properties, and ISO 10993-1, ISO 17665-1:2006, and AAMI TIR30:2003 for biocompatibility, sterilization, and reprocessing. These standards define the acceptable methods and performance benchmarks for such devices.
Comparison to Predicate Devices: The core of a 510(k) relies on demonstrating that the new device performs as safely and effectively as a legally marketed predicate device. The "ground truth" for substantial equivalence is met if the new device's characteristics and performance fall within the established safety and efficacy profile of the predicates.

8. The sample size for the training set

This section is not applicable. This device is a physical bone plate, not an AI/ML algorithm that requires a "training set."

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

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

Summary

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January 25, 2023

Image /page/0/Picture/11 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font size.

Double Medical Technology Inc. Yan Zuo Deputy International RA Supervisor No.18, Shanbianhong East Road, Haicang District Xiamen, Fujian 361026 China

Re: K221150

Trade/Device Name: Advanced Bone Plate 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 22, 2022 Received: November 29, 2022

Dear Yan Zuo:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Shumava Ali -S

Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K221150

Device Name Advanced Bone Plate

Indications for Use (Describe) Indications for use:

Type of Use ( Select one or both, as applicable )
❌ Prescription Use (Part 21 CFR 801 Subpart D)▢ Over-The-Counter Use (21 CFR 801 Subpart C)	❌ Prescription Use (Part 21 CFR 801 Subpart D)	▢ Over-The-Counter Use (21 CFR 801 Subpart C)
❌ Prescription Use (Part 21 CFR 801 Subpart D)	▢ Over-The-Counter Use (21 CFR 801 Subpart C)

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1. Submitter
Name	Double Medical Technology Inc.
Address	No. 18, Shanbianhong East Road, Haicang District, Xiamen,361026, P. R. China
Phone	+86 592 6885079
Contact person	Yan Zuo
Date prepared	Jan 20th, 2023
2. Proposed Device
Trade/proprietary name	Advanced Bone Plate
Common or usual name	Plate, Fixation, Bone;Screw, Fixation, Bone
Classification name	Single/multiple component metallic bone fixation applianceand accessories (Primary);Smooth or threaded metallic bone fixation fastener
Regulation number	21 CFR 888.3030 (Primary);21 CFR 888.3040
Product code	HRS; HWC
Regulatory class	II
Classification panel	Orthopedic
3. Predicate Device

K221150 - 510(k) Summary

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	Primary predicate device:
	K141527 DePuy Synthes Variable Angle Locking HandSystem
	Additional predicate devices:
	K103243 Synthes (USA) 2.4mm VA-LCP Intercarpal FusionSystem
	K152974 Wright ORTHOLOC®3Di Foot ReconstructionSystem
Legally marketeddevice(s) to whichequivalence is claimed	K090692 Wright ORTHOLOC® 2.0/ 2.4 Plate System
	K171852 Wright DARCOTM Locking Bone Plate System
	K142121 Wright ORTHOLOC® Calcaneal Plating System
	K130108 Double Engine Bone Plate and Bone Screw System
	K141383 Acumed Hand Plating System
	K151277 NOVASTEP Airlock® osteosynthesis plate system
	K222194 Baby Gorilla®/Gorilla® Plating System
	K132898 Biomet A.L.P.S. Calcaneal Plating System
	K132886 Smith&Nephew Variable- Angle Locking
	Reason for 510(k)submission

4. Device Description

5. Indications for Use

The Advanced Bone Plate (AIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM, ITVAL Foot & Ankle VAL System, and Distal Fibular VAL Plate) is indicated for internal fixation. Specific indications for the plates included in the system as follows:

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The AIMIMINI VARIABLE ANGLE LOCKING PLATES SYSTEM is indicated for the internal fixation (fractures, osteotomies, arthrodesis, replantations and reconstructions) of the hand (metacarpals and phalanges) and wrist of adults and adolescents (age 12-21 years) in which growth plates have fused or will not be crossed by fixation.

The ITVAL Foot & Ankle VAL System is indicated for internal fixation (fractures, osteotomies, fusions, nonunions, malunions, small fragment replantations) of the foot and ankle in adults and adolescents (age 12-21 years) possessing normal or osteopenic bone where growth plates have fused or will not be crossed by fixation.

The Distal Fibular VAL Plate is indicated for internal fixation (fractures, osteotomies, nonunions, malunions, small fragment replantations) of the distal fibula of adults and adolescents (age 12-21 years) where growth plates have fused or will not be crossed by fixation.

6. Comparison of Technological Characteristics with the Predicate Device

The rationale for substantial equivalence is based on consideration of the following characteristics:

Regulatory Classification: Same as the predicate devices

Indications for Use: Substantially equivalent (SE) to the predicate devices

Materials: Bone plates in Advanced Bone Plate are made of titanium alloy following ASTM F1472, and bone screws in Advanced Bone Plate are made of titanium alloy following ASTM F136. Both of the materials of bone plates and bone screws are substantially equivalent (SE) to the predicate devices.

Design Features: The subject Advanced Bone Plate shares the same fundamental technological characteristics as the predicate systems. The same design features of the subject and predicate systems such as variable angle locking technology, limited contact profiles, anatomic contours, and similar size ranges. Based on the presented comparisons and discussions, the subject Advanced Bone Plate does not raise any new issues of safety and efficacy.

7. Non-Clinical Performance Data

7.1 Biocompatibility testing

The biocompatibility evaluation for the Advanced Bone Plate was conducted in accordance

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with the FDA Guidance "Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process".

7.2 Mechanical testing

The mechanical tests of bone plates were performed per ASTM F382-17 Standard Specification and Test Methods for Metallic bone plate and Three-point Bending Test Method to demonstrate substantially equivalent of safety and efficacy with the predicate device. According to ASTM F382-17 and Three-point Bending Test Method, test methods are used to determine the Bending Stiffness, Bending Strength and Bending Structural Stiffness.

The mechanical tests of bone screws were performed per ASTM F543-17 Standard Specification and Test Methods for Metallic Medical Bone Screws to demonstrate substantially equivalent of safety and efficacy with the predicate device. According to ASTM F543-17, test methods are used to determine the Torsion Test, Insertion/removal Test and Pullout Test.

7.3 Sterilization & Reprocessing

The Advanced Bone Plate is provided as non-sterile. It required to be sterilized via Overkill Approach (Half-Cycle method) to reach a SAL of 10-6 by the hospital prior to surgery. The sterilization method is presented in the instruction for use, 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.

Implants and instruments must be carefully cleaned before initial sterilization. The cleaning instructions presented in the instruction for use have been validated per FDA guidance AAMI TIR30:2003 "A compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices.

8. Clinical Data

No clinical performance data was provided to demonstrate substantially equivalence.

9. Conclusion

Advanced Bone Plate is compared to the predicate devices in respect of safety and effectiveness. The information provided within this premarket notification demonstrates that proposed device is determined to be substantially equivalent (SE) to the predicate device.

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.