Ideal® locking plate system is indicated for buttressing mutifragmentary distal femur fractures including: supra-condylar; intra-articular and extra-articular condylar fractures, periprosthetic fractures in normal or osteopenic bone, nonunions and malunions.

Device Description

Ideal® locking plate system contains locking plates with various specifications, cortical and locking screws with various specifications, and various specific instruments. The bone plates are used for fixation of bones. The screws are used for fix the plates on the bones and the instruments are used for completing the surgery.

The bone plates are manufactured from unalloyed titanium that conforms to ASTM F67. The cortical and locking screws are made of Ti6A14V ELI that meets to ASTM F136. The materials of titanium and Ti6A14V ELI 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 document is a 510(k) premarket notification for a medical device called the "Ideal® Locking Plate System." It describes the device, its intended use, and claims substantial equivalence to predicate devices based on non-clinical (bench) testing.

However, the document does not contain information about a study that would involve acceptance criteria related to device performance in a clinical setting, such as a study with human readers, AI assistance, or the establishment of ground truth by medical experts.

Therefore, many of the requested items cannot be extracted from this document as they are not applicable to the type of submission described. This is a submission for a metallic bone fixation appliance, and the evidence provided focuses on mechanical and material properties through bench testing, not clinical performance metrics typically associated with AI-driven or diagnostic devices.

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

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

Acceptance Criteria (Bench Test Standards)	Reported Device Performance (Compliance)
ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates:	Complies with standards.
- Static four point bending	(Details not provided, but compliance stated)
- Dynamic four point bending	(Details not provided, but compliance stated)
ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws:	Complies with standards.
- Torsional properties	(Details not provided, but compliance stated)
- Driving torque	(Details not provided, but compliance stated)
- Pull out test	(Details not provided, but compliance stated)

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 specified in the document for any of the bench tests.
Data Provenance: The tests were conducted to demonstrate compliance with ASTM standards, which are international standards. The device manufacturer is Jiangsu Ideal Medical Science & Technology Co., Ltd. in China. The specific location where the bench tests were performed is not mentioned within the text, but it can be inferred that they were part of the submission process from a Chinese manufacturer. The tests are non-clinical, so "retrospective or prospective" does not apply in the clinical sense.

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. This submission relies on engineering bench tests, not clinical evaluation requiring expert ground truth for interpretation of images or other clinical data.

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

Not applicable. Adjudication methods are relevant for clinical studies, especially those involving human interpretation of data. This submission is based on physical and mechanical testing against recognized 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

Not applicable. This device is a metallic bone fixation system, not a diagnostic or AI-assisted device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant or discussed.

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

Not applicable. This device does not involve algorithms or AI. It is a physical implant.

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

Ground Truth: The "ground truth" for the bench tests would be the specifications and performance requirements defined by the ASTM standards (ASTM F 382-99 and ASTM F 543-07). The device's performance is compared directly against these established engineering criteria, not against biological or clinical "ground truth" like pathology or expert consensus.

8. The sample size for the training set

Not applicable. This submission evaluates a physical medical device, not an AI model requiring a training set.

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

Not applicable. As above, no training set or AI model is involved.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three intertwined snakes around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus. The seal is black and white.

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

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

March 3, 2015

Re: K141825 Trade/Device Name: Ideal® Locking Plate System Regulation Number: 21 CFR 888.3030 Regulation Name: Single/Multiple Component Metallic Bone Fixation Appliances and Accessories Regulatory Class: Class II Product Code: HRS. HWC Dated: November 18, 2014 Received: January 2, 2015

Dear Ms. Alice 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

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Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. 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/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 Industry and Consumer Education 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 yours.

Mark N. Melkerson -S

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known)

K141825

Device Name

Ideal® Locking Plate System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

2 Prescription 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 A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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[苏艾迪尔医疗科技股份有限公司

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

1. Date of Submission: Feb. 23, 2015
1. Submitter / 510(K) Holder

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

Contact Person: Miss Li Wei Tel: (86) 0512-58550488 Fax: (86) 0512-58550988 E-mail: leeway_922@126.com

3. Proposed Device Name

Trade name: Ideal® Common name: Locking Plate System

Classification Name: Plate, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HRS Regulation Number: 21 CFR 888.3030

Classification Name: Screw, Fixation, Bone Device Class: Class II Classification Panel: Orthopedic Panel Product Code: HWC Regulation Number: 21 CFR 888.3040

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4. Predicate Devices

Predicate Device #1:

510 (k) Number: K130340 Product Name: Locking Bone Plates and Scews Submitter: Weigao Orthopaedic Device Co., Ltd.

Predicate Device #2:

510 (k) Number: K110354 Product Name: Synthes 4.5mm VA-LCP Curved Condylar Plate System Submitter: Synthes

Predicate Device #3:

510 (k) Number: K130108 Product Name: Double Engine Bone Plate and Bone Screw Systems Submitter: Xiamen Double Engine Medical Material Co., Ltd.

5. Device Description

6. Indication for Use/Intended Use

7. Non-Clinical Testing

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

ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates, including the following items:

Static four point bending

- Dynamic four point bending

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ASTM F 543-07, Standard Specification and Test Metallic Medical Bone Screws including the following item:

- Torsional properties
- Driving torque
- Pull out test

8. Substantially Equivalent Conclusion

The intended use of Ideal® locking plate system is same as that of the predicate device #2 and The intended use of Ideal® locking plate system is less than that of the predicate device #1 and #3.

Ideal® locking plate system has similar technological characteristics as all predicate devices.

The proposed device, the Ideal® locking plate system, is determined to be Substantially Equivalent (SE) to the predicate device, K130340 locking bone plates and screws, K110354 Synthes 4.5mm VA-LCP Curved Condylar Plate System and K130108 Double Engine Bone Plate and Bone Screw Systems, in respect of safety and effectiveness.

Regulation Number and Section

N/A