Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.

The femoral component and tibial tray are for cemented use (biological fixation).

The patellar component and metaphyseal stem (K080199) are for cemented use only.

Indications for Posterior Stabilized Knee Replacement:

Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply.

Indications for Constrained Knee Replacement:

Constrained knee systems are designed for use in patients in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral and/ or lateral collateral ligament) are absent or incompetent. Total Knee indications still apply.

Device Description

The Agility Symmetric™ Total Knee System is intended for the knee joint. The system consists of metallic femoral and tibial components (including an available metaphyseal stem previously cleared in K080199) and a potellar component (also cleared in K080199).

The FEMORAL COMPONENT is designed for left/right orientations. The femoral component is manufactured from cast cobalt chromium/ molybdenum (CoCrMo). The femoral component is available in five sizes (3-7) and will have two condylar pegs to aid in rotational stability. It is mesh coated with ASTM F67 titanium.

The TIBIAL TRAY is a symmetric designed component, eliminating the need for left/right orientations. The tibial component is manufactured from wrought titanium alloy (Ti6Al4V). The tibial tray features a central post, a pair of gussets, and 2 to 4 pegs on the underside providing rotational stabilization and increased tray strew holes in the tibial tray allow for optional screw fixation. The tibial tray is designed with locking features permitting an ultra-high polyethylene (UHMWPE) tibial insert to be snapped into place. The tibial tray has 5 sizes (3-7) and is mesh coated with ASTM F67 titanium.

Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.

AI/ML Overview

The prompt asks to describe the acceptance criteria and the study proving a device meets them, but the provided text is a 510(k) clearance letter for a total knee replacement system (Agility Symmetric Total Knee System). This document does not describe acceptance criteria for an AI/ML medical device, nor does it detail a clinical study with human readers or AI assistance.

Instead, it's a premarket notification for a medical implant and focuses on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Therefore, I cannot fulfill the request as it pertains to an AI/ML medical device's acceptance criteria and study, based on the provided text. The text outlines:

Device Name: Agility Symmetric™ Total Knee System
Regulation Number/Name: 21 CFR 888.3565 / Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
Product Codes: MBH, JWH
Indications for Use: Total Knee Replacement, Posterior Stabilized Knee Replacement, Constrained Knee Replacement (details specific conditions like rheumatoid arthritis, osteoarthritis, failed osteotomies, ligament integrity, etc.).
Predicate Devices: K080199 (Symmetric™ Total Knee System - primary), K141635 (Arthrex iBalance® TKA System - secondary)
Device Description: Components (femoral, tibial tray, patellar, metaphyseal stem), materials (CoCrMo, Ti6Al4V), and coating (ASTM F67 titanium mesh).
Technological Comparison: Differences from predicates in coating material and bone interface features (e.g., removal of central post/gussets, addition of condylar pegs), but deemed to not raise new questions of safety and effectiveness.
Non-Clinical Tests Summary & Conclusions:
- Fatigue testing per ASTM F3210 (femoral knee) and ASTM F1800 (tibial tray, tibial tray and modular stem).
- Wear testing per ISO 14243-1.
- Particle characterization per ASTM F1877-16.
- Shear-off testing for tibial locking mechanism per ASTM 1814.
- Cleaning validation per ISO 19227.
- Biocompatibility assessment per ISO 10993-1.
- Sterilization assessment per ISO 11135 and AAMI TIR28.
- Uncemented design validation per ISO 21536.
- Morse taper modular connection assessment per ISO 21536 and ASTM F1814.
- Constraint and contact area assessment per ASTM F1223 and ISO 21536.
Clinical Testing: Not Applicable. This further confirms that no human-in-the-loop or standalone AI/ML performance study was conducted.

In summary, the provided document does not contain the information required to answer the prompt regarding acceptance criteria and study data for an AI/ML medical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".

November 6, 2024

Medisurge, LLC Megan Morrissey Director of QA/RA 2140 Oak Industrial Dr. NE Grand Rapids, Michigan 49505

Re: K242412

Trade/Device Name: Agility SymmetricTM Total Knee System 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: August 12, 2024 Received: August 14, 2024

Dear Megan Morrissey:

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 (the 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 available 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.

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

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30. Design controls; 21 CFR 820.90. Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-regulatory

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

assistance/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,

Peter G.

Allen -S

Digitally signed by Peter G. Allen -S Date: 2024.11.06 15:22:17 -05'00'

For

Lixin Liu 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

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

Indications for Use

Submission Number (if known)

K242412

Device Name

Agility Symmetric™ Total Knee System

Indications for Use (Describe)

Indications:

Indications for Total Knee Replacement:

1. Rheumatoid arthritis,
1. Correction of functional deformity.
1. Osteoarthritis.

Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result.
Failed osteotomies, unicompartmental replacement, or total knee replacement.

The femoral component and tibial tray are for cemented use (biological fixation).

The patellar component and metaphyseal stem (K080199) are for cemented use only.

