The patient should be skeletally mature to receive a World Knee replacement system. Patients should have adequate bone stock and size to support and accept the prosthesis. The patient's need for knee replacement should be due to one or more of the following conditions:

. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
. Inflammatory degenerative joint disease including rheumatoid arthritis.
Functional deformity such as varus, valgus or flexion deformities.
. Revision procedures where other treatments or devices have failed.
. Fractures that are unmanageable using other techniques.

The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Device Description

Devices covered in this 510(K) are a range extension to previously cleared 510(K) applications for World Knee system. The range extension consists of titanium tibial baseplates for the World knee, and a change to the meniscal insert connection mechanism for the World knee. The tibial baseplate is made of Titanium available in cemented version. The World Knee meniscal inserts are available as posterior stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal inserts are manufactured from UHMWPE.

AI/ML Overview

This document is a 510(k) premarket notification for the "World Knee Total Knee System." It's a submission to the FDA for a medical device and describes its indications for use and performance testing related to its substantial equivalence to previously cleared predicate devices.

Here's an analysis of the provided text in relation to acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a table of "acceptance criteria" for a software or AI-driven medical device, nor does it report performance in terms of metrics like sensitivity, specificity, or accuracy which are common for AI/software devices. This submission is for a physical orthopedic implant.

Instead, the "Performance Testing" section describes a series of non-clinical mechanical tests performed on the World Knee System to ensure its physical integrity and safety. The acceptance criteria for these tests would be defined by the referenced ASTM standards. The reported performance is that these tests were "conducted to verify that the performance of the World Knee system is adequate for anticipated in-vivo use" and that "Non-clinical testing results support the substantial equivalence claim."

Here's a re-interpretation of "acceptance criteria" for this physical device:

Acceptance Criteria (Implied from Standard/Purpose)	Reported Device Performance
Meet strength requirements for modular components (ASTM F1814)	Testing conducted to verify adequate performance.
Meet assembly requirements for modular components (ASTM F1814)	Testing conducted to verify adequate performance.
Meet fatigue strength requirements for tibial plate (ASTM F1800)	Testing conducted to verify adequate performance.
Meet endotoxin limits (AAMI ST72)	Testing conducted to verify adequate performance and safety.
Demonstrate substantial equivalence in design, materials, and intended use to predicate devices	Non-clinical data supports safety and effectiveness, and equivalence.

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

This document describes testing for a physical orthopedic implant, not a software (AI) device. Therefore, the concepts of "test set" sample size and "data provenance" (country of origin, retrospective/prospective) are not directly applicable in the way they would be for an AI device.

The "sample size" for the performance tests would refer to the number of physical components or assemblies tested according to the referenced ASTM standards. This information is not provided in the document.

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

This is not applicable as the device is a physical implant, not an AI device requiring expert-established ground truth for a test set. The "ground truth" for a physical device is established through engineering and material science principles, and adherence to validated testing standards (like ASTM).

4. Adjudication Method for the Test Set

This is not applicable for a physical implant. Performance is evaluated against objective engineering standards.

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

This is not applicable. The device is a physical knee implant, not an AI system that assists human readers.

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

This is not applicable. The device is a physical implant, not an algorithm.

7. The Type of Ground Truth Used

For this medical device (a knee implant), the "ground truth" for evaluation is based on established engineering and material science standards, biomechanical principles, and compliance with recognized standards organizations like ASTM. The safety and effectiveness are "ground-truthed" by demonstrating that the device meets the physical and biological requirements for its intended use, often through:

Mechanical Testing Results: Demonstrating strength, fatigue resistance, and durability under simulated physiological loads.
Material Characterization: Verifying that materials meet specifications and are biocompatible.
Clinical Literature/Predicate Device Equivalence: Relying on the known performance and safety profile of similar predicate devices that have been used safely in patients for years.

8. The Sample Size for the Training Set

This is not applicable. The device is a physical orthopedic implant, not an AI system that undergoes training.

