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The 3DMetal Tibial Cones are indicated for use with the GMK Hinge knee systems, as well as the GMK tibial extension stems and offsets.

Specific indications are as follows:

• · Severely painful and/or disabled joint as a result of arthritis, theumatoid arthritis or polyarthritis.
• · Post traumatic loss of joint configuration.
• · Considerable loss of function of the knee joint.
• · High-grade joint destruction requiring additional stabilization and reconstruction of bone defects.
• · Primary implantation failure.
• · Former revision arthroplasty.

The 3DMetal Tibial Cones are implantable devices to be used as fillers in cases of severe bone deficiency. The subject devices are to be cemented to the GMK Revision and GMK Hinge systems' tibial trays. The subject devices have a full-density layer that prevents cement occluding the pores of the external layer.

The purpose of this submission is to gain clearance for the tibial cones available in centred and eccentric versions. The tibial cones are available in sizes XS, S, M, and L with heights of 20 mm and 25 mm.

The subject devices are intended to be used with the cleared indications for use and the tibial trays of Medacta's GMK Revision (K102437) and GMK Hinge (K130299) systems.

The 3DMetal Tibial Cones are manufactured with titanium alloy substrate, which is identical to predicate devices Regenerex Porous Titanium Sleeve Augments (K072336). However the subject devices' material is processed using electron beam melting (EBM) similar to the material of referenced device Delta TT Acetabular System (K141395).

This document is a 510(k) premarket notification for a medical device called "3DMetal Tibial Cones." The purpose of this notification is to demonstrate that the device is substantially equivalent to legally marketed predicate devices, and therefore does not require a premarket approval application (PMA).

Here's an analysis of the acceptance criteria and study information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not present a formal table of acceptance criteria with specific numerical targets and reported device performance. Instead, it states that "testing was conducted to written protocols with acceptance criteria that were based on standards and FDA guidance documents." The performance data is described qualitatively, referencing compliance with various ASTM standards.

However, based on the performance data section, we can infer the types of tests conducted and their implied acceptance criteria (compliance with standards).

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

The document does not specify the sample size for any of the non-clinical mechanical or pyrogenicity tests. It simply states that "testing was conducted to written protocols."

The data provenance is from non-clinical laboratory testing performed by the manufacturer, Medacta International SA. There is no mention of country of origin for the data beyond the manufacturer's location (Switzerland), and the studies are inherently prospective as they were conducted to support this submission.

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

Not applicable. This submission focuses on the substantial equivalence of a physical medical device (tibial cones) for knee replacement, based on mechanical testing and material properties, not on diagnostic performance or interpretation by experts. Therefore, there is no "ground truth" in the traditional sense established by experts for a test set.

4. Adjudication Method for the Test Set:

Not applicable. As there is no ground truth requiring expert consensus or interpretation, no adjudication method 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 submission is for an implantable medical device, not an AI-powered diagnostic tool. Therefore, an MRMC comparative effectiveness study involving human readers and AI assistance is irrelevant and was not performed.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

Not applicable. This is not an algorithm or AI-based device.

7. The Type of Ground Truth Used:

The "ground truth" in this context refers to the established scientific and engineering standards and principles demonstrated through laboratory testing. The device is evaluated against:

• Mechanical performance standards: ASTM F1800-12, ASTM F1044-05, ASTM F1160-14, ASTM F1147-05, ASTM F1854-09.
• Biocompatibility standards: Implied by comparison to predicate devices and general standards for implantable materials.
• Material composition standards: ISO 5832-3:1996, ASTM F2924-12a.
• Pyrogenicity standards: European Pharmacopoeia §2.6.14, USP chapter .

Essentially, the ground truth is the device's ability to consistently meet these recognized safety and performance benchmarks.

8. The Sample Size for the Training Set:

Not applicable. This is not an AI/machine learning device that requires a training set. The device's design and manufacturing processes are based on established engineering principles and material science.

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

Not applicable. As there is no training set for an AI/machine learning model, this question is not relevant.

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