The LPS Intercalary component is intended for use in primary and revision knee joint replacement and in oncology cases with the Limb Preservation System (LPS). The previously cleared indications for use for this system are the following:

The LPS is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

· malignant tumors (e.g., osteosarcoma, chondrosarcoma, giant cell tumors, bone tumors) requiring extensive resection and replacement;
· patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
· revision cases for a failed previous prosthesis requiring extensive resection and replacement;
· severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The distal femoral component, the tibial components, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.

Device Description

The intercalary component serves as a segmental component in the previously cleared Limb Preservation System (LPS, K003182). The dovetail intercalary component is a 3piece assembly 55 mm in length. The three pieces are comprised of a male segment, a female segment and a connecting pin. The male-female parts connect as a dovetail connection and locked with a pin screwed through both segments. The dovetail intercalary component is made of cobalt chrome.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the "LPS Lower Extremity Dovetail Intercalary." This document is a regulatory submission to the FDA, primarily focused on establishing substantial equivalence to a previously cleared device. It does not describe a clinical study or performance testing with specific acceptance criteria that demonstrate the device meets those criteria.

Therefore, many of the requested sections about acceptance criteria, study details, sample sizes, expert ground truth, adjudication, MRMC studies, or standalone performance studies cannot be extracted from this document, as they are not present.

The 510(k) summary explicitly states: "The substantial equivalence of the LPS Dovetail Intercalary is substantiated by its similarity in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). The design and materials of the LPS Dovetail Intercalary have been modified from the existing LPS Intercalary component cleared in K003182, however DePuy believes this new component is substantially equivalent."

This indicates that the primary "study" or evidence for this device is a comparison to a predicate device (K003182) to demonstrate substantial equivalence, rather than a de novo clinical study with new performance criteria.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided. The document does not describe specific performance acceptance criteria (e.g., accuracy, sensitivity, specificity, mechanical strength thresholds) for the device itself, nor does it report device performance against such criteria. The focus is on substantial equivalence to a predicate device rather than de novo performance testing against new metrics.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided. No test set or data provenance from a performance study is described.

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)

Cannot be provided. No test set requiring expert-established ground truth is described.

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

Cannot be provided. No test set requiring adjudication is described.

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

Cannot be provided. This device is a total knee prosthesis component, not an AI or imaging device, so an MRMC study is not relevant and not discussed.

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

Cannot be provided. This device is a physical implant, not an algorithm. Standalone performance for an algorithm is not applicable.

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

Cannot be provided. As no specific performance study is detailed, no ground truth type is mentioned.

8. The sample size for the training set

Cannot be provided. This device is a physical implant, not a machine learning model, so there is no concept of a "training set."

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

Cannot be provided. Not applicable (see point 8).

Summary

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page 1 of 2

510(k) Summary LPS_Dovetail Intercalary

04/085

A. Contact Person:

Tiffani Rogers Regulatory Affairs TEL: (574) 371-4927, FAX (574) 371-4987, EMAIL TRogers1@dpyus.jnj.com

B. Device Information:

Trade Name:	LPS (Limb Preservation System) Lower ExtremityDovetail Intercalary
Common Name:	Total Knee Prosthesis
Classification Nameand Regulatory Class:	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis: Class II per 21CFR §888.3560
Product Code:	87 JWH

C. Indications for Use:

The Limb Preservation System (LPS) is intended for use in replacement of the mid-shaft portion of the femur, proximal, distal and/or total femur, and proximal tibia, especially in cases that require extensive resection and replacement. Specific diagnostic indications for use include:

malignant tumors (e.g., osteosarcoma, chondrosarcoma, giant cell tumors, bone tumors) . requiring extensive resection and replacement;
. patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
. revision cases for a failed previous prosthesis requiring extensive resection and replacement;
severe trauma requiring extensive resection and replacement. .

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The distal femoral component, the tibial components, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.

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Page 2 of 2

510(k) Summary (continued) LPS Dovetail Intercalary

K0411085

D. Device Description:

E. Substantial Equivalence:

The substantial equivalence of the LPS Dovetail Intercalary is substantiated by its similarity in sterilization, packaging and indications for use to the LPS (K003182 cleared on June 27, 2001). The design and materials of the LPS Dovetail Intercalary have been modified from the existing LPS Intercalary component cleared in K003182, however DePuy believes this new component is substantially equivalent.

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Image /page/2/Picture/1 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 or bird-like figure with three wing-like shapes extending from its body.

JUL 222 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tiffani D. Rogers Regulatory Affairs Associate DePuy Orthopaedics, Inc. P.O. Box 988 700 Orthopaedic Drive Warsaw, Indiana 46581-0988

Re: K041085

Trade/Device Name: LPS Lower Extremity Dovetail Intercalary Regulation Numbers: 21 CFR 888.3560 Regulation Names: Knee joint, patellofemorotibial, polymer/metal/polymer semiconstrained cemented prosthesis Regulatory Class: II

Product Codes: JWH Dated: April 23, 2004 Received: April 26, 2004

Dear Ms. Rogers:

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 – Ms. Tiffani D. Rogers

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis lotter will and A your and 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) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Sincerely yours,
Mark A. Melkersen

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

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Indications for Use 510(k) Number (if known): K041085 Device Name:

Indications for Use:

· malignant tumors (e.g., osteosarcoma, chondrosarcoma, giant cell tumors, bone tumors) requiring extensive resection and replacement;
· patient conditions of noninflammatory degenerative joint disease (NIDJD), e.g. avascular necrosis, osteoarthritis, and inflammatory joint disease (IJD), e.g., rheumatoid arthritis, requiring extensive resection and replacement;
· revision cases for a failed previous prosthesis requiring extensive resection and replacement;
· severe trauma requiring extensive resection and replacement.

The LPS is also intended for use in bone loss post-infection, where the surgeon has elected to excise the bone and replacement is required.

The distal femoral component, the tibial components, tibial stems, metaphyseal sleeves, and the non-porous coated straight and bowed stems are intended for cemented use only.

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
OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General, Restorative, and Neurological Devices

Page	of ______
510(k) Number	K041085

Regulation Number and Section

§ 888.3560 Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace a knee 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 a tibial component or components and a retropatellar resurfacing component made of ultra-high molecular weight polyethylene. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.