IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.

Acutec Headless Compression Screw:

Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.

Cannulated Screw:

Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.

Device Description

IRENE Cannulated Screw System includes two kinds of screws, Acutec Headless Compression Screw and Cannulated Screw. Acutec Headless Compression Screw has six different diameters in various lengths and is manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).

AI/ML Overview

This is a 510(k) premarket notification for a medical device, which focuses on demonstrating substantial equivalence to a predicate device rather than on clinical safety and effectiveness studies with acceptance criteria as typically understood for AI/ML devices. Therefore, much of the requested information regarding acceptance criteria, study types, ground truth, and expert involvement is not applicable in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria: The primary "acceptance criteria" here are established through mechanical testing to demonstrate that the new device (IRENE Cannulated Screw System) is at least as safe and effective as the predicate devices. The standard used is ASTM F543-13, Standard Specification and Test Methods for Metallic Medical Bone Screws.
Reported Device Performance: The document states: "Results of testing indicates no difference 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." Specific numerical performance metrics (e.g., specific torque values, pullout strengths) are not provided in this summary document. The summary indicates that the tests conducted were:
- Torsional properties
- Driving torque test
- Axial pullout test

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

This is not applicable as there is no "test set" in the context of an AI/ML device for diagnostic or prognostic performance. The "test set" here refers to physical samples of the screws used for mechanical testing. The specific number of screws tested is not mentioned in this summary.
Data provenance: The mechanical tests were performed on the proposed device (IRENE Cannulated Screw System) and the predicate devices. The manufacturing location for the proposed device is Tianjin, P.R. China.

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

This is not applicable. Ground truth establishment by experts (e.g., radiologists) is relevant for AI/ML diagnostic studies, not for mechanical testing of bone screws. The "ground truth" for mechanical properties is determined by physical measurement instruments according to established engineering standards.

4. Adjudication Method for the Test Set:

This is not applicable. Adjudication methods are specific to subjective human assessment in diagnostic or clinical studies. Mechanical tests have objective measurement outcomes.

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:

This is not applicable. This is a 510(k) for a physical medical device (bone screws), not an AI/ML diagnostic or assistive device.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This is not applicable. This is not an algorithm.

7. The Type of Ground Truth Used:

For the mechanical tests, the "ground truth" is the physical measurement taken by calibrated instruments in accordance with the specified standard (ASTM F543-13). This is an objective, quantitative ground truth.

8. The Sample Size for the Training Set:

This is not applicable. There is no "training set" as this is a physical device, not an AI/ML model that is trained on data.

9. How the Ground Truth for the Training Set Was Established:

This is not applicable for the same reason as point 8.

In summary, the provided document is a 510(k) summary for a conventional medical device (bone screws). The "study" referenced is a series of mechanical tests comparing the proposed device to predicate devices to demonstrate substantial equivalence, rather than a clinical trial or AI/ML performance study with traditional acceptance criteria for diagnostic accuracy.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with a symbolic representation of a parent cradling a child.

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

Tianjin ZhengTian Medical Instrument Co., Ltd Wang Qi Regulatory Affairs Specialist No.318, Jingyi Road, Airport Economic Zone Tianjin, CN 100082 P.R. China

October 23, 2017

Re: K170056

Trade/Device Name: IRENE Cannulated Screw System Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth Or Threaded Metallic Bone Fixation Fastener Regulatory Class: Class II Product Code: HWC Dated: September 26, 2017 Received: 09/26/2017

Dear Wang Qi:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K170056

Device Name IRENE Cannulated Screw System

Indications for Use (Describe)

IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.

Acutec Headless Compression Screw:

Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.

Cannulated Screw:

Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.

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

Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

In accordance with 21 CFR$807.92 and the Safe Medical Devices Act of 1990, the following information is provided for IRENE Cannulated Screw System 510(k) premarket notification. The submission was prepared in accordance with the FDA guidance document, "Format for Traditional and Abbreviated 510(k)", issued on August 12, 2005.

