The DARCO™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, joint fusion, and reconstruction of small bones of the feet, and toes. The system can be used in both adult and pediatric patients.

The DARCO ™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, revision procedures, joint fusion, and reconstruction of small bones of the feet, ankles and toes. The system can be used in both adult and pediatric patients.

Device Description

The DARCO™ Locking Bone Plate system is comprised of a variety of titanium plates and screws designed for internal fixation of bone fragments. The plates are designed with rhombus (parallelogram) plates with an assortment of width, lengths, and configurations to address varying patient anatomy. The system includes locking and non-locking 2.7 mm and 3.5 mm diameter screws of various lengths.

AI/ML Overview

This document is a 510(k) Summary of Safety and Effectiveness for the DARCO™ Locking Bone Plate System, essentially a premarket notification for a medical device. As such, it does not contain a study proving the device meets acceptance criteria in the typical sense of a clinical or performance study with defined performance metrics and acceptance thresholds like those seen for AI/ML devices.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K061808 DARCO™ Locking Bone Plate System) through non-clinical testing and comparison of characteristics. The "acceptance criteria" here is met by demonstrating that the modified device performs at least as well as the predicate device in relevant non-clinical tests.

Here's an analysis based on the provided text, addressing your points where applicable:

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

Since this is a substantial equivalence submission for a mechanical device, the "acceptance criteria" are implied by successful completion of mechanical and performance tests, demonstrating equivalence to the predicate. Specific numerical acceptance criteria are not explicitly stated in the summary, but rather the conclusion that the testing supports substantial equivalence.

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Summary of Study Results)
Equivalent pullout strength	Testing performed, supports substantial equivalence.
Equivalent insertion characteristics	Testing performed, supports substantial equivalence.
Equivalent removal characteristics	Testing performed, supports substantial equivalence.
Equivalent ultimate/yield strength	Testing performed, supports substantial equivalence.
Equivalent screw head locking torques	Testing performed, supports substantial equivalence.
No new types of questions of safety or effectiveness	Design characteristics do not raise new questions.

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 provided summary. The summary refers to "testing" but does not give specific numbers of components tested.
Data Provenance: The testing is "non-clinical" and likely conducted in a controlled lab environment by Wright Medical Technology, Inc. The country of origin and whether it's retrospective or prospective are not relevant for this type of non-clinical mechanical testing.

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 is a submission for a physical medical device (bone plate system), not an AI/ML device requiring expert ground truth for image interpretation or diagnosis. The "ground truth" here is mechanical performance as measured in lab tests.

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

Not applicable. This is not an AI/ML device undergoing a clinical study with human readers/interpreters. The "adjudication" is based on comparing test results against established engineering standards or the predicate device's performance.

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 is a physical medical device, not an AI system. No MRMC study was performed.

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 (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device, in the context of demonstrating substantial equivalence, is primarily mechanical and material properties as measured through standardized engineering tests (e.g., measuring pullout strength, torque, yield strength). The comparison is made against the performance of the legally marketed predicate device (K061808 DARCO™ Locking Bone Plate System) to demonstrate "at least as good as" performance.

8. The sample size for the training set

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

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

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

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. Inside the circle is a stylized symbol that resembles three human profiles facing to the right, with flowing lines above them.

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

Wright Medical Technology, Inc. Val Myles Senior Regulatory Affairs Specialist 1023 Cherry Road Memphis. Tennessee 38117

September 21, 2017

Re: K171852

Trade/Device Name: DARCOTM Locking Bone 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 Dated: August 29, 2017 Received: August 30, 2017

Dear Ms. Myles:

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 (DICE) 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 (DICE) 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

510(k) Number (if known)

K171852

Device Name DARCO™ Locking Bone Plate System

Indications for Use (Describe)

The DARCO™ Locking Bone Plate System is intended for use in stabilization of fresh fractures, ioint fusion. and reconstruction of small bones of the feet, and toes. The system can be used in both adult and pediatric patients.

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)

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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Image /page/3/Picture/0 description: The image is a logo for Wright. The logo has a red and orange geometric shape on the left, followed by the word "WRIGHT" in red, and the words "FOCUSED EXCELLENCE" in gray below. The geometric shape is made up of two overlapping trapezoids, one red and one orange.

1023 Cherry Road Memphis, TN 38117 wright.com

510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

In accordance with the Food and Drug Administration Rule to implement provisions of the Safe Medical Devices Act of 1990 and in conformance with 21 CFR 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the DARCO™ Locking Bone Plate System.

(a)(1).	Submitted By:	Wright Medical Technology, Inc.1023 Cherry RoadMemphis, TN 38117
	Date:	June 16, 2017
	Contact Person:	Val MylesRegulatory Affairs SpecialistOffice (901) 290-5162Fax (901) 867-4190
(a)(2).	Proprietary Name:	DARCO™ Locking Bone Plate System
	Common Name:	Single/Multiple component metallic BoneFixation Plate
	Classification Name and Reference:	21 CFR 888.3030 – Single/multiple componentmetallic bone fixation appliances andaccessories
	Device Product Code, Device Panel:	HRS - Orthopedic
(a)3.	Predicate Device:	K061808 DARCO™ Locking Bone Plate System

(a)(4). Device Description

(a)(5). Intended Use

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(a)(6). Technological Characteristics Comparison

The DARCO™ System 3.5 mm locking screw head has been modified and is substantially equivalent to the predicate. The subject device has identical indications, identical material and similar design features compared to screws in the DARCO® System.

(b)(1). Substantial Equivalence- Non-Clinical Evidence

Testing and rationale related to pullout strength, insertion, removal, ultimate/yield, and screw head locking torques were performed to demonstrate substantial equivalence. The safety and effectiveness of the DARCO ™ Locking Plate System is adequately supported by the testing, rationales, substantial equivalence information, and comparison of design characteristics provided within this premarket notification.

(b)(2). Substantial Equivalence- Clinical Evidence

N/A

(b)(3). Substantial Equivalence- Conclusions

The design characteristics of the subject system do not raise any new types of questions of safety or effectiveness. From the evidence submitted in this 510(k), the subject devices can be expected to perform at least as well as the predicate devices.

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.