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The ADVANCE® Porous Coated Spiked Tibial Base is indicated for use in knee arthroplasty in skeletally mature patients with the following conditions:

1. Non-inflammatory degenerative joint disease: including osteoarthritis, traumatic arthritis, or avascular necrosis

2. Inflammatory degenerative joint disease, including rheumatoid arthritis;

3. Correction of functional deformity

4. Revision procedures where other treatments or devices have failed; and treatment of fractures that are unmanageable using other techniques.

The ADVANCE® Porous Coated Spiked Tibial Base is for uncemented use only.

The subject device is a line extension of the ADVANCE® Total Knee System.

The ADVANCE® Porous Coated Spiked Tibial Base is a porous coated tibial component with spikes on the distal surface for additional fixation. The design features are summarized below:

• Manufactured from titanium alloy ●
• Titanium sintered bead porous coating .
• Offered in the same size ranges as the predicate device ●
• Compatible with all 510(k) cleared ADVANCE® II Tibial Inserts and . EVOLUTION® Adaptive Inserts

This document is a 510(k) Pre-Market Notification from the FDA regarding a medical device, the ADVANCE® Porous Coated Spiked Tibial Base. It does not describe an AI/ML device or a study involving such a device based on the prompt's request.

Therefore, none of the requested information about acceptance criteria, device performance, sample sizes, expert ground truth, adjudication methods, MRMC studies, standalone performance, or training set details is present in the provided text.

The document primarily focuses on demonstrating substantial equivalence to a predicate device for regulatory approval for a physical medical implant. It mentions:

• Device Name: ADVANCE® Porous Coated Spiked Tibial Base
• Regulation Number: 21 CFR 888.3565
• Regulation Name: Knee joint patellofemorotibial metal/polymer porous-coated uncemented prosthesis
• Class: Class II
• Product Code: MBH
• Indications for Use: (listed on page 2 and 4)
• Predicate Device: ADVANCE® HA Coated Spiked Tibial Base and HA Coated Modular Keel (K043083)
• Reference Devices: ADVANCE® II Porous Coated Modular Titanium Tibial Component (K061223) and EVOLUTION® CS/CR Porous Coated Femur (K140735)
• Nonclinical Testing: Rotational stability testing and fatigue evaluation per ASTM F1800 was performed on the primary predicate device. Porous coating characterization was done for the reference device. The subject device leveraged this data due to identical structural geometries and porous coatings.
• Clinical Testing: "Clinical data was not provided for the subject devices." (page 5)

Since no AI/ML component is mentioned or implied, the requested details for evaluating an AI/ML device are not applicable.

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