The Metallic Intramedullary Nail System, is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments. The intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail.

AI/ML Overview

The provided document describes the acceptance criteria and a study demonstrating the substantial equivalence of the "Metallic Intramedullary Nail System" to a predicate device. However, this is a premarket notification for a medical device (intramedullary nail), which is a physical implant, not an AI/ML-powered device or diagnostic tool. Therefore, many of the requested categories (like MRMC study, human reader improvement with AI assistance, ground truth establishment for AI models, training set details) are not applicable to this type of device and study.

The study performed is a non-clinical mechanical performance test, comparing the device to a predicate device based on engineering standards, not a clinical study involving patients or expert interpretation of diagnostic output.

Here's an analysis based on the information available, addressing the applicable categories:

Acceptance Criteria and Device Performance

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

The acceptance criterion for this device is "Substantial Equivalence" to the predicate device, specifically regarding its mechanical performance and other characteristics. The device performance is demonstrated through non-clinical testing.

Acceptance Criteria Category/Characteristic	Predicate Device Performance / Characteristic	Proposed Device Performance / Characteristic	Conclusion (Meets/Does Not Meet)
Product Code	HSB	HSB	Meets (Same)
Regulation No.	888.3020	888.3020	Meets (Same)
Class	II	II	Meets (Same)
Classification Name	Rod, Fixation, Intramedullary And Accessories	Rod, Fixation, Intramedullary And Accessories	Meets (Same)
Intended Use	Simple, compound first- and second-degree tibial shaft fractures; Pseudarthrosis and delayed union	Simple, compound first- and second-degree tibial shaft fractures; Pseudarthrosis and delayed union	Meets (Same)
Configuration	Nail, Screw and End cap	Nail, Screw and End cap	Meets (Same)
Screw Feature	Single cortical fixation achieved by proximal threaded locking screw.	Single cortical fixation achieved by proximal threaded locking screw.	Meets (Same)
Sterile	Supplied non-sterile, to be sterilized prior to use (SAL 1x10^-6)	Supplied non-sterile, to be sterilized prior to use (SAL 1x10^-6)	Meets (Same)
Single Use	Yes	Yes	Meets (Same)
Labeling	Conforms to 21 CFR 801	Conforms to 21 CFR 801	Meets (Same)
Mechanical Specification (Nail & Screw)	Tested per ASTM F1264:2003 R2007 (Specific quantitative results for bending strength, fatigue life are not provided in this summary, but the method is the criterion).	Tested per ASTM F1264:2003 R2007. The summary states: "the mechanical test demonstrated the results of both devices are very similar."	Meets (Similar results based on standard test)
Material Specification	Titanium Alloy (Ti-6Al-4V ELI); Conforms to ASTM F136 Standard	Titanium Alloy (Ti-6Al-4V ELI); Conforms to ASTM F136 Standard	Meets (Same)
Dimensions (Physical Specification)	Ranges provided for Nail (diameter, length), Screw (diameter, length), End Cap (diameter, length)	Ranges provided for Nail (diameter, length), Screw (diameter, length), End Cap (diameter, length) Note: Dimensions are different, but the mechanical test results are reported as similar.	Meets (Differences in dimensions are acceptable if mechanical performance is similar)

Study Information (Applicable to Non-Clinical Mechanical Testing):

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications". It does not specify a "sample size" in terms of number of devices tested, but rather that the device was tested per ASTM F 1264-03(Reapproved 2007). This standard dictates the test methods for intramedullary fixation devices, including specimen preparation and required number of specimens for various tests (e.g., static bending, fatigue). The provenance of the data is from the manufacturer, Tianjin Walkman Biomaterial Co., Ltd, in China, as part of their 510(k) submission. These are prospective non-clinical tests.

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 in this context refers to the physical properties and mechanical performance of the materials and devices as measured using standardized laboratory tests, not expert interpretation of images or clinical outcomes. The "ground truth" is established by the specifications in ASTM F1264 and ASTM F136.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. Adjudication methods are used to resolve discrepancies in expert interpretation, which is not relevant for objective mechanical testing.

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 a non-clinical mechanical performance study of a physical implant, not an AI/ML diagnostic device involving human readers.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a non-clinical mechanical performance study of a physical implant, not an AI/ML diagnostic device with an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance is derived from mechanical testing standards (ASTM F 1264-03(Reapproved 2007)) and material specifications (ASTM F136 Standard for Titanium Alloy). The device's performance is compared against these engineering standards and to the predicate device's performance under these same standards.

8. The sample size for the training set
Not applicable. There is no "training set" as this is not an AI/ML model.

9. How the ground truth for the training set was established
Not applicable. There is no "training set." The performance of the predicate device serves as a benchmark for comparison, and both devices are evaluated against established engineering standards.

