DePuy 1 Gentamicin 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

DePuy 1 Gentamicin Bone Cement is a self curing cement, to which one gram of Gentamicin is added in 40 grams PMMA (Polymethyl methacrylate) cement for allowing the seating and securing of a metal or plastic prosthesis to living bone.

AI/ML Overview

The provided text is a 510(k) summary for the DePuy 1 Gentamicin Bone Cement. It does not contain information about acceptance criteria, device performance metrics, or any studies using a test set of data with ground truth established by experts.

Here's what can be extracted from the document, though it doesn't directly answer your specific questions related to AI device evaluation:

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

This document does not provide a table of acceptance criteria or reported device performance in the context of diagnostic accuracy, sensitivity, specificity, etc., as one would expect for an AI/ML medical device. The "device performance" in this context refers to its physical and chemical properties.

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 is a PMMA bone cement, not a data-driven device. The document mentions "product testing" and "conformance with voluntary performance standards" as part of the substantial equivalence determination, but no details on sample size, data provenance, or study design are provided for these tests.

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. There is no concept of "ground truth" or expert review in the context of this traditional medical device's 510(k) submission.

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

Not applicable.

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 is a bone cement, not an AI-assisted diagnostic device.

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

Not applicable.

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

Not applicable.

8. The sample size for the training set:

Not applicable. This device does not involve a "training set" in the machine learning sense.

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

Not applicable.

Summary of available information from the document:

Device Name: DePuy 1 Gentamicin Bone Cement
Indications for Use: For use in the second stage of a two-stage revision for total joint arthroplasty after the initial infection has been cleared.
Substantial Equivalence Basis: Similarity in indications for use, design, materials, sterilization, and packaging to predicate devices (DePuy 1 Bone Cement, BACTISEAL Catheter, OrthoGuard AB Antimicrobial Sleeve).
Testing Mentioned: "Product testing and conformance with voluntary performance standards" were used for the determination of substantial equivalence. However, no specific details about the nature of these tests, acceptance criteria, or results are provided in this summary. The tests would likely relate to the material properties, mechanical strength, gentamicin elution, and biocompatibility, as per relevant standards for bone cements.

In conclusion, the provided document is a 510(k) summary for a traditional medical device (bone cement) and therefore does not contain the specific information requested regarding acceptance criteria and studies for an AI/ML-driven device.

Summary

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

K023103 page 1/2

510(k) Summary

DePuy 1 Gentamicin Bone Cement

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Cheryl K Hastings Director, Regulatory Affairs (574) 372-7006 FAX (574) 371-4987

B. Device Information:

Proprietary Name:	DePuy 1 Gentamicin Bone Cement
Common Name:	Polymethyl methacrylate (PMMA) bone cementwith Antibiotic
Regulatory Class andClassification Name:	Class III; no classification name has beenestablished by FDA
Product Code:	MBB

C. Indications for Use:

DePuy 1 Gentamicin is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

D. Device Description:

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

K023103 page $\frac{2}{2}$

E. Substantial Equivalence:

The substantial equivalence of the DePuy 1 Gentamicin Bone Cement is demonstrated by its similarity in indications for use, design, materials, sterilization and packaging to DePuy 1 Bone Cement, the BACTISEAL Catheter (Codman) and OrthoGuard AB Antimicrobial Sleeve (Smith and Nephew).

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

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

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract symbol that resembles a stylized caduceus or a representation of human figures. The symbol consists of three curved lines that converge and then diverge, creating a sense of movement and dynamism.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP 2 9 2003

Ms. Cheryl K. Hastings Director, Regulatory Affairs DePuy Orthopaedics, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

Re: K023103

Trade/Device Name: DePuy 1 Gentamicin Bone Cement Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: June 30, 2003 Received: July 1, 2003

Dear Ms. Hastings:

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.

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

Page 2- Ms. Cheryl K. Hastings

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) 594-4639. 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 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 A. Millham

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

{4}------------------------------------------------

K023/03

510(k) Number (if known) Device Name

DePuy 1 Gentamicin Bone Cement

Indications for Use

DePuy 1 Gentamicin is indicated for use in the second stage of a two stage revision for total joint arthroplasty after the initial infection has been cleared.

(Please do not write below this line - Continue on another page if necessary) Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark n Millman
(Division Sign-Off)

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

510(k) Number K023103

Prescription Use > > (Per 21 CFR §801 109)

Over-the-Counter Use No

(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.”