DePuy CMW 1, 2 and 3 Bone Cements are indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, osteoarthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

Device Description

DePuy CMW 1, 2 and 3 Bone Cements are self-curing cements. The cements allow the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made: Changes are being made to the formulation of the bone cement liquid components. A warning is being deleted from the labeling for DePuy CMW 3 Bone Cement.

AI/ML Overview

This 510(k) submission (K053003) is for a Polymethyl Methacrylate (PMMA) Bone Cement, which is a Class II device. PMMA bone cements are considered low-risk and therefore exempt from extensive clinical trials. Instead, the primary method for demonstrating safety and effectiveness for such devices is through establishing substantial equivalence to legally marketed predicate devices.

The provided document does not contain details of a clinical study with acceptance criteria, sample sizes, expert ground truth, or MRMC studies, as it's a submission for a bone cement, not typically a device that undergoes such rigorous comparative effectiveness testing in the same way as, for example, an AI diagnostic tool.

Instead, the submission relies on the concept of substantial equivalence, meaning the new device is as safe and effective as a legally marketed predicate device.

Here's an analysis based on the provided text, addressing the points where information is available or can be inferred, and explicitly stating where information is not present given the nature of the device and submission type:

1. Table of Acceptance Criteria and Reported Device Performance

This type of table is typically used for devices where specific performance metrics (e.g., sensitivity, specificity, accuracy for a diagnostic device) are measured against predefined targets. For a bone cement, the "acceptance criteria" revolve more around physical, chemical, and biological properties, and demonstration of equivalency to existing legally marketed devices.

The document implicitly states the acceptance criteria as meeting the performance/characteristics of the predicate devices. The "reported device performance" is then the demonstration through various tests (often mechanical, chemical, biocompatibility) that the device meets these equivalent properties. However, specific numerical acceptance criteria and detailed performance results from such tests are not presented in this summary document. The summary states:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial equivalence to predicate devices regarding:	DePuy believes that the modified DePuy CMW 1, 2 and 3 Bone Cements described in this submission are substantially equivalent to the previously cleared and approved bone cements based on similarities in formulations, manufacturing methods and intended use. (This implies that underlying analyses, likely physical and chemical testing, were conducted to support these similarities, but the report does not detail the results of those tests).
- Formulations	(Not detailed in this summary but assumed to be demonstrated in the full submission)
- Manufacturing methods	(Not detailed in this summary but assumed to be demonstrated in the full submission)
- Intended use (fixation of prostheses to living bone)	Stated in Indications for Use, which aligns with predicate devices.
- Safety and Effectiveness (as demonstrated by similarity)	The FDA's substantial equivalence determination implies these criteria were met.

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

Sample Size for Test Set: Not applicable in the context of this 510(k) summary for a bone cement. There isn't a "test set" of clinical cases in the way an AI diagnostic device would have for performance evaluation. The "test set" would refer to samples of the bone cement tested in vitro for its physical, chemical, and mechanical properties, or potentially in animal studies for biocompatibility. These details are not provided in the summary, which focuses on the regulatory outcome.
Data Provenance: Not applicable in the context of this 510(k) summary. The "data" here would be from laboratory testing of the bone cement itself, rather than clinical patient data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: Not applicable. Ground truth, in the AI/diagnostic sense, is not established for this type of device. The "ground truth" for a bone cement would be its inherent physical and chemical properties and its biocompatibility, confirmed through standard laboratory testing and manufacturing controls.
Qualifications of Experts: Not applicable in the AI/diagnostic sense. The experts involved would be material scientists, chemists, and toxicologists who conducted the necessary laboratory and biocompatibility tests, and potentially orthopaedic surgeons validating the intended use and performance in surgical simulated environments. Their qualifications are not mentioned in this summary.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. There is no "test set" that requires adjudication by human readers/experts in this submission.

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

MRMC Study: No. This is a bone cement, not an AI diagnostic device. Therefore, MRMC studies and "human readers improving with AI" are not relevant to this submission.

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

Standalone Performance: No. This device is a bone cement, not an algorithm.

