The CONQUEST FN system is comprised of contoured locking bone plates and compatible locking and non-locking bone screws. The subject premarket notification describes additional lengths of the proximal locking compression screws to the Smith & Nephew CONQUEST FN system. The subject devices are manufactured from the same 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 document is a 510(k) premarket notification for a medical device called CONQUEST FN, which is an internal fracture fixation device. The document focuses on demonstrating substantial equivalence to predicate devices, primarily through mechanical testing (axial pullout strength).

It does not contain information related to a study proving the device meets acceptance criteria based on its performance in interpreting medical images or diagnosing conditions. The acceptance criteria described are for mechanical properties of the device (e.g., pullout strength), not for AI/ML performance metrics like sensitivity, specificity, or AUC which would be relevant to an imaging-based AI device.

Therefore, I cannot provide a response that includes the requested information regarding:

A table of acceptance criteria and reported device performance related to diagnostic accuracy.
Sample size used for the test set and data provenance (as no such test set is described for diagnostic performance).
Number of experts and their qualifications for ground truth establishment.
Adjudication method for the test set.
MRMC comparative effectiveness study.
Standalone performance.
Type of ground truth used (clinical outcomes, pathology, expert consensus).
Sample size for the training set.
How ground truth for the training set was established.

The document is primarily a regulatory submission for a physical orthopedic implant, not an AI/ML-driven diagnostic imaging device. The "acceptance criteria" mentioned in the document refer to engineering/biomechanical performance standards for the implant itself, such as axial pullout strength, and bacterial endotoxin limits for sterility.

Summary of relevant information from the document (limited to what is present):

Acceptance Criteria and Performance (related to the physical device):

Acceptance Criteria for Axial Pullout Strength: Not explicitly quantified in the provided text, but stated as "met the acceptance criteria" for two different tests. These criteria likely refer to specific biomechanical standards or comparisons to predicate devices.
Reported Device Performance for Axial Pullout Strength:
- OR-17-111: "Result concluded that the CONQUEST FN Locking Screws met the acceptance criteria and exhibited similar or superior axial pullout strength compared to the predicate device [Targon FN Titanium System]."
- OR-17-164: "Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device [cannulated screws]."
Acceptance Criteria for Sterility: "Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance, 'Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile,' 'Pyrogen and Endotoxin Testing: Questions and Answers,' and ANSI/AAMI ST72."
Reported Device Performance for Sterility: "met the acceptable endotoxin limits."

Other information:

Sample size for testing pullout strength: Not specified.
Nature of data: Pre-clinical (mechanical testing in a lab setting), not human patient data.
Ground truth: For mechanical tests, the "ground truth" is the measured physical property (axial pullout strength) compared against a defined standard or predicate performance. For sterility, it is the endotoxin level measurement compared to the standard. This is not "ground truth" in the diagnostic sense.
No information on AI/ML components or studies for diagnostic performance is present in this document.

Summary

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December 22, 2017

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Smith & Nephew Allison Chan Regulatory Affairs Specialist II 1450 E Brooks Road Memphis, Tennessee 38116

Re: K172785

Trade/Device Name: CONOUEST 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: December 11, 2017 Received: December 12, 2017

Dear Ms. Chan:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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.

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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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

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

510(k) Number (if known)

K172785

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)

Prescription Use (Part 21 CFR 801 Subpart D)

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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017

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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" in black and orange. The words "smith&nephew" are written in a stylized font, with the "&" symbol connecting the two names.

Submitted by:	Smith & Nephew, Inc.Advance Surgical Devices Division1450 East Brooks RoadMemphis, Tennessee 38116
Date of Summary:	December 11,2017
Contact Person and Address:	Allison ChanRegulatory Affairs Specialist IIT (901) 399-1098F (901) 566-7022
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

Intended Use

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

Comparison to Technological Characteristics with Predicate Device

Device comparisons described in this premarket notification demonstrated that the proposed CONQUEST FN proximal locking compression screws are substantially equivalent to the legally marketed predicate devices listed below with regard to intended use, indications for use, and performance characteristics.

The subject proximal locking compression screws features characteristics very similar to the CONQUEST FN system proximal locking compression screws cleared via K152686, with the primary differences being shorter overall screw length and minor thread length differences. All other design aspects, indications for use, intended use, material and fundamental scientific technology remain the same as those in K152686.

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Summary of Pre-Clinical Testing

o OR-17-111: Axial Pullout Strength Evaluation was conducted on the CONQUEST FN proximal locking compression screws as compared to the Targon FN Titanium System. 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 device.
OR-17-164: Axial Pullout Strength Evaluation was conducted on the CONQUEST FN . proximal locking compression screws as compared to the cannulated screws. Results of the test concluded that the CONQUEST FN proximal locking screws met the acceptance criteria and exhibited similar or superior axial pullout strength as compared to the predicate device.

Bacterial endotoxin testing was completed and met the acceptable endotoxin limits as stated in FDA Guidance , "Submission and Review of Sterility Information in Premarket Notification (510(k)) Submissions for Devices Labeled as Sterile," "Pyrogen and Endotoxin Testing: Questions and Answers," and ANSI/AAMI ST72.

Substantial Equivalence Information

The substantial equivalence of the CONQUEST FN proximal locking compression screws is based on its similarities in indications for use, design features, sterilization methods, and materials to the predicate systems listed in the following table.

Manufacturer	Description	SubmissionNumber	ClearanceDate
Smith & Nephew	CONQUEST FN(Primary Predicate)	K152686	3/17/2016
Smith & Nephew	Cannulated Screws and Washers	K111994	10/11/2011
Aesculap ImplantSystems, LLC	Targon FN System	K102057	12/21/2010
FxDevices	POGO Screw	K080649	11/25/2008

Table 5.1: Substantially Equivalent Predicates to CONQUEST FN Proximal Locking Compression Screws

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.