Syntec Osteo-plate and screw Fixation is intended to be used on small bones or large bones for fracture fixation, including the fractures of clavicle, scapula, pelvis, long bones (humerus, ulna, radius, femur, tibia, and fibula), and small bones (metacarpals, metatarsals, and phalanges).

Device Description

Those are designed with various sizes of partially and fully threaded to satisfy with different kinds of fractures as using on small bones or large bones. The subject components are plates available in width from 3.8mm to 17.5mm, in total length from 15mm to 319mm and the hole numbers are 2 to 22 holes. The threads of the screws are available in diameters from 2.4mm to 7.3mm, and in length from 6mm to 180mm. Those screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.

AI/ML Overview

This document describes a 510(k) premarket notification for a medical device and is a submission for substantial equivalence to a predicate device, not a study proving the device meets acceptance criteria via clinical trials or AI performance metrics. Therefore, many of the requested fields regarding acceptance criteria, AI performance, ground truth, expert involvement, and sample sizes for training/test sets are not applicable in this context.

Here's the information extracted from the provided text, modified to acknowledge the nature of a 510(k) submission:

1. Acceptance Criteria and Reported Device Performance

For a 510(k) submission, the "acceptance criteria" are typically defined by demonstrating substantial equivalence to a predicate device through engineering performance tests, rather than clinical outcomes. The device performance is reported as meeting or being comparable to the predicate device in specific mechanical tests.

Acceptance Criterion (Type of Test)	Reported Device Performance
Compression strength of plates and screws	Demonstrated substantial equivalence to predicate device.
Pull-out strength of screws	Demonstrated substantial equivalence to predicate device.
Torsional strength of screws	Demonstrated substantial equivalence to predicate device.
Material composition (ASTM F138, ASTM F136)	Complies with ASTM F138 and ASTM F136 standards.

2. Sample Size for Test Set and Data Provenance

Sample size used for the test set: Not explicitly stated. The document refers to "test results" from mechanical tests rather than human subject testing or specific data sets.
Data provenance: The mechanical tests were performed on the "Syntec Osteo-plate and screw Fixation" device. The provenance of the data is internal testing conducted by Syntec Scientific Corporation in Taiwan. The tests compare the new device to the predicate device (Syntec-Taichung Non-sterile Bone Plate and Screw implants). This would be considered internal, laboratory-based, prospective testing of the device prototypes.

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

Not applicable. This is a 510(k) submission for a physical medical device based on mechanical testing, not a study involving expert-established ground truth for a diagnostic or AI device.

4. Adjudication Method for the Test Set

Not applicable. There is no adjudication method described as this is not a study requiring human review or consensus.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size

Not applicable. This is a 510(k) submission for a physical medical device. MRMC studies are typically for diagnostic devices or AI systems.

6. If a Standalone Study (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This is a 510(k) submission for a physical medical device, not an algorithm or AI system.

7. The Type of Ground Truth Used

The "ground truth" for this type of submission is the established mechanical performance of the legally marketed predicate device (Syntec-Taichung Non-sterile Bone Plate and Screw implants) and compliance with recognized industry standards (ASTM F138, ASTM F136) for material properties. The claim is that the new device performs equivalently in these mechanical tests.

8. The Sample Size for the Training Set

Not applicable. This is a 510(k) submission for a physical medical device. There is no "training set" in the context of AI or machine learning. The device design is based on engineering principles and existing designs.

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

Not applicable. As there is no training set, no ground truth was established for it in the context of this 510(k) submission.

Summary

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K092889

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JUN 2 5 2010

510(K) SUMMARY

Submitter's name : Address :

Contact person :

Common name:

Produce Code :

Predicate device:

Name of the device :

Classification name :

Regulation Number :

Trade or proprietary name :

Syntec Scientific Corporation 2, Kung San Rd, Chuan Shing Industrial Zone, Shen Kang, Chang Hua, Taiwan Tel : 886-4-7987099 Fax: 886-4-7987077 Carol Chang Syntec Osteo-plate and screw Fixation Syntec Osteo-plate and screw Fixation bone plate and bone screw Smooth or threaded metallic bone fixation fastener. HWC, HRS 888.3030, 888.3040 II Syntec-Taichung Non-sterile Bone Plate and Screw Implants (K983495) August 01, 2009

Preparation of the date:

Material:

Class :

The Syntec Osteo-plate and screw Fixation provides two materials, Stainless Steel and Titanium Alloy (Ti-6Al-4V) and commercially followed by ASTM F138, and ASTM F136.

