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

metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
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 of the proximal and/or distal femur;
patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

Device Description

The Orthogenesis LPS Proximal Tibial Replacement system is designed to be implanted for the The Orthogenesis Er of Proximal Troul'se primary knee systems, this system is used when the amount of resection and restoration is extreme (e.g. in oncology cases, endstage revision). It consists of a titanium tibial replacement, a polyethylene tibial bearing component, Orthogenesis LPS stems and Segments.

AI/ML Overview

The provided text is a 510(k) summary for a medical device called the Orthogenesis LPS Proximal Tibial Replacement. This document is a premarket notification to the FDA, demonstrating that the device is substantially equivalent to a legally marketed predicate device.

Crucially, a 510(k) summary does not typically include detailed studies proving the device meets specific acceptance criteria in the way a clinical trial or performance study would for a novel device or a PMA submission. The focus of a 510(k) is to establish substantial equivalence to a predicate device, often relying on design comparisons, material testing, and conformance to voluntary performance standards, rather than direct human clinical outcome studies for acceptance criteria performance.

Therefore, many of the requested details about acceptance criteria, study design, sample sizes, ground truth, and expert involvement are not present in this 510(k) summary.

Here's a breakdown of what can be extracted and what is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Implied by Substantial Equivalence to Predicate)	Reported Device Performance (Implied by Substantial Equivalence and Testing)
Material Biocompatibility: Materials used (titanium, polyethylene) are known to be biocompatible and are used in predicate devices.	Device uses titanium and polyethylene, consistent with predicate devices and established medical device standards.
Mechanical Strength/Durability: Device components should withstand physiological loads for intended use.	Substantial equivalence is based on "product testing and conformance with voluntary performance standards" (para. E). Specific tests and criteria are not detailed in this summary.
Sterilization Efficacy: Device can be effectively sterilized.	"Sterilization" is listed as a basis for substantial equivalence (para. E). Specific methods and validation are not detailed.
Packaging Integrity: Device packaging maintains sterility and integrity.	"Packaging" is listed as a basis for substantial equivalence (para. E). Specific methods and validation are not detailed.
Clinical Performance: Device should perform as intended to replace portions of the tibia in specific indications (e.g., metastatic disease, severe arthropathy).	Substantially equivalent to predicate devices (S-ROM Noiles Rotating Hinge Knee, K896048 and K905810; Orthogenesis LPS system) for "use, design, materials, sterilization and packaging" (para. E). No clinical performance metrics (e.g., success rates, complication rates) are provided as acceptance criteria to be met by a specific study.

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. This 510(k) summary does not describe a clinical test set in the sense of a patient cohort or data set used to evaluate the device's performance against clinical acceptance criteria. The "product testing" mentioned likely refers to bench testing of materials and mechanical properties, not human clinical data.

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. Ground truth for a clinical test set is not specified because a clinical test set is not described.

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

Not Applicable / Not Provided. No adjudication method is described as a clinical test set is not detailed.

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

No. This device is a prosthetic implant, not an AI-assisted diagnostic or imaging device. Therefore, an MRMC study is not relevant.

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

No. This device is a prosthetic implant, not an algorithm.

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

Not Applicable / Not Provided. As no clinical test set is described, no specific type of ground truth is mentioned. The "ground truth" for a 510(k) in this context is primarily the established safety and effectiveness of the predicate device, which the new device aims to be substantially equivalent to, based on non-clinical data.

8. The sample size for the training set

Not Applicable / Not Provided. This device does not involve a "training set" in the context of machine learning or AI.

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

Not Applicable / Not Provided. As no training set is relevant, no ground truth establishment for it is described.

Summary of the Study that Proves the Device Meets Acceptance Criteria (as per 510(k) framework):

The "study" in this context is the Substantial Equivalence Determination process outlined in the 510(k) submission.

Basis of Equivalence: The manufacturer, DePuy, Inc., asserts that the Orthogenesis LPS Proximal Tibial Replacement is substantially equivalent to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810) and the Orthogenesis LPS system.
Evidence for Equivalence: This determination was based on:
- A detailed device description: Comparing the new device's features to the predicate.
- Product testing: Likely referring to bench testing for mechanical properties, material compatibility, and other engineering specifications, demonstrating that the device meets relevant performance standards (though specific results or criteria are not detailed in this summary).
- Conformance with voluntary performance standards: Implies that the device has been tested against recognized industry standards applicable to knee prostheses.
- Comparison of Indications for Use, design, materials, sterilization, and packaging to the predicate devices.

Conclusion: The FDA's issuance of a letter stating substantial equivalence (K011810) on SEP - 7 2001, effectively serves as the "proof" within the 510(k) regulatory pathway that the device meets the necessary criteria (which are primarily about being as safe and effective as a legally marketed predicate device). This approval does not typically involve the presentation of new clinical data from human studies unless there's a significant difference from the predicate device that raises new safety or effectiveness questions.

