Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Device Description

The applicant device of Trauson Bone Screw consists of screws made of medic 11 grade 3 16L stainless steel that meet ASTM 138 is intended for fixation of fractures, fusions, or osteotomies of bones of the hand and foot. The screws are Type HA with spherical undersurface of head, shallow, asymmetrical buttress thread, and deep screw head. The applicant devices are not sterile. No new materials are used in the development of this implant.

AI/ML Overview

This document describes the 510(k) submission for the Trauson Bone Screw, indicating that it's a medical device (a bone screw) and that its approval is based on demonstrating "substantial equivalence" to a predicate device, not on meeting specific, independently established acceptance criteria through a clinical or performance study that would generate the kind of data requested in the prompt.

Here's a breakdown based on the provided text, highlighting what can be answered and what cannot:

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

Acceptance Criteria Category	Specific Criteria (if discernible)	Reported Device Performance
Material Composition	Medical grade 316L stainless steel meeting ASTM 138	Device is made of Medic 11 grade 316L stainless steel meeting ASTM 138 (Note: discrepancy "Medic 11 grade 316L" vs. "medical grade 316L" appears, but the intent is material compliance).
Biocompatibility	Compliance with ISO 10993 standards	"all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993"
Mechanical Properties	Not explicitly stated (e.g., specific torque values, pullout strength)	Bench tests conducted for Torsional properties, Insertion Torque, Pullout Test; results are referenced generally as being "similar physical and mechanical specifications" to the predicate, with "slight" variants not influencing effectiveness/safety. Specific numerical results are not provided in this summary.
Substantial Equivalence	Similar classification, intended use, sterilization, performance, biocompatibility, chemical specifications, and physical/mechanical specifications to predicate device.	The device "has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications and similar physical and mechanical specifications" with the predicate device. "The only difference... is some physical specifications variant which is too slight to influence the effectiveness and safety."

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

Sample Size: Not applicable in the context of the provided information. This submission relies on "substantial equivalence" to a predicate device, which typically involves bench testing rather than clinical performance (patient) studies with sample sizes.
Data Provenance: The bench tests were "conducted" as part of the submission process, but the country of origin of the testing data itself is not specified beyond the manufacturer being in China. The nature of these tests is prospective for this specific device.

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. Ground truth and expert consensus are concepts typically associated with diagnostic AI or image analysis. This submission is for a physical orthopedic implant. The "ground truth" for the material and mechanical properties would be established by industry standards (ASTM, ISO) and laboratory testing protocols.

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

Not applicable. Adjudication methods are usually relevant for expert review in clinical studies or assessment of diagnostic outcomes. Bench testing for mechanical properties would involve standardized measurement and verification against pre-defined specifications.

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

Not applicable. This is not an AI/diagnostic device.

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

Not applicable. This is not an AI/diagnostic device.

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

The "ground truth" for this device's performance is established by material standards (ASTM 138) for its composition and biological evaluation standards (ISO 10993) for biocompatibility. For mechanical properties, it would be the physical and mechanical specifications of the predicate device as the benchmark for substantial equivalence, determined through laboratory bench tests.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. As above, there is no "training set" for this type of medical device submission.

Summary

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K073159 #1/3

Appendix I. 510(k) Summary

JUL 2 3 2008

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:

Applicant Device Information Trade/Proprietary Name: Trauson Bone Screw Common Name: Smooth or threaded metallic bone fixation fastener Classification Name: Screw, fixation, bone Device Class: II Product Code: HWC Regulation Number: 888.3040 Intended Use:

Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

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. 5300 Playa Vista Drive, Unit 15 Los Angeles, CA 90094, USA Phone: +86-21-64264467 x 152 Fax: +86-21-64264468 x 809 Email: Diana.hong@mid-link.net &: Eric.chen@mid-link.net

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K073159 #2/3

Premarket Notification 510(k) Submission-510(k) Summary Report No .: A20060011

Predicate Device K-number: K060071 Device Name: Nexa Compression Screw Device Trade Name: Nexa Compression Screw

Manufactured by:

Nexa Orthopedics, Inc., (dba Futura Biomedical, LLC) 10675 Sorrento Valley Road, Suite 1 00 San Diego, CA 92121

4. Device Description

The applicant devices are not sterile. No new materials are used in the development of this implant.

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K073159 * 3/3

Premarket Notification 510(k) Submission-510(k) Summary Report No .: A20060011

5. Test Data

The applicant device material only contains Medic 11 grade 3 16L stainless steel that meets ASTM 138, and the material is medical grade and widely used in the industry which requires no biocompatibility testing.

However, the all conducted Biological Evaluation Tests are in compliance with the standards of ISO 10993, "Biological Evaluation of Medical Devices". The compatibility of all the component material in the finished product was provided.

Bench tests of the applicant device are conducted to determine the Torsional properties, Insertion Torque, Pullout Test, please see the Appendix 2, ASTM Test Report

Substantially Equivalence 6.

Comparison Analysis:

The Applicant device has the same classification information, intended use, sterilization specifications, performance, biocompatibility, chemical specifications and similar physical and mechanical specifications with the predicate device. The only difference between applicant device and predicate device is some physical specifications variant which is too slight to influence the effectiveness and safety. No new question was raised.

Conclusion:

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

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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 stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 2 3 2008

Trauson (Jiangsu) Medical Instrument Co., LTD. % Diana Hong Lane 999, Ahongshan No. 2 Road Suite 8D, No. 19 Shanghai, China 200030

Re: K073159

Trade/Device Name: Trauson Bone Screw, Models HA 3.5 and 4.5 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: July 21, 2008 Reccived: July 22, 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 Kegulations, 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 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.

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Page 2 - Ms. Diana Hong

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 its toll-frec number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark M. Milliman

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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Appendix II. Indications for Use

510(k) Number: K073159

Device Name: Trauson Bone Screw

Indications for Use:

Trauson Bone Screw is indicated for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

Prescription Use (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)

Signature of
Witness

(Division Sign-Off) (Division Digiston of General, Restorative, and Neurological Devices of of 1 Page

510(k) Number

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.