The China Nails are indicated for simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nails are for single use only.

Device Description

Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table.

China Nails and Accessories	Diameter	Length
Intramedullary Nails
Universal Nails	9, 10, 11 mm	17 cm
Right and Left Hand Nails	9, 10, 11 mm	26 - 46 cm
Screws
Lag Screws	8.6 mm	70 - 125 mm
Compression Screws	6.2 mm	65 - 120 mm
Nail Cap Set Screws	6.6 mm	0, 5, 10 mm
Distal Locking Screw	4.5 mm	20 - 65 mm
	5.0 mm	20 - 110 mm

The implants are manufactured from titanium alloy (Ti-6Al-4V).

AI/ML Overview

This document describes the Smith & Nephew China Nails and Accessories, an intramedullary nail system. The information provided is for a 510(k) premarket notification, which is a submission to the FDA demonstrating that the device is substantially equivalent to legally marketed predicate devices. Therefore, the "acceptance criteria" and "study" are framed within the context of demonstrating substantial equivalence through non-clinical performance testing rather than a clinical trial with specific performance metrics.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Material Equivalence	Manufacturing Material: Titanium Alloy (Ti-6Al-4V)	Implants are manufactured from titanium alloy (Ti-6Al-4V)	Matches predicate devices.
Design/Component Equivalence	Overall design and components (Intramedullary Nails, Screws, Nail Cap Set Screws)	Design and components are similar to predicate devices (TRIGEN InterTAN, SURESHOT TAN, TRIGEN Low Profile Bone Screws)	Confirmed through comparison of device descriptions and features.
Indications for Use Equivalence	Indications for China Nails	Same as TRIGEN InterTAN: simple long bone fractures; severely comminuted, spiral, long oblique and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, following tumor resection and grafting; bone lengthening and shortening; subtrochanteric fractures; ipsilateral femoral shaft/neck fractures; intertrochanteric fractures; and intracapsular fractures.	Directly comparable and found to be the same.
Technological Characteristics Equivalence (Mechanical Testing)	Fatigue testing performance	Confirmed to be equivalent to predicate devices.	No specific quantitative acceptance criteria or results were provided, but equivalence was stated.
Technological Characteristics Equivalence (Wear Evaluation)	Wear evaluation performance	Confirmed to be equivalent to predicate devices.	No specific quantitative acceptance criteria or results were provided, but equivalence was stated.
Safety and Effectiveness	No new issues related to safety and effectiveness	Determined that there are no new issues.	Based on the equivalence of materials, design, indications, and mechanical testing.

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

Test Set (for mechanical testing): The document does not specify the exact sample size for the fatigue testing and wear evaluation. It only states that "Mechanical testing was conducted." Given the nature of medical device premarket notifications, these tests typically involve a statistically relevant number of samples to demonstrate performance.
Data Provenance: The data is from non-clinical bench testing conducted by the manufacturer, Smith & Nephew, Inc. There is no mention of human subject data, and the context indicates that clinical data was not needed for this submission. The testing would have been performed in a laboratory setting.

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

Ground Truth for Test Set: Not applicable in the traditional sense for a clinical study. For bench testing, the "ground truth" is established by engineering principles, accepted test methods (e.g., ASTM or ISO standards for medical implants), and comparison against predicate device performance. The experts involved would be biomechanical engineers, material scientists, and regulatory specialists within Smith & Nephew responsible for designing, executing, and interpreting the mechanical tests. Their specific number and qualifications are not detailed in this summary.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1, 3+1) are used for clinical studies involving multiple human readers or evaluators to resolve discrepancies in diagnoses or assessments. This submission relies on non-clinical mechanical testing and comparison to predicate devices, where adjudication of subjective interpretations is not relevant.

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/software device and no MRMC study was conducted. The device is a physical orthopedic implant.

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

Not applicable. This is not an algorithm or software. It is a physical medical device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

For this 510(k) submission, the "ground truth" for demonstrating substantial equivalence is based on:
- Engineering Standards and Specifications: Adherence to established material properties and dimensional specifications.
- Bench Test Results: Quantitative and qualitative data from fatigue testing and wear evaluation according to industry-accepted protocols.
- Predicate Device Performance: The established performance characteristics and safety profile of the legally marketed predicate devices (Smith & Nephew TRIGEN InterTAN, Smith & Nephew SURESHOT TAN and Accessories, Smith & Nephew TRIGEN Low Profile Bone Screws). The China Nails and Accessories are considered "substantially equivalent" if their performance in these tests is comparable to the predicate devices.

8. The Sample Size for the Training Set

Not applicable. This is a physical medical device, not a machine learning or AI model that requires a training set. The "training" for such a device involves product development, manufacturing processes, quality control, and adherence to design specifications based on engineering principles.

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

Not applicable for the same reasons as point 8.

