Smartset GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Device Description

SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone.

AI/ML Overview

This document is a 510(k) summary for a medical device called "SmartSet GMV Endurance Gentamicin Bone Cement." It details the device's information, indications for use, and a claim of substantial equivalence to previously marketed predicate devices.

However, the provided text does not contain information about specific acceptance criteria or an associated study that proves the device meets those criteria.

Generally, for a 510(k) submission, the "study" would be a series of tests demonstrating that the new device performs as safely and effectively as a predicate device. These tests often include:

Mechanical Property Testing: To ensure the cement has adequate strength, fatigue resistance, and other physical characteristics suitable for its intended use.
Biocompatibility Testing: To confirm that the materials are not harmful to the body.
Leaching Studies: To assess the release rate of the antibiotic (Gentamicin) and ensure it's effective without being toxic.
Sterilization Validation: To confirm the sterilization process is effective.

The FDA's review letter confirms that the device was found substantially equivalent, implying that the submitted data (which is not fully included here) demonstrated this equivalence.

Therefore, with the provided text, I cannot complete the table or answer most of your specific questions as the detailed study information is absent.

Here's a breakdown of what can be inferred or stated based on the provided text, and what is missing:

1. Table of acceptance criteria and the reported device performance

Cannot be provided. The document states that "The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards." However, it does not specify what those "voluntary performance standards" were, what the acceptance criteria within those standards were, or the explicit results of the product testing against those criteria.

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

Cannot be provided. The document mentions "product testing" but provides no details on sample sizes, types of tests (e.g., in-vitro, in-vivo), origins of data, or whether it was retrospective or prospective.

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 this type of device/submission. This question typically applies to AI/ML or diagnostic devices where human expert interpretation is used to establish a "ground truth" for evaluating algorithm performance. For bone cement, performance is usually assessed through objective physical, chemical, and biological tests, not expert consensus on image interpretation.

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

Not applicable. As above, this pertains to expert review and consensus, which is not described or typically used for evaluating the performance of bone cement.

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 question is specific to AI-assisted diagnostic or interpretation devices. The SmartSet GMV Endurance Gentamicin Bone Cement is a therapeutic material, not a diagnostic tool, and does not involve human readers interpreting cases or AI assistance in that context.

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

Not applicable. This device is bone cement, it does not involve an algorithm.

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

Not explicitly stated, but inferred. For bone cement, "ground truth" would generally be established by:
- Mechanical Engineering Standards: Established benchmarks for strength, fatigue, working time, setting time, etc.
- Biocompatibility Standards: ISO standards for cytotoxicity, sensitization, irritation, etc.
- Pharmacological Standards: For antibiotic release profile and efficacy, likely in-vitro elution studies.
- These are based on scientific evidence and established testing methodologies, not typically "expert consensus" in the way it's used for diagnostic accuracy studies.

8. The sample size for the training set

Not applicable. This device is not an AI/ML algorithm that requires a "training set."

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

Not applicable. As above, no training set for an algorithm is involved.

Conclusion:

The provided 510(k) summary is a high-level document stating intent and claiming substantial equivalence. It does not include the detailed technical reports, test protocols, specific acceptance criteria, or raw performance data that would be part of a full 510(k) submission. Therefore, it's impossible to fully answer your questions based only on this text. The FDA's letter simply confirms that the submitted information (which is not provided here) was sufficient to demonstrate substantial equivalence.

Summary

{0}------------------------------------------------

(033382

FEB - 5 2004

510(k) Summary SmartSet GMV Endurance Gentamicin Bone Cement

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Tiffani D. Rogers Regulatory Affairs Associatc (574) 371-4927

Device Information:

Proprietary Name:	SmartSet GMV Endurance Gentamicin
	Bone Cement
Common Name:	Polymethylmethacrylate (PMMA) and styrene co-polymer bone cement with Antibiotic
Regulatory Class andClassification Name:	Class II; 21 CFR 888.3027
Product Code:	LOD

C. Indications for Use:

SmartSet GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been clearcd.

D. Device Description:

SmartSet GMV Endurance Gentamicin Bone cement is a self-curing cement, containing one seating and securing of seating and securing of a metal or plastic prosthesis to I ving bone. -

E. Substantial Equivalence:

The substantial equivalence of the SmartSet GMV Endurance Bone Cement is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to DePuy 1 Gentamicin Bone Cement (K023103), Simplex P with Tobramycin Bone Ccment (K014199), St and Endurance Bone Cement (P960001/S003). Endurance Bone Cement (KU14199)
to Class II by the EDA official (P960001/S003). Endurance Bone Cement was down classified to Class II by the FDA effective August 16, 2002.

The determination of substantial equivalence for this device was based on a detailed device description, product testing and conformance with voluntary performance standards.

{1}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image is a 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 symbol that resembles an eagle or bird-like figure. The symbol is composed of three curved lines that converge at the bottom.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 5 2004

Ms. Tiffani D. Rogers Regulatory Affairs Associate Depuy Orthopacdics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581

Rc: K033382

Trade/Devicc Name: Smartset GMV Endurance Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: Il Product Code: I.OD Dated: December 29, 2003 Received: December 30, 2003

Dear Ms. Rogers:

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, Insting 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 he 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 docs 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 clectronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{2}------------------------------------------------

Page 2- Ms. Tiffani D. Rogers

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 McMillan

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

Enclosure

{3}------------------------------------------------

Indications for Use

510(k) Number (if known): K033382_________________________________________________________________________________________________________________________________________

. . . . .

Device Name: ___SmartSet GMV Endurance Gentamicin Bone Cement Indications for Use:

Smartset GMV Endurance Gentamicin Bone Cement is indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

Prescription Use X Over-The-Counter Use AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 807 Subpart C) (PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Craive

for Mark A. Milliken

Page __ of ___________________________________________________________________________________________________________________________________________________________________

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.”