Intracapsular fractures of the femoral neck
Intertrochanteric fractures of the femur
Tibial plateau fractures
Fractures of the dorsal pelvic ring
Pelvic sacroiliac joint disruption
Ankle arthrodesis
Other indications where cancellous screws are currently used and a guided system may be beneficial

Device Description

The Dyna Locking Cannulated Screw™ consists of various sizes of cannulated screws and washers. Cannulated screws are designed to be inserted over guide pins and provide several potential benefits over standard screws especially the precision with which they can be placed. Guide pins can be used for provisional fracture fixation, facilitating accurate fracture reduction before definitive fixation with screws. In addition, the guide pins can be placed percutaneously with potential benefits of decreased surgical morbidity. A washer may be used as an extension of the cannulated screw where the cortical bone is soft or thin. All implants of Dyna Locking Cannulated Screw™ are single use device, supplied non-sterile and manufactured from titanium alloy(Ti-6AI-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Cannulated Screw™.

AI/ML Overview

This looks like a 510(k) premarket notification for a medical device called the "Dyna Locking Cannulated Screw™". This document is a submission to the FDA (Food and Drug Administration) to demonstrate that the device is substantially equivalent to legally marketed predicate devices.

Let's break down the information to answer your request.

Important Note: The provided document is a 510(k) summary and the FDA's clearance letter. It does not contain information about an AI/ML device, nor does it describe acceptance criteria in the context of AI performance metrics (like sensitivity, specificity, AUC). Instead, it demonstrates substantial equivalence to predicate devices primarily through design, material, and mechanical performance comparison. Therefore, many of your requested points related to AI device evaluation (e.g., ground truth, MRMC study, human-in-the-loop performance, training set) are not applicable to this type of submission.

I will answer the questions based on the information available in the provided 510(k) document, clarifying when a question is not applicable to this type of device.

Description of Acceptance Criteria and the Study that Proves the Device Meets Acceptance Criteria

This 510(k) submission for the "Dyna Locking Cannulated Screw™" is based on demonstrating substantial equivalence to existing predicate devices, rather than meeting specific performance acceptance criteria for an AI algorithm. The "acceptance criteria" here refer to the device's ability to perform mechanically and functionally with similar characteristics to the predicate devices. The study proving this involves engineering analyses of mechanical properties and a comparison of design, materials, and intended use.

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

Acceptance Criteria Category	Specific Criteria (Implicit via Substantial Equivalence to Predicate)	Reported Device Performance (as demonstrated by comparison)
Mechanical Performance	- Equivalent pull-out strength to predicate devices.	- Conducted engineering analyses based on geometric/material comparison.
	- Equivalent bending strength to predicate devices.	- Conducted engineering analyses based on geometric/material comparison.
	- Equivalent torsional strength to predicate devices.	- Conducted engineering analyses based on geometric/material comparison.
Material Composition	- Manufactured from titanium alloy (Ti-6Al-4V ELI) in accordance with ASTM F136.	- Meets ASTM F136 standard for Ti-6Al-4V ELI.
Design Characteristics	- Cannulated screws, various sizes, use of washers.	- Consistent with the design of predicate cannulated screws.
Intended Use	- Indications for use are equivalent to predicate devices.	- Identical list of indications for use as presented in the document.
Sterilization State	- Supplied non-sterile.	- Supplied non-sterile, consistent with common practice for implantable devices that are sterilized prior to use.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Sample Size for Test Set: This is not applicable in the traditional sense for a non-AI/ML mechanical device submission of this nature. The "test set" here refers to the actual physical device for which mechanical tests and comparisons were performed. The document implies samples of the Dyna Locking Cannulated Screw™ were tested or modeled. Specific numbers are not provided in this summary, but typically involve a sufficient number of units to demonstrate reproducibility of mechanical properties.
Data Provenance: The engineering analyses would have been conducted by the manufacturer, U & I Corporation, located in Kyunggi-Do, Korea. These are likely prospective tests performed on manufactured samples or models of the device to characterize its mechanical properties.

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. For a mechanical fixation device, "ground truth" is established by direct measurement of physical properties and adherence to recognized mechanical standards (e.g., ASTM F136 for materials). Expert radiologists or clinicians are involved in defining the intended use and potentially in clinical evaluation of similar devices, but not in establishing "ground truth" for the mechanical test set itself in this specific context. The engineers performing the tests and comparing specifications serve as the "experts" for this aspect.

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

Not Applicable. Adjudication methods like 2+1 or 3+1 are used for human expert consensus in diagnostic or prognostic AI studies. For mechanical testing, the results are typically quantitative and objective measurements (e.g., force required for pull-out, bending moment). Engineering standards and statistical analysis are used to determine if the results meet predefined specifications or are comparable to predicate devices.

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 device is a bone fixation screw; it is not an AI-assisted diagnostic tool or an imaging device involving human readers. Therefore, an MRMC study is irrelevant to this submission.

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

Not Applicable. This is a physical, mechanical medical device, not an algorithm. There is no "standalone" algorithm performance to evaluate.

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

The "ground truth" for this device's performance relies on objective mechanical test data (e.g., measurements of pull-out strength, bending strength, torsional strength) and standard material specifications (e.g., ASTM F136 for titanium alloy). The comparison of these properties to those of legally marketed predicate devices forms the basis of the substantial equivalence assertion.

8. The sample size for the training set

Not Applicable. This is not an AI/ML device, so there is no "training set."

