1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where on or more compartments are involved.
1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.
  This device is intended for use with bone cement.

Device Description

The Maxim® RPG PS Femoral Components are composed of Co-Cr-Mo. The posterior stabilized femoral components provide posterior femoral rollback via a femoral cam that articulates with a polyethylene post on the tibial component. The minor modifications made were to the trochlear groove, and PS Box.
There are three sizes available in both right and left configurations for the Maxim® RPG PS Femoral Components. The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur.

AI/ML Overview

This document describes the Biomet Maxim® RPG PS Femoral Component, a knee joint prosthesis. The information provided is a 510(k) summary for premarket notification, which focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data as typically seen for novel devices.

Therefore, many of the requested elements regarding acceptance criteria, specific study design, and performance metrics (especially those involving human readers or AI) are not applicable or not present in the provided text. This is typical for a 510(k) submission where equivalence is established through design, materials, and non-clinical testing.

Here's an analysis based on the available text:

1. Table of acceptance criteria and the reported device performance

Acceptance Criteria (Implicit)	Reported Device Performance
Substantial equivalence to predicate device (Maxim® PS Femoral Component) in terms of overall design, geometry, materials, fixation enhancements, and intended use.	"In terms of overall design, including geometry, materials, and fixation enhancements, as well as intended use, the Maxim® RPG PS Femoral Component is equivalent to the predicate device."
Demonstrated safety and effectiveness through mechanical analysis (non-clinical testing).	"Mechanical analysis was completed to determine substantial equivalence."
Device modifications (trochlear groove and PS Box) do not alter the fundamental mechanism of action or safety/effectiveness compared to the predicate.	"The minor modifications made were to the trochlear groove, and PS Box." (Implicitly, these changes did not prevent a finding of substantial equivalence through mechanical testing).
Intended Use remains consistent with the predicate.	The listed indications for use are presented as the intended use of the device and are implicitly accepted as consistent with the predicate device for a 510(k) clearance. "The Maxim® RPG PS Femoral Component is indicated for: 1) Painful and disabled knee joint... 2) Correction of varus, valgus... 3) Correction or revision of unsuccessful osteotomy..."

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

Not Applicable. The submission states: "Clinical Testing: Clinical testing was not used to determine substantial equivalence." Instead, non-clinical mechanical analysis was performed. Details of the sample size for this mechanical analysis are not provided in the summary, nor is the provenance of any data beyond the fact it was "mechanical analysis."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not Applicable. No clinical test set demanding expert-established ground truth was used for this 510(k) submission. Mechanical testing does not typically involve expert ground truth in this manner.

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

Not Applicable. No clinical test set requiring adjudication was used.

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 physical knee prosthesis, not an AI or imaging device that would involve human readers or AI assistance.

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

Not Applicable. This device is a physical knee prosthesis, not an algorithm.

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

For the non-clinical mechanical testing, the "ground truth" would be established by engineering standards and specifications for material properties, component integrity, and performance under simulated loads, compared to the predicate device's known characteristics and performance. No direct patient outcomes or expert consensus for diagnosis/treatment were used for this particular submission.

8. The sample size for the training set

Not Applicable. No training set was used as this is not an AI/algorithmic device, and no clinical studies are reported for this 510(k). The "training" for such a device would be its historical development and iterative design process, not a formal training set in the context of an algorithm or clinical trial.

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

Not Applicable. As no training set was used in the context of a clinical or algorithmic study, no ground truth was established for it.

Summary

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K012348

Image /page/0/Picture/2 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, stylized font with a thick black outline. Below the logo, the words "CORPORATE HEADQUARTERS" are written in a smaller, thinner font.

SUMMARY OF SAFETY AND EFFECTIVENESS

Applicant or Sponsor:

Biomet. Inc. P.O. Box 587 Warsaw, Indiana 46581-0587

Contact Person:

Michelle L. McKinley Regulatory Specialist

Proprietary Name: Maxim® RPG PS Femoral Component

Common or Usual Name: femoral knee component

Classification Name: Knee joint patellofemorotibial polymer/metal/polymer semiconstrained cemented prosthesis (CFR 888.3560)

Device Classification: Class II

Device Product Code: 888.3560

Legally Marketed Device to which Substantial Equivalence is Claimed: Maxim® PS Femoral Component

Device Description:

There are three sizes available in both right and left configurations for the Maxim® RPG PS Femoral Components. The anatomic component design allows the surgeon to reconstruct the anatomic dimensions and kinematics of the natural femur.

