MAXIM RPG PS FEMORAL COMPONENT by BIOMET, INC.

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

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.