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., osteosarcomas, chondrosarcomas, 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, and the non-porous coated straight and bowed stems are intended for cemented use only.

Device Description

The LPS components are designed for the replacement of the mid-shaft portion of the femur. proximal, distal and/or total femur, and proximal tibia. Unlike primary hip and knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). A total femoral replacement is possible in those cases where no part of the femur can be salvaged.

AI/ML Overview

The provided text is a 510(k) Summary for a medical device called LPS (Total Knee Prosthesis/Femoral Stem Prosthesis). This document details the device's intended use, description, and its claim of substantial equivalence to previously cleared devices.

Crucially, this document is a 510(k) Summary for a device (a prosthetic implant), not an AI/ML-driven medical device or software product that would typically involve acceptance criteria and a study proving its performance in the manner requested.

Therefore, most of the requested information regarding acceptance criteria, study design, sample sizes, expert ground truth, MRMC studies, standalone performance, and training sets is not applicable to this type of medical device submission.

Here's an explanation based on the provided text, highlighting what is and isn't available:

1. Table of Acceptance Criteria and Reported Device Performance

Not Applicable in the traditional sense for an AI/ML device. This document is for a physical orthopedic implant. Acceptance criteria for such devices typically revolve around mechanical testing, biocompatibility, sterilization validation, and conforming to relevant material standards. These are usually established through compliance with voluntary performance standards (as mentioned in section E) and internal company specifications, rather than clinical performance metrics like sensitivity, specificity, or AUC as seen in AI/ML products.
Reported Device Performance: The document states that the substantial equivalence is based on:
- Similarity in design, sterilization, and packaging to the LPS (K003182).
- Similarity in materials (cobalt chrome) to the S-ROM Noiles Rotating Hinge Knee (K870730).
- Similarity in indications for use to the Howmedica Global Modular Replacement System (GMRS) (K023087).

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

Not Applicable. There is no "test set" in the context of an AI/ML algorithm being evaluated. The equivalence claim is based on comparison to existing, already-approved devices, along with what would typically be non-clinical performance data (e.g., mechanical tests) which are not detailed in this summary.

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

Not Applicable. This is not a study requiring expert-established ground truth for an algorithm.

4. Adjudication Method for the Test Set

Not Applicable.

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 is for a prosthetic implant, not an AI-assisted diagnostic tool.

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

Not Applicable.

7. The type of ground truth used

Not Applicable in the context of AI/ML. For a physical implant, "ground truth" might refer to established engineering principles, material science data, and clinical outcomes data from similar predicate devices, which are implicitly part of the substantial equivalence determination.

8. The sample size for the training set

Not Applicable. There is no "training set" for a physical medical device.

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

Not Applicable.

Summary of what can be gleaned from the document regarding "acceptance" for this specific device:

The "acceptance" in this context refers to the FDA's determination of substantial equivalence to legally marketed predicate devices. The "study" that proves this involves demonstrating:

Design Similarity: The LPS is similar in design to the previously cleared LPS (K003182).
Material Equivalence: The specified material (cobalt chrome) is similar to materials used in the S-ROM Noiles Rotating Hinge Knee (K870730).
Indications for Use Alignment: The indications for use are similar to the Howmedica Global Modular Replacement System (GMRS) (K023087).
Conformance with Standards: The determination was also based on "conformance with voluntary performance standards," which would involve non-clinical testing (e.g., mechanical strength, fatigue, wear) to ensure the device performs as expected for its intended use and materials. Specific criteria for these tests are not provided in this summary but would be part of the full 510(k) submission.

In essence, the "study" for this type of device is a comprehensive technical and comparative analysis against established benchmarks and predicate devices, rather than a clinical trial or algorithm performance evaluation.

Summary

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

K033959 (pg 1 of.

510(k) Summary LPS

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

JUL 0 1 2004

A. Contact Person: Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs TEL: (574) 371-4905, FAX (574) 371-4987, EMAIL dweissma@dpyus.jnj.com

B. Device Information:

Proprietary Name:	LPS
Common Name:	Total Knee ProsthesisFemoral Stem Prosthesis
Classification Nameand Regulatory Class:	Knee joint patellofemorotibial polymer/metal/polymersemi-constrained cemented prosthesis: Class II per21 CFR §888.3560Hip joint metal/polymer semi-constrained cementedprosthesis: Class II per 21 CFR §888.3350
Product Code:	87 JWH, 87 JDI

C. Indications for Use (changes are in bold from those cleared in K003182):

malignant tumors (e.g., osteosarcomas, chondrosarcomas, 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, and the non-porous coated straight and bowed stems are intended for cemented use only.

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

K033959 (fig 2 of 2)

510(k) Summary (continued)

LPS

D. Device Description (unchanged from that cleared in K003182):

E. Substantial Equivalence (same device as that cleared in K003182, only the material has changed to cobalt chrome):

The substantial equivalence of the LPS is substantiated by its similarity:

. in design, sterilization and packaging to the LPS (K003182 cleared on June 27, 2001).
. in materials to the S-ROM Noiles Rotating Hinge Knee (K870730 cleared on May 26, 1987).
. in indications for use to the Howmedica Global Modular Replacement System (GMRS) (K023087 cleared on December 16, 2002).

The determination of substantial equivalence for this device was based on a detailed device description and conformance with voluntary performance standards.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a human figure, represented by three curved lines that form the shape of a person's head and torso.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 01 2004

Ms. Dina L. Weissman, J.D. Legal Consultant, Regulatory Affairs DePuy, Inc. 700 Orthopaedic Drive Warsaw. Indiana 46581

Re: K033959

Trade/Device Name: LPS Regulation Number: 21 CFR 888.3560, 21 CFR 888.3350 Regulation Name: Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis, Hip joint metal/polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Code: JWH, JDI Dated: April 20, 2004 Received: April 21, 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. Dina 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) 594-4659. 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,

Miriam. C. Provost
for

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

Indications for Use

510(k) Number (if known): K033959 rbs Device Name:

Indications for Use: (changes from those cleared in K003182 are in bold)

ions for Use: (Changes from those crearce in 1500 roid-shaft portion of the femur.
The LPS is intended for use in replacement of the mid-shaft on eases that The LPS is intended for use in replacement cimal tibia, especially in cases that
proximal, distal and/or total femur, and proximal andications a proximal, distal and of total lemar, and promise with diagnostic indications for use include:

malignant tumors (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, . malignant tumors (e.g.), tensive resection and replacement;
bone tunnols) requiring extensive its station in the soint disease (NIDJD), . patient conditions of nominflammatory adgenerals is in the placement e.g., avascular necrosis; osteour.in Mo, testensive resection and replacement;
e.g., theumalord artifitis, requiring careering extensive resection . and replacement;
and replacement,
severe trauma requiring extensive resection and replacement. .

The LPS is also intended for use in bone loss post-infection, where the I he LT S is also intended for the bone and replacement is required.

The distal femoral component, the tibial components, and the non-porous coated I ne distan temoral comps 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)

Muriam C. Provost

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

Page 1 of 1

(Posted November) 9,000)Jumber________________________________________________________________________________________________________________________________________________

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.