The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery.

The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.

The Search Evolution porous coated femoral component is designed for use without bone cement.

Device Description

The Search Evolution (LC) Total Knee System is available with two femoral designs. Each retains the PCL, ligament cruciate (LC) during implantation and both femoral components are manufactured from CoCrMo. One is non-porous coated and is intended to be used with bone cement. The other is porous coated and intended to be used without bone cement. The coating is Ti, which conforms to ISO 5832 and is applied using the plasma spray technique.

AI/ML Overview

This document describes a 510(k) summary for the Search Evolution (LC) Total Knee System (Porous Coated). As such, it focuses on demonstrating substantial equivalence to predicate devices rather than establishing novel performance criteria and proving them through dedicated studies with acceptance criteria, as one would for a new, non-substantially equivalent device or a software-as-a-medical-device (SaMD).

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the typical sense for a SaMD or a novel device, is not directly applicable to this submission. This is a traditional medical device (implant) where performance is primarily established through compliance with established guidance documents, comparison to existing predicate devices, and standard mechanical testing.

However, I can extract and infer information that aligns with the spirit of your request within the context of a 510(k) submission for a non-active medical device.

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

For devices like total knee systems, "acceptance criteria" are typically defined by compliance with applicable standards and guidance documents, as well as by demonstrating that the device performs at least as safely and effectively as legally marketed predicate devices. The performance data presented here refers to the completion of required testing, not specific quantitative performance metrics against pre-defined acceptance criteria for a novel clinical outcome.

Acceptance Criterion (Inferred from Guidance & Predicate Equivalence)	Reported Device Performance
Mechanical Performance: Compliance with applicable standards for mechanical integrity (e.g., fatigue strength, wear resistance).	"All required testing per 'Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses' were done where applicable.""In addition, testing per 'Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement' were completed."
Material Biocompatibility: Materials used are biocompatible and safe for implantation.	"The coating is Ti, which conforms to ISO 5832..." (for porous coated femoral component). (CoCrMo for femoral components is a standard implant material).
Porous Coating Adhesion/Integrity: Performance of the porous coating for uncemented fixation.	Testing per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" (this guidance would cover aspects related to porous coatings).
Intended Use Equivalence: Ability to replace a knee joint for specified indications.	Stated intended use matches predicate devices: "The Search Evolution (LC) Total Knee System is intended to replace a knee joint in order to relieve pain and restore knee function, for indications such as, osteoarthritis, inflammatory arthritis, traumatic arthritis, varus, valgus or flexion deformities and revision surgery."
Fixation Method Equivalence: Demonstrated safety and effectiveness for both cemented (non-porous) and uncemented (porous) fixation.	"Substantial equivalence to the intended use of uncemented fixation for the porous coated femoral component is established by: 21 CFR 888.3565; Product Code: MBH. Guidance document: 'Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coasted Uncemented Prostheses; Guidance for Industry and FDA'."

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

This document does not describe a clinical study with a "test set" in the context of observational data or a clinical trial. The "testing" mentioned refers to non-clinical, benchtop mechanical and material testing conducted according to relevant standards and guidance documents. Therefore, sample size, data provenance (country, retrospective/prospective), etc., are not applicable in the way they would be for a clinical study on human subjects or an AI/software device.

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

Not applicable. "Ground truth" in this context would implicitly be the established scientific and engineering principles codified in the relevant ISO standards and FDA guidance documents for orthopedic implant testing. Engineers and materials scientists involved in the testing would interpret and apply these standards.

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

Not applicable, as there is no "test set" of clinical cases requiring adjudication. Adherence to testing protocols and results interpretation would follow standard engineering practices.

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 device is a passive orthopedic implant, not an AI or imaging device that involves "readers" or "AI assistance."

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

Not applicable. This device is a passive orthopedic implant, not an algorithm.

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

For this type of device, the "ground truth" for performance is primarily established through:

Compliance with recognized Consensus Standards: e.g., ISO, ASTM, which define test methods and performance requirements for materials and mechanical properties.
Compliance with FDA Guidance Documents: These provide specific recommendations for mechanical testing and biocompatibility assessments for orthopedic implants.
Established performance of predicate devices: The "ground truth" for safety and effectiveness is largely based on the historical performance and regulatory clearance of the legally marketed predicate devices.

8. The sample size for the training set

Not applicable. There is no "training set" in the context of this device.

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

Not applicable. There is no "training set" in the context of this device.

