Locking 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 proposed device, Locking Bone Screw, is made of Titanium Alloy (6Al-4V ELI) that meets ASTM F136 - 08e1 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) which is intended to be used with Orthmed Locking Compressing Bone Plate for bone reconstruction, osteotomy, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device.

AI/ML Overview

Here's the breakdown of the acceptance criteria and study information based on the provided document:

Acceptance Criteria and Device Performance

Acceptance Criteria (Bench Tests)	Reported Device Performance (Summary)
ASTM F543-07 compliance	Met design specifications and demonstrated similar performance to predicate device
Substantial Equivalence to predicate device (K081513)	Determined to be Substantially Equivalent (SE)

Study Details

Sample size used for the test set and the data provenance:
- Test Set Sample Size: Not specified. The document states "Bench tests were conducted to verify that the proposed device met all design specifications," but does not provide details on the number of screws or conditions tested.
- Data Provenance: The tests are non-clinical (bench tests) and were performed by the manufacturer, Changzhou Orthmed Medical Instrument Co., Ltd. The document does not specify the country of origin for the data beyond that. The nature is non-clinical, so "retrospective or prospective" does not apply in the typical sense; these are controlled laboratory tests.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This is a non-clinical bench test study for a bone screw. Ground truth in the context of expert consensus or medical diagnosis is not relevant here. The "ground truth" is adherence to engineering standards (ASTM F543-07) and performance metrics typically measured in mechanical testing (e.g., torque, bending strength, fatigue).
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not Applicable. Adjudication methods like 2+1 are typically used for clinical studies involving interpretation of medical images or patient outcomes, not for mechanical bench tests of a bone screw. Performance is measured objectively against engineering standards.
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 is a non-clinical bench test for a bone screw. It does not involve human readers or AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (bone screw), not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Engineering Standards and Predicate Device Performance: The "ground truth" for the non-clinical tests was established by adherence to a recognized international standard (ASTM F543-07) and by demonstrating "similar performance" to a legally marketed predicate device (Merete 3.5mm Locking Screws, K081513). This means the device's mechanical properties and functionality were measured against defined engineering specifications and compared to an existing, approved device.
The sample size for the training set:
- Not Applicable. This is a physical medical device (bone screw) and not an AI/ML algorithm that requires a training set.
How the ground truth for the training set was established:
- Not Applicable. As this is not an AI/ML algorithm study, there is no training set or associated ground truth.

Summary

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Exhibit #2 510(k) Summary for K100721

NOV 2 3 2010

Exhibit #2 510(k) Summary

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

The Assigned 510(k) Number: _K100721

Date of Prepared: 12Nov 2010 1.

Proposed Device Identification 2.

Trade/ Proprietary Name:Locking Bone Screw

Common Name:Smooth or threaded metallic bone fixation fastener

Classification Name:Screw, fixation, bone

Device Class: Il

Product Code:HWC

Regulation Number: 21 CFR 888.3040

Intended Use:

I wone Screw isindicated for bone reconstruction, osteotomy, arthrodesis, joint fusion,fracture repair, and fracture fixation of bones appropriate for the size of the device.

Sponsor Information 3.

Establishment Registration Number: 3005597716 Changzhou Orthmed Medical Instrument Co.,Ltd No.177, Qinling Road, New Zone, Changzhou, Jiangsu, China, 213022 Phone: +86-519-85123770-8055 .Fax:+86-519-85123776

Submission Correspondent

Ms. Diana Hong, Mr. Lee Fu Shanghai Mid-Link Business Consulting Co., Ltd Suite 5D, No.19, Lane 999, Zhongshan No.2 Road(S) Shanghai, 20030, China Tcl: +86-21-64264467 Fax: 240-238-7587 Email: Diana.hong@mid-link.net

loR2

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Predicate Device Identification 4.

Merete 3.5mm Locking Screws as cleared under K081513.

ડ. Device Description

The proposed device, Locking Bone Screw, is made of Titanium Alloy (6Al-4V ELI) that meetsASTM F136 - 08e1 Standard Specification for Wrought Titanium-6 Vanadium ELI (Extra Low Interstitial) Alloy for Surgical Implant Applications (UNS R56401) which is intended to be used with Orthmed Locking Compressing Bone Plate for bonc reconstruction,osteotomy, arthrodesis, joint fusion,fracture repair, and fracture fixation of bones appropriate for the size of the device.

Model Name	HCQ04(Normal Head)	HC5Q04(Normal Head/Flat Head)	HCQ04(Normal Head)	HCZ04(Tapered Head)
Diameter (mm)	3.5	5.0	6.5	5.0
Length(mm)	10~65every 1mm	10~120every 1mm	20~120every 1mm	18~85every 1mm

Table 1 Specifications

Substantially Equivalence 6.

Both the proposed and predicate device has same classification, similar intended use. Both of them were made of Titanium Alloy (6Al-4V ELI) that meets ASTM F136 - 08e1. The performance test was performed on both, the result demonstrated that they have similar performance. Therefore, the proposed device, Locking Bone Screw, is determined to be Substantially Equivalent (SE) to the predicate device, Merete 3.5mm Locking Screws as cleared under K081513.

7. Non-Clinical Test Conclusion

Bench tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The tests were performed per the following standards: ASTM F543-07, Standard Specification and Test Methods for Metallic Medical BoneScrews.

100

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

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

Changzhou Orthmed Medical Instrument Co., Ltd. % Shanghai Midlink Business Consulting Co., Ltd. Ms. Diane Hong Suite 5D, No. 19, Lane 999 Zhongshan No.2 Road (S) Shanghai, China 20030

NOV 2 3 2013

Re: K100721

Trade/Device Name: Locking Bone Screw Model HCO04. HCZ04 Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: November 12, 2010 Received: November 15, 2010

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. 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 cran he 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

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Page 2 - Ms. Diane Hong

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); medical device reporting (reporting of medical 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 vours.

Barbara Buchmu

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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Indication for Use

K10072 510(k) Number:

NOV 2 3 2010

CALL - CALL - CALL - COMMER - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CALL - CA

Device Name: Locking Bone Screw

Indications for Use:

Locking 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 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)

Smata for nym
(Division Signa)

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510(k) Number K100721

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.