Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
Failure of previous joint replacement procedure,
Correction of varus, valgus, or posttraumatic deformity.
Correction or revision of unsuccessful osteotomy or Arthrodesis

Device designed for use in patients with metal sensitivity. .
Standard surgical and rehabilitative procedures are indicated with . this device.
The device is a single use device intended for use with bone . cement.

Device Description

The femoral components found in this submission (AGC® and Maxim®) are identical to their predecessors (K981996) with the exception of the vendor who will complete the nitrogen ion implantation on the Ti-6Al-4V femoral surfaces.

AI/ML Overview

The provided document is a 510(k) summary for a medical device (Titanium Femoral Knee Components) and a related FDA letter. It does not describe an AI medical device or a study involving AI. The device is a traditional medical implant.

Therefore, many of the requested fields related to AI performance, ground truth, experts, and training/test sets are not applicable to this document. The document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing, particularly regarding a vendor change for nitrogen ion implantation.

Here's an attempt to answer the questions based only on the provided text, indicating "Not applicable" or "Not provided" where the information is not present for this type of device and submission.

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

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence to predicate device (K981996)	Achieved. The device is "functional within their intended use."
Material unchanged from predicate	Confirmed. The femoral components "have not been modified from their original state in terms of materials."
Design unchanged from predicate	Confirmed. The femoral components "have not been modified from their original state in terms of... design."
Sizing unchanged from predicate	Confirmed. The femoral components "have not been modified from their original state in terms of... sizing."
Indications unchanged from predicate	Confirmed. The femoral components "have not been modified from their original state in terms of... indications."
Nitrogen ion implantation process is comparable/acceptable	Not explicitly detailed, but implied by the "non-clinical laboratory testing" result that the device is "functional within their intended use."
No significant safety or effectiveness concerns compared to predicate	Implied by the FDA's substantial equivalence determination.

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

Sample Size: Not applicable. This submission is for a knee implant based on substantial equivalence, not an AI device with test sets. The "non-clinical testing" likely refers to bench testing, not patient data.
Data Provenance: Not applicable. No patient data or test set information is provided. Non-clinical testing implies lab/bench data.

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)

Number of Experts: Not applicable. This is not an AI device nor an AI-based study.
Qualifications of Experts: Not applicable.

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

Adjudication Method: Not applicable. This is not an AI device nor an AI-based study.

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

MRMC Study: No, not applicable. This is not an AI device.

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

Standalone Performance: No, not applicable. This is not an AI device.

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

Type of Ground Truth: Not applicable for an AI context. For this device, "ground truth" would relate to the physical and mechanical properties of the device meeting design specifications and performance standards, likely established through engineering specifications and material science testing.

8. The sample size for the training set

Sample Size for Training Set: Not applicable. This is not an AI device that undergoes training.

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

Ground Truth for Training Set: Not applicable. This is not an AI device.

Summary

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

K041466 1fl

BIOMET

JUI 01 2004

510(k) Summary

Sponsor:	Biomet Manufacturing, Corp.P.O. Box 587Warsaw, IN 46581-0587
Contact Person:	Tracy Bickel Johnson, RACRegulatory AssociateBiomet Manufacturing Corp.(574) 267-6639
Proprietary Name:	Titanium Femoral Knee Components (Maxim® and AGC®)
Common Name:	Knee Femoral Components (K981996)

Classification Name: Cemented semi-constrained polymer/metal/polymer knee prosthesis (888.3560)

Substantially Equivalent Devices: Titanium Femoral Components (K981996)

Device Description: The femoral components found in this submission (AGC® and Maxim®) are identical to their predecessors (K981996) with the exception of the vendor who will complete the nitrogen ion implantation on the Ti-6Al-4V femoral surfaces.

Intended Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
Failure of previous joint replacement procedure, 2)
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy or arthrodesis
- Device designed for use in patients with metal sensitivity. .
- Standard surgical and rehabilitative procedures are indicated with this device. .
- The device is a single use device intended for use with bone cement. .

Summary of Technologies: The femoral components in this submission have not been modified from their original state in terms of materials, design, sizing, and indications. The only modification is a vendor change for nitrogen ion implantation.

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device(s) are functional within their intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

MAILING ADDRESS	P.O. Box 587
SHIPPING ADDRESS	56 E. Bell Drive
OFFICE	574.267.6639
FAX	574.267.8137
E MAIL	biomet@biomet.com

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of human figures.

JUL 01 2004

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Tracy J. Bickel Biomet Manufacturing Corporation 56 East Bell Drive Warsaw, Indiana 46582

Re: K041466 Trade/Device Name: Titanium Femoral Knee Components Regulation Number: 21 CFR 888.3560 Regulation Name: Knee joint, patellofemorotibial, polymer/metal/polymer semi-constrained cemented prosthesis Regulatory Class: II Product Code: JWH Dated: June 1, 2004 Received: June 2, 2004

Dear Ms.Bickel:

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.

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

Page 2 - Tracy J. Bickel

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 (301) 594-4659. 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 its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

(d Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known):

Device Name: Titanium Femoral Knee Components

Indications For Use:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where one or more compartments are involved,
1. Failure of previous joint replacement procedure,
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy or Arthrodesis
- Device designed for use in patients with metal sensitivity. .
- Standard surgical and rehabilitative procedures are indicated with . this device.
- The device is a single use device intended for use with bone . cement.

Prescription Use X __ 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)

uriam C. Provost

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

Page 1 of 1

K041466 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.