The Freedom® Total Knee System consists of a femoral component, poly tibial component, and a patellar component. The Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:

Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Correction of functional deformities.
Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
Moderate valgus, varus, or flexion trauma.
Knee fractures untreatable by other methods
This system is intended for cemented use only.

Device Description

The Freedom® Total Knee System is comprised of a femoral component (cruciate retaining and posterior stabilizing), all-poly tibial component and a patellar component as described below.
The Freedom® Total Knee System's Femoral component is offered in both cruciate retaining and posterior stabilizing designs. The Femoral components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom® Total Knee System's Femoral Component is made of Cobalt-Chromium-Molybdenum and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection.
The Freedom® Total Knee System's Tibial baseplate component is fabricated from ultra high molecular weight polyethylene and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. Both the Total Knee System CR and PS Tibial Inserts have identical locking mechanisms to mate with the Tibial Base Plate. The Freedom® Total Knee System Patellar component is available in a symmetric design fabricated from industry standard UHMWPE (ASTM F648). Testing of the Freedom® Total Knee System has been performed out to 135 degrees which demonstrates high flexion of the total knee device.

AI/ML Overview

The provided text describes the 510(k) summary for the Maxx Orthopedics Freedom® Total Knee System. This document outlines the device's characteristics, intended use, and its substantial equivalence to predicate devices. However, it does not contain information about acceptance criteria or a study proving the device meets those criteria in the context of device performance metrics typically associated with AI/ML systems (e.g., sensitivity, specificity, AUC). Instead, the performance testing section refers to mechanical and material characteristics.

Therefore, I cannot populate the requested table and answer the study-related questions as the information is not present in the provided document.

Here's why and what can be extracted:

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

Cannot be created based on the provided text. The document states: "Evaluations were performed to determine the material and mechanical characteristics of the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. This testing shows that the Freedom® Total Knee System functions as intended and is safe and effective for its intended use."
This indicates that performance testing was done, but the specific acceptance criteria (e.g., maximum wear rate, minimum fatigue life, specific range of stability) and the reported device performance against those criteria are not detailed in this summary. It only states that the device "functions as intended" and is "safe and effective."

Regarding the study that proves the device meets the acceptance criteria:

The document mentions "Performance Testing" was conducted to determine the material and mechanical characteristics. However, it does not provide the specific details required for the following requested points:

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective):
* Not provided. The nature of the "test set" for mechanical and material characteristics would typically be specific components or full implant assemblies, not human data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
* Not applicable/Not provided. For mechanical testing of an orthopedic implant, ground truth is established through standardized engineering tests, not expert human assessment in the way it's done for AI/ML diagnostic tools.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
* Not applicable/Not provided. This is relevant for human-interpreted diagnostic findings, not mechanical testing.

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 total knee replacement system, not an AI/ML diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
* Not applicable. This device is a total knee replacement system; there is no algorithm in this context.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
* For material and mechanical properties, the "ground truth" would be established by engineering standards and specifications (e.g., ASTM standards for material properties, ISO standards for wear testing, fatigue testing parameters). The document references "Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA," which would outline these standards.

8. The sample size for the training set:
* Not applicable/Not provided. There is no "training set" in the context of mechanical testing for a conventional medical device like a knee implant.

9. How the ground truth for the training set was established:
* Not applicable/Not provided. See point 8.

In summary, the provided 510(k) pertains to a physical medical device (a total knee system) and its mechanical/material performance, not an AI/ML-based device. Therefore, many of the requested criteria and study details, which are typical for AI/ML device evaluations, are not present or applicable to this document.

Summary

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FEB - 6 2009

510(k) Summary for

Maxx Orthopedics Freedom® Total Knee System

1. SPONSOR

Maxx Orthopedics, Inc. 2260 Butler Pike Suite 100 Plymouth Meeting, PA 19462

Contact Person: Nach Dave Telephone: 732-718-1385

Date Prepared: January 14, 2009

2. DEVICE NAME

Proprietary Name: Common/Usual Name: Classification Name:

Freedom® Total Knee System Total Knee Replacement

Knee joint patellofemorotibial polymer/metal/polymer semi-constrained cemented prosthesis.

3. PREDICATE DEVICES

Biomet Ascent Femoral and All-Polvethylene Tibial Bearing Knee System . (K021559, K982869)
Howmedica Osteonics Scorpio Femoral and Tibial Components, (K032829, . K030978, K042343, K071991, K051977).

