The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.

Device Description

The IRENE Locking Compression Plate System is designed for internal fixation of bones that subject to fracture. The system includes bone plates and screws that can be used with the plate. Various sizes of plate are available for different fracture areas or clinical conditions. Bone screws are incorporated in the system and are intended to fix with plate with appropriate size. The plate has a limited-contact design. The plate system is provided unsterile. And the system is intended for single-use.

AI/ML Overview

This document is a 510(k) Summary for the IRENE Locking Compression Plate System, which is a medical device for orthopedic fixation. It's a regulatory filing, not a research study. Therefore, most of the information requested about acceptance criteria and study details (like sample sizes, expert adjudication, MRMC studies, ground truth) is not applicable or present in this type of document because it describes a submission for regulatory clearance, not the results of a clinical effectiveness study.

Here's an analysis of the provided text based on your request, highlighting what's available and what's explicitly stated as not applicable:

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

The document does not provide a table of acceptance criteria with specific numerical performance targets. Instead, it states that the device's performance was evaluated against predicate devices using recognized ASTM standards. The acceptance criterion implicitly is that the proposed device performs comparably to the predicate devices and meets the requirements of these standards.

The document states:

"Results of testing indicates no gap between the level of performance of proposed device and the predicate device" (Page 6)

The performance data mentioned are:

Plate: Static and dynamic testing conducted as per ASTM F382-13.
Screw: Torsional properties, driving torque, and pull-out strength conducted as per ASTM F543-13.

No specific numerical results for these tests are provided, only the general conclusion of "no gap" in performance compared to predicate devices.

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

Sample size: Not specified. The document refers to "mechanical testing" and "testing the mechanical properties of the proposed and predicate device" (Page 5, 6) but does not provide the number of units/samples tested for either the proposed or predicate device.
Data provenance: The mechanical testing was conducted by Tianjin ZhengTian Medical Instrument Co., Ltd. in China, as indicated by the submitter's address (Page 3). It is preclinical (bench) testing, not clinical data from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. This was preclinical mechanical testing, not a study requiring expert clinical opinion for ground truth.

4. Adjudication method for the test set

Not applicable. This was preclinical 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 device is a bone fixation plate system, not an AI diagnostic or assistive tool. No MRMC study was conducted.

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

Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used

Not applicable in the conventional sense of clinical ground truth (e.g., pathology, outcomes). The "ground truth" for this submission's performance evaluation lies in the established mechanical testing standards (ASTM F382-13 and ASTM F543-13) and the performance of legally marketed predicate devices. The goal was to show the proposed device met these standards and was comparable to predicates.

8. The sample size for the training set

Not applicable. This device is a physical product, not an AI/ML algorithm that requires a training set.

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

Not applicable. This device is a physical product, not an AI/ML algorithm.

Summary

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

Tianjin Zhengtian Medical Instrument Co., Ltd Yifan Fu Regulatory Affairs Specialist No.318, Jingyi Road, Airport Economic Zone Tianjin, 300308 CHINA

February 25, 2016

Re: K151508 Trade/Device Name: IRENE Locking Compression 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: January 8, 2016 Received: January 13, 2016

Dear Yifan Fu:

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 Parts 801); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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" (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 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 Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Form Approved: OMB No. 0910-0120

Expiration Date: January 31, 2017

See PRA Statement below.

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

K151508

510(k) Number (if known)

Device Name

IRENE Locking Compression Plate System

Indications for Use (Describe)

The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.

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

즈 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)

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Section 10 510(k) Summary

This document is prepared to provide sufficient information for an understanding of the basis for the determination of substantial equivalence, as required by 21 CFR section 807.92(c).

