The patient should be skeletally mature to receive a knee replacement. 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 Genius Knee replacement system is indicated for cemented fixation with bone cement (PMMA) only.

Device Description

The Genius Knee system is a modular knee system consisting of a femoral component, meniscal insert, a patella and a tibial baseplate. The femoral component and tibial baseplate components are manufactured from cast cobalt chromium alloy and are intended for use with bone cement. The femoral component is available with femoral pegs, or as modular peg variant. The modular femoral peg is manufactured from wrought cobalt chromium alloy. The femoral component and meniscal inserts are available as posterior stabilised or cruciate retaining variants. Cruciate retaining meniscal inserts are available as standard or ultracongruent designs. All variants of the meniscal insert and patella are manufactured from UHMWPE.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device called the "Genius Total Knee System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials with acceptance criteria directly applicable in the way you're asking. Therefore, the information typically requested in your prompt (e.g., sample size for test set, number of experts for ground truth, MRMC studies, standalone performance, training set details) is generally not part of a 510(k) for a knee replacement system, as it's not a diagnostic AI/ML device.

However, I can extract the relevant information regarding the performance testing and the grounds for substantial equivalence.

Here's the breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

For a knee replacement system undergoing 510(k) clearance, the "acceptance criteria" are typically defined by engineering parameters and validated through non-clinical bench testing, ensuring the device meets established mechanical and material standards for orthopedic implants. The "reported device performance" is that the device met these engineering and material specifications.

Acceptance Criteria Category	Reported Device Performance
Mechanical/Physical Performance (Non-Clinical Testing)	Non-clinical testing and engineering evaluations verify that the performance of the Genius Knee system is adequate for anticipated in-vivo use. The device passed the following tests:
Range of Motion	Adequately demonstrated acceptable range of motion.
Modular Component Interlock Strength	Met specified strength requirements for modular component interlocking.
Component Contact Area and Stress	Met specified criteria for contact area and stress distribution.
Component Constraint	Met specified constraint requirements.
Tibial Plate Fatigue	Withstood fatigue testing as per established standards.
UHMWPE Tibial Post Strength	Met specified strength requirements for the UHMWPE tibial post.
Modular Component Assembly	Demonstrated proper assembly as designed.
Modular Component Disassembly	Demonstrated proper disassembly as designed (when applicable for modularity).
Endotoxin (LAL)	Passed Endotoxin (LAL) Testing, indicating biocompatibility.
Substantial Equivalence to Predicate Devices	The Genius Knee System was found substantially equivalent to the listed predicate devices in terms of intended use, indications for use, materials, and similar design. Non-clinical testing results support this claim. The subject devices are expected to perform adequately during clinical use.

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

This is not applicable in the context of a 510(k) for a physical knee implant based on non-clinical bench testing. There isn't a "test set" of patient data in the way you might find for an AI/ML diagnostic device. The "test set" consists of physical devices that undergo various mechanical and material tests. The provenance of the data is from in-house engineering and material testing labs.

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

This is not applicable. "Ground truth" in this context is defined by objective engineering and material standards (e.g., ISO, ASTM standards for orthopedic implants), not by expert medical interpretation of data. The expertise lies in the engineers and material scientists conducting and evaluating the tests.

4. Adjudication Method for the Test Set

This is not applicable. The results of the non-clinical tests are objective measurements against established technical specifications, not subjective interpretations requiring adjudication.

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. This device is a physical knee implant, not an AI-assisted diagnostic or treatment planning tool that would involve human readers or AI assistance.

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

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

7. The Type of Ground Truth Used

The "ground truth" for the performance of the Genius Total Knee System is based on:

Engineering and Material Standards: Compliance with relevant national and international standards (e.g., ASTM, ISO) for static, dynamic, and fatigue strength, material properties, and biocompatibility of orthopedic implants.
Predicate Device Performance: The expectation that, by demonstrating similar design, materials, and mechanical performance to legally marketed predicate devices, the subject device will perform equivalently in clinical use.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" of data for this type of device submission.

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

This is not applicable.

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

The study proving the device meets its "acceptance criteria" (defined as adequate mechanical and material performance for in-vivo use and substantial equivalence to predicate devices) consists of a battery of non-clinical bench tests and engineering evaluations. These tests covered aspects such as range of motion, modular component interlock strength, contact area and stress, component constraint, tibial plate fatigue, UHMWPE tibial post strength, modular component assembly and disassembly, and endotoxin (LAL) testing.