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

Not Applicable. As there is no training set for an AI/ML model, this question is irrelevant to this device submission.

Summary

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12 KII2240

JAN - 4 2012

5. 510(k) Summary

Manufacturer:	U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050Gyeong-Je Kwon, Regulatory Affairs Specialist
Sponsor:	U & I Corporation529-1, Yonghyun-dong, UijungbuKyunggi-Do, Korea 480-050
Sponsor Contact:	Gyeong-Je Kwon, Regulatory Affairs Specialist
Date Prepared:	August 01, 2011
Device Name:	Trade Name: Dyna Locking Cannulated Screw™™
Common Name:	Bone Fixation Screws
Classification Name:	21 CFR 888.3040 - Smooth or threaded metallic bonefixation fastener
Product Code:	HWC - Screw, Fixation, Bone
Predicate Devices:	Richards Cannulated Screw (K951389)Synthes Cannulated Screw (K962823, K963192, K963172,K021932, K962011)

Description of Device:

All implants of Dyna Locking Cannulated Screw™ are single use device, supplied

Dyna Locking Cannulated Screw™

U&i CORPORATION

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non-sterile and manufactured from titanium alloy(Ti-6AI-4V ELI) in accordance with ASTM F136. Specialized instruments made from surgical grade stainless steel are available for the instrumentation and removal of the Dyna Locking Cannulated Screw™.

Intended Use:

Intracapsular fractures of the femoral neck .
Intertrochanteric fractures of the femur .
Tibial plateau fractures .
Fractures of the dorsal pelvic ring .
Pelvic sacroiliac joint disruption .
Ankle arthrodesis .
Other indications where cancellous screws are currently used and a guided . system may be beneficial

Substantial Equivalence:

The Dyna Locking Cannulated Screw™ is substantially equivalent to Richards Cannulated Screw(K951389) and Synthes Cannulated Screw(K962823, K963192, K963172, K021932, K962011) in design, material, mechanical performance, function and intended use. Engineering analyses of pull-out, bending, and torsional strength were conducted based on geometric/material comparison to predicate devices.

Dyna Locking Cannulated Screw™

U&i CORPORATION

K112242

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Image /page/2/Picture/1 description: The image shows the 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 image of an eagle with its wings spread, facing to the right.

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

U & I Corporation % Mr. Gyeong-Je Kwon Regulatory Affairs Specialist 529-1, Yonghyun-dong, Uijungbu Kyunggi-Do, Korea 480-050

JAN - 4 2012

Re: K112240

Trade/Device Name: Dyna Locking Cannulated Screw Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: II Product Code: HWC Dated: November 16, 2011 Received: December 20, 2011

Dear Mr. Kwon:

We have reviewed your Section 510(k) premarket notification of intent to market the device in indication We nave reviewed your becaon 910(t) pressessed is substantially equivalent (for the indications ferenced above and nave determined and and and and and one smarketed in interstate for use stated in the citilosure/to regars actment date of the Medical Device Americal Device commence prof to May 20, 1978, the excordance with the provisions of the Federal Food, Drug, devices that have occh recuired in assee approval of a premarket approval application (PMA). and Cosment Act (Act) that do not require appear the general controls provisions of the Act. The Y ou may, ulerefore, market the devices, basjon to unements for annual registration, listing of general controls provisions of mactice, labeling, and prohibitions against misbranding and devices, good manufacturing practices, as starting and on related to contract liability adulteration. TTCase note: "CDTC" accorner 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 If your device is classified (boo acove) Existing major regulations affecting your device can be may be subject to additional controls. "Billeting and the 200 to 898. In addition, FDA may fouria in the South of I concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled on a bucked on a case and other requirements of the Act
that FDA has made a determination that your device complies with other matt that I DA has made a determination administered by other Federal agencies. You must of ally rederal statutes and regulations and and limited to: registration and listing (21 comply with an the Act 3 requirements, and 801); medical device reporting (reporting of medical

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Page 2 - Mr. Gyeong-Je Kwon

device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de neceretation adverse overies (21 CFR Part 820); and if applicable, the electronic forth in the qualisms by the estimal (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 11 you desire spectiv as reading a l Centers Offices/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 Tou may 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,

Erin Keith

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 Statement

510(k) Number (if known): K112240

Device Name: Dyna Locking Cannulated Screw™

Indications for Use:

Intracapsular fractures of the femoral neck ●
Intertrochanteric fractures of the femur .
Tibial plateau fractures .
Fractures of the dorsal pelvic ring .
Pelvic sacroiliac joint disruption .
Ankle arthrodesis .
Ankle arthreations where cancellous screws are currently used and a guided . system may be beneficial

Over-The-Counter Use × Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Hthind for

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

510(k) Number

U&i CORPORATION

Dyna Locking Cannulated Screw™

Regulation Number and Section

§ 888.3040 Smooth or threaded metallic bone fixation fastener.

(a)
Identification. A smooth or threaded metallic bone fixation fastener is a device intended to be implanted that consists of a stiff wire segment or rod made of alloys, such as cobalt-chromium-molybdenum and stainless steel, and that may be smooth on the outside, fully or partially threaded, straight or U-shaped; and may be either blunt pointed, sharp pointed, or have a formed, slotted head on the end. It may be used for fixation of bone fractures, for bone reconstructions, as a guide pin for insertion of other implants, or it may be implanted through the skin so that a pulling force (traction) may be applied to the skeletal system.(b)
Classification. Class II.