The EVOLVE® EPS OTHOLOC™ System is extended to offer two longer screw lengths and four shorter plates. The driver-screw interface is also being modified. The plates are identical to the predicate in hole/slot placement and depth, plate shape and material. The subject screws have identical profile and thread form. The screws may be used with or without the plates.

AI/ML Overview

The provided text indicates that the EVOLVE® EPS ORTHOLOC™ System is a bone plate and screw system, and the submission is for an extension of the existing system (K100146) to include longer screw lengths, shorter plates, and a modified driver-screw interface. The study performed is a non-clinical, mechanical study, not a clinical study involving human or animal subjects. Therefore, many of the requested categories are not applicable.

Here's the information based on the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Study Type
Mechanical Performance	Ultimate Torque	Performed at least as well as predicate	Non-clinical testing
Mechanical Performance	Pull-Out Strength	Performed at least as well as predicate	Non-clinical testing
Mechanical Performance	Off-axis Locking Comparison	Performed at least as well as predicate	Non-clinical testing
Equivalence	Materials	Identical to predicate	Comparison
Equivalence	Indications	Identical to predicate	Comparison
Equivalence	Screw and Thread Profiles	Identical to predicate	Comparison
Equivalence	Plate Shapes and Features	Identical to predicate	Comparison
Equivalence	Instrumentation	Utilizes same instruments as predicate	Comparison

Study Details

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

Sample Size: Not explicitly stated in terms of number of screws/plates tested, but the study refers to "ultimate torque testing, pull-out data, and off-axis locking comparison." It's common in mechanical testing to test multiple samples to ensure repeatability and statistical significance, but the exact number isn't provided here.
Data Provenance: The data is from non-clinical laboratory testing performed by Wright Medical Technology, Inc.

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

Not Applicable. This was a non-clinical, mechanical performance study. "Ground truth" in the context of expert review is not relevant for this type of testing. The acceptance criteria were based on predefined mechanical engineering standards and comparison to a predicate device.

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

Not Applicable. As a non-clinical engineering study, an adjudication method for case evaluation is not relevant. The performance metrics (e.g., torque values, pull-out forces) were direct measurements.

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 mechanical device, not an AI or diagnostic imaging device. 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 mechanical device. No algorithm or standalone performance testing was performed.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not Applicable (or "Predicate Device Performance Data"). For this non-clinical study, the "ground truth" for comparison was the established mechanical performance of the predicate EVOLVE® EPS ORTHOLOC™ System (K100146) and relevant engineering standards for bone fixation devices. The goal was to demonstrate that the modified device performed "at least as well as" the predicate.

8. The sample size for the training set:

Not Applicable. This documentation does not describe a machine learning algorithm, and thus there is no training set in that context. The "training" for such a device involves design and manufacturing processes, not data for an AI model.

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

Not Applicable. No training set for an AI model was used.

Summary

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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 CRF 807.92, this information serves as a Summary of Safety and Effectiveness for the use of the EVOLVE® EPS ORTHOLOC™ System.

A.1. Submitted By:	Wright Medical Technology, Inc.5677 Airline RdArlington, TN 38002
Date:	August 9, 2010
Contact Person:	Kelsey LeeRegulatory Affairs Specialist I(901) 290-5909
A.2. Proprietary Name:	EVOLVE® EPS ORTHOLOCTM
Common Name:	Bone Plate System/Bone Screw System
Device Classification Regulation:	21 CFR 888.3030--Class II
Device Product Code & Panel:	HRS: Single/multiple component metallic bonefixation appliances and accessories.HWC: Screw, fixation, bone87 Orthopedics
A.3. Predicate Device:	EVOLVE® EPS ORTHOLOC™ System(K100146)

A.4. Device Description

The design features of the EVOLVE® EPS ORTHOLOC™ system are substantially equivalent to the design features of the predicate EVOLVE® EPS ORTHOLOC™

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A.5. Intended Use

The subject EVOLVE® EPS ORTHOLOC™ system has the same intended use as the predicate.

The EVOLVE® EPS ORTHOLOC™ is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

A.6. Technological Characteristics Comparison

The subject EVOLVE® EPS ORTHOLOC™ and the legally marketed predicate EVOLVE® EPS ORTHOLOC™ System have identical indications, utilize the same instruments, and are manufactured out of the same materials. The subject and predicate components are fully compatible.

The subject EVOLVE® EPS ORTHOLOC™ adds two additional lengths of screws, four shorter plates, offers a modified drive feature on the screw heads and may be used with or without the plates.

B.1. Substantial Equivalence - Non-Clinical Evidence

Substantial equivalence was shown through ultimate torque testing, pull-out data, and offaxis locking comparison. The results of the tests show that the subject EVOLVE® EPS ORTHOLOCTM can be expected to perform at least as well as the legally marketed predicate EVOLVE® EPS ORTHOLOCTM

The safety and effectiveness of the subject EVOLVE® EPS ORTHOLOC™ System is adequately supported by the substantial equivalence information, materials information, and comparison of design characteristics provided within this Premarket Notification.

B.2. Substantial Equivalence - Clinical Evidence

N/A

B.3. Substantial Equivalence - Conclusions

Substantial equivalence is shown through ultimate torque testing, pull out data and off-axis locking comparison. The materials, indications, screw and thread profiles, and plate shapes and features are identical between the subject and predicate. The subject and predicate differ in drive feature depth, screw lengths and plate lengths; no new questions concerning safety and effectiveness have been raised. From the evidence presented in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The overall design is simple and professional, reflecting the department's role in public health and welfare.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Wright Medical Technology, Inc. c/o Ms. Kelsey Lee Regulatory Affairs Specialist 5677 Airline Road Arlington, Tennessee 38002

DEC 2 2010

Re: K102352

Trade/Device Name: EVOLVE® EPS ORTHOLOCTM 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: October 29, 2010 Received: November 2, 2010 ・・ — ・

Dear Ms. Lee:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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CFR Part 807); labeling (21 CFR Part 801); 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.

Sincerely, yours,

For
Mark N. Melkerson

Mark Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): KIO 2.3 5 2

Device Name: EVOLVE® EPS ORTHOLOC™ System

Indications For Use:

The EVOLVE® EPS ORTHOLOC™ System is intended for fixation of fractures, osteotomies and non-unions of the olecranon, humerus, radius and ulna.

Prescription Use xxx (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

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Soutte for mxm
(Division Sign

(Division Sign) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102352

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.