DePuy 1 Gentamicin Bone Cement and SmartSet GMV Endurance Gentamicin Bone Cement are 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

DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements are self-curing coments, containing one gram of Gentamicin in 40 grams PMMA (Polymethyl methacrylate, and Polymethy) methacrylate and styrene co-polymer). The cements allow the seating and securing of a metal or plastic prosthesis to living bone.

AI/ML Overview

This submission is a 510(k) for a medical device (bone cement), and as such, it does not typically contain "acceptance criteria" or a "study that proves the device meets the acceptance criteria" in the way one might expect for an AI/ML device performance evaluation.

510(k) submissions focus on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving performance against specific quantitative acceptance criteria through a clinical study with a test set, ground truth, and expert adjudication as described in your request. The "proof" in a 510(k) comes from showing that the new device has the same intended use, similar technological characteristics, and performs as safely and effectively as a predicate device, or if there are differences, that those differences do not raise new questions of safety or effectiveness.

Therefore, many of the requested data points (e.g., sample size for test set, number of experts, MRMC study, standalone performance) are not applicable to this type of regulatory submission for this device.

However, I can interpret the available information in the context of your request to the best extent possible for a 510(k).

Here's an analysis based on the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) for substantial equivalence, there are no explicit quantitative "acceptance criteria" for performance metrics like sensitivity, specificity, or AUC that would be typical for an AI/ML device. The "acceptance criteria" here are implicitly the characteristics of the predicate device, and the "reported device performance" is the claim of substantial equivalence.

Acceptance Criterion (Implicitly based on Predicate)	Reported Device "Performance" / Justification for Equivalence
Intended Use: Second stage revision for total joint arthroplasty after initial infection cleared.	Same: "have the same basic design and the same intended use as the originally cleared bone cements." (K041656 / K023103, K033382, K033563)
Technological Characteristics:- Composition (PMMA bone cement with antibiotic)- Gentamicin as antibiotic- Self-curing	Similar (with change):- "self-curing cements, containing one gram of Gentamicin in 40 grams PMMA"- Change: Gentamicin Sulphate changed from micronised to non-micronised particles.
Performance (Safety & Effectiveness): No new questions of safety or effectiveness raised by changes.	Justification: "Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin manufactured with non-micronised are substantially equivalent to the previously cleared antibiotic bone cements manufactured with micronised Gentamicin."

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not applicable. There is no "test set" in the context of an AI/ML performance study as this is a material change to an existing device. Substantial equivalence is based on comparison to predicate devices, not on a new clinical study with a specific test cohort to generate performance metrics.
Data Provenance: Not applicable. The "data" here refers to the characteristics of the predicate device and the new device. The information is derived from the device's design, materials, and manufacturing process.

3. Number of Experts Used to Establish Ground Truth and Qualifications

Not applicable. There is no "ground truth" establishment by experts in the context of an AI/ML performance study for this type of submission. The safety and effectiveness of the predicate device would have been established through its original clearance, and the current submission relies on comparisons to that.

4. Adjudication Method

Not applicable. No adjudication method is mentioned or relevant to this type of medical device submission.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. No MRMC study was done. This type of study is relevant for evaluating the impact of an AI algorithm on human reader performance, which is not the subject of this 510(k).

6. Standalone (Algorithm Only) Performance Study

Not applicable. There is no AI algorithm involved with this medical device (bone cement).

7. Type of Ground Truth Used

Not applicable. There is no "ground truth" as a clinical reference standard in the context of an AI/ML study. The basis for safety and effectiveness is substantial equivalence to legally marketed predicate devices, which implicitly means the predicate devices' safety and effectiveness were already established.

8. Sample Size for the Training Set

Not applicable. There is no "training set" as this is not an AI/ML device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. See point 8.

Summary

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

JUL 01 2004

Image /page/0/Picture/1 description: The image contains the text "Koy1i656" at the top. Below the text is a logo that includes a solid black circle followed by the word "DePuy" in a stylized font. Underneath the logo, there is some additional text that is difficult to read due to its small size and image quality. The overall image appears to be a scan or photograph of a document or label.

SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Tiffani RogersRegulatory Affairs Associate
TRADE NAME:	DePuy 1 Gentamicin Bone CementSmartSet GMV Endurance Gentamicin Bone Cement.
COMMON NAME:	Polymethyl Methacrylate (PMMA) bone cement withAntibiotic.Polymethyl Methacrylate (PMMA) and styrene co-polymerbone cement with Antibiotic.
CLASSIFICATION:	Class II; 21 CFR 888.3027
DEVICE PRODUCT CODE:	LOD
SUBSTANTIALLY EQUIVALENT DEVICE:	DePuy 1 Gentamicin Bone Cement (K023103), SmartSet GMVEndurance Gentamicin Bone Cement (K033382) and SmartSetGHV Gentamicin Bone Cement (K033563)

DEVICE DESCRIPTION:

INTENDED USE AND INDICATIONS:

DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements are indicated for use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements have the same basic design and the same intended use as the originally cleared bone cements. The Gentamicin Sulphate used in the cements is to be changed from micronised particles to non-micronised particles. Based on similarities in design, material, manufacturing method and intended use, DePuy believes that the DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin manufactured with non-micronised are substantially equivalent to the previously cleared antibiotic bone cements manufactured with micronised Gentamicin. Lek Pharmaceutical and Chemical Company d.d are to remain the supplier of the active ingredient Gentamicin Sulphate.

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

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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tiffani Rogers DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581- 0988

JUL 01 2004

Re: K041656

Trade/Device Name: DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD, MBB Dated: June 17, 2004 Received: June 18, 2004

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, 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.

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

Page 2 - Tiffani 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.

Miriam C. Provost

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): Device Name: DePuy 1 Gentamicin and SmartSet GMV Endurance Gentamicin Bone Cements

Indications for Use;

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)

Page | of | (Posted November 13, 2003)

Muriam C. Provost

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

Ko41656 510(k) Number_

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.”