4. DEVICE DESCRIPTION

The Freedom® Total Knee System is comprised of a femoral component (cruciate retaining and posterior stabilizing), all-poly tibial component and a patellar component as described below.

The Freedom® Total Knee System's Femoral component is offered in both cruciate retaining and posterior stabilizing designs. The Femoral components are available in right and left configurations, and eight sizes to accommodate varying anatomy. The Freedom® Total Knee System's Femoral Component is made of Cobalt-Chromium-Molybdenum and is intended for cemented application to replace the articulating surface of the distal femur in a measured resection.

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Image /page/1/Picture/0 description: The image contains a handwritten text that appears to be a combination of letters and numbers. The text on the left is illegible, but the text on the right appears to be "4213". The handwriting is somewhat messy and difficult to read.

The Freedom® Total Knee System's Tibial baseplate component is fabricated from ultra high molecular weight polyethylene and is intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection. Both the Total Knee System CR and PS Tibial Inserts have identical locking mechanisms to mate with the Tibial Base Plate. The Freedom® Total Knee System Patellar component is available in a symmetric design fabricated from industry standard UHMWPE (ASTM F648). Testing of the Freedom® Total Knee System has been performed out to 135 degrees which demonstrates high flexion of the total knee device.

5. INTENDED USE

The Freedom® Total Knee System consists of a femoral component, tibial base plate, and a patellar component. The Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:

Severe knee joint pain, loss of mobility, and disability due to: rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Correction of functional deformities. .
Post-traumatic loss of knee joint contour, particularly when there is ● patellofemoral erosion, dysfunction, and/or prior patellectomy.
. Moderate valgus, varus, or flexion trauma.
Knee fractures untreatable by other methods .

6. TECHNOLOGICAL CHARACTERISTICS AND SUBSTANTIAL EQUIVALENCE

The proposed Freedom® Total Knee System and the predicate devices are identical in that they all consist of tibial baseplate components and/or femoral component, and patella components. Both the Freedom® Total Knee System femoral component and the predicate femoral component are manufactured from Cobalt-Chromium-Molybdenum. Both the proposed and predicate tibial components are made from ultra high molecular weight polyethylene. Both the proposed and predicate device patella components are made from UHMWPE.

Both the proposed product and the predicate devices have been designed to mimic the normal knee geometry. Both the proposed and predicate devices are available in a variety of femoral sizes, tibial sizes and patella sizes that are intended to mimic normal human anatomy. The articulating surface of the proposed Freedom® Total Knee System femoral and tibial components, are similar to the articulating surface of the predicate systems and are functionally equivalent devices. Both the proposed and

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K082-09 #3/3

predicate devices are made of biocompatible materials and are designed similarly to the predicate devices.

7. PERFORMANCE TESTING

Evaluations were performed to determine the material and mechanical characteristics of the Freedom® Total Knee System according to the Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA. This testing shows that the Freedom® Total Knee System functions as intended and is safe and effective for its intended use. The testing was performed to demonstrate the mechanical characteristics of the Freedom® Total Knee System

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, with its wings forming a flowing, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.

Public Health Service

FEB = 6 2009

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Maxx Orthopedics, Inc. % Medical Device Consultants, Inc. Ms. Mary McNamara-Cullinane 49 Plain Street North Attleboro, Massachusetts 02760

Re: K082019

Trade/Device Name: The Freedom® Total Knee System

Regulation Number: 21 CFR 888.3560

Regulation Name: Knee joint patellofemorotibial polymer semi-constrained cemented prosthesis

Regulatory Class: II Product Code: JWH Dated: January 14, 2009 Received: January 15, 2009

Dear Ms. McNamara-Cullinane:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Ms. Mary McNamara-Cullinane

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Millman

Mark N. Melkerson 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): K082019

The Freedom® Total Knee System Device Name:

Indications for Use:

Severe knee joint pain, loss of mobility, and disability due to: rheumatoid . arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Correction of functional deformities. .
Post-traumatic loss of knee joint contour, particularly when there is . patellofemoral erosion, dysfunction, and/or prior patellectomy.
Moderate valgus, varus, or flexion trauma.
Knee fractures untreatable by other methods ●

This system is intended for cemented use only.

Prescription Use _ X (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 NECESSARY) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off Division of General, Restorative, and Neurological Devices

510(k) Number.

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.