Summary

{0}------------------------------------------------

123948

Smith & Nephew, Inc. Summary of Safety and Effectiveness China Nails and Accessories

MAR 1 4 2013

Contact Person and Address:

Date of Summary: December 19, 2012

Jason Sells Group Manager, Regulatory Affairs Smith & Nephew, Inc. 7135 Goodlett Farms Parkway Cordova. TN 38016 (901) 399-5520

Name of Device: China Nails and Accessories Common Name: Intramedullary nail and accessories Device Classification Name and Reference: 21CFR 888.3030 Single/multiple component metallic bone fixation appliances and accessories

Device Class: II Panel Code: Orthopaedics/87 JDS

Predicate Devices:

Smith & Nephew TRIGEN InterTAN (K040212) Smith & Nephew SURESHOT TAN and Accessories (K092748) Smith & Nephew TRIGEN Low Profile Bone Screws (K111025)

Device Description:

Subject devices of this submission are China Nails and Accessories. The implant components included in the system are described in the following table.

China Nails and Accessories	Diameter	Length
Intramedullary Nails
Universal Nails	9, 10, 11 mm	17 cm
Right and Left Hand Nails	9, 10, 11 mm	26 - 46 cm
Screws
Lag Screws	8.6 mm	70 - 125 mm
Compression Screws	6.2 mm	65 - 120 mm
Nail Cap Set Screws	6.6 mm	0, 5, 10 mm
Distal Locking Screw	4.5 mm	20 - 65 mm
	5.0 mm	20 - 110 mm

The implants are manufactured from titanium alloy (Ti-6Al-4V).

Intended Use:

Substantial Equivalence Information:

The overall design, materials, and indications for the China Nails and Accessories are substantially equivalent to the commercially available predicate devices. China Nails and Accessories are similar to predicate devices as follows.

{1}------------------------------------------------

Smith & Nephew, Inc. Summary of Safety and Effectiveness China Nails and Accessories

The indications for the China Nails and Accessories are the same as for the . TRIGEN InterTAN.
All three systems (China Nail, TRIGEN InterTAN and the SURESHOT TAN Nail) . include an option to use the combination lag screw/compression screw design.
All three systems (China Nail, TRIGEN InterTAN and the SURESHOT TAN Nail) . are manufactured from titanium alloy.
The distal screw holes for the China Nails and the SURESHOT TAN Nail . Systems incorporate internal threads to aid in screw stability.
The Locking Screw have the same design as the TRIGEN Low Profile Bone . Screw cleared in K111025. The only difference is the surface anodization. The TRIGEN Low Profile Bone Screws are anodized while the China Nails Locking Screws are non-anodized.

Based on the comparisons, it is determined that the China Nails and Accessories are substantially equivalent to the predicate devices.

Technological Characteristics

Mechanical testing was conducted and the results were compared to testing conducted on predicate devices. Fatigue testing and a wear evaluation confirmed that the China Nails and Accessories are equivalent to the predicate devices and that there are no new issues related to the safety and effectiveness of the subject devices. Clinical data was not needed to support the safety and effectiveness of the subject devices

Conclusion

Based on the indications for use, similarities of designs, and the performance testing, it is determined that the China Nails and Accessories are substantially equivalent to the predicate devices.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three overlapping wings, representing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-00002

March 14, 2013

Smith & Nephew, Incorporated % Mr. Jason Sells Group Manager, Regulatory Affairs 1450 Brooks Road Memphis, Tennessee 38116

Re: K123948

Trade/Device Name: China Nails and Accessories Regulation Number: 21 CFR 888.3030

Regulation Name: Single/multiple component metallic bone fixation appliances and accessories

Regulatory Class: Class II Product Code: JDS Dated: December 19, 2012 Received: December 21, 2012

Dear Mr. Sells:

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. Drue, 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

{3}------------------------------------------------

Page 2 - Mr. Jason Sells

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/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Image /page/3/Picture/6 description: The image shows the name "Erin Keith" in a stylized font. The first name, "Erin," is written in a simple, bold font. The last name, "Keith," is written in a more decorative font, with the letters outlined and filled with patterns.

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

Enclosure

{4}------------------------------------------------

510(k) Number (if known): K123948

K123948

Device Name: China Nails and Accessories

Indications for Use:

The China Nails are indicated for simple long bone fractures; severely comminuted, rnic Unina Nallo and segmental fractures; nonunions and malunions; polytrauma and multiple fractures; prophylactic nailing of impending pathologic fractures; reconstruction, multiple fractures, prophylaole hating bone lengthening and shortening; subtrochanteric following turnor roodotion and gatt/neck fractures; intertrochanteric fractures; and intracapsular fractures. The Smith & Nephew, Inc. China Nail is for single use only.

Over-The-Counter Use AND/OR
Prescription Use (Optional Format 1-2-96) (Part 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Casey Hanley, Ph.D.
Division of Orthopaedic Devices

Page 1 of

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.