Components with CST porous coating are indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (ID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong "Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component:

This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
This device is intended for cemented use only.
Specific uses with CR-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

Device Description

The Gender Solutions Natural-Knee Flex (N-K Flex) and NexGen CR-Flex GSF components are semiconstrained, nonlinked condylar knee prosthesis that are designed to have a maximum active flexion of 155 degrees. The GSM and GSF femoral component designations indicate that the design of the femoral components has been modified to address specific anatomical features of the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

AI/ML Overview

This document describes a 510(k) premarket notification for knee prosthesis components and does not contain information about a study proving a device meets acceptance criteria as typically found in a clinical or AI/device performance study.

Instead, it refers to mechanical testing to demonstrate substantial equivalence to predicate devices, which is a different type of evaluation. No AI/device performance metrics (like sensitivity, specificity, or AUC) are included.

Therefore, I cannot populate the table or answer the specific questions related to acceptance criteria, device performance, sample size, ground truth, expert involvement, or AI-related studies.

Here's a breakdown of why the request cannot be fully fulfilled based on the provided text:

No Acceptance Criteria or Performance Data for a "Device" in the common sense of an AI/diagnostic device: The document describes new components for a knee replacement system. The relevant "acceptance criteria" here are likely related to mechanical properties, material compatibility, and overall design and manufacturing standards for implants, not diagnostic performance metrics.
No "Study" in the context of device performance: The document states: "Clinical data and conclusions were not needed for these devices." Instead, it relies on non-clinical performance data (mechanical testing) to show substantial equivalence.
No AI or diagnostic component: This is a physical medical device (knee implant) and the filing pertains to its design and material characteristics, not its performance in interpreting data or aiding diagnosis.
No "Ground Truth" or "Experts" in the requested context: Since there's no diagnostic or AI component, there's no ground truth (e.g., pathology report, clinical outcome for diagnostic accuracy) or expert adjudication for interpretive tasks.

Based on the provided text, the available information is as follows:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Substantial equivalence to predicate device (K070214, K060370)	Mechanical testing demonstrates substantial equivalence to predicate devices.
Ability to provide increased flexion capability (up to 155 degrees)	Designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.
Compatibility with specific articular surfaces/polyethylene	Designed for use with specified articular surfaces (e.g., NexGen Trabecular Metal CR Monoblock, Prolong Highly Crosslinked Polyethylene CR articular surfaces, Gender Solutions Natural-Knee Flex Congruent articular surfaces)
Adherence to indicated uses	The device meets the indications for use as described in the submission.

2. Sample size used for the test set and the data provenance: Not applicable. The document refers to mechanical testing, not a diagnostic or clinical test set with human or patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No ground truth for a diagnostic test set was established.
4. Adjudication method for the test set: Not applicable.
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 is not an AI device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm.
7. The type of ground truth used: Not applicable in the context of diagnostic accuracy. The "ground truth" for this device would be its mechanical properties meeting engineering specifications and its biomaterial compatibility, demonstrated through pre-clinical mechanical testing and comparison to legally marketed predicate devices.
8. The sample size for the training set: Not applicable. This is not a machine learning device or software.
9. How the ground truth for the training set was established: Not applicable.

Additional Information from the Document:

Study Type: Non-clinical (mechanical testing) was performed. Clinical data was deemed "not needed."
Purpose: To demonstrate substantial equivalence to predicate devices for regulatory clearance (510(k)).
Device Type: Total Knee Prosthesis components (femoral components).
Key finding: Mechanical testing demonstrates substantial equivalence to predicate devices.

Summary

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KO71107 (ps 1 of 3)

Summary of Safety and Effectiveness

JUL - 6 2007

Submitter:	Zimmer, Inc.P.O. Box 708Warsaw, IN 46581-0708
Contact Person:	Brandon Hipsher, RACSenior Associate, Corporate Regulatory AffairsTelephone: (574) 371-8083Fax: (574) 372-4605
Date:	April 18, 2007
Trade Name:	Gender Solutions™ Natural-Knee® Flex System;NexGen® Complete Knee Solution CR-Flex GenderSolutions Female (GSF) Femoral Component
Common Name:	Total Knee Prosthesis
Classification Nameand Reference:	Knee joint patellofemorotibialpolymer/metal/polymer semiconstrained cementedprosthesis21 CFR § 888.3560
	Knee joint patellofemorotibial metal/polymerporous-coated uncemented prosthesis21 CFR § 888.3565
Predicate Devices:	Gender Solutions Natural-Knee Flex System,manufactured by Zimmer, Inc., K070214, clearedMarch 16, 2007.NexGen Knee Gender Solutions Female (GSF)Femoral Components, manufactured by Zimmer,Inc., K060370, cleared April 28, 2006.
Device Description:	The Gender Solutions Natural-Knee Flex (N-KFlex) and NexGen CR-Flex GSF components aresemiconstrained, nonlinked condylar kneeprosthesis that are designed to have a maximumactive flexion of 155 degrees. The GSM and GSFfemoral component designations indicate that thedesign of the femoral components has beenmodified to address specific anatomical features of

. .

{1}------------------------------------------------

Kc71107 (pg. 2 of 3)

the distal femur that can be seen in patients of either gender, but are more typical of male and female patients, respectively.

