The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions such as: painful, disabling joint disease of the knee resulting from degenerative arthritis , theumatoid arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.

Device Description

The Madison Total Knee System is a modular knee system consisting of a femoral component, tibial insert, tibial baseplate, tibial stem extensions, and a patella. The system components are designed to be Cruciate-Retaining and Ultra-Congruent. The femoral component and tibial baseplate are manufactured from Cobalt Chrome and are to be implanted with cement. The tibial stem extensions are manufactured from titanium alloy, and the tibial insert and patella components are manufactured from UHMWPE. All implant components are provided sterile.

AI/ML Overview

The provided document is a 510(k) summary for the Madison Total Knee System, a medical device. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study proving that the device meets specific acceptance criteria in the context of diagnostic accuracy or performance against a predefined clinical threshold.

Therefore, many of the requested categories for acceptance criteria and study details are not directly applicable to this type of regulatory submission, which primarily relies on non-clinical testing and comparison to an established predicate device.

Here's an attempt to answer based on the provided text, highlighting where information is absent or not relevant to the typical understanding of acceptance criteria for diagnostic devices:

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

The document does not explicitly present "acceptance criteria" in the sense of predefined thresholds for clinical performance (e.g., accuracy, sensitivity, specificity) for a diagnostic AI device. Instead, it describes non-clinical testing performed to demonstrate safety and effectiveness for a knee implant, primarily focused on mechanical properties and material characteristics. The reported "performance" is that the device passed these tests, indicating compliance with the relevant ASTM standards and demonstrating functionality.

Acceptance Criteria Category (Implied)	Reported Device Performance
Material Properties:
UHMWPE Characterization (ASTM F648)	Met standard requirements
Mechanical Performance:
Range of Motion (Tibiofemoral, ASTM F2083)	Met standard requirements
Constraint (Tibiofemoral, ASTM F1223)	Met standard requirements
Contact Area/Stress (Tibiofemoral)	Acceptable performance
Component Interlock Strength	Acceptable performance
Range of Motion/Constraint (Patellofemoral, ASTM F1223)	Met standard requirements
Contact Area/Stress (Patellofemoral)	Acceptable performance
Tibial Baseplate Cantilever Fatigue (ASTM F1800)	Met standard requirements
Sterilization & Biocompatibility:
Bacterial Endotoxin Testing	Acceptable levels

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

This information is not provided for the non-clinical tests. The tests were performed on "test units representative of finished devices," implying laboratory testing of physical samples rather than data from human subjects. Therefore, provenance like country of origin or retrospective/prospective data collection is not applicable.

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)

This information is not applicable as the testing described is non-clinical, focusing on mechanical and material properties of an implant, not interpretive diagnostic performance requiring expert adjudication of ground truth.

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

This information is not applicable as it pertains to expert consensus for diagnostic ground truth, which is not relevant to the non-clinical testing of a knee implant.

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

An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic AI devices, not for a knee implant. The document explicitly states: "Clinical data were not needed to support the safety and effectiveness of the subject device."

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

This information is not applicable as the device is a knee implant, not an algorithm or AI system.

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

For the non-clinical testing, the "ground truth" would be established by the specified ASTM standards and engineering principles that define acceptable material properties and mechanical performance. There is no biological or diagnostic ground truth (like expert consensus or pathology) involved.

8. The sample size for the training set

This information is not applicable. As a physical implant, there is no "training set" in the context of machine learning.

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

This information is not applicable as there is no training set for a machine learning model.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.

October 22, 2019

Implanet, S.A. % Hollace Rhodes Vice President, Orthopedic Regulatory Affairs MCRA. LLC 1050 K Street NW, Suite 1000 Washington, District of Columbia 20001

Re: K192084

Trade/Device Name: Madison 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 Dated: August 2, 2019 Received: August 2, 2019

Dear Hollace Rhodes:

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 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

510(k) Number (if known)

K192084

Device Name Madison Total Knee System

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Device Trade Name:	Madison Total Knee System
Common Name:	Total Knee Prosthesis
Manufacturer:	Implanet, S.A.Technopole Bordeaux MontesquieuAllée Francois Magendie33650 MartillacFrancePhone: (+33) 557 995 555Facsimile: (+33) 557 995 700
Contact:	Régis Le CouëdicRegulatory Affairs & Quality DirectorPhone: +33 685 22 26 55Email: rlc@implanet.com
Prepared by:	MCRA, LLC1050 K Street NW, Suite 1000Washington, DC 20001Phone: (202) 552-5800
Date Prepared:	October 1, 2019
Classification:	21 CFR 888.3560
Class:	II
Product Code:	JWH

Indications for Use:

The Madison Knee System is intended for total knee replacement. Madison Knee components are for use in total knee arthroplasty to relieve pain and restore knee functions for indications such as: painful, disabling joint disease of the knee resulting from degenerative arthritis, theumatoid arthritis or post-traumatic arthritis; and revision of previous unsuccessful knee replacement or other procedure. These components are indicated for cemented fixation only.

Device Description:

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Predicate Device:

The Scorpio NRG Knee System (K915192, K071991) serves as the predicate device.

Technological Characteristics Comparison:

The Madison Total Knee System and its predicate device are similar in size, material, and geometry. Both the subject and predicate devices are fixed, cruciate-retaining, and are to be used with bone cement. Both systems are semi-constrained and utilize a metal-on-polyethylene articulation. There are no substantial differences in technological characteristics between the two devices and as such the Madison Total Knee System introduces no new issues of safety or effectiveness.

Nonclinical Testing:

All necessary testing has been performed for the worst-case Madison Total Knee System components to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Clinical data were not needed to support the safety and effectiveness of the subject device.

The device performance was characterized through the following tests:

Range of Motion (Tibiofemoral) as per ASTM F2083 ●
Constraint (Tibiofemoral) as per ASTM F1223 ●
Contact Area/Contact Stress (Tibiofemoral)
Component Interlock Strength
Range of Motion/Constraint (Patellofemoral) as per ASTM F1223
Contact Area/Contact Stress (Patellofemoral) ●
Tibial Baseplate Cantilever Fatigue as per ASTM F1800 ●
UHMWPE Characterization as per ASTM F648 ●
Bacterial Endotoxin Testing

Conclusion:

The Madison Total Knee is substantially equivalent to the predicate device with respect to its indications for use, design, function, and method of fixation.

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.