The DePuy RECLAIM Revision Hip System is indicated for cementless use in the treatment of failed previous hip surgery, including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or other total hip replacement.

Device Description

The ReClaim Revision Hip System is a modular tapered hip stem system that is intended for use in revision hip arthroplasty.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the DePuy RECLAIM Revision Hip System:

The provided document describes a 510(k) submission for a medical device, which focuses on demonstrating substantial equivalence to predicate devices rather than proving a new device meets specific clinical acceptance criteria through clinical trials. Therefore, much of the requested information regarding clinical study design, ground truth, expert consensus, and human reader performance is not applicable to this type of submission.

The "acceptance criteria" discussed here are primarily technical and performance-based to show the new device is as safe and effective as existing legally marketed devices.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance
Mechanical Performance (Fatigue)	Neck fatigue testing per ISO-7206-6:1992 specification.	"RECLAIM neck fatigue testing meets the ISO-7206-6:1992 specification when tested to 10 million cycles at 1200 lbf in air."
Material/Design Performance (Fatigue)	Distal fatigue testing per ISO 7206-4:1989 requirements/benchmarks set by predicate devices.	"Distal fatigue testing per ISO 7206-4:1989 demonstrated that the subject device achieved higher maximum loads prior to failure when compared to the predicate Spectrum and Solution devices."
Overall Safety and Effectiveness	Demonstrated substantial equivalence to predicate devices in intended use, indications for use, materials, geometry, design, and performance, with no new issues of safety or effectiveness.	The submission concludes: "The subject DePuy RECLAIM Revision Hip System is substantially equivalent to the predicate devices identified in this premarket notification." The FDA concurred with this determination.

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

This is not applicable as there was no clinical test set in the traditional sense. The "test set" was generated through non-clinical mechanical testing (fatigue tests).

Sample Size: Not explicitly stated for the mechanical tests, but implied multiple units would be tested to demonstrate conformance to ISO standards and for comparison against predicate devices.
Data Provenance: Laboratory testing data, likely conducted by the manufacturer or a contracted lab. No country of origin for clinical data as none was used. The focus is on the device's physical properties.
Retrospective/Prospective: Not applicable to mechanical testing.

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

This is not applicable. For mechanical testing, the "ground truth" is defined by the established ISO standards and the physical properties of the materials and design, measured by engineering specialists. No human experts were used to establish a "ground truth" for diagnostic or clinical outcomes from a patient dataset.

4. Adjudication Method for the Test Set

This is not applicable. Mechanical test results are objective measurements against established engineering standards, not subjective interpretations requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. The submission explicitly states: "No clinical testing was required to demonstrate substantial equivalence." Therefore, no effect size of human readers improving with AI vs. without AI assistance can be reported.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

This is not applicable. The device is a physical hip implant, not an AI algorithm or software.

7. The Type of Ground Truth Used

The "ground truth" for the non-clinical testing was based on:

International Standards: Adherence to ISO-7206-6:1992 for neck fatigue and ISO 7206-4:1989 for distal fatigue.
Comparative Performance: The mechanical performance (e.g., maximum loads prior to failure) was compared directly to legally marketed predicate devices (DePuy Spectrum Modular System, K033893, and DePuy Solution Hip System, K060581).

8. The Sample Size for the Training Set

This is not applicable. There was no "training set" as this device is a physical implant, not an AI/ML algorithm that requires training data.

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

This is not applicable, as there was no training set.

Summary

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KID200000g 1/2)

Section 5: 510 (k) Summary

(As required by 21 CFR 807.92 and 21 CFR 807.93)

NAME OF SPONSOR:	DePuy (Ireland)LoughbegRingaskiddyCo. CorkIrelandEstablishment Registration Number: 9616671
510(K) CONTACT:	Rhonda MyerSenior Regulatory Affairs AssociateTelephone: (574) 371-4927Facsimile: (574) 371-4987Electronic Mail: Rmyer7@its.jnj.com
DATE PREPARED:	July 14, 2010
PROPRIETARY NAME:	DePuy RECLAIM Revision Hip System
COMMON NAME:	Hip Stem Prosthesis
CLASSIFICATION ANDREGULATION:	Class III per 21 CFR 888.3330: Hip jointmetal/metal semi-constrained, with anuncemented acetabular component, prosthesis(KWA)Class II per 21 CFR 888.3353: Hip jointmetal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis(LZO)
DEVICE PRODUCT CODE ANDDESCRIPTION:	KWA: prosthesis, hip, semi-constrained (metaluncemented acetabular component)LZO: prosthesis, hip, semi-constrained,metal/ceramic/polymer, cemented or non-porous,uncemented
SUBSTANTIALLY EQUIVALENTDEVICE(S):	DePuy Spectrum Modular System, K033893DePuy Solution Hip System, K060581

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DEVICE DESCRIPTION:

The ReClaim Revision Hip System is a modular tapered hip stem system that is intended for use in revision hip arthroplasty.

INDICATIONS AND INTENDED USE:

Indications:

Intended Use:

Total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components.

Summary of Technologies/Substantial Equivalence:

The substantial equivalence of the subject RECLAIM Revision Hip System is demonstrated by similarities in intended use, indications for use, materials, geometry, design and performance as compared to the predicate devices. The changes presented in this 510(k) do not present new issues of safety or effectiveness.

Non-clinical Testing:

RECLAIM neck fatigue testing meets the ISO-7206-6:1992 specification when tested to 10 million cycles at 1200 lbf in air. Distal fatigue testing per ISO 7206-4:1989 demonstrated that the subject device achieved higher maximum loads prior to failure when compared to the predicate Spectrum and Solution devices. This testing, coupled with evaluations of the device design and geometry, demonstrated that the subject devices met the applicable performance requirements and are as safe and effective as the predicates.

Clinical Testing:

No clinical testing was required to demonstrate substantial equivalence.

Conclusion:

The subject DePuy RECLAIM Revision Hip System is substantially equivalent to the predicate devices identified in this premarket notification.

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Image /page/2/Picture/1 description: The image shows the 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 a stylized image of an eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

DePuy (Ireland) % DePuy Orthopaedics, Inc. Ms. Rhonda Myer Senior Regulatory Affairs Associate 700 Orthopaedic Drive Warsaw, Indiana 46582

NOV 2 3 2010

Re: K102080

Trade/Device Name: DePuy RECLAIM Revision Hip Stem Regulation Number: 21 CFR 888.3330 Regulation Name: Hip joint metal/metal semi-constrained, with an uncemented acetabular component, prosthesis Regulatory Class: Class III Product Code: KWA, LZO Dated: November 10, 2010 Received: November 12, 2010

Dear Ms. Myer:

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 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); medical device reporting of medical

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Page 2 - Ms. Rhonda Myer

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

ncerely yours.

Вавае Вжецнр

Mark N. Melkerson Director Division of Surgical, Orthopedic, and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section 4: Indications for Use Statement

510 (k) Number (if known): _K102080(pq 1/1)

Device Name: DePuy RECLAIM Revision Hip System

NOV 2 3 2010

Indications for Use:

Prescription Use X (Part 21 CFR 801 Subpart D)

AND/OR

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

(Please do not write below this line. Continue on another page if needed.)

Omtu for mxm
(Division Sign-off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102080

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.