Intended Use:

N-K Flex System:

· Components with CSTi porous coating are indicated for uncemented or cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
· Components without CSTi porous coating are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
· The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal™ CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90prefix 17 or 20mm Prolong " Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

NexGen CR-Flex GSF Femoral Components:

· This device is indicated for patients with severe knee pain and disability due to:
- -Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
- -Collagen disorders, and/or avascular necrosis of the femoral condyle.
- -Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.

{2}------------------------------------------------

K071107 (pg. 3 of 3)

	- Moderate valgus, varus, or flexiondeformities.- The salvage of previously failed surgicalattempts or for a knee in which satisfactorystability in flexion cannot be obtained at thetime of surgery.• This device is intended for cemented use only.• Specific uses with CR-Flex GSF femorals:- Provides increased flexion capability forpatients who have both the flexibility anddesire to increase their flexion range.- The CR-Flex GSF femoral, when used with90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or20mm Prolong Highly CrosslinkedPolyethylene CR articular surfaces, or withGender Solutions™ Natural-Knee® FlexCongruent articular surfaces, is designed foruse with a functional posterior cruciateligament and when load bearing range ofmotion (ROM) is expected to be less than orequal to 155 degrees.
Comparison to Predicate Device:	Except for changes in component compatibility, thesubject components are identical to the predicatedevice.
Performance Data (Nonclinicaland/or Clinical):	Non-Clinical Performance and Conclusions:
	Mechanical testing of the subject devicesdemonstrates that they are substantially equivalentto the predicate devices.
	Clinical Performance and Conclusions:
	Clinical data and conclusions were not needed forthese devices.

. .

{3}------------------------------------------------

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 with three lines representing its wings and head. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL -6 2007

JUL

Zimmer, Inc. % Mr. Brandon Hipsher, RAC Senior Associate, Corporate Regulatory Affairs P.O. Box 708 Warsaw, Indiana 46581

Re: K071107

Trade/Device Name: Gender Solutions™ Natural-Knee® Flex System; NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Female (GSF) Femoral Component Regulation Number: 21 CFR 888.3565 Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis Regulatory Class: Class II Product Codes: MBH, JWH Dated: June 1, 2007 Received: June 4, 2007

Dear Mr. Hipsher:

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. Iisting 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

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Page 2 - Mr. Brandon Hipsher, RAC

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. 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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 N. Melkerson Director Division of General, Restorativ and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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K071107

Indications for Use

510(k) Number (if known):

Device Name:

Gender Solutions™ Natural-Knee® Flex System; NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component

Indications for Use:

Gender Solutions "Natural-Knee" Flex System:

· Components with CST porous coating are indicated for uncemented use in skeletally mature individuals with intact medial and lateral collateral ligaments undergoing primary surgery for rehabilitating knees damaged as a result of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (IJD).
· Components without CSTi are indicated for cemented use in skeletally mature individuals with intact medial and lateral collateral ligaments with conditions of Noninflammatory Degenerative Joint Disease (NIDJD) or Inflammatory Joint Disease (ID), correctable varus-valgus deformity and moderate flexion contracture, or failed previous surgery where pain, deformity or dysfunction persists.
· The N-K Flex femoral provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range. When used with N-K Flex, NexGen Trabecular Metal" CR Monoblock, 90-prefix NexGen CR, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong "Highly Crosslinked Polyethylene CR articular surfaces, it is designed for use when load bearing ROM is expected to be less than or equal to 155 degrees.

NexGen® Complete Knee Solution CR-Flex Gender Solutions™ Femoral Component:

· This device is indicated for patients with severe knee pain and disability due to:
- Rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis,
- Collagen disorders, and/or avascular necrosis of the femoral condyle.
- Post-traumatic loss of joint configuration, particularly when there is patellofemoral erosion, dysfunction or prior patellectomy.
- Moderate valgus, varus, or flexion deformities.
- The salvage of previously failed surgical attempts or for a knee in which satisfactory stability in flexion cannot be obtained at the time of surgery.
· This device is intended for cemented use only.
· Specific uses with CR-Flex GSF femorals:
- Provides increased flexion capability for patients who have both the flexibility and desire to increase their flexion range.
- The CR-Flex GSF femoral, when used with 90-prefix NexGen CR articular surfaces, 00-prefix 10, 12 or 14mm or 90-prefix 17 or 20mm Prolong Highly Crosslinked Polyethylene CR articular surfaces, or with Gender Solutions Natural-Knee Flex Congruent articular surfaces, is designed for use with a functional posterior cruciate ligament and when load bearing range of motion (ROM) is expected to be less than or equal to 155 degrees.

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 needed)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)Division of General, Restorative,and Neurological Devices	Page 1 of 1
--------------------------------------------------------------------------------------	-------------

Signature

510(k) Number	K071107
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Regulation Number and Section

§ 888.3565 Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis.

(a)
Identification. A knee joint patellofemorotibial metal/polymer porous-coated uncemented 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 is designed to achieve biological fixation to bone without the use of bone cement. This identification includes fixed-bearing knee prostheses where the ultra high molecular weight polyethylene tibial bearing is rigidly secured to the metal tibial base plate.(b)
Classification. Class II (special controls). The special control is FDA's guidance: “Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.” See § 888.1 for the availability of this guidance.