1. 510(k) Submitter and Owner
  Tianjin ZhengTian Medical Instrument Co., Ltd Address: No.318, Jingyi Road, Airport Economic Zone, Tianjin, P.R. China Official Correspondent: Xiang, Zhaojun Position: Regulatory Affairs Supervisor Tel: +86 10 82292929 Fax: +86 10 82290740 E-mail: xiangzhaojun@naton.cn Date of Preparation of the Summary: Feb 25th, 2016
1. Submission Contact Fu, Yifan Position: Regulatory Affairs Specialist Tel: +86 10 82292929 E-mail: fuyifan@naton.cn
1. Proposed Device

Trade name - IRENE Locking Compression Plate System Common name - Locking compression plate and screw Class: Class 2

Regulation -21 CFR 888.3030, Product Code HRS (Bone Fixation Plate) -21 CFR 888.3040, Product Code HWC (Bone Fixation Screw)

Review Panel: Orthopedic

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single-use.

Indications for Use:

The IRENE Locking Compression Plate System is indicated for patients with age above 21 for fixation of fractures. Indicated facture areas include ulna, radius, humerus, femur, and tibia.

1. Predicate Device

	Predicate Device 1	Predicate Device 2	Predicate Device 3
510(k) Number	K101400	K100721	K112819
Predicate Device Name	Locking Bone Plate	Locking Bone Screw	3.5mm Locking Screw
Manufacturer	Changzhou Orthmed Medical Instrument Co., Ltd.	Xiamen Double Engine Medical Material Co., Ltd.
Classification	888.3030(HRS)	888.3040(HWC)	888.3040(HWC)

1. Preclinical Data
  Mechanical testing is conducted to demonstrate differences in technological characteristics of the proposed device to predicate device do not raise new question regarding safety and effectiveness, and Substantially Equivalent to the predicate device is thus concluded. The testing incorporates the following standards as test method to evaluate the performance of both proposed and predicate device:
1. ASTM F 382-99 (Reapproved 2008), Standard Specification and Test Method for Metallic Bone Plates.
1. ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
1. Clinical Data

No clinical data is presented in this submission.

1. Substantial Equivalence Comparison

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IRENE

Element	Proposed DeviceIRENE Plate andScrew	Predicate DeviceOrthmed Plate andScrew	Predicate DeviceDouble Engine3.5mm LockingScrew
Class	2	2	2
Regulationnumber	Plate: 21 CFR888.3030Screw: 21 CFR888.3040	Plate: 21 CFR888.3030Screw: 21 CFR888.3040	Not referencedScrew: 21 CFR888.3040
Intended use	Internal fixation ofbone fractures	Internal fixation ofbone fractures	Internal fixation ofbone fractures
Design	Plate: straight, tubularcross-section, lockingcompression screwhole, has limitedcontact area.	Plate: straight,tubular cross-section, lockingcompression screwhole, has limitedcontact area.Dimensions andcontour has slightdifference.Screw: self-tapping,fully threadedlocking screw. Thecontour has veryslight difference.	Not referencedScrew: 3.5mmdiameter, self-tapping lockingscrew.
Material	Plate: titaniumScrew: titanium alloy	Plate: titanium alloyScrew: titaniumalloy	Not referencedScrew: titaniumalloy
How Supplied	Non-sterile	Non-sterile	Non-Sterile
Single-UseOnly	Yes	Yes	Yes
Sterilization	Moist heatsterilization prior touse	Moist heatsterilization prior touse	Moist heatsterilization priorto use
Performancedata	Plate: static anddynamic testingconducted as perASTM F382-13Screw: torsional	Plate: static anddynamic testingconducted as perASTM F382-13Screw: torsional	Not referencedScrew:
properties, drivingtorque and pull-outstrength are conductedas per ASTM F543-13	properties, drivingtorque and pull-outstrength areconducted as perASTM F543-13	performancetesting conductedas per ASTMF543-07

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IRENE

The proposed device is found to possess highly similar technological characteristics on design under the premises of sharing same intended use. Device performance is compared through the testing of mechanical properties of the proposed and predicate device by methods stipulated in published standards in order to evaluate whether differences existing in the design raise safety issue by compromising performance. Results of testing indicates no gap between the level of performance of proposed device and the predicate device, through which the differences are deemed not relevant to device performance and has been justified, and the conclusion of Substantial Equivalence is reached.

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.