The OrthoGuard AB Antimicrobial Sleeve is intended to be used as an accessory surrounding orthopaedic pins and wires during external fixation of bones. The OrthoGuard AB Antimicrobial Sleeve is indicated to inhibit bacterial colonization on the pin/wire.

Device Description

The OrthoGuard AB Antimicrobial Sleeve consists of polyurethane tubing coated on the inner and outer surfaces with an antimicrobial coating of gentamicin complexed with lauryl sulfate in a matrix of nitrocellulose and polyurethane. The OrthoGuard AB Antimicrobial Sleeve is provided at a maximum length for the longest pin/wire length and can be cut to desired lengths for smaller lengths of pins and wires selected for bone fixation. OrthoGuard AB Antimicrobial Sleeves are available in splined (longitudinal internal ridges for interference fit) or non-splined design in various diameters to match currently marketed orthopaedic pin/wire diameters.

AI/ML Overview

The provided text describes a medical device, the OrthoGuard AB Antimicrobial Sleeve, and its FDA 510(k) submission for market clearance. However, it does not contain the specific details required to answer the prompt regarding acceptance criteria and the study proving the device meets those criteria.

The document lists various performance characteristics that the device was subjected to (in-vitro elution tests, in-vivo elution tests, ETO sterilization study, packaging integrity test, etc.), and states that "The data from these tests support the safety and effectiveness of the device and substantial equivalence to legally marketed devices."

Crucially, the document does not:

Define specific acceptance criteria (e.g., "bacterial colonization inhibition must be X% over Y days").
Report quantitative device performance against those criteria.
Provide details on sample sizes, ground truth establishment, expert involvement, or any comparative effectiveness studies.

Therefore, I cannot complete the table or the other requested points based on the provided text. The document is a 510(k) summary, which generally focuses on justification for substantial equivalence, rather than detailed study results and acceptance criteria.

Based on the provided text, the following information is NOT available to answer your request:

A table of acceptance criteria and the reported device performance: Not specified.
Sample size used for the test set and the data provenance: Not specified.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not specified, as ground truth typically refers to objective biological or clinical outcomes, not expert consensus for this type of device.
Adjudication method for the test set: Not applicable, as expert adjudication is usually for subjective image interpretation, not for device performance like antimicrobial efficacy.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size: Not applicable; this type of study is for diagnostic devices, not for a physical device like an antimicrobial sleeve.
If a standalone study was done: The document mentions "performance characteristics" and various in-vitro and in-vivo tests, implying studies were done to assess the device itself, but specific details of "standalone" performance (e.g., without human-in-the-loop, which is irrelevant for this device) are not provided.
The type of ground truth used: For antimicrobial efficacy, ground truth would typically be microbiological cultures or quantitative bacterial counts. This is implied by "microbial activity tests" and "antimicrobial release rate tests," but the specific type of ground truth and how it was established are not detailed.
The sample size for the training set: Not applicable; this device is not an AI/ML algorithm.
How the ground truth for the training set was established: Not applicable; this device is not an AI/ML algorithm.

Summary

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KO12193

JUL 11 2002

510(k) Summary of Safety and Effectiveness OrthoGuard AB Antimicrobial Sleeve

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:	9 July 2002
Contact Person:	Jeff F. DoerzbacherManager, Clinical/Regulatory Affairs
Proprietary Name:	OrthoGuard AB Antimicrobial Sleeve
Common Name:	Antimicrobial Pin/Wire Sleeve
Classification Name and Reference:	Smooth or threaded metallic bone fixationfastener (21 CFR 888.3040)
Device Product Code and Panel Code:	JEC, NJA - Orthopedics/87

Predicate Device / Substantial Equivalence Information

The OrthoGuard AB Antimicrobial Sleeve is similar to the following devices:

Smith & Nephew External Fixation System (K994143) EBI X Dyna Fix System SC Bone Screws (K961433) Antimicrobial Multi-Lumen Central Venous Catheter (K900263) Niagara Dialysis Catheter (K965178) Bio-Guard AB Coated Catheter (K863354) Antimicrobial Peritoneal Dialysis Coil Catheter (K961392)

All of the devices listed above are either used for orthopaedic use and/or contain antimicrobial agents, and are considered substantially equivalent to the OrthoGuard AB Antimicrobial Sleeve.

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Device Description

The OrthoGuard AB Antimicrobial Sleeve is provided at a maximum length for the longest pin/wire length and can be cut to desired lengths for smaller lengths of pins and wires selected for bone fixation. OrthoGuard AB Antimicrobial Sleeves are available in splined (longitudinal internal ridges for interference fit) or non-splined design in various diameters to match currently marketed orthopaedic pin/wire diameters.

Intended Use

Technological Characteristics

Although the OrthoGuard AB Antimicrobial Sleeve is not identified predicate devices, the intended use and material composition are substantially equivalent to the characteristics found in one or more of the legally marketed predicate devices. Any differences that exist do not significantly affect the safety and effectiveness of the OrthoGuard AB Antimicrobial Sleeve

Performance Characteristics

The OrthoGuard AB Antimicrobial Sleeve was subjected to the following testing and analyses: in-vitro elution tests, in-vivo elution tests. ETO sterilization study, packaging integrity test, ETO residual tests, product design configuration tests, coating adherence/consistency/conformity tests, microbial activity tests, antimicrobial release rate tests, fatigue (in-vitro) tests, product stability tests, biocompatibility tests, and quality control tests. The data from these tests support the safety and effectiveness of the device and substantial equivalence to legally marketed devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal for the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville: MD 20850

JUL 11 2002

Mr. Jeff F. Doerzbacher Manager, Clinical/Regulatory Affairs Smith & Nephew, Inc. Orthopaedic Division 1450 Brooks Road Memphis, Tennessee 38116

Re: K012193

Trade/Device Name: OrthoGuard AB Antimicrobial Sleeve Regulation Number: 21 CFR §888.3040 Regulation Name: Smooth or threaded metallic bone fixation fastener Regulatory Class: Class II Product Code: JEC, NJA Dated: May 15, 2002 Received: May 16, 2002

Dear Mr. Doerzbacher;

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.

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Page 2 – Mr. Jeff F. Doerzbacher

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); 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.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Stpt Rhodes

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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Premarket Notification Indications Enclosure

510(k) Number: K012193

Page 1 of

Device Name: OrthoGuard AB Antimicrobial Sleeve

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use
X
(Per 21 CFR 801.109)

Over-The Counter Use (Optional Format 1-2-96)

Styet Plurdy

(Division Sign-Off Division of Genera. Restorative and Neurological Du . Rees

510(k) Number_________________________________________________________________________________________________________________________________________________________________

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.