Description of the Device:

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K092889 #2/3

screws have been designed for fitting on different symptoms of fractures and the plates have been designed to distribute for local anatomies and should be necessary to be used with its intended screws. Basically, the screws used to fasten plates onto bone, or, as lag screws, to hold together fragments of bone. We have totally the same kinds of the screws and plates as the predicate devices' functions, but with self-tapping or self-drilling to promote the operation efficiency. Besides this, we have another alternative screws and plates which are designed with locking head of the screws taken place with the traditional screw head, and threaded aside locking hole of the plates taken place with the aside plain hole of the plates.

Indications for Use:

Technology Characteristics:

The design, materials and indications for use of the Osteo-plate and screw are equivalent to device previously approved for market in the United States.

	Predicate Device	Applicant
Sponsor	Syntec Scientific Corporation	Syntec Scientific Corporation
Device name	Syntec-Taichung Non-sterileBone Plate and Screw implants	Syntec Osteo-plate and screwFixation
510(k) number	K983495	-
Regulation number/name/ class/ productcode	Class II §888.3030, 888.3040Single/ Multiple componentmetallic bone fixationappliances and accessories/Smooth or threaded metallicbone fixation fastenerHRS, HWC	Class II §888.3030, 888.3040Smooth or threaded metallic bonefixation fastenerHRS, HWC
Intended Use	The bone plates and screws areprovided non-sterile. The	Syntec Osteo-plate and screwFixation is intended to be used on

Device Comparison Table:

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K092889 #3/3

	devices are intended to treatfractures of various bones,including the clavicle, scapula,pelvis, long bone (humerus,ulna, radius, femur, tibia, andfibula), and small bone(metacarpals, metatarsals, andphalanges).	mini, small bones or large bonesfor fracture fixation, including thefractures of clavicle, scapula,pelvis, long bone (humerus, ulna,radius, femur, tibia, and fibula),and small bone (metacarpals,metatarsals, and phalanges).
Diameters of screws	From 1.5mm to 7.3mm	From 2.4mm to 7.3mm
Lengths of plates	From 17mm to 262mm	From 15mm to 319mm
Materials	Stainless steel andtitanium alloy (Ti-6Al-4V)	Stainless steel andtitanium alloy (Ti-6Al-4V)

Performance Data:

The test results of the Compression strength of plates and screws, Pull-out strength of screws, and Torsional strength of screws were compared to the results of the Syntec-Taichung Non-sterile Bone Plate and Screw implants and demonstrated substantial equivalence.

Conclusion:

The Syntec Osteo-plate and screw Fixation is no new issue of safety or effectiveness. The device does not additional concerns regarding safety and effectiveness and may, therefore, be considered substantially equivalent to the predicate device.

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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 consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or a bird in flight, composed of flowing lines.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

JUN 2 6 2010

Syntec Scientific Corporation % Ms. Carol Chang 3F1. 96 Chung Hsiao E. Rd. Sec. 3 Taipei China (Taiwan) 106

Re: K092889

Trade/Device Name: Syntec Osteo-plate and screw Fixation 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: June 10, 2010 Received: June 15, 2010

Dear Ms. Chang:

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); medica! device reporting (reporting of medical

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Page 2 - Ms. Carol Chang

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

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

Enclosure

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INDICATION FOR USE

Indications for Use

510(k) Number (if known): K092889 Device Name: Syntec Osteo-plate and screw Fixation Indications for Use:

Prescription Use _____________________________ AND/OR 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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Smuta for mxin

Division Sign-Q Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092889

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.