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The Freedom® Metal Backed Tibial Component consists of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert that are designed to be used with the Freedom® Total Knee System. The Maxx Orthopedics' Freedom® Total Knee System is indicated for patients with severe knee pain and disability due to:

Severe knee joint pain, loss of mobility, and disability due to: rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis.
Correction of functional deformities.
Post-traumatic loss of knee joint contour, particularly when there is patellofemoral erosion, dysfunction, and/or prior patellectomy.
Moderate valgus, varus, or flexion trauma.
Knee fractures untreatable by other methods.

The Maxx Orthopedics' Freedom Total Knee System is intended for cemented use only. This device is for single use only.

Device Description

The Maxx Orthopedics' Freedom® Metal Backed Tibial Component and Ultra High Molecular Weight Polyethylene (UHMWPE) insert are compatible with the Maxx Orthopedics Freedom® Total Knee System subject of K082019. The Maxx Orthopedics' Freedom® Total Knee System subject of K082019 is comprised of a femoral component, tibial component and patella component.

The Freedom® Metal Backed Tibial Component and UHMWPE insert are intended to be used with the Freedom® Total Knee System. The proposed metal backed Tibial Component and UHMWPE insert will be used in place of the all-poly tibial component with the Freedom® Total Knee System.

The proposed metal backed tibial component consists of a cobalt-chromiummolybdenum tray, and the insert is made from UHMWPE. These components are intended for cemented application to replace the articulating surface of the proximal tibia in a measured resection.

The tibia base components are designed with a keel portion which extends into the proximal tibial medullary canal. The more distal portion of the tibial base has a flat plate that rests on the patient's tibial plateau region. On the underside of this plate are cement recesses allowing allow for cement interdigitation which helps to provide rotational stability. The Freedom® Knee tibial inserts have an interlocking relation to the tibial base. The Freedom® Knee femoral components articulate with the bearing base (proximal) surface of the tibial inserts. The articulating surface of these inserts is identical to the articulating surface of the all-poly liner components mentioned in the already cleared Freedom® Total Knee System (K082019).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information based on the provided text:

1. Acceptance Criteria and Reported Device Performance

The document does not explicitly state numerical acceptance criteria for performance metrics (e.g., minimum fatigue life, maximum wear rate). Instead, the acceptance is based on demonstrating mechanical and functional similarity to predicate devices and adherence to relevant guidance documents.

Acceptance Criteria (Implied)	Reported Device Performance
Mechanical and functional similarity to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems.	"Mechanical and functional testing described in K082019 and in Section 8 demonstrates that the Freedom® Metal Backed Tibial Component are mechanically and functionally similar to the parent Freedom UHMWPE Tibial Component and other legally marketed knee systems." Additionally, "The proposed and predicate devices are made of biocompatible materials and are technological designed and identical in materials." "The articulating surface of the proposed Maxx Orthopedics Freedom® femoral and tibial components, are similar to the articulating surface of the predicate systems and are functionally equivalent devices."
Adherence to Class II Special Controls Guidance Document: Knee Joint Patellofemorotibial and Femorotibial Metal/Polymer Porous-Coated Uncemented Prostheses; Guidance for Industry and FDA.	"Evaluations were performed to determine the material and mechanical characteristics of the Maxx Orthopedics' Freedom® Metal Backed Tibial Component and the Freedom® Total Knee System according to the Class II Special Controls Guidance Document..." "The verification and validation testing performed which demonstrated that the Metal Backed Tibial Component functions as intended and is safe and effective for its intended use."
Substantial Equivalence to Predicate Devices (Exactech Optetrak Total Knee Tibial Components K030686)	The FDA's 510(k) clearance letter explicitly states, "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices..." The document highlights that "The proposed Maxx Orthopedics' Freedom® Metal Backed Tibial Component and the predicate devices are identical in that they all consist of a cobalt-chrome molybdenum (CoCrMo) tray and a UHMWPE insert." and both "have been designed to mimic the normal knee geometry." and "are available in a variety of tibial tray and insert sizes."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of clinical data or human-interpreted data. The performance testing describes mechanical and functional testing, not a clinical study on patients. Therefore, information regarding sample size and data provenance (country of origin, retrospective/prospective) for a test set is not applicable or provided.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not applicable as the document describes mechanical and functional testing of a medical device, not a study requiring expert interpretation of diagnostic data to establish ground truth.

4. Adjudication Method for the Test Set

This information is not applicable for the same reasons as point 3.

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

This information is not applicable. The document describes the mechanical testing and substantial equivalence of a knee implant, not an AI or imaging diagnostic device. Therefore, MRMC studies are not relevant.

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

This information is not applicable. The device is a physical knee implant, not an algorithm.

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

For the mechanical and functional testing, the "ground truth" would be established by engineering standards, material specifications, and biomechanical performance requirements derived from the Class II Special Controls Guidance Document and comparisons to predicate devices. This is not the same as a clinical "ground truth" established by pathology or expert consensus.

8. The Sample Size for the Training Set

This information is not applicable. The device is a physical knee implant, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the same reasons as point 8.

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