The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty.

Device Description

AI/ML Overview

This document is a 510(k) summary for the DePuy Luster Stem, a hip prosthesis. It focuses on demonstrating substantial equivalence to previously cleared devices rather than providing a study with acceptance criteria and performance data in the context of an AI/algorithm-driven medical device.

Therefore, most of the requested information (acceptance criteria, device performance, sample sizes, expert qualifications, ground truth, MRMC study, standalone performance, training set details) is not applicable or not provided in this document.

Here's how to break down the request based on the provided text:

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

Not applicable / Not provided. This document is a 510(k) for a physical medical device (hip prosthesis) demonstrating substantial equivalence, not an AI/algorithm device with performance metrics like sensitivity, specificity, etc. The "acceptance criteria" here implicitly refer to meeting the requirements for substantial equivalence, which is assessed based on design, material, and intended use similarities to predicate devices.

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 / Not provided. There is no "test set" in the context of an AI/algorithm evaluation for this physical device. The review is based on device design specifications, materials, and intended use compared to predicate devices.

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 / Not provided. No "ground truth" establishment by experts is described for a test set in this 510(k) submission. FDA reviewers assess the submission against regulatory guidelines and predicate device information.

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

Not applicable / Not provided. There is no test set or adjudication process described for the performance of an AI/algorithm.

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 / Not provided. This is a physical hip prosthesis, not an AI-assisted diagnostic tool. Therefore, an MRMC study is not relevant.

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

Not applicable / Not provided. There is no algorithm discussed for standalone performance.

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

Not applicable / Not provided. The "ground truth" concept as applied to AI performance metrics is not relevant here. The substantial equivalence is based on established FDA-cleared predicate devices.

8. The sample size for the training set

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

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

Not applicable / Not provided. There is no "training set" or "ground truth" establishment for a training set in this context.

Summary derived from the provided document:

The DePuy Luster Stem is a hip prosthesis submitted for 510(k) clearance by demonstrating substantial equivalence to previously cleared predicate devices. The basis of equivalence is a comparison of design, material, and intended use.

Acceptance Criteria (Implied for 510(k) Substantial Equivalence):
The primary acceptance criterion for this 510(k) submission is that the DePuy Luster Stem is substantially equivalent to legally marketed predicate devices in terms of:

Indications for Use: The Luster Stem has the same intended use as the predicate devices.
Technological Characteristics: The Luster Stem shares similar design, materials, and functional principles with predicate devices. Any differences (e.g., surface finish) do not raise new questions of safety or effectiveness.

Study/Evidence that Proves Acceptance Criteria are Met:
The "study" here is a comparison analysis outlined in the 510(k) submission against predicate devices, rather than a clinical trial with end-point statistics.

Table of Comparison for Substantial Equivalence:

Feature	DePuy Luster Stem	ENURANCE (K942370)	CPT (K960658)	EXETER (K974054, K980843)
Material	Cobalt-Chrome	Cobalt-Chrome	Cobalt-Chrome	316L Stainless Steel
Use	Cemented	Cemented	Cemented	Cemented
Design	Medial 30° Collar, Proximal Flange, Two Tapers, Polished Finish	Medial 30° Collar, Proximal Flange, Two Tapers, Matte Finish (lateral & distal), grit blasted (proximal flange)	Collarless, Slim Profile, Two Tapers, Polished Finish	Collarless, Slim Profile, Two Tapers, Polished Finish
Modular Heads	Yes	Yes	Yes	Yes
EndCaps/Centralizers/Cement Restrictors	Yes	Yes	Yes	Yes
Intended Use	Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty.	Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty.	Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty.	Femoral component in total hip arthroplasty for degenerative joint disease, fracture, or failed previous arthroplasty.

Reported Device Performance:

The document asserts that "The Luster Stem is identical in design, material and intended use to the FDA cleared Endurance (K942370) femoral stem." The only difference noted is the surface finish. It also states similarities to the CPT and Exeter systems, particularly regarding material, polished surface, and cemented use. The FDA's clearance letter confirms that the device is "substantially equivalent" for its stated indications for use. This indicates that based on the comparative analysis, the device is expected to perform as safely and effectively as its predicate devices.