Indications for Posterior Stabilized Knee Replacement:

Indications for Constrained Knee Replacement:

Type of Use (Select one or both, as applicable)

< | Prescription Use (Part 21 CFR 801 Subpart D)

ver-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

K242412 Page 1 of 2
510(k) #:	K242412	510(k) Summary	Prepared on: 2024-10-29
Contact Details	21 CFR 807.92(a)(1)
Applicant Name	Medisurge, LLC
Applicant Address	2140 Oak Industrial Dr. NE Grand Rapids MI 49505 United States
Applicant Contact Telephone	616-295-7190
Applicant Contact	Megan Morrissey
Applicant Contact Email	mmorrissey@medisurge.com
Device Name	21 CFR 807.92(a)(2)
Device Trade Name	Agility Symmetric™ Total Knee System
Common Name	Total Knee System
Classification Name	Prosthesis, Knee, Patello/Femorotibial, Semi-Constrained, Uncemented, Porous, Coated, Polymer/Metal/Polymer
Regulation Number	888.3565
Product Code(s)	MBH, JWH
Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K080199	Symmetric™ Total Knee System	JWH
K141635	Arthrex iBalance® TKA System	MBH
Device Description Summary		21 CFR 807.92(a)(4)

21 CFR 807.92(a)(5)

Mating geometries for the previously cleared (K080199) TIBIAL INSERT, METAPHYSEAL STEM, REVISION STEM, and PATELLAR COMPONENT have not changed from the predicate devices.

Intended Use/Indications for Use

{5}------------------------------------------------

Indications:

Indications for Total Knee Replacement:

Rheumatoid arthritis,
Correction of functional deformity,
Osteoarthritis,
Degenerative arthritis in older patients whose age, weight and activity level are compatible with an adequate long-term result,
Failed osteotomies, unicompartmental replacement, or total knee replacement.

The femoral component and tibial tray are for cemented use (biological fixation).

The patellar component and metaphyseal stem (K080199) are for cemented use only.

Indications for Posterior Stabilized Knee Replacement:

Posterior stabilized knee systems with a deep articular surface are designed for use in patients in primary and revision surgery, where the anterior and posterior cruciate ligaments are incompetent and the collateral ligaments remain intact. Total Knee indications still apply.

Indications for Constrained Knee Replacement:

Constrained knee systems are designed for use in primary and revision surgery, where the posterior cruciate ligament and one or both of the collateral ligaments (i.e. medial collateral ligament) are absent or incompetent. Total Knee indications still apply.

Indications for Use Comparison

The indications are similar between the primary predicate device, with the exception that the primary predicate device is for cemented use only and the subject device is for cemented use. However, the secondary predicate device is indicated for cemented or uncemented use.

Technological Comparison

The articulating geometry of the femoral component are equivalent between the primary predicate device. The difference is that the primary predicate device is plasma sprayed with ASTM F1580 Commercially Pure Titanium and the subject device is mesh coated with ASTM F67 Commercially Pure Titanium. The changes from the primary predicate device involve the bone interface, the removal of the central post and gussets, and addition of the condylar pegs. However, the secondary predicate device is mesh coated with ASTM F67.

The geometry of the tibial tray component. The difference is that the primary predicate device is plasma sprayed with ASTM F1580 Commercially Pure Titanium and the subject device is mesh coated with ASTM F67 Commercially Pure Titanium.

Non-Clinical and/or Clinical Tests Summary & Conclusions

Non-clinical testing was conducted on the Agility Symmetric™ Total Knee System according to special controls guidance document "Knee Joint Patellofemorotibial Metal Polymer Porous-Coated Uncemented Prosthesis - Class II Special Controls Guidance Document for Industry and FDA".

The femoral knee underwent fatigue testing per ASTM F3210 to confirm the implant endurance.
The tibial tray underwent fatigue testing per ASTM F1800 to confirm the implant endurance.
The tibial tray and modular stem underwent fatigue testing per ASTM F1800 to confirm the combined implance.
The system underwent wear testing per ISO 14243-1, particle characterization per ASTM F 1877-16.
· The system tibial locking mechanism underwent shear-off testing per ASTM 1814.
· The system underwent cleaning validation per ISO 19227.
· The system biocompatibility was assessed per ISO 10993-1.
· The system sterilization was assessed per ISO 11135 and AAMI TIR28.
· The femoral knee uncemented design was validated per ISO 21536 to confirm surgical technique guidance.
· Morse taper modular connection was assessed per ISO 21536 and ASTM F1814.
· Constraint and contact area was assessed per ASTM F1223 and ISO 21536.

Clinical Testing Not Applicable.

The proposed device has the same intented). The proposed device has similar technological characteristics to the predicate(s), and the information provided herein demonstrates that:

any differences do not raise new questions of safety and effectiveness; and
the proposed device is at least as safe and effective as the legally marketed predicate device(s).

21 CFR 807.92(a)(5)

21 CFR 807.92(a)(6)

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.