The UNIVATION® Unicompartmental Knee System is indicated for cemented use only in patients undergoing surgery for a severely painful and/or disabled joint damaged as a result of osteoarthritis, traumatic arthritis, or a failed previous implant when only one condyle of the knee (medial) is affected.

Device Description

The UNIVATION® Unicompartmental Knee System is a prosthesis that replaces only one compartment of the knee condyle which consists of a femoral, tibial and meniscal components that are available in a wide range of sizes. The UNIVATION® Unicompartmental Knee System components are medial unicondylar knee replacements for either the right or left knee. The femoral and tibial components are manufactured from CoCrMo, the meniscal components are manufactured from UHMWPE. The femoral and tibial components are available with either a PMMA (polymethylmethacrylate) or ZrN (Zirconium nitride) coating. All components are sterile and for single use only.

AI/ML Overview

Here's an analysis of the provided text regarding acceptance criteria and the supporting study:

The provided document describes a UNIVATION® Unicompartmental Knee System, which is a medical device, and the information is from a 510(k) summary, likely for FDA clearance. This type of document focuses on demonstrating substantial equivalence to a previously cleared device, rather than proving efficacy or diagnostic accuracy through clinical studies in the way an AI or diagnostic device would.

Therefore, many of the requested categories for acceptance criteria and study details (especially those related to AI, human readers, ground truth establishment, training sets, etc.) are not applicable to this type of device and its submission.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Acceptance Criteria	Reported Device Performance
Material Equivalence	Same fundamental scientific technology and materials as the predicate device (K081293).	The fundamental scientific technology and materials for UNIVATION® Unicompartmental Knee System remain the same as the predicate (K081293). (Femoral and tibial components: CoCrMo; Meniscal components: UHMWPE. Coatings: PMMA or ZrN).
Indications for Use Equivalence	Indications for use are equivalent to the predicate device.	The indications for use remain unchanged and are equivalent to the predicate. (Indicated for cemented use in patients with severely painful/disabled joint due to osteoarthritis, traumatic arthritis, or failed previous implant, when only one medial condyle is affected).
Design Modification Risk Assessment & Performance (Femur)	Bone interface geometry evaluation for design modifications of the femur component (at posterior fin and distal teeth) to ensure performance similar to the legally marketed predicate. Tested according to ISO 14879-1:2000 for 5 million load cycles.	Customized endurance testing based on ISO 14879-1:2000 for 5 million load cycles was conducted. The results for the modified femur component were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System.
Design Modification Risk Assessment & Performance (Tibia)	Bone interface geometry evaluation for design modifications of the tibia component (at posterior fin and distal teeth) to ensure performance similar to the legally marketed predicate. Tested according to ASTM F1800-07 for 10 million load cycles.	Customized endurance testing based on ASTM F1800-07 for 10 million load cycles was conducted. The results for the modified tibia component were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System.
Sterility	All components are sterile.	Stated in device description: "All components are sterile and for single use only." (No specific test data provided in this summary, but this is a general requirement for such devices).
Single Use	All components are for single use only.	Stated in device description: "All components are sterile and for single use only." (No specific test data provided in this summary, but this is a general requirement for such devices).

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

Sample Size for Test Set: Not applicable/Specified. For this type of orthopedic implant, "test set" typically refers to the physical samples of the modified components used in the mechanical/endurance testing, not a dataset of patient images or clinical outcomes. The document states "customized endurance testing" was used, implying a certain number of physical components were tested, but the exact count is not provided.
Data Provenance: Not applicable in the context of clinical/patient data. The "data" here comes from mechanical/endurance laboratory testing of the device components.

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

Not applicable. "Ground truth" in this context is established by the physical properties and performance metrics defined by the ISO and ASTM standards (e.g., deflection, fatigue life, failure modes). Experts (engineers, materials scientists) are involved in designing and conducting the tests, but it's not a "consensus-based ground truth" on clinical observations.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used for human review of clinical data (e.g., radiology images). This submission relies on objective mechanical engineering performance testing against established standards.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, not applicable. MRMC studies are used for diagnostic imaging devices to assess how AI affects human reader performance. This device is an orthopedic implant.

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

No, not applicable. This device is an implant, not an algorithm.

7. The Type of Ground Truth Used

Mechanical Performance Standards. The "ground truth" for the performance of the modified components is their ability to withstand defined stress/load cycles (5 million cycles for femur, 10 million cycles for tibia) without failure or exhibiting similar performance characteristics to the predicate device, as specified by ISO 14879-1:2000 and ASTM F1800-07 standards.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of an AI algorithm for this device submission.

