MODIFICATION TO VERSABOND BONE CEMENT by SMITH & NEPHEW, INC.

VersaBond® Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, rheumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

Device Description

VersaBond Bone Cement consists of two separate components: polymer powder and monomer liguid. The two components are packaged together and are pre-measured, sterilized components which, when mixed, form a radiopaque, rapidly setting bone cement.

AI/ML Overview

The provided text is a 510(k) summary for VersaBond® Bone Cement and a letter from the FDA. It does not describe an "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the context of performance metrics for a medical device that would involve a test set, ground truth, or expert review.

Instead, this document focuses on demonstrating substantial equivalence to a previously cleared predicate device (K001160). The "acceptance criteria" here is implicitly that the device is substantially equivalent to the predicate in terms of its characteristics and intended use.

Here's how to address the request based on the provided information, although it will be limited due to the nature of the document:

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

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (from text)
Intended Use Equivalence: The device's indications for use are the same as the predicate.	VersaBond® Bone Cement's indications for use are identical to the predicate device cleared under K001160.
Chemical Formulation Equivalence: The device's chemical formulation is the same as the predicate.	The chemical formulation of VersaBond® Bone Cement is identical to that of the device cleared under K001160. Similarities include identical constituents for the bone cement/liquid monomer.
Technological Characteristics Equivalence: The device's design features are identical or very similar, leading to similar physical and mechanical properties.	The device is designed to incorporate identical or very similar physical and mechanical properties. Design features are substantially equivalent to the device cleared under K001160.

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

Not Applicable. This document does not describe a performance study involving a test set as would be relevant for devices that require proof of diagnostic accuracy, clinical effectiveness through new data, or similar metrics. The review is based on a comparison to a predicate device.

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. No ground truth for a test set was established as part of this submission, as it relies on substantial equivalence to a predicate, not new performance data.

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

Not Applicable. There was no test set or adjudication process described in this document.

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 document is for bone cement, not an AI-assisted diagnostic device. Therefore, no MRMC study, human readers, or AI assistance is relevant.

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

Not Applicable. This device is a bone cement, not an algorithm or software. Therefore, no standalone performance study in that context was performed.

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

Implicit Ground Truth: The "ground truth" in this context is the safety and effectiveness of the predicate device (K001160), which would have been established through its own regulatory clearance process, and which this device claims substantial equivalence to. No new ground truth, in the sense of clinical validation data for this specific device, is explicitly presented in this summary.

8. The sample size for the training set

Not Applicable. This document does not describe a machine learning algorithm or a training set.

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

Not Applicable. This document does not describe a machine learning algorithm or a training set.

Summary

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NOV 28 2003	510(k) Summary of Safety and EffectivenessVersaBond® Bone Cement
Submitted By:		Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116
Date:		November 5, 2003
Contact Person:		David HenleySenior Clinical/Regulatory Affairs SpecialistTel: (901) 399-6487Fax: (901) 398-5146
Proprietary Name:		VersaBond® Bone Cement
Common Name:		Polymethylmethacrylate (PMMA) Bone Cement
Classification Name and Reference:		Polymethylmethacrylate (PMMA) Bone Cement21 CFR 888.3027, Class II
Device Product Code and Panel Code:		LOD/Orthopedics/87

Device Description:

Intended Use:

VersaBond Bone Cement is indicated for use as bone cement in arthroplastic procedures of the hip, knee, and other joints to fix plastic and metal prosthetic parts to living bone when reconstruction is necessary because of osteoarthritis, traumatoid arthritis, traumatic arthritis, avascular necrosis, nonunion of fractures of the femur, osteoporosis, secondary severe joint destruction following trauma or other conditions, and revision of previous arthroplasty procedures.

Technological Characteristics:

The chemical formulation of VersaBond Bone Cement, that is the subject of this submission, is identical to that of the device cleared under K001160. Similarities include the identical constituents for the bone cement / liquid monomer and identical indications for use. The device is designed to incorporate identical or very similar physical and mechanical properties.

Substantial Equivalence Information:

The indications for use, chemical formulation, and design features of VersaBond Bone Cement are substantially equivalent to the device cleared under K001160.

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Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 28 2003

Mr. David Henley Senior Clinical/Regulatory Affairs Specialist Smith & Nephew, Inc. Orthopaedic Division 1450 E. Brooks Road Memphis, Tennessee 38116

Re: K033509

Trade/Device Name: Versabond Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: November 5, 2003 Received: November 6, 2003

Dear Mr. Henley:

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. Iisting 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 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.

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Page 2 - Mr. David Henley

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), please contact the Office of Compliance at (301) 594-4659. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Mark N. Wilkerson

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

Enclosure

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Indications for Use Statement VersaBond® Bone Cement

KO33509 510(k) Number (if known): __________

Device Name: VersaBond® Bone Cement

Indications for Use:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N Millham

Fiestorative and Neurological Devices

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Prescription Use (Per 21 CFR 801.109)

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

Regulation Number and Section

§ 888.3027 Polymethylmethacrylate (PMMA) bone cement.

(a)
Identification. Polymethylmethacrylate (PMMA) bone cement is a device intended to be implanted that is made from methylmethacrylate, polymethylmethacrylate, esters of methacrylic acid, or copolymers containing polymethylmethacrylate and polystyrene. The device is intended for use in arthroplastic procedures of the hip, knee, and other joints for the fixation of polymer or metallic prosthetic implants to living bone.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Class II Special Controls Guidance Document: Polymethylmethacrylate (PMMA) Bone Cement.”