The applicant device of Trauson Bone Plate made of medic 11 grade 3 16L stainless steel that meet ASTM F138 is intended for the fixation of fractures of humerus. The plates vary essentially through different lengths, number of plate holes. The applicant devices are not sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.

AI/ML Overview

The provided text describes a submission for a medical device called "Trauson Bone Plate" and its substantial equivalence to a predicate device. However, it does not contain the detailed information typically associated with acceptance criteria and a study proving a device meets those criteria in the context of an AI/ML or diagnostic device.

This document pertains to a Class II metallic bone fixation appliance, which is a physical implant, not an AI/ML system or a diagnostic device that would have performance metrics like sensitivity, specificity, or AUC against a ground truth.

Therefore, many of the requested fields (like sample size for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, and ground truth types) are not applicable to this type of device and are not present in the provided text.

Based on the information given, here's what can be extracted and what cannot:

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

Acceptance Criteria	Reported Device Performance
Mechanical Strength (Bending Proof Load)	Determined by bench tests following ASTM F382.
Mechanical Strength (Run-out Load)	Determined by bench tests following ASTM F897.
Material Biocompatibility	Made of medical grade 316L stainless steel meeting ASTM F138. Materials are widely used and have known biocompatibility. No new materials.
Substantial Equivalence to Predicate Device (K041965)	Declared "Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety."
Intended Use	Fixation of fractures of humerus.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):

Not applicable / Not provided. The tests mentioned are bench tests on the physical device components, not studies on patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):

Not applicable / Not provided. Ground truth, in the context of diagnostic performance or AI, is not relevant for a bone plate's mechanical and material properties.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable / Not provided. Adjudication is not relevant for bench testing of material properties.

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. This type of study is entirely irrelevant for a bone fixation plate.

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

Not applicable. This device is a physical implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Ground truth for mechanical/material properties: Adherence to established ASTM standards (F138 for material, F382 and F897 for mechanical tests). The "ground truth" here is the specified performance criteria defined by these standards.

8. The sample size for the training set:

Not applicable / Not provided. There is no "training set" for a physical medical device in this context.

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

Not applicable / Not provided. There is no "training set" or "ground truth" in the AI/ML sense. The ground truth for the device's properties is based on industry-standard material and mechanical testing protocols.

Summary

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Attachment II 510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

The Assigned 510(k) Number is: K073432

Applicant Device Information Trade/Proprietary Name: Trauson Bone Plate Common Name: Single/multiple component metallic bone fixation appliances and accessories Classification Name: Plate, fixation, bone Device Class: II Product Code: HRS Regulation Number: 888.3030 Review Panel: Orthopedic Intended Use: Trauson Bone Plate is intended for the fixation of fractures of humerus.

2. Submitter Information

Establishment Registration Name: TRAUSON (JIANGSU) MEDICAL INSTRUMENT CO., LTD. 31 Houcun Road, Niutang Town Changzhou, Jiangsu CHINA 213163 Phone: +86-757-86280075 Fax: +86-757-86397179

Contact Person of the Submission:

Ms. Diana. Hong, Mr. Eric. Chen Shanghai Mid-link Consulting Co., Ltd. Suite 8D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 200030, CHINA Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net Please CC: Eric.chen@mid-link.net

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3. Predicate Device

K Number: K041965

Trade Name: ARTHREX HUMERAL FRACTURE PLATES AND SCREWS

4. Device Description

The applicant devices are not sterile. The materials are wildly used in the industry with well know biocompatibility. No new materials are used in the development of this implant. No surface modified or coated.

5. Test Data

Bench tests of the applicant device following ASTM F382 and ASTM F897 are conducted to determine the mean bending proof load and run-out load, please see the Appendix 2, ASTM Test Report

6. Substantially Equivalence

The applicant device is Substantially Equivalent (SE) to the predicate device in terms of Effectiveness and Safety.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The caduceus is depicted in black, and the text is also in black. The overall design is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Trauson (Jiangsu) Medical Instrument Co., Ltd. % Shanghai Midlink Business Consulting Co., Ltd. Ms. Diana Hong Suite 8D, Zhongxin Zhongshan Mansion No. 19. Lane 999. Zhong Shan No.2 Road Shanghai, 200030, China

AUG 1 3 2008

Re: K073432

Trade/Device Name: Trauson Bone Plate Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: II Product Code: HRS Dated: July 29, 2008 Received: July 29, 2008

Dear Ms. Hong:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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Page 2 - Ms. Diana Hong

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 100-100.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Mullerson

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

Enclosure

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Attachment III Indications for Use

510(k) Number:K073432 Device Name: __ Trauson Bone Plate

Indications for Use:

Trauson Bone Plate is intended for the fixation of fractures of humerus.

Prescription Use __ V_ (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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Saubare Buchnd former

Div vision of General, Restorative, and Neurological Devices

510(k) Number K073432

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.