9. How the Ground Truth for the Training Set Was Established

Not applicable. (See #8)

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study conducted was a mechanical/endurance testing program focused on the design modifications made to the femur and tibia components of the UNIVATION® Unicompartmental Knee System.

Purpose: To evaluate the bone interface geometry of the modified components and demonstrate that their performance characteristics are similar to the previously cleared predicate device (K081293). This was done to address potential risks identified in a risk analysis of the design changes.
Methodology:
- Femur Component: Customized endurance testing based on ISO 14879-1:2000.
- Tibia Component: Customized endurance testing based on ASTM F1800-07.
Test Duration/Cycles:
- Femur: 5 million load cycles.
- Tibia: 10 million load cycles.
Results: "The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System." This indicates that the modified components performed equivalently to the predicate under the specified mechanical stress tests, thus meeting the key acceptance criteria for demonstrating substantial equivalence for the design changes.

Summary

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K131167	Page 1 of 2
B.	510(k) SUMMARY (as required by 21 CFR 807.92)
	UNIVATION® Unicompartmental Knee SystemOctober 08, 2013
COMPANY:	Aesculap Implant Systems® LLC3773 Corporate ParkwayCenter Valley, PA 18034Establishment Registration Number: 3005673311
CONTACT:	Julie Tom Wing610-984-9147 (phone)610-791-6882 (fax)
TRADE NAME:	UNIVATION®
COMMON NAME:	Unicompartmental Knee System
CLASSIFICATION NAME:	Prosthesis, Knee, Femorotibial, Semi-constrained,Cemented, Metal/Polymer
REGULATION NUMBER:	888.3530
CLASSIFICATION:	Class II
PRODUCT CODE:	HRY
PANEL:	Orthopedic

SUBSTANTIAL EQUIVALENCE

Aesculap Implant Systems®, LLC. UNIVATION® Unicompartmental Knee System is substantially equivalent to the original UNIVATION® Unicompartmental Knee System cleared in 510(K) K081293. The indications for use are equivalent to the predicate.

DEVICE DESCRIPTION

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K131167

INDICATIONS FOR USE

The indications for use remain unchanged as follows:

TECHNOLIGICAL CHARACTERISTICS (compared to Predicate(s)}

The entire UNIVATION® Unicompartmental Knee System was cleared under 510(K) K081293. The fundamental scientific technology and materials for UNIVATION® Unicompartmental Knee System remain the same. The indications for use are equivalent to the predicate.

The only differences are a design modification of the femur and tibia at posterior fin and distal teeth.

PERFORMANCE DATA

Aesculap conducted a risk analysis of the design modifications and as a result of the risk assessment, customized endurance testing based upon ISO 14879-1:2000 and ASTM F1800-07 were used to evaluate bone interface geometry of both modified femur and tibia components for 5 million load cycles and 10 million load cycles, respectively, The results were found to be similar to the legally marketed UNIVATION® Unicompartmental Knee System.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and 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 a stylized symbol featuring three parallel lines that curve and flow, resembling a human figure or a symbol of health and well-being.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

October 17, 2013

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Aesculan Implant Systems, LLC Ms. Julie Tom Wing Regulatory Affairs Specialist 3773 Corporate Parkway Center Valley, Pennsylvania 18034

Re: K131167

Trade/Device Name: UNIVATION* Unicompartmental Knec System Regulation Number: 21 CFR 888.3530 Regulation Name: Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis Regulatory Class: Class II Product Code: HRY Dated: September 18, 2013 Received: September 20, 2013

Dear Ms. Tom Wing:

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 accordunce 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device fabeling must be truthful and not misleading.

If your device is classified (see above) into cither class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical

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Page 2 - Ms. Julie Tom Wing

device-related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers. International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also. please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803). please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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) 796-7100 or at its Internet address http://www.fda.goy/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Mark N. Melkerson -S

Mark N. Melkerson Director Division of Orthonedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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UNIVATION Unicompartmental Knee System

Page 1 of 1

INDICATIONS FOR USE STATEMENT A.

510(k) Number:_K131167

Device Name: UNIVATION® Unicompartmental Knee System

Indications for Use:

X Prescription Use_ ______________

(per 21 CFR 801.109)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

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Regulation Number and Section

§ 888.3530 Knee joint femorotibial metal/polymer semi-constrained cemented prosthesis.

(a)
Identification. A knee joint femorotibial metal/polymer semi-constrained cemented prosthesis is a device intended to be implanted to replace part of 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 consist of a femoral component made of alloys, such as cobalt-chromium-molybdenum, and a tibial component made of ultra-high molecular weight polyethylene and is limited to those prostheses intended for use with bone cement (§ 888.3027).(b)
Classification. Class II.