Summary

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KO11810

510(k) Summary Orthogenesis LPS Proximal Tibial Replacement

DePuy, Inc. 700 Orthopaedic Drive Warsaw, IN 46581

A. Contact Person:

Janet G. Johnson, RAC Group Leader, Regulatory Submissions (219) 371-4907

B. Device Information:

Proprietary Name:	Orthogenesis LPS Proximal Tibial Replacement and Orthogenesis LPS Tibial Bearing
Common Name:	Proximal Tibial Replacement Prosthesis
Classification Name and Regulatory Class:	Knee joint femorotibial metal/polymer constrained cemented prosthesis: Class II per 21 CFR §888.3510
Product Code:	87 KRO

C. Indications for Use:

. metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) requiring extensive resection(s) and replacement(s) of the proximal and/or distal femur;
. 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 of the proximal and/or distal femur;
patients suffering from severe arthropathy of the hip and/or knee that does not respond to any conservative therapy or better alternative surgical treatment;
revision cases requiring extensive resection(s) and replacements of the proximal, distal or total femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

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D. Device Description:

E. Substantial Equivalence:

The substantial equivalence of the Orthogenesis LPS Proximal Tibial Replacement is substantiated by its I he Subsumian bqur. For use, design, materials, sterilization and packaging to the S-ROM Noiles Rotating Hinge Knee (K896048 and K905810), and the Orthogenesis LPS system.

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

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Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff entwined with two snakes, often used as a symbol of medicine. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

SEP - 7 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Janet G. Johnson Group Leader, Regulatory Submissions DePuy Orthopaedics, Inc. 700 Orthopaedic Drive P.O. Box 988 Warsaw, Indiana 46581-0988

Re: K011810

Trade Name: Orthogenesis LPS Proximal Tibial Replacement System Regulation Number: 21 CFR 888.3510 Regulation Name: Knee joint femorotibial metal/polymer constrained cemented prosthesis Regulatory Class: Class II Product Code: KRO Dated: June 8, 2001 Received: June 11, 2001

Dear Ms. Johnson:

We have reviewed your Section 510(k) premarket 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, 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. Janet G. Johnson

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will and w yourse of substantial equivalence of your device to a legally prematics notification " 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 and If you desire specific ad 100 to for in vitro diagnostic devices), please contact the Office of additionally 21 OF It Far at 659. Additionally, for questions on the promotion and advertising of Compliance ut (201) 594-1667 - 1ffice of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). regulation ontined, "Nilocranaing oresponsibilities under the Act may be obtained from the Outler general mioninates, 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,

Sus. Wl mo

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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KO11810 Orthogenesis LPS Proximal Tibial Replacement

Indications for Use

The Orthogenesis LPS is intended for use in replacement of the mid-shaft or intercalary portion of the I he Orthogellesis LT S is mended for ase in replacement tibia, especially in cases that require extensive resection and restoration. Specific diagnostic indications for use include:

metastatic diseases (e.g., osteosarcomas, chondrosarcomas, giant cell tumors, bone tumors) . metastatic unseases (0.g.) osteboard ment(s) of the proximal and/or distal femur;
requiring extensive resection(o) and systemerative joint disease (NIDJD), e.g. avascular . patient conomons of nominaniatory dogent disease (IJD), e.g., rheumatoid arthritis, requiring necerosis, obteour in the, applacement of the proximal and/or distal femur;
extents suffering from severe arthropathy of the hip and/or knee that does not respond to any . patients burr therapy or better alternative surgical treatment;
coniservaire there areau resection(s) and replacements of the proximal, distal or total . femur or proximal tibia.

The distal femoral and tibial components, tibial stems and non-porous coated femoral stems are intended for cemented use only.

(Please do not write below this line - Continue on another page if necessary)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR §801.109) OR

Over-the-Counter Use

(Optional Format 1-2-96)

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

510(k) Number K011810

Regulation Number and Section

§ 888.3510 Knee joint femorotibial metal/polymer constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer constrained cemented prosthesis is a device intended to be implanted to replace part of a knee joint. The device limits translation or rotation in one or more planes and has components that are linked together or affined. This generic type of device includes prostheses composed of a ball-and-socket joint located between a stemmed femoral and a stemmed tibial component and a runner and track joint between each pair of femoral and tibial condyles. The ball-and-socket joint is composed of a ball at the head of a column rising from the stemmed tibial component. The ball, the column, the tibial plateau, and the stem for fixation of the tibial component are made of an alloy, such as cobalt-chromium-molybdenum. The ball of the tibial component is held within the socket of the femoral component by the femoral component's flat outer surface. The flat outer surface of the tibial component abuts both a reciprocal flat surface within the cavity of the femoral component and flanges on the femoral component designed to prevent distal displacement. The stem of the femoral component is made of an alloy, such as cobalt-chromium-molybdenum, but the socket of the component is made of ultra-high molecular weight polyethylene. The femoral component has metallic runners which align with the ultra-high molecular weight polyethylene tracks that press-fit into the metallic tibial component. The generic class also includes devices whose upper and lower components are linked with a solid bolt passing through a journal bearing of greater radius, permitting some rotation in the transverse plane, a minimal arc of abduction/adduction. This generic type of device is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.