The ORTHOLOCM 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters. These screws are manufactured from stainless steel conforming to ASTM F2229. The design features of the ORTHOLOC™ 3DSi Locking Screws are identical to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System Locking Screws.

AI/ML Overview

Here's an analysis of the provided text regarding the Ortholoc™ 3DSi Locking Screws, focusing on acceptance criteria and study information.

It's important to note that this document is a 510(k) Summary of Safety and Effectiveness, which is a premarket notification for a medical device. In the context of 510(k) submissions, the primary "study" is often a demonstration of substantial equivalence to a previously cleared predicate device, rather than a de novo clinical trial with traditional acceptance criteria for performance metrics like sensitivity, specificity, and accuracy.

Acceptance Criteria and Device Performance

The core "acceptance criteria" in a 510(k) for devices like this are the demonstration of substantial equivalence to a predicate device. This is primarily assessed by comparing indications for use, technological characteristics, and material properties.

Acceptance Criteria (for Substantial Equivalence to Predicate K102352)	Reported Device Performance (ORTHOLOC™ 3DSi Locking Screws)
Indication for Use: Should be identical to the predicate.	Identical: "System indications for both subject ORTHOLOC™ 3DSi Locking Screws and predicate EVOLVE® EPS ORTHOLOC™ (K102352) are identical."
Technological Characteristics: Should be identical or minor changes only.	Identical with minor change: "The subject ORTHOLOC™ 3DSi Locking screws are identical to the previously cleared EVOLVE® EPS ORTHOLOC™ Locking screws (K102352) with only minor change to feature call-outs on the engineering drawing."
Material: Identical to the predicate.	Identical: "manufactured from stainless steel conforming to ASTM F2229," same as predicate (implied by "materials information" and "composition of design characteristics" leading to conclusion of no new safety/effectiveness questions).
Diameter and Size Range: Identical to the predicate.	Identical: "identical in indication for use, diameter, size range and material to the predicate."
Safety and Effectiveness: No new types of safety and effectiveness questions.	Conclusion: "No new types of safety and effectiveness questions can be expected. From the evidence given in the Premarket Notification, the subject devices can be expected to perform at least as well as the predicate devices."

Study Proving Acceptance Criteria:

The "study" in this context is the comparison report submitted in the Premarket Notification (510(k)). This report directly addresses the substantial equivalence criteria listed above.

Detailed Breakdown of Study Information:

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- N/A: This type of device (locking screws) typically does not involve a "test set" in the sense of patient data or clinical images for performance evaluation (e.g., diagnostic accuracy). The "testing" refers to material and mechanical property comparisons to a predicate device, as well as verification of design specifications. The document states "Substantial Equivalence - Non-Clinical Evidence" and "Substantial Equivalence - Clinical Evidence N/A". This indicates that no clinical "test set" of patient data was used or required for this 510(k) submission.
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):
- N/A: As there was no clinical "test set" requiring ground truth establishment (e.g., for diagnostic accuracy), no experts were used for this purpose in this submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- N/A: No clinical test set.
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:
- No: This device is a mechanical implant (locking screws) and not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is not applicable.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No: This is a physical medical device, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- N/A: For this type of 510(k) submission, the "ground truth" for substantial equivalence is primarily established by engineering specifications, material standards (ASTM F2229), and documented design features of both the new device and the predicate. The "truth" is whether the new device meets the same specifications and characteristics as the predicate.
The sample size for the training set:
- N/A: This is not an AI/machine learning device, so there is no concept of a "training set" for an algorithm.
How the ground truth for the training set was established:
- N/A: No training set.

Summary

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Image /page/0/Picture/0 description: The image shows the text "K113339 Page 1/2 DEC 12 2011" on the left side and the word "WRIGHT" on the right side. The text on the left side appears to be handwritten, while the word on the right side is in a bold, sans-serif font. The word "WRIGHT" also has a thick, black line underneath it.

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 ORTHOLOC™ 3DSi Locking Screws.

A.1. Submitted By:	Wright Medical Technology, Inc.5677 Airline RdArlington, TN 38002
Date:	October 28, 2011
Contact Person:	Peggy S. RiversRegulatory Affairs Specialist(901) 867-4759
A.2. Proprietary Name:	ORTHOLOC™ 3DSi Locking Screws
Common Name:	Locking Screws
Device Classification Regulation:	21 CFR 888.3030—Class II
Device Product Code & Panel:	HRS: Plate, Fixation Bone87 Orthopedics
A.3. Predicate Device:	K102352—EVOLVE® EPS ORTHOLOC™ System

A.4. Device Description

The ORTHOLOCM 3DSi Locking Screws are made from implant grade stainless steel and are available with cortical and cancellous thread forms in multiple length and diameters.

These screws are manufactured from stainless steel conforming to ASTM F2229.

The design features of the ORTHOLOC™ 3DSi Locking Screws are identical to the design features of the predicate devices EVOLVE® EPS ORTHOLOC™ System Locking Screws.

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K113339 Page 2/2 WRIGHT.

A.5. Intended Use

The system indications for both subject ORTHOLOC™ 3DSi Locking Screws and predicate EVOLVE® EPS ORTHOLOC™ (K102352) are identical.

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

A.6. Technological Characteristics Comparison

The subject ORTHOLOC™ 3DSi Locking screws are identical to the previously cleared EVOLVE® EPS ORTHOLOC™ Locking screws (K102352) with only minor change to feature call-outs on the engineering drawing.

B.1. Substantial Equivalence - Non-Clinical Evidence

Substantial equivalence is demonstrated through materials information and a composition of design characteristics.

B.2. Substantial Equivalence - Clinical Evidence

N/A

B.3. Substantial Equivalence - Conclusions

The subject screws are identical in indication for use, diameter, size range and material to the predicate. No new types of safety and effectiveness questions can be expected. From the evidence given 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 USA. The seal features a stylized eagle with three lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.

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

DEC 1 2 2011

Wright Medical Technology, Inc. % Ms. Peggy S. Rivers 5677 Airline Rd. Arlington, TN 38002

Re: K113339

Trade/Device Name: Ortholoc™ 3DSi Locking Screws Regulation Number: 21 CFR 888.3030 Regulation Name: Single/multiple component metallic bone fixation appliance and accessories Regulatory Class: II Product Code: HRS. HWC Dated: November 11", 2011 Received: November 14th, 2011

Dear Ms. Rivers:

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.

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Page 2 - Ms. Peggy S. Rivers

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 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 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/ReportalProblem/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 yours.

Sincerely yours,

Evin S. Keith

J Mark N. Melkerson 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):

Device Name: EVOLVE® EPS ORTHOLOC ™ System with ORTHOLOC™ 3DSi Locking Screws

Indications For Use:

EVOLVE® EPS ORTHOLOC™ System: Intended for fixation of fractures, osteotomies and nonunions of the olecranon, humerus, radius, and ulna

Prescription Use X (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)

Michael Chas

fn mxm

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

510(k) Number K 113339

Page 1 of 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.