The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

Device Description

The BioBuck™ Cement Restrictor is a bioabsorbable version and modification of the Buck™ Cement Restrictor that was cleared for marketing by FDA on 27 June 1979 (K791125). The material for the BioBuck device is PolyActive®, a biocompatible copolyether. PolyActive is currently used to manufacture other cement restrictor devices (Shuttle Stop , K000587; SynPlug™ , K010840).

AI/ML Overview

This document is a 510(k) summary for the BioBuck™ Cement Restrictor and primarily focuses on establishing substantial equivalence to predicate devices rather than presenting a detailed study proving the device meets specific acceptance criteria through performance data. Therefore, many of the requested elements for a study evaluating device performance cannot be extracted from this text.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

The document does not explicitly state acceptance criteria or report specific performance data for the BioBuck™ Cement Restrictor. It focuses on the device's design, materials, and intended use being "identical" or "very similar" to predicate devices, implying that their established performance is sufficient for proving substantial equivalence.

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

This information is not provided because no specific performance study on a test set is described.

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)

This information is not provided because no specific performance study on a test set is described.

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

This information is not provided because no specific performance study on a test set is described.

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

This information is not provided. The device is a physical medical device (cement restrictor), not an AI or imaging diagnostic tool, so an MRMC comparative effectiveness study involving human readers and AI is not applicable.

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

This information is not provided. The device is a physical medical device (cement restrictor), not an algorithm.

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

This information is not provided because no specific performance study to establish ground truth is described. For this type of device, ground truth would likely relate to mechanical properties, biocompatibility, and clinical outcomes, but no such studies are detailed.

8. The sample size for the training set

This information is not provided because no training set is relevant for this type of physical device (cement restrictor).

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

This information is not provided because no training set is relevant for this type of physical device (cement restrictor).

Summary of what can be extracted related to "acceptance criteria" and "proof":

The "acceptance criteria" for the BioBuck™ Cement Restrictor, as presented in this 510(k) summary, are implicitly tied to demonstrating substantial equivalence to existing predicate devices.

The study that proves the device meets the acceptance criteria (i.e., substantial equivalence) is the comparison to predicate devices.

Key points of this "proof" (comparison study):
- Intended Use: "The intended use of the BioBuck Cement Restrictor is identical to the predicate devices."
- Technological Characteristics/Principles of Operation: "The principles of operation for the BioBuck Cement Restrictor are identical to the Buck Cement Restrictor... The design and material of the BioBuck device has the same technological characteristics as one or more of the predicate devices."
- Design and Material: "The BioBuck device shape and design are very similar to the Buck predicate device, and the BioBuck device is manufactured from the identical material as the Shuttle Stop and SynPlug predicate devices."
- Predicate Devices Used: Buck™ Cement Restrictor (K791125), Shuttle Stop® Cement Restrictor (K000587), SynPlug™ Cement Restrictor (K010840).

In essence, the "acceptance criteria" here are that the BioBuck™ Cement Restrictor is functionally and materially similar enough to established predicate devices that it presents no new questions of safety or effectiveness. The "study" is the detailed comparison of its characteristics against those of the legally marketed predicates. The FDA's letter acts as the "proof" by affirming that based on this comparison, the device is deemed "substantially equivalent."

Summary

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510(k) Summary of Safety and Effectiveness BioBuck™ Cement Restrictor

Submitted By:	Smith & Nephew, Inc.Orthopaedic Division1450 Brooks RoadMemphis, TN 38116	NOV 1 9 2002
Date:	October 31, 2002
Contact Person:	David HenleySenior Clinical/Regulatory Affairs SpecialistTel: (901) 399-6487Fax: (901) 398-5146
Proprietary Name:	BioBuck™ Cement Restrictor
Common Name:	Cement Restrictor
Classification Name and Reference:	Cement Obturator
Device Product Code and Panel Code:	Orthopedics/87/LZN
Predicate Devices:	Buck™ Cement Restrictor (K791125)Shuttle Stop® Cement Restrictor (K000587)SynPlug™ Cement Restrictor (K010840)

Device Description:

Intended Use:

The BioBuck Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

Technological Characteristics:

The principles of operation for the BioBuck Cement Restrictor are identical to the Buck Cement Restrictor, as well as the Shuttle Stop and SynPlug. All are cement plugs that are inserted in the intramedullary canal during implantation of a joint prosthesis to prevent the migration of bone cement. The design and material of the BioBuck device has the same technological characteristics as one or more of the predicate devices.

Substantial Equivalence Information:

The intended use of the BioBuck Cement Restrictor is identical to the predicate devices. The BioBuck device shape and design are very similar to the Buck predicate device, and the BioBuck device is manufactured from the identical material as the Shuttle Stop and SynPlug predicate devices.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20850

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

NOV 1 9 2002

K023680 Re: Trade Name: BioBuck™ Cement Restrictor Regulation Number: 21 CFR 878.3300 Regulation Name: Cement Obturator Regulatory Class: II Product Code: LZN Dated: October 31, 2002 Received: November 1, 2002

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, 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.

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- . 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,

Mark N. Millerson

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

Enclosure

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Indications for Use Statement BioBuck™ Cement Restrictor

510(k) Number (if known):

Device Name: BioBuck™ Cement Restrictor

Indications for Use:

The BioBuck™ Cement Restrictor is a bullet-shaped plug with stabilizing and sealing rings intended for intramedullary occlusion during cemented hip and shoulder arthroplasty.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark N Milkerem

(Division Sign-Off) Division of General, Restorative and Nourological Devices

stock number K023680

Prescription Use (Per 21 CFR 801.109) OR

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

Regulation Number and Section

§ 878.3300 Surgical mesh.

(a)
Identification. Surgical mesh is a metallic or polymeric screen intended to be implanted to reinforce soft tissue or bone where weakness exists. Examples of surgical mesh are metallic and polymeric mesh for hernia repair, and acetabular and cement restrictor mesh used during orthopedic surgery.(b)
Classification. Class II.