The Ideal™ Intramedullary Nail System is intended to provide temporary fracture fixation and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union).

Device Description

The Ideal™ Intramedullary Nail System is intended to provide temporary fracture and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delayed union). It consists of intramedullary nail. locking screw and end cap. 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. The locking screw passes through the holes at the proximal and distal sections of intramedullary nail for preventing rotation and axial compression. The end cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads. All implants of intramedullary nail system are manufactured from Ti-6A1-4V allov that meets the requirements of ASTM F-136. The materials are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

AI/ML Overview

The provided text describes a 510(k) summary for the Ideal™ Intramedullary Nail System, a medical device intended for temporary fracture fixation and stabilization of the tibia. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard)	Reported Device Performance (Test Conducted)
ASTM F1264-03 (Reapproved 2007) - Static bending requirements	Static bending test
ASTM F1264-03 (Reapproved 2007) - Static torsion requirements	Static torsion test
ASTM F1264-03 (Reapproved 2007) - Dynamic bending requirements	Dynamic bending test
ASTM F 543-07 - Pullout strength requirements	Pull out test

2. Sample size used for the test set and the data provenance:

Sample Size: The document does not specify the exact sample size (number of nails or screws) used for each of the non-clinical tests.
Data Provenance: The tests were conducted by the manufacturer, Jiangsu Ideal Medical Science & Technology Co., Ltd., which is based in China. The data would therefore be considered prospective non-clinical test data.

3. 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 testing study, not a clinical study involving human or animal subjects that would require expert-established ground truth for a test set. The "ground truth" here is adherence to specified ASTM standards.

4. Adjudication method for the test set:

Not Applicable. As a non-clinical bench testing study, there is no need for an adjudication method as would be used in a clinical trial to resolve discrepancies in expert interpretation. The performance is objectively measured against predefined engineering standards.

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 document pertains to a physical medical implant (an intramedullary nail system), not an AI-powered diagnostic or interpretive device. Therefore, an MRMC study comparing human readers with and without AI assistance is not relevant and was not performed.

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

No. This is not an AI algorithm. The tests performed are standalone in the sense that they assess the physical properties of the device itself (mechanical strength, resistance to forces) without human-in-the-loop interaction in the testing process. However, this question typically refers to the performance of an AI algorithm operating independently, which is not applicable here.

7. The type of ground truth used:

The ground truth for this device's performance is based on established engineering standards and specifications, specifically ASTM (American Society for Testing and Materials) standards. The device's performance is compared against the requirements outlined in ASTM F1264-03 (Reapproved 2007) for intramedullary fixation devices and ASTM F 543-07 for metallic medical bone screws.

8. The sample size for the training set:

Not Applicable. This is not a machine learning or AI device that requires a training set.

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

Not Applicable. As this device does not utilize a training set, the establishment of ground truth for such a set is not relevant.

Summary

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Section 5 of Traditional 510(K) Submission:

510 (K) Summary

This 510(K) Summary of safety and effectiveness information is being submitted in accordance with requirement of 21 CFR807.92

The assigned 5 10(k) Number: K132428

Date of Submission: Sept. 11.2013
Submitter / 510(K)Holder

Jiangsu Ideal Medical Science & Technology Co., Ltd. East Area, Jinfeng Industry Park Zhangjiagang Citv Jiangsu Province, China 215625

Contact Person: Mr. Hui Gang Cai Tel: (86) 0512-58550488 Fax: (86) 0512-58550988 E-mail: caihuig@126.com

3. Proposed Device Name

Trade name: Ideal™ Common name: Intramedullary Nail System Classification Name: Intramedullary fixation rod Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HSB Regulation Number: 21 CFR 888.3020

4. Predicate Devices

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

5. Device Description

DEC 2 0 2013

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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. The locking screw passes through the holes at the proximal and distal sections of intramedullary nail for preventing rotation and axial compression. The end cap which screws into the threaded end of the intramedullary nail provides intraoperative lengths adjustment and prevents tissues growth into nail threads.

All implants of intramedullary nail system are manufactured from Ti-6A1-4V allov that meets the requirements of ASTM F-136. The materials are widely used in the industry with well-known biocompatibility. No new materials are used in the development of this implant.

6. Indication for Use/Intended Use

The Ideal" Intramedullary Nail System is intended to provide temporary fracture fixation and stabilization of the tibia. (Simple, compound first- and second-degree tibial shaft fractures, pseudarthrosis and delaved union).

7. Non-Clinical Testing

Bench tests were conducted to verify that the proposed device met all design specifications and was Substantially Equivalent (SE) to the predicate device. The test results demonstrated that proposed device complies with the following standards:

ASTM F1264-03 (Reapproved 2007). Standard Specification and Test Methods for Intramedullary Fixation Devices, including the following items:

- Static bending test
- Static torsion test
- Dynamic bending test

ASTM F 543-07. Standard Specification and Test Methods for Metallic Medical Bone Screws- pullout strength, including the following item:

Pull out test

8. Substantially Equivalent Conclusion

The Ideal™ Intramedullary Nail System has same intended use and similar technological characteristics as the predicate device. The proposed device, the Ideal 131 Intramedullary Nail System, is deternined to be Substantially Equivalent (SE) to the predicate device. K121312 Intramedullary Nailing System, in respect to safety and effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

December 20, 2013

Jiangsu Ideal Medical Science & Technology Company, Limited % Ms. Bo Gong Shanghai Yarui Consultant Company, Limited Room 503, Building 8, 600 Liu Zhou Road Shanghai, 200233 China

Re: K132428

Trade/Device Name: Ideal™ Intramedullary Nail System Regulation Number: 21 CFR 888.3020 Regulation Name: Intramedullary fixation rod Regulatory Class: II Product Codes: HSB Dated: September 19, 2013 Received: September 30, 2013

Dear Ms. Gong:

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 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. Bo Gong

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/ResourcesforYou/industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/ReportalProblem/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,

Ronald P. Jean -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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Section 4 of Traditional 510(K) Submission:

Indications for Use

510(k) Number: K132428

Device Name: Ideal™ Intramedullary Nail System

Indications For Use:

Prescription Use_ X AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of Center for Devices and Radiological Health (CDRH)

Elizabeth L. Frank -S

Division of Orthopedic Devices

ldeal™, Jiangsu Ideal Medical

Regulation Number and Section

N/A