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. Total hip replacement is indicated in the following conditions:

A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
Avascular necrosis of the femoral head.
Acute traumatic fracture of the femoral head or neck.
Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface hemiarthroplasty, and arthroplasty, or total hip replacement.
Certain cases of ankylosis.

Device Description

The Spectrum Modular System is a three-piece, uncemented femoral hip prosthesis consisting of a proximal body, a distal stem and a locking nut. The proximal bodies and distal stems are interchangeable, allowing each to be independently positioned. They are available in a variety of proximal body lengths, distal body diameters and lengths.

AI/ML Overview

This document is a 510(k) summary for the Spectrum Modular System, a femoral hip joint uncemented prosthesis. It describes the device, its intended use, and its substantial equivalence to predicate devices, but it does not contain information about acceptance criteria or a study proving the device meets those criteria, nor does it detail any specific performance metrics or clinical study results for the Spectrum Modular System itself.

Therefore, I cannot provide the requested table or answer most of the questions based on the provided text. The submission focuses on establishing substantial equivalence to previously cleared devices rather than presenting novel performance data.

Here's an assessment based on what is provided:

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

Not provided. The document does not specify any quantitative acceptance criteria or report performance metrics for the Spectrum Modular System.

2. Sample size used for the test set and the data provenance:

Not applicable/Not provided. No specific test set or clinical study data for the Spectrum Modular System is discussed. The submission relies on substantial equivalence.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not provided. No test set requiring ground truth establishment is mentioned.

4. Adjudication method for the test set:

Not applicable/Not provided.

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 document pertains to a medical device (hip prosthesis), not an AI diagnostic tool or system that would involve human readers or AI assistance.

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

Not applicable. This is not an algorithm or AI-based device.

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

Not applicable/Not provided.

8. The sample size for the training set:

Not applicable/Not provided. This is not an AI/machine learning device that would require a training set.

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

Not applicable/Not provided.

Summary of what the document does provide:

Device: Spectrum Modular System, a three-piece, uncemented femoral hip prosthesis.
Indications for Use: Total hip arthroplasty for conditions such as osteoarthritis, traumatic arthritis, rheumatoid arthritis, congenital hip dysplasia, avascular necrosis, acute traumatic fracture, failed previous hip surgery, and certain cases of ankylosis.
Substantial Equivalence: The submission asserts substantial equivalence to predicate devices (Titan Porocoat Hip Prosthesis K001991, Malory Head Modular Calcar K001660, ZMR Hip System Revision Taper K992667, Link Mp Reconstruction Hip K955296) based on having the "same intended use and basic design."
Regulatory Information: Class II device, Product Code LPH, 21 CFR 888.3358.

The provided text is a regulatory submission focused on demonstrating substantial equivalence to pre-existing, legally marketed devices, which is a common pathway for medical device clearance in the United States. It does not include performance data from studies specifically designed to prove its own efficacy or meet pre-defined acceptance criteria.

Summary

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

K033893 page 17

MAR 1 2 2004

510(k) Summary

Name of Sponsor:	DePuy Orthopaedics, Inc.700 Orthopaedic DriveWarsaw, Indiana 46581-0988Est. Reg. No. 1818910
510(k) Contact:	Dina L. Weissman, J.D.Legal Consultant, Regulatory AffairsPhone: (574) 371-4905FAX: (574) 371-4987Email: Dweissma@dpyus.jnj.com
Trade Name:	Spectrum Modular System
Common Name:	Femoral Hip Joint Uncemented Prosthesis
Classification:	Class II device per 21 CFR 888.3358:Hip joint metal/polymer semi-constraineduncemented prosthesis
Device Product Code:	87LPH Hip joint metal/polymer semi-constrained uncemented prosthesis
	No performance standards have been establishedunder Section 514 of the Federal Food, Drug,and Cosmetic Act for femoral hip stems.
Substantially Equivalent Devices:	Titan Porocoat Hip Prosthesis	K001991
	Malory Head Modular Calcar	K001660
	ZMR Hip System Revision Taper	K992667
	Link Mp Reconstruction Hip	K955296
Device Descriptions:	The Spectrum Modular System is a three-piece,uncemented femoral hip prosthesis consisting ofa proximal body, a distal stem and a locking nut.The proximal bodies and distal stems areinterchangeable, allowing each to beindependently positioned. They are available ina variety of proximal body lengths, distal bodydiameters and lengths. The system is

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

510(k) Summary (continued)

Indications for use:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface hemiarthroplasty, and arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

Substantial equivalence:

The Spectrum Modular System uncemented femoral hip prosthesis has the same intended use and basic design as the predicate devices and is therefore substantially equivalent.

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

Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized representation of three human figures.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Diana L. Weissman, J.D. Depuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedics Drive Warsaw, Indiana 46581-0988

Re: K033893 Trade/Device Name: Spectrum Modular System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH Dated: December 15, 2003 Received: December 16, 2003

MAR 1 2 2004

Dear Ms. Weissman:

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. Diana L. Weissman, J.D.

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 vours.

Sincerely yours,

L. Mark A. McMillan

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}------------------------------------------------

510(k) Number (if known): Ko 3 S89 3

Device Name: Spectrum Modular System

Indications for Use:

1. A severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia.
1. Avascular necrosis of the femoral head.
1. Acute traumatic fracture of the femoral head or neck.
1. Failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement.
1. Certain cases of ankylosis.

This device is intended for single use.

Concurrence of CDRH, Office of Device Evaluation

Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
(Division Sign-Off)

Division of General, R. storative, and Neurological Devices

510(k) Number K033893

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented 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 has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.