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

This is not applicable.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

November 27, 2019

Signature Orthopaedics Pty Ltd. Declan Brazil Managing Director 7 Sirius Road Lane Cove, NSW 2066 Australia

Re: K190577

Trade/Device Name: World Knee Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH. MBH Dated: October 24, 2019 Received: October 28, 2019

Dear Declan Brazil:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 labeling must be truthful and not misleading.

If your device is classified (see above) into either 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

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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 of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

For Ting Song, Ph.D. Acting Assistant Director DHT6A: Division of Joint Arthroplasty Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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INDICATIONS FOR USE STATEMENT 1

Device Name: World Knee Total Knee System

Indications for Use:

. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
. Inflammatory degenerative joint disease including rheumatoid arthritis.
Functional deformity such as varus, valgus or flexion deformities.
. Revision procedures where other treatments or devices have failed.
. Fractures that are unmanageable using other techniques.

The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Prescription Use: Yes (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use: No (Part 29 CFR 801 Subpart C)

(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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2 510(K) SUMMARY

Manufacturer:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066Australia
Device Trade Name:	World Knee Total Knee System
Common Name:	Total Knee Prosthesis
Contact:	Dr. Declan BrazilManaging Director of Signature Orthopaedics
Prepared By:	Signature Orthopaedics Pty Ltd7 Sirius RoadLane Cove, NSW 2066AustraliaPhone: +61 (2) 9428 5181Fax: +61 (2) 8456 6065
Date Prepared:	November 26th, 2019
Classification:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (JWH, 21CFR 888.3560)Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis (MBH)
Predicate Devices:	Primary Predicate:
	Signature Orthopaedics World Total Knee System (K180750 & K181530) Signature Orthopaedics Genius Total Knee System (K170613)
	Secondary Predicates:
	Signature Orthopaedics Active-X Knee System (K160159) Smith & Nephew Genesis II Total Knee System (K030612 & K032683)
	Reference Predicate:
	Signature Orthopaedics Pegasus Stem (K133370)

Device Description:

Devices covered in this 510(K) are a range extension to previously cleared 510(K) applications for World Knee system. The range extension consists of titanium tibial

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baseplates for the World knee, and a change to the meniscal insert connection mechanism for the World knee. The tibial baseplate is made of Titanium available in cemented version. The World Knee meniscal inserts are available as posterior stabilized or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal inserts are manufactured from UHMWPE.

Indications for Use:

. Non-inflammatory degenerative joint disease including osteoarthritis, traumatic arthritis, or avascular necrosis.
Inflammatory degenerative joint disease including rheumatoid arthritis.
Functional deformity such as varus, valgus or flexion deformities.
. Revision procedures where other treatments or devices have failed.
Fractures that are unmanageable using other techniques.

The World Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Performance Testing:

Non-clinical testing and engineering evaluations were conducted to verify that the performance of the World Knee system is adequate for anticipated in-vivo use. Nonclinical testing carried out on the World Knee system included:

Modular component interlock strength testing per ASTM F1814
. Modular component assembly testing per ASTM F1814
Tibial plate fatigue strength testing per ASTM F1800
. Endotoxin testing per AAMI ST72

Substantial Equivalence:

The Signature Orthopaedics World Knee System has the same intended use, indications for use, materials and similar design features to the predicate devices. Non-clinical testing results support the substantial equivalence claim.

Comparison of technological characteristics

The World Knee System design is similar to Signature Orthopaedics World Knee Systems (K180750 & K181530). The World Knee tibial plate material is similar to Smith & Nephew Genesis II Total Knee System (K030612 & K032683). The World Knee Meniscal insert material is the same as Signature Orthopaedics Genius Knee System (K170613), Signature Orthopaedics Active-X Knee System (K160159) and Smith & Nephew Genesis II Total Knee System (K030612 & K032683).

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Conclusions:

Technical comparison of the subject and predicate devices demonstrates equivalence in device design, intended use, indications for use and material. Non-clinical data support the safety and effectiveness of the Signature Orthopaedics World Knee Total Knee System.

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.