7. The Type of Ground Truth Used

Type of Ground Truth: For a bone cement, the "ground truth" would be established through a combination of:
- Physical and Chemical Characterization: Laboratory testing to confirm the material composition, viscosity, setting time, mechanical strength (e.g., compressive strength, fatigue strength), and other properties against recognized standards (e.g., ISO for bone cements).
- Biocompatibility Testing: In vitro and/or in vivo tests (often animal studies) to ensure the material is not toxic, allergenic, or otherwise harmful to living tissue.
- Comparison to Predicate Device Data: Demonstrating that the modified cement performs equivalently to the previously approved (predicate) bone cements across these various properties.
  The summary itself does not detail these ground truths but implies they were used to establish "similarities in formulations, manufacturing methods and intended use."

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. As this is not an AI/machine learning device, there is no "training set."

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

How Ground Truth Established: Not applicable, as there is no training set. If referring to the development and validation of the bone cement itself, the "ground truth" for its characteristics (as described in point 7) would have been established through well-defined material science and biocompatibility testing protocols, adhering to relevant industry standards and regulatory guidelines.

Summary

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K053003

NOV 2 2 2005 SUMMARY OF SAFETY AND EFFECTIVENESS

NAME OF FIRM:	DePuy Orthopaedics, Inc.P.O. Box 988700 Orthopaedic DriveWarsaw, IN 46581-0988
510(k) CONTACT:	Natalie S. HeckManager, Regulatory Affairs
TRADE NAME:	DePuy CMW 1 Bone CementDePuy CMW 2 Bone CementDePuy CMW 3 Bone Cement
COMMON NAME:	Polymethyl Methacrylate (PMMA) Bone Cement
CLASSIFICATION:	Class II; 21 CFR 888.3027
DEVICE PRODUCT CODE:	LOD
SUBSTANTIALLY EQUIVALENTDEVICES:	DePuy 1 Bone Cement (P960001/S003)*
	DePuy 2 Bone Cement (P960001/S006)*
	DePuy 3 Bone Cement (P960001/S004)*
	SmartSet GMV Endurance Gentamicin Bone Cement(K033382).
	SmartSet MV Endurance Bone cement (P960001/S1)*(previously branded Endurance Bone Cement)
	* DePuy 1 Bone Cement, DePuy 2 Bone Cement, DePuy 3 Bone Cement and SmartSet MV Endurance Bone Cement wereapproved by FDA under PMA Supplement, prior to the FDAreclassification of PMMA cement as Class II, effective August16, 2002.

DEVICE DESCRIPTION:

DePuy CMW 1, 2 and 3 Bone Cements are self-curing cements. The cements allow the seating and securing of a metal or plastic prosthesis to living bone. The following modifications are being made:

Changes are being made to the formulation of the bone cement liquid components.

A warning is being deleted from the labeling for DePuy CMW 3 Bone Cement.

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INTENDED USE AND INDICATIONS:

DePuy CMW 1, 2 and 3 Bone Cements are indicated for the fixation of prostheses to living bone in orthopaedic musculoskeletal surgical procedures for rheumatoid arthritis, traumatic arthritis, osteoporosis, avascular necrosis, collagen disease, severe joint destruction secondary to trauma or other conditions, and revision of previous arthroplasty.

BASIS OF SUBSTANTIAL EQUIVALENCE:

Based on similarities in formulations, manufacturing methods and intended use, DePuy believes that the modified DePuy CMW 1, 2 and 3 Bone Cements described in this submission are substantially equivalent to the previously cleared and approved bone cements.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with its wings spread.

NOV 2 2 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Natalie Heck Manager, Regulatory Affairs DePuy Orthopaedics, Inc PO Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K053003

Trade/Device Name: DePuy CMW 1, 2 and 3 Bone Cements Regulation Number: 21 CFR 888.3027 Regulation Name: Polymethylmethacrylate (PMMA) bone cement Regulatory Class: II Product Code: LOD Dated: October 24, 2005 Received: October 27, 2005

Dear Ms. Heck:

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 - Natalie Heck

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 (240) 276-0120. 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/industry/support/index.html.

Sincerely yours,

Mark N. Melkerson

Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications Statement

510(k) Number (if known):

Device Name: DePuy CMW 1, 2 and 3 Bone Cements

Indications for Use:

Prescription Use (Part 21 CFR 801.Subpart D)

OR/AND

Over-The Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Division Sign Off

Page 1 of

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

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.”