The document claims that these non-clinical testing results support the substantial equivalence claim to several predicate devices, including the DePuy PFC Sigma Knee System (K943462), Signature Orthopaedics Active-X Knee System (K160159), Biomet Vanguard Complete Knee System (K113550), DePuy AMK System (K864671), and New Era Orthopaedics NEO Total Knee System (K142388). The conclusion is that "The subject devices are expected to perform adequately during clinical use."

Summary

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

July 17, 2017

Re: K170613

Trade/Device Name: Genius Total Knee System Regulation Number: 21 CFR 888.3560 Regulation Name: Knee Joint Patellofemorotibial Polymer/Metal/Polymer Semi-Constrained Cemented Prosthesis Regulatory Class: Class II Product Code: JWH Dated: June 6, 2017 Received: June 8, 2017

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. 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 statutes and regulations administered by other Federal agencies. You must comply

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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 devicerelated 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 Industry and Consumer Education at its toll-free 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" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely,

Mark N. Melkerson -S

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

Enclosure

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INDICATIONS FOR USE STATEMENT 1

510(k) Number (if Known): K170613

Device Name: Genius Total Knee System

Indications For Use:

The patient should be skeletally mature to receive a knee replacement. 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 Genius 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:	Genius 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:	February 23rd, 2017
Classification:	Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis (JWH, 21CFR 888.3560)
Predicate Devices:	Substantial equivalence to the following device is claimed:• Johnson & Johnson Professional Inc. Darwin KneeSystem (K943462) now Depuy PFC Sigma KneeSystem• Signature Orthopaedics Active-X Knee System(K160159)• Biomet Vanguard Complete Knee System (K113550)• DePuy AMK System (K864671)• New Era Orthopaedics NEO Total Knee System

Device Description:

(K142388)

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patella are manufactured from UHMWPE.

Indications for Use:

The patient should be skeletally mature to receive a knee replacement. 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 Genius 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 Genius Knee system is adequate for anticipated in-vivo use. Nonclinical testing carried out on the Genius Knee system included:

Range of motion analysis
. Modular component interlock strength testing
. Component contact area and stress testing
. Component constraint testing
. Tibial plate fatigue testing
. UHMWPE tibial post strength analysis
. Modular component assembly testing
. Modular component disassembly testing
. Endotoxin (LAL) Testing

Substantial Equivalence:

The Genius Knee System has the same intended use, indications for use, materials and similar design as the DePuy PFC Sigma Knee System (K943462), Signature Orthopaedics Active-X Knee System (K160159), Biomet Vanguard Complete Knee System (K113550), DePuy AMK System (K864671) and New Era Orthopaedics NEO Total Knee System (K142388). Non-clinical testing results support the substantial equivalence claim. The subject devices are expected to perform adequately during clinical use.

Comparison of technological characteristics

Reconstructive total knee joint replacement is the technological principle for both the subject devices and the predicate devices. At a high level, the subject and predicate devices are based on the following same technological elements:

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. The indication for use of the subject devices is the same as one or more of the predicate devices
. The intended surgery sites of the subject devices matches the intended surgery sites of the predicates
. The subiect devices are manufactured from the same materials at least one of the predicates for femoral, meniscal, tibial tray and patella components
. The subject devices are for use with cemented fixation which is in line with at least one of the predicates
. The range of sizes of the subject devices are within the range of sizes of at least one of the predicates for femoral, meniscal, tibial tray and patella components
. The modular locking mechanisms are the same as at least one of the predicates
. The subject device is available in posterior stabilized and cruciate retaining variants which is the same as at least one of the predicates
. The subject device is available with a highly congruent cruciate retaining meniscal insert which is the same as at least one of the predicates
. The subject device is fixed bearing which is the same as at least one of the predicates

The following technological differences exist between the subject and predicate devices:

Some of the design features are different between the subject and predicate ● devices
. Some of the femoral variants of the subject device are not available with some of the predicates devices
. The metallic material used on at least one of the predicates differs to what is used in the subject devices
. The polymeric material used on at least one of the predicates differs slightly to what is used in the subject devices
. The modular locking mechanism of the tibial tray differs in at least one of the predicates

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.