The Medline Cannulated Screws are indicated for use in bone reconstruction, osteotomies, arthrodesis, joint fusion, fracture repair, and fracture fixation of bones appropriate for the size of the device. Screws are intended for single use only.

Device Description

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Medline Cannulated Screw. This type of filing is for medical devices that are substantially equivalent to a predicate device and typically does not include extensive clinical studies or acceptance criteria tables related to AI/software performance. Instead, it focuses on demonstrating safety and effectiveness through mechanical testing and comparison to an already approved device.

Therefore, many of the requested categories (2-9) are not applicable to this document as they pertain to studies involving AI/software for diagnostic or image analysis, which is not the nature of this device.

Here's the information extracted and an explanation for the non-applicable sections:

Acceptance Criteria and Device Performance

This document does not present specific acceptance criteria in the way one might for a software or AI-driven device, nor does it report performance metrics like sensitivity or specificity. Instead, the "acceptance" is based on demonstrating substantial equivalence to a predicate device through material composition, design, and functional performance testing.

The document states:
"Functional performance testing of the Medline Cannulated Screws demonstrated device effectiveness in accordance with relevant ASTM F382 and F543 test methods."

These ASTM standards cover mechanical testing of metallic bone screws, such as bending fatigue, torsional strength, and static axial pull-out. The "acceptance criteria" are implied to be that the Medline Cannulated Screws meet or exceed the performance thresholds defined by these ASTM standards, which would be comparable to the predicate device.

Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Device effectiveness in accordance with ASTM F382	Demonstrated effectiveness (performance met standards)
Device effectiveness in accordance with ASTM F543	Demonstrated effectiveness (performance met standards)
Substantial equivalence in materials and design to predicate device	Achieved (stated in "Summary of Technological Characteristics")

Non-Applicable Sections for this Device (Medline Cannulated Screws - a physical implant)

The following sections are designed for AI/software-driven medical devices and are not relevant to the 510(k) submission for a physical orthopedic implant like the Medline Cannulated Screw:

Sample size used for the test set and the data provenance: Not applicable. There is no "test set" of data in the context of AI/software for this physical device. Performance is assessed through mechanical testing of physical samples.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth, in the context of diagnostic AI, involves expert interpretation of data. For a bone screw, performance is measured mechanically and objectively.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable. There is no expert adjudication for the mechanical performance of a screw.
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 relates to AI assistance for human readers, which is not relevant for a physical implant.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. There is no algorithm for this device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The "ground truth" for a bone screw's performance is its mechanical properties as measured by standardized tests.
The sample size for the training set: Not applicable. There is no "training set" as this is not an AI/machine learning device.
How the ground truth for the training set was established: Not applicable. No training set exists.

Summary

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K130319 (pg 1/2)

510(k) Summary

MAY 3 1 2013

Summary Preparation Date

May 17, 2013

Submitter / 510(k) Sponsor

Medline Industries, Inc. One Medline Place Mundelein, IL 60060

Contact Person

Matt Clausen Sr. Regulatory Affairs Specialist Phone: 847-643-4785 Fax: 847-643-4482

Device Name / Classification

Device Name: Orthopedic Cannulated Screw Proprietary Name: Medline Cannulated Screw Common Name: Bone Screw Classification Name: Screw, Fixation, Bone (21 CFR 888.3040, product code - HWC)

Predicate Device (primary)

Wright Compression Screws (Wright Medical), K082320

Device Description

The Medline Cannulated Screws are manufactured from titanium alloy or stainless steel. The screws are offered in various diameters, lengths, and thread lengths. Both headed and headless screw options are available as well as optional washers for the headed screws. A comparison of the materials and design features of the subject and predicate screws reflects substantial equivalence. The Medline Cannulated Screw sizes are within the currently marketed sizes, diameter and length, of the identified predicate devices.

Indications for Use

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Summary of Technological Characteristics

Information within this Premarket Notification demonstrates that there are no significant differences in technological characteristics between Medline's Cannulated Screws and the cited predicate devices.

Summary of Non-Clinical Testing

The safety and effectiveness of Medline's Cannulated Screws is adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification. Functional performance testing of the Medline Cannulated Screws demonstrated device effectiveness in accordance with relevant ASTM F382 and F543 test methods.

Summary of Clinical Testing

N/A

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Cannulated Screw is safe, effective and substantially equivalent as described herein.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

May 31, 2013

Medline Industries, Incorporated % Mr. Matt Clausen . Sr. Regulatory Affairs Specialist One Medline Place Mundelein, Illinois 60060

Re: K130319

Trade/Device Name: Medline Cannulated Screws Regulation Number: 21 CFR 888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: HWC Dated: March 6, 2013 Received: March 7, 2013

Dear Mr. Clausen:

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

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Page 2 - Mr. Matt Clausen

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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" (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/Resourcesfor You/Industry/default.htm.

Sincerely yours,	Erin Keith
For	Mark N. Melkerson
	Director
	Division of Orthopedic Devices
	Office of Device Evaluation
	Center for Devices and
	Radiological Health

Enclosure

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Image /page/4/Picture/0 description: The image shows the logo for Medline. The logo consists of the word "MEDLINE" in a stylized, italicized font. Above and below the text are two parts of a compass, with the top part pointing upwards and the bottom part pointing downwards. The logo is in black and white.

Medline Industries, Inc. www.medline.com

One Medline Place Mundelein, II. 60060 1.847.643.4736

Indications for Use

510(k) Number (if known): K130319 (pg 1/1)

Device Name: Medline Cannulated Screws

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Elizabeth||司册ank -S

Division of Orthopedic Devices

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.