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 Manager Tel: +86 10 82292929 Fax: +86 10 82290740 E-mail: xiangzhaojun@naton.cn Date of preparation of the Summary: Oct 17, 2017

2. Submission Contact

Wang, Qi Position: Regulatory Affairs Specialist Tel: +86 10 82292929 E-mail: wangqi@naton.cn

3. Proposed Device

Trade Name: IRENE Cannulated Screw System Common Name: Screw, Fixation, Bone Class: Class 2 Regulation: 21 CFR 888.3040 Product Code: HWC (Bone Fixation Screw) Review Panel: Orthopedic

Device description:

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manufactured from Titanium Alloy (ASTM F 136 and ISO 5832-3). Cannulated Screw has four different diameters in various lengths and contains two optional washers. Cannulated Screw and washers are manufactured from Titanium Alloy (ISO 5832-3).

Indication for use:

IRENE Cannulated Screw System is intended for fracture fixation, fusion and osteotomies of bones appropriate for the size of the device. For specific screw indications please see below.

Acutec Headless Compression Screw:

Used for fusion, fractures, or osteotomies of the clavicle, humerus, radius, ulna, ilium, femur, patella, fibula, tibia, talus, malleolus, calcaneus and other small bones.

Cannulated Screw:

Intended for bone fracture fixation and bone fragment fixation. Washers may be used with the Cannulated Screw in cases where the patient has poor bone quality.

	Predicate Device 1	Predicate Device 2	Reference Device
510(k)Number	K063298	K100359	K151508
PredicateDevice Name	OsteoMed HeadlessCannulated ScrewSystem	DARCO® HeadedCannulated Screws	IRENE LockingCompression PlateSystem
Manufacture	OsteoMed	Wright	Zhengtian
Classification	888.3040(HWC)	888.3040(HWC)	888.3040(HWC)888.3030(HRS)

4. Predicate Device and Reference Device

5. Preclinical Data

Mechanical testing is conducted to demonstrate that differences in technological characteristics of the proposed device to predicate device do not raise new questions regarding safety and effectiveness, and Substantially Equivalent to the predicate device is thus concluded. The testing including torsional properties, driving torque test and axial pullout test incorporates the following standard as test method to evaluate the performance of both proposed and predicate device: ASTM F543-13, Standard

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Specification and Test Methods for Metallic Medical Bone Screws.

6. Clinical Data

No clinical data is presented in this submission.

7. Substantial Equivalence Comparison

Table 1: comparison between Acutec Headless Compression Screw and predicate devices 1

Element	Proposed DeviceAcutec Headless CompressionScrew	Predicate Device 1OsteoMed Headless CannulatedScrew System
Class	2	2
Regulationnumber	21 CFR 888.3040	21 CFR 888.3040
Indicationfor use	Used for fusion, fractures, orosteotomies of the clavicle,humerus, radius, ulna, ilium,femur, patella, fibula, tibia, talus,malleolus, calcaneus and othersmall bones.	The OsteoMed Headless ScrewSystem is indicated for use inbone reconstruction, osteotomy,arthrodesis, joint fusion, fracturerepair, and fracture fixation ofbone appropriate for the size ofthe device. Screws are intendedfor single use only.
Material	Ti6Al4V	Ti6Al4V
Design	Fully threaded, headless,cannulated	Headless, cannulated
Diameter	2.5~7.5mm	2.0~6.5mm
Length	8~120mm	10~120mm
Supplied	Non-sterile	Non-sterile
Single-useonly	Yes	Yes
Sterilization	Steam sterilization	Steam sterilization

Table 2: comparison between Cannulated Screw and predicate devices 2

Element	Proposed Device	Predicate Device 2
	Cannulated Screw	Wright DARCO® Headed
		Cannulated Screws
Class	2	2
Regulation number	21 CFR 888.3040	21 CFR 888.3040

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Indication for use
	Intended for bone fracturefixation and bone fragmentfixation. Washers may beused with the CannulatedScrew in cases where thepatient has poor bonequality.	Intended for use over a guide pinor wire for bone fracture fixationand bone fragment fixation.Washers may be used with thescrews in cases where thepatients has poor bone quality.
	Material	Ti6Al4V	Ti6Al4V
	Design	self-tapping,cannulated	self-tapping/self-drilling,cannulated
	Diameter	3.5~7.3mm	2.7~7.5mm
	Length	20~110mm	8~120mm
	Supplied	Non-sterile	Non-sterile
	Single-use only	Yes	Yes
Sterilization	Steam sterilization	Steam sterilization

8. Substantial Equivalence Conclusion

The proposed device is found to possess 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 difference 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

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.