Microware Bone Plates and Bone Screws are provided non-sterile. Microware Bone Plates and Bone Screws are intended to treat fractures of various bones, including the clavicle, pelvis, scapula, long bone (humerus, ulna, radius, femur, tibia and fibula), and small bone (metacarpals, metatarsals and phalanges).

Microware Bone Plates and Bone Screws Accessories:

The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles.
The spiked washer is used for ligament reattachment or fixation.
The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.

Device Description

The added devices do not change the original intended use, material, label, and package. The added devices with changes are described as follows:

Added cortex, cancellous, and shaft screws are designed with self-tapping flutes and are easier to insert into the bone than non-self-tapping screws.
Added cortex screws 1.5 and 2.0mm are designed with a cruciform recess and can be applied with a cruciform tool.
Added screws of all sizes are designed with a hexalobular socket and they can improve torque transmission to facilitate easy insertion and removal.
Added cannulaed screws extend diameter specification with 6.5, 4.5, 4.0, 3.0 and 2.4mm.
Added implants include the round washer, spherical washer, spiked washer, and support screw which can be used with or without other implants.
Added screws extend length specifications.

AI/ML Overview

The provided document is a 510(k) summary for PREDICATE DEVICES, not a study that proves a device meets specific acceptance criteria. This submission is to establish substantial equivalence for Microware Bone Plates and Bone Screws to existing predicate devices. Therefore, a detailed study with acceptance criteria, sample sizes, expert ground truth, MRMC studies, or standalone performance metrics as specified in your request are not included.

However, I can extract the information related to the performance testing demonstrating substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance

Instead of formal acceptance criteria and quantitative performance metrics as might be found in a clinical study for an AI/diagnostic device, this 510(k) submission relies on performance testing to demonstrate substantial equivalence to predicate devices. The acceptance criterion is implicitly that the new device's performance in these tests is comparable to or better than the predicate devices, thereby ensuring it is as safe and effective.

Performance Test	Reported Device Performance
Axial Pullout	Demonstrated substantial equivalence to predicate devices.
Self-Tapping Performance	Demonstrated substantial equivalence to predicate devices.
Driving Torque	Demonstrated substantial equivalence to predicate devices.
Torsional Properties	Demonstrated substantial equivalence to predicate devices.

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

Not applicable. This is a 510(k) submission for orthopedic implants, not a clinical study involving a test set of data. The "test set" here refers to the physical devices undergoing mechanical performance testing.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. This is for mechanical device performance, not for establishing ground truth on medical diagnoses.

4. Adjudication Method

Not applicable.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This type of study is typically done for diagnostic devices, particularly those involving human interpretation, to compare human performance with and without AI assistance. This document is for orthopedic implants.

6. Standalone Performance Study

Yes, in a sense. The performance testing (axial pullout, self-tapping performance, driving torque, torsional properties) characterizes the standalone physical and mechanical properties of the device itself. This is done without human-in-the-loop for the test execution.

7. Type of Ground Truth Used

The "ground truth" for the mechanical performance testing would be established by standardized testing methods and material science principles, comparing the new device's properties against established benchmarks and the predicate devices' known characteristics. It's not "expert consensus, pathology, or outcomes data" in a clinical sense.

8. Sample Size for the Training Set

Not applicable. There is no AI algorithm being developed or "trained" in this context. The "training set" would implicitly refer to the design, manufacturing, and quality control processes that lead to the final device.

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

Not applicable, as there is no "training set" for an AI algorithm. The device's design and manufacturing rely on engineering specifications, material standards (e.g., stainless steel and titanium alloy), and adherence to good manufacturing practices, all aimed at producing a safe and effective implant.

Summary

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Special 510(k) Summary of Safety and Effectiveness 3.

Submitter's Name: Microware Precision Co., Ltd.

Address: No. 12, Keyuan 2nd Rd., Situn District, Taichung City 40763, Taiwan Phone No: +886-4-24636275

Fax No: +886-4-24636276

Contact Person: Harrison Du

Preparation date: October/02/2011

Registration Number: 3007738812

Device Name: Microware Bone Plates and Bone Screws

Proprietary Name: Microware Bone Plates and Bone Screws

Classification Name: Class II

CFR 888.3040: screw, fixation, bone- HWC CFR 888.3030: washer, bolt, non-spinal, metallic- NDG CFR 888.3030: plate, fixation, bone-HRS CFR 888.3030: appliance, fixation, nail/blade/plate combination, multiple component-KTT

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Predicate Device Information:

Microware Bone Plates and Bone Screws (K072562) Kens Internal Fixation System (K090786) Synthes 2.4mm Cannulated Screw (K012945) Synthes Metallic Spiked Washers (K013806) Synthes Spherical Washers (K052483)

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K111008 #2/3

Materials:

The added devices are manufactured from stainless steel and titanium alloy that are the same as Microware Bone Plates and Bone Screw (K072562).

Indication for use:

Microware Bone Plates and Bone Screws Accessories:

1. The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
1. The spherical washer is used to increase bone contact area for distributing the forces/load, and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles.
1. The spiked washer is used for ligament reattachment or fixation.
1. The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.

Device Description:

The added devices do not change the original intended use, material, label, and package. The added devices with changes are described as follows:

Added cortex, cancellous, and shaft screws are designed with self-tapping flutes and are 1. easier to insert into the bone than non-self-tapping screws.
Added cortex screws 1.5 and 2.0mm are designed with a cruciform recess and can be applied 2. with a cruciform tool.
Added screws of all sizes are designed with a hexalobular socket and they can improve torque 3. transmission to facilitate easy insertion and removal.
Added cannulaed screws extend diameter specification with 6.5, 4.5, 4.0, 3.0 and 2.4mm. 4.
Added implants include the round washer, spherical washer, spiked washer, and support న్. screw which can be used with or without other implants.
Added screws extend length specifications. 6.

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KIII008 #3/3

In addition, a new set of recommended sterilization parameters are added to the "Instruction for use".

Substantial Equivalence:

Performance testing included axial pullout, self-tapping performance, driving torque, torsional properties and the results demonstrated substantial equivalence to the predicate devices.

A comparison has shown that the proposed device is very similar or identical in terms of indication for use, material, followed performance and standard, and sterilization to the predicate devices, and no significant difference between the proposed and predicate devices has been found. Thus, the "Microware Bone Plates and Bone Screws" is substantially equivalent to the predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three curved lines representing its wings and body. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle symbol.

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

Microware Precision Co., Ltd. % Mr. Harrison Du No. 12, Keyuan 2nd Road Situn District Taichung City, Taiwan 40763

MAY - 2 2012

Re: K111008

Trade/Device Name: Microware Bone Plates and Bone 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, KTT, NDG Dated: April 02, 2012

Received: April 2, 2012

Dear Mr. Du:

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 or any I vithe 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 OFF at 807), accimig (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Harrison Du

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/Resourcesfor You/Industry/default.htm.

Sincerely vours,

Eunice Keith

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

Enclosure

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Indications for Use 2.

510{k) Number (if known):

Device Name: Microware Bone Plates and Bone Screws Indications for Use:

Microware Bone Plates and Bone Screws Accessories:

1. The round washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone.
1. The spherical washer is used to increase bone contact area for distributing the forces/load and prevent the screw head from sinking into the bone. In addition, it can be applicable on the insertion at acute angles.
1. The spiked washer is used for ligament reattachment or fixation.
1. The support screw is anchored in cancellous bone by its thread. It supports the countersink head of a cannulated screw in cancellous bone.

Prescription Use	X
(Part 21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K111008

Page 1 of 1

510(k) Submission ver.S003

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.