Summary of Device Performance and Substantial Equivalence:

The document primarily establishes the device's performance through its substantial equivalence to already legally marketed predicate devices and by demonstrating compliance with applicable FDA guidance documents and recognized standards.

The predicate devices used for comparison are:

Columbus (CR) Total Knee System (K022672)
Search Evolution Total Knee System (K021313)
Scorpio Posterior Cruciate Retaining Knee System (K974556)
Gem Knee System (K994214)

The "performance data" refers to the completion of required non-clinical benchtop testing as outlined in the following guidance documents:

"Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses"
"Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement"

This allows the FDA to conclude that the device is as safe and effective as the predicate devices, thereby permitting its marketing.

Summary

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JAN 1 5 2004

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510(k) SUMMARY OF SAFETY AND EFFECTIVENESS in Accordance with SMDA of 1990

SEARCH EVOLUTION (LC) TOTAL KNEE SYSTEM

July 7, 2003

COMPANY:	Aesculap®, Inc.3773 Corporate ParkwayCenter Valley, PA 18034
CONTACT:	Joyce Kilroy, Director of Regulatory Affairs/Quality Assurance800-258-1946 (phone)610-791-6882 (fax)joyce.kilroy @ aesculap.com (email)
TRADE NAME:	Search Evolution (LC) Total Knee System (Porous Coated)
COMMON NAME:	Porous Coated Femoral Component
DEVICE CLASS:	CLASS II
PRODUCT CODE:	MBH
CLASSIFICATION:	888.3565
REVIEW PANEL:	Orthopedics

INTENDED USE

The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.

The Search Evolution porous coated femoral component is designed for use without bone cement

DEVICE DESCRIPTION

PERFORMANCE DATA

All required testing per "Draft Guidance for the Preparation of Premarket Notifications (510(k)s) for Cemented, Semi-Constrained Total Knee Prostheses" were done where applicable. In addition, testing per "Guidance Document for Testing Orthopedic Implants with Modified Metallic Surfaces Apposing Bone or Bone Cement" were completed.

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次032108

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SUBSTANTIAL EQUIVALENCE

Aesculap believes that the new porous coated femoral component of the Search Evolution Total Knee System is substantially equivalent in design to:

Columbus (CR) Total Knee System (K022672) .
Search Evolution Total Knee System (K021313) .
Scorpio Posterior Cruciate Retaining Knee System (K974556) .
Gem Knee System (K994214) .

Substantial equivalence to the intended use of uncemented fixation for the porous coated femoral component is established by:

21 CFR 888.3565; Product Code: MBH .
Guidance document: "Class II Special Controls Guidance Document: Knee Joint . Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coasted Uncemented Prostheses; Guidance for Industry and FDA".

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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" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a bird-like figure with three curved lines representing wings or streams.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

'JAN 1 5 2004

Ms. Joyce Kilroy Director Regulatory Affairs Aesculap, Inc. 3773 Corporate Parkway Center Valley, PA 18034

Re: K032108

K032108
Trade/Device Name: Scarch Evolution (LC) Total Knee System (Porous Coated) Regulation Number: 21 CFR 888.3565 Regulation Number: 21 C.FK 886.3503
Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: II Product Code: MBH Dated: October 16, 2003 Received: October 17, 2003

Dear Ms. Kilroy:

We have reviewed your Section 510(k) premarket notification of intent to market the device we have reviewed your Section 910(x) premained in substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketcol in interstate for use stated in the encrosure) to regally mancted to the Medical Device Amendments, or to commerce prof to May 20, 1770, the enactired in accordance with the Federal Food. Drug, devices that have bect recurse in accordance who a premarket approval application (PMA). and Cosmelle Act (Act) that do not require approvine as a controls provisions of the Act. The You may, therefore, market the device, equirements for annual registration, listing of general controls provisions of the recess, 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 If your device is Classified (see above) the Existing major regulations allecting your device can be may be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the exac ocements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean I Teast of advised that I Dr o lossailer of the complies with other requirements of the Act that I DA has made a necessions administered by other Federal agencies. You must of any it ciclar statutes and regalations and admited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CTN in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic north in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Ms. Joyce Kilroy

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

Sincercly yours,

Mark N. Mulhern

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): _ K032108

Search Evolution (LC) Total Knee System (Porous Coated) Device Name:

Indications For Use:

The Search Evolution tibial tray and non-porous coated femoral component are designed for use with bone cement.

The Search Evolution porous coated femoral component is designed for use without bone cement.

Prescription Use (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 IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for Mark N. Milliken

tiv

Ko32108

Page 1 of 1

Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.