The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

AI/ML Overview

The provided text describes mechanical testing conducted for the CONQUEST FN device to demonstrate its substantial equivalence to predicate devices. However, it does not contain information about a study involving human readers or AI assistance. Therefore, questions related to MRMC studies, human reader improvement with AI, and standalone AI performance cannot be answered from the provided text.

Here's the information extracted from the document regarding the acceptance criteria and the study that proves the device meets the acceptance criteria:

1. Table of Acceptance Criteria and Reported Device Performance:

Test Name	Acceptance Criteria	Reported Device Performance
Axial Pullout Strength Evaluation (CONQUEST FN Locking screws)	Met the acceptance criteria (Specific numerical criteria not provided)	Exhibited similar or superior axial pullout strength compared to the predicate.
Insertion Torque Performance (CONQUEST FN locking screws)	Met the acceptance criteria (Specific numerical criteria not provided)	Exhibited similar or superior insertion torque performance compared to the predicate.
Removal Torque Performance (CONQUEST FN Locking screws)	Met the acceptance criterion (Specific numerical criteria not provided)	Expected to have acceptable torsional performance with regard to removal torque.
Torsional Strength Evaluation (CONQUEST FN Locking Screws)	Met the acceptance criteria (Specific numerical criteria not provided)	Exhibited similar or superior torsional strength compared to the predicate.
Construct Fatigue Testing (CONQUEST FN System)	Met the acceptance criteria (Specific numerical criteria not provided)	Expected to have similar construct stability during fatigue as compared to the predicate.
Construct Fatigue Evaluation (CONQUEST FN System vs. Three Cannulated Screws in a Simulated Femoral Neck Fracture Model)	Met the acceptance criteria (Specific numerical criteria not provided)	Exhibited similar or superior construct fatigue as compared to the predicate.
Construct Fatigue Evaluation (One-hole CONQUEST FN locking plate vs. Three Cannulated Screw)	Met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to the predicate.	Met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to the predicate. (Note: The text implies directly meeting the criteria, which is "similar or superior," not just "similar or superior performance" as a result).

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

The document describes pre-clinical mechanical testing. Typically, for such tests, "sample size" refers to the number of devices or constructs tested. The specific number of samples for each test (e.g., how many screws for pullout strength, how many constructs for fatigue) is not provided in the given text.

The data provenance is from pre-clinical mechanical testing conducted by Smith & Nephew, Inc. The country of origin is not explicitly stated for the testing, but Smith & Nephew is based in Memphis, Tennessee, USA. The data is prospective as it was generated specifically for the 510(k) submission to compare the new device against predicates.

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

This question is not applicable to this type of mechanical testing. Ground truth in this context is established by the physical testing methods and the measured mechanical properties, not by expert consensus on images or pathology.

4. Adjudication Method for the Test Set:

This question is not applicable to mechanical testing. Adjudication methods like 2+1 or 3+1 are used for expert reviews, typically in image interpretation or clinical trials, not for direct physical measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs. without AI assistance:

No, an MRMC comparative effectiveness study was not done. The provided text focuses exclusively on pre-clinical mechanical testing of a bone fixation device, not on AI-assisted diagnostic or interpretative tasks. Therefore, there is no information on human reader improvement with or without AI.

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

No, a standalone algorithm performance study was not done. The device being described is a physical medical implant (bone fixation system), not a software algorithm or AI device.

7. The Type of Ground Truth Used:

The ground truth used for these tests is mechanical performance metrics derived from standardized or accepted pre-clinical testing methods (e.g., axial pullout strength, insertion torque, torsional strength, fatigue life). The comparison is against established predicate device performance as a benchmark for substantial equivalence.

8. The Sample Size for the Training Set:

This question is not applicable. The CONQUEST FN is a physical implant, not an AI model requiring a "training set."

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

This question is not applicable as there is no training set for a physical implant device.

Summary

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

March 17, 2016

Smith & Nephew, Incorporated Bradley Heil Regulatory Affairs Manager 1450 East Brooks Road Memphis, Tennessee 38116

Re: K152686 Trade/Device Name: CONQUEST FN Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliances and accessories Regulatory Class: Class II Product Code: JDO, KTT Dated: February 16, 2016 Received: February 18, 2016

Dear Mr. Heil:

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

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(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

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/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 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 vours.