Intended Use:

The Maxim® RPG PS Femoral Component is indicated for:

1. Painful and disabled knee joint resulting from osteoarthritis, rheumatoid arthritis, traumatic arthritis where on or more compartments are involved.
  MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

FAX 219.267.8137

E-MAIL biomet@hiomet.com

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Image /page/1/Picture/0 description: The image shows the logo for Biomet Corporate Headquarters. The word "BIOMET" is in a bold, stylized font. Below the logo, the words "CORPORATE HEADQUARTERS" are printed in a smaller, sans-serif font. The text is black and the background is white.

1. Correction of varus, valgus, or posttraumatic deformity.
1. Correction or revision of unsuccessful osteotomy, arthrodesis, or failure of previous joint replacement procedure.

This device is intended for use with bone cement.

Summary of Technologies: In terms of overall design, including geometry, materials, and fixation enhancements, as well as intended use, the Maxim® RPG PS Femoral Component is equivalent to the predicate device. Minor changes were made to the predicate femoral component.

Non-Clinical Testing: Mechanical analysis was completed to determine substantial equivalence.

Clinical Testing: Clinical testing was not used to determine substantial equivalence.

Maxim® is a registered trademark of Biomet,Inc.

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

에

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 219.267.6639

ドヘメ 219.267.81300087

E-MAIL . biomet@biomet.com

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.

Public Health Service

AUG 1 5 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Michelle L. McKinley Regulatory Specialist Biomet Inc. P.O. Box 587 Warsaw, Indiana 46581

Re: K012348

Trade Name: Maxim® RPG PS Femoral Component Regulation Number: 888.3560 Regulatory Class: II Product Code: JWH Dated: July 7, 2000 Received: August 4, 2000

Dear Ms. McKinley:

We have reviewed your Section 510(k) notification of intent to market the device referenced we have reviewed your Section 510(x) flouintially equivalent (for the indications for use to May 28, 1076, the above and we nave determined the devices marketed in interstate commerce provinces has needsessified in stated in the eliebourcy to device Amendments, or to devices that have been reclassified in your cou enactifield date of the Medical Dovice Parlena. Food, Drug, and Cosmetic Act (Act). You mays accordance with the provisions of the reachers' rood, of the Act. The general therefore, market the device, subject to the genirements for annual registration, listing of devices, controls provisions or the neater request required in the misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III If your device is classified (see above) into such additional controls. Existing major regulations (Premarket Approval), it may of subject to oder as a subteral Regulations, Title 21, Parts 800 to 895. allecting your device can or round nation assumes compliance with the current Good A Substantally oquirvatent downent, as set forth in the Quality System Regulation (QS) for Manufacturing I ractio regulation (21 CFR Part 820) and that, through periodic (QS) Medical Devices. General regulation (FDA) will verify such assumptions. Fallure to inspections, the rood and Drug Nammouties (1 x 2 x 1 x 1 x addition, FDA may publish contply with the GMI Tegatation into readeral Register. Please note: this response to your premarks contonting your submission does not affect any obligation you might It spollse to your promative no in 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your device as described in your 510(k) prematet notification. The FDA finding of substantial equivalence of your device to a legally marketed nontication. The I Driving of succion for your device and thus, permits your device to proceed to the market.

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Page 2 - Dr. Walter Abendschein

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and If you desire spoentle arriver diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, (201) 594-1639. Traditional (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small mormation on Jour rope at its toll-free number (800) 638-2041 or at (301) 443-6597, or at its Internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

Amplellestonfor

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

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510(k) Number (if known):

Device Name: Maxim® RPG PS Femoral Component

Indications for Use:

The Maxim® RPG PS Femoral Component is indicated for:

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

This device is intended for use with bone cement.

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE OF ANOTHER PAGE IS NEEDED)

Brmhheurofmann
Division Sign Off

Division of General, Restorative and Neurological Devic

510(k) Number K012348

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.