Summary

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510(K) SUMMARY OF SAFETY AND EFFECTIVENESS

SPONSOR OF THIS 510(K):	DePuy, Inc.P.O. Box 988Warsaw, Indiana 46581-0988
510(K) CONTACT:	Sally FoustDePuy Orthopaedics, Inc.Sr. Regulatory Submissions Associate(219) 372-7455; FAX (219) 267-7098E-mail: Sally_Foust@ccgate.depuy.com
TRADE NAME:	DePuy Luster Stem
COMMON NAME:	Hip Prosthesis
CLASSIFICATION:	Class II per 888.3350, Hip joint metal/polymer semi-constrained cemented prosthesis
DEVICE CODE:	JDI
EQUIVALENT DEVICES:	DePuy Cemented Hip Prosthesis (Endurance)(K942370)CPT Hip Prosthesis (K960658)Exeter Total Hip System (K974054, K980843)

DEVICE DESCRIPTION AND INTENDED USE:

The DePuy Luster Stem is a polished, distally tapered femoral stem with a proximal anterior/posterior flange, a medial 30° collar, and an oval driver hole in the lateral proximal shoulder. The DePuy Luster Stem is available in five sizes (1, 2, 3, 4, and 5) each with two offset options, standard and high, and is manufactured from forged cobalt chrome molybdenum alloy. The DePuy Luster Stem is indicated for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of a patient whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty.

BASIS OF SUBSTANTIAL EQUIVALENCE:

The Luster Stem is identical in design, material and intended use to the FDA cleared Endurance (K942370) femoral stem. Both stems are distally tapered femoral stems with a proximal anterior/posterior flange, a medial 30° collar, and an oval driver hole in the lateral proximal shoulder. Both stems have a 12/14mm self-locking male taper at the neck to allow for the use of interchangeable modular metal or ceramic femoral heads. Both stems are available in five sizes (1, 2. 3. 4. and 5) each with a standard and high offset option. Both stems accept a PMMA centralizer at the distal tip and may be used with a cement restrictor. Both stems are manufactured from forged cobalt chrome molybdenum alloy and are intended for cemented use as the femoral component in total hip arthroplasty for replacing the hip joint of patients whose hip joint has been damaged by degenerative joint disease, fracture, or the failure of a previous arthroplasty. The only difference

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between the Luster stem and the FDA cleared Endurance stem is that the entire surface finish of the I uster stem is polished while the Endurance stem has a matte finish on the lateral and distal stem, and is grit blasted under the proximal flange.

The Luster stem is similar in material, design, and intended use to the FDA cleared CPT Hip Prosthesis in that the both stems are manufactured from cobalt chrome, are polished, and are intended for cemented use with the use of femoral canal centering devices (i.e., centralizers). The Luster stem is similar in design and intended use to the FDA cleared Exeter Total Hip System in that hoth stems are polished and are intended for cemented use with the use of femoral canal centering devices.

Based on similarities of design, materials and intended use, DePuy believes that the Luster Stem 1s substantially equivalent to the FDA cleared Endurance, CPT, and Exeter Hip Systems.

	LUSTER	ENURANCE(K942370)	CPT(K960658)	EXETER(K974054,K980843)
Material	Cobalt-Chrome	Cobalt-Chrome	Cobalt-Chrome	316L StainlessSteel
Use	Cemented	Cemented	Cemented	Cemented
Design	Medial 30°Collar,ProximalFlange,Two Tapers,Polished Finish	Medial 30°Collar,ProximalFlange,Two Tapers.Matte Finish	Collarless,Slim Profile,Two Tapers,Polished Finish	Collarless,Slim Profile,Two Tapers,Polished Finish
ModularHeads	Yes	Yes	Yes	Yes
EndCaps/Centralizers/CementRestrictors	Yes	Yes	Yes	Yes

The following table summarizes the similarities:

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Image /page/2/Picture/2 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 a stylized image of an eagle with its wings spread.

Nov 2 5 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Sally Foust Senior Requlatory Submissions Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re : K983136 Trade Name: DePuy Luster Stem Requlatory Class: II Product Code: JDI September 4, 1998 Dated: Received: September 8, 1998

Dear Ms. Foust:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions aqainst misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Ms. Sally Foust

This letter will allow you to begin marketing your device as described in your 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 labelinq regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Celia M. Witten, Ph.D., M.D.
Director
Division of General and

Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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510(k) Number (if known)_ K963136

Device Name: DePuy Luster Stem

Indications for Use:

Concurrence of CDRH, Office of Device Evaluation

Prescription Use_ X (Per 21 CFR 801.109)

Over-The-Counter Use_

(Divis Sign-Off Division of General Restorative Devices 510(k) Number

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Regulation Number and Section

§ 888.3350 Hip joint metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A hip joint metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. This generic type of device includes prostheses that have a femoral component made of alloys, such as cobalt-chromium-molybdenum, and an acetabular resurfacing component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.