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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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

510(k) Number (if known)

K152686

Device Name CONQUEST FN

Indications for Use (Describe)

The Smith & Nephew CONQUEST FN is indicated for displaced intracapsular femoral neck fractures.

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

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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:

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Image /page/3/Picture/1 description: The image shows the Smith & Nephew logo. The logo consists of an orange flower-like symbol on the left, followed by the text "We are smith&nephew". The words "We are" are in gray, while "smith&nephew" is in orange.

Submitted by:	Smith & Nephew, Inc.Advance Surgical Devices Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	March 15, 2016
Contact Person and Address:	Bradley HeilRegulatory Affairs ManagerT (901) 399-6339F (901) 566-7831
Name of Device:	CONQUEST FN
Common Name:	Internal Fracture Fixation Device
Device Classification Name andReference:	21 CFR 888.3030 Single/multiple component metallic bonefixation appliances and accessoriesClass II
Panel Code:	Orthopedics/87
Product Code:	JDO, KTT

Device Description

The subject premarket notification describes the Smith & Nephew CONQUEST FN. The subject internal fixation plating system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. All described implant devices are manufactured from implant-grade stainless steel (316L) and designed for single-use. They will be provided in a sterile packaged option and will be sterilized via Gamma irradiation.

Intended Use

CONQUEST FN is intended for use in internal fixation of femoral neck fractures

Indications for Use

The Smith & Nephew CONQUEST FN is indicated for displaced and undisplaced intracapsular femoral neck fractures.

Technological Characteristics

Device comparisons described in this premarket notification demonstrated that the proposed CONQUEST FN implants are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, and performance characteristics. The subject CONQUEST FN features characteristics very similar to the Targon FN cleared via K102057, with the primary differences being material changes and the utilization of POGO Screw technology (K080649). To accommodate for differences between the subject device and the predicate cleared via K102057, mechanical testing was conducted to compare the two devices.

Substantial Equivalence Information

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When compared to the predicate devices listed below, substantial equivalence is based upon similar function, intended use, indications for use and overall design to the devices listed in the table below.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Aesculap ImplantSystems, LLC	Targon FN System (Primary Predicate)	K102057	12/21/10
FxDevices	POGO Screw	K080649	11/25/08
Smith & Nephew	Smith & Nephew Cannulated Screws andWashers	K111994	10/11/2011

Table 1: Substantially Equivalent Predicates to CONQUEST FN

Summary of Pre-Clinical Testing

Axial Pullout Strength Evaluation was conducted on the CONQUEST FN Locking screws. Results of the test concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate.
. Insertion Torque Performance was conducted on the proposed locking screws. Results of the testing concluded that the CONQUEST FN screws met the acceptance criteria and exhibited similar or superior insertion torque performance compared to the predicate.
. Removal Torque Performance was conducted on the CONQUEST FN Locking screws. Results of the test concluded that the subject device met the acceptance criterion and is expected to have acceptable torsional performance with regard to removal torque.
Torsional Strength Evaluation was conducted on the CONQUEST FN Locking Screws. ● Results of the test concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior torsional strength compared to the predicate.
. Construct Fatigue Testing was conducted on the CONQUEST FN System. Results of the test concluded that the CONQUEST FN system met the acceptance criteria and is expected to have similar construct stability during fatigue as compared to the predicate.
Construct Fatigue Evaluation of the CONQUEST FN System as compared to Three Cannulated Screws in a Simulated Femoral Neck Fracture Model. Results of the test concluded that the CONQUEST FN System met the acceptance criteria and exhibited similar or superior construct fatigue as compared to the predicate.
Construct Fatigue Evaluation was conducted on the one hole CONQUEST FN locking plate as compared to Three Cannulated Screw. Results of the test concluded that the CONQUEST FN one hole locking plate met the acceptance criteria by having at least similar or superior construct fatigue performance as compared to the predicate.

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Conclusion

This 510(k) premarket notification is being submitted to request clearance for CONQUEST FN. Based on the similarities to the predicate components and a review of the mechanical testing performed, the devices are substantially equivalent to the predicate systems listed in Table 1.

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.