Summary

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MAR 1 9 2014

Section 3 510 (k) Summary

Project #: M0162013Ad

Section 3 510(k) Summary

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

The assigned 510(k) Number: _K132078

l. Date of Submission: 06/27/2013
1. Sponsor Identification

Tianjin Walkman Biomaterial Co., Ltd No. 19, Technology Road, Tianjin Tianyu Science and Technology Garden JinghaiEast. Tianjin, P.R. China 301609

Establishment Registration Number: Not yet registered

Contact Person: Ms. FengmeiRen Position: Management Representative Tel: +86-22-68660780 Fax: +86-22-68660776 Email: wm-rfm@126.com

1. Submission Correspondent
  Ms. Diana Hong & Mr. Lee Fu Mid-Link Consulting Co.. Ltd P.O. Box 120-119 Shanghai, 200120, China Tcl: +86-21-22815850 Fax: 240-238-7587 Email: info@mid-link.net

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Project #: M0162013Ad

1. Proposed Device Identification
  Proposed Device Trade Name: Metallic Intramedullary Nail System

Classification Name: rod, fixation, intramedullary and accessories; Classification: II: Product Code:HSB; Regulation Number: 21 CFR888.3020; Review Panel: Orthopedic:

Intended Use Statement:

· Simple, compound first- and second-degree tibial shaft fractures
· Pseudarthrosis and delayed union
1. Predicate Device Identification

510(k) Number: K121312 Product Name: Intramedullary Nail System Manufacturer: Weigao Orthopaedic Device Co., Ltd

Device Description 6.
The Metallic Intramedullary Nail System, is a temporary fixation intramedullary nail designed for fracture fixation and stabilization of the tibia. The system consists of intramedullary nail, locking screw, end cap and instruments.

The intramedullary nail is available in a variety of lengths and diameters to meet assorted anatomical needs. Each of the nails is secured by a series of screws that pass through holes manufactured into the proximal and distal sections of each nail.

1. Non-Clinical Test Conclusion
  Non clinical tests were conducted to verify that the proposed device met all design specifications as was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that the proposed device complies with the following standards:

ASTM F 1264-03(Reapproved 2007), Standard Specification and Test Methods for Intramedullary Fixation Devices

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Substantially Equivalent (SE) Conclusion 8.

The following table compares the DEVICE to the predicate device with respect to intended use, technological characteristics and principles of operation, etc.

Item	Proposed Device	Predicate Device
Product Code	HSB	Same
Regulation No.	888.3020	Same
Class	II	Same
Classification Name	Rod, Fixation, Intramedullary And Accessories	Same
Intended Use	Simple, compound first- and second-degree tibial shaft fracturesPseudarthrosis and delayed union	Same
Configuration	Nail, Screw and End cap	Same
Screw Feature	Single cortical fixation achieved by proximal threaded locking screw.	Same
Sterile	The devices are supplied non-sterile, it should be sterilized prior to use by professional and the sterilization should achieve SAL 1×10-6.	Same
Single Use	Yes	Same
Labeling	Conforms to 21 CFR 801	Same
PhysicalSpecification	Nail	Proximal/Distal Diameter: φ10/φ8 mm, φ10/φ10 mm, φ10/φ9 mmLength: 240 mm - 340 mm in 5 mm increments.	Proximal Distal Diameter: φ10/φ9 mm, φ10/φ10 mm, φ11/φ9 mm, φ11/φ10 mm, φ11/φ11 mm, φ12/φ12 mm, φ13/φ13 mmLength: 240 mm - 465 mm in 5 mm increments.
	Screw	Proximally threaded screwDiameter: φ6 mm, Length: 20-75 mm	Proximally threaded screwDiameter: φ4 mm, Length: 18-80 mmDiameter: φ5 mm, Length: 26-100 mmDiameter φ6 mm, Length: 18-100 mm
	End Cap	Diameter: φ10 mm, Length: 16mm	Diameter: φ10 mm, Length: 14 mmDiameter φ8 mm, Length: 11.5 mm, 16.5mm, 17.5mm, 21.5mm and 26.5mm
MechanicalSpecification	Nail	Tested per ASTM F1264:2003 R2007	Same
	Screw	Tested per ASTM F1264:2003 R2007	Same
Material Specification	Titanium Alloy (Ti-6Al-4V ELI)	Same
	Conforms to ASTM F136 StandardSpecification for WroughtTitanium-6Aluminum-4 Vanadium ELI(ExtraLow Interstitial) Alloy for Surgical Implant Applications (UNSB 56401)	Same

Table 3-1 Comparison of Technology Characteristics

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Section 3 510 (k) Summary

The proposed device is mainly different in dimension with the predicate device, but the mechanical test demonstrated the results of both devices are very similar.

The proposed device. Metallic Intramedulary Nail System, is determined to be Substantially Equivalent (SE) to the predicate device, Intramedullary Nail System (K121312), in respect of safety and effectiveness.

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Public Health Service

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

March 19. 2014

Tianjin Walkman Biomaterial Co., Limited % Ms. Diana Hong General Manager Mid-Link Consulting Co., Limited P.O. Box 120-119 Shanghai, 200120, CHINA

Re: K132078

Trade/Device Name: Metallic Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: Class II Product Code: HSB Dated: February 25, 2014 Received: February 27, 2014

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. Iisting 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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,

Vincen官网 - S

for

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

Enclosure

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Project #:M0162013Ad

Section 2 Indications for Use

510(k) Number: K132078 Device Name: Metallic Intramedullary Nail System

Indications for Use:

· Simple, compound first- and second-degree tibial shaft fractures;
· Pseudarthrosis and delayed union.

OPRESCRIPTION USE (Part 21 CFR 801 Subpart D)

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)

Casey L. Hanley, Ph.D.

Division of Orthopedic Devices

Page 1 of 1

Regulation Number and Section

§ 888.3020 Intramedullary fixation rod.

(a)
Identification. An intramedullary fixation rod is a device intended to be implanted that consists of a rod made of alloys such as cobalt-chromium-molybdenum and stainless steel. It is inserted into the medullary (bone marrow) canal of long bones for the fixation of fractures.(b)
Classification. Class II.