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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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The GMK® Total Knee System is designed for cemented use in total knee arthroplasty, if there is evidence of sufficient sound bone to seat and support the components.

This knee replacement system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis.

• Avascular necrosis of femoral condyle.

• · Post traumatic loss of joint configuration.
• · Primary implantation failure.

Tibial wedges cemented are to be attached to the tibial baseplate with both the fixing cylinders and bone cement.

The GMK HINGE knee prosthesis is designed for cemented use in total knee arthroplasty when the preoperative diagnosis of the joint determines that the bone and stability situation require the implantation of a constrained prosthesis.

The GMK HINGE knee system is indicated in the following cases:

· Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis, rheumatoid arthritis or polyarthritis associated with bone loss and/or severe joint instability

· Considerable loss of function of the knee joint

· High-grade joint destruction requiring additional stabilization with stems and reconstruction of bone defects with metal augmentation

· Failure of a primary prosthesis (e.g. infection, loosening)

· Former revision arthroplasty

· Post traumatic loss of joint configuration

· Avascular necrosis of femoral condyle.

Tibial augmentation are to be screwed to the tibial baseplate with both the two provided fixing screws.

When a GMK HINGE® implant is used it is mandatory to implant both the femoral and tibial components with an extension stem.

The GMK Revision-Femoral Distal Augmentations have been designed to allow the surgeon to selectively fill bone deficiencies and to aid in adjusting the height of the joint line. In addition, these augments can help to achieve a stable fixation between the implant and the bone.

The purpose of this submission is to gain clearance for additional femoral distal augmentation thicknesses of 12 mm, 16 mm, and 20 mm, which can be used with the 5 mm thick posterior wedges. The previously cleared femoral distal augmentation sizes (referred to K102437 as femoral distal wedges) were for 4 mm, 8 mm, and 12 mm.

The subject devices are matched with the GMK Revision STD femoral component, GMK Revision PS femoral component and the GMK Hinge femoral component. The distal wedge is fixed to the femoral component through a thickness-specific titanium alloy screw packaged with it.

The GMK Revision-Femoral Distal Augmentations are manufactured from high nitrogen stainless steel, which is identical to the predicate device GMK Revision and GMK Hinge femoral distal augmentations (also referred to as wedges) which are available in size range 1-6 with thicknesses of 4 mm, 8 mm, and 12 mm.

This document is a 510(k) premarket notification for a medical device called "GMK Revision-Femoral Distal Augmentation." It focuses on demonstrating substantial equivalence to a predicate device, rather than providing a detailed study that defines and proves the device meets specific performance acceptance criteria.

The information provided does not include:

• A table of acceptance criteria and reported device performance in the context of diagnostic or AI-driven performance.
• Sample sizes for test sets, data provenance, or details about training sets.
• Information on experts (number, qualifications, adjudication methods) for establishing ground truth.
• Details about Multireader Multicase (MRMC) comparative effectiveness studies or standalone algorithm performance.
• Specific ground truth types like pathology or outcomes data.

Instead, this document focuses on mechanical and manufacturing characteristics, and a comparison with a predicate device to argue for substantial equivalence.

Here's a breakdown of what is available related to performance and testing:

1. Acceptance Criteria and Reported Device Performance:

The document doesn't present "acceptance criteria" in the typical sense for an AI/diagnostic device (e.g., sensitivity, specificity, accuracy). Instead, it discusses the device's ability to withstand physiological loads and maintain stability.

2. Sample Size for Test Set and Data Provenance:

• Sample Size: Not explicitly stated as a numerical sample size of "cases" or "patients." The performance data refers to "worst-case product configuration" for mechanical testing, implying a limited number of physical prototype tests. For LAL testing, no sample size is given.
• Data Provenance: Not specified regarding country of origin or whether it's retrospective/prospective. The testing appears to be lab-based mechanical and biological testing of the device itself (or its material), not clinical trial data.

3. Number of Experts and Qualifications:

• Not applicable. This document does not describe studies involving human readers or expert evaluation as part of device performance assessment.

4. Adjudication Method:

• Not applicable. No expert consensus or adjudication method is described.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

• No. This is a premarket notification for a knee implant component, not an AI or diagnostic tool. Therefore, no MRMC study or AI assistance effectiveness is discussed.

6. Standalone (Algorithm Only) Performance:

• No. This is a physical medical device; there is no algorithm or AI component discussed for standalone performance.

7. Type of Ground Truth Used:

• For the mechanical tests (withstanding loads, fretting, stability), the "ground truth" is derived from the physical properties and behavior of the device under simulated physiological conditions.
• For biocompatibility, the "ground truth" is established through standardized biological safety testing (e.g., LAL testing) and material characterization.

8. Sample Size for the Training Set:

• Not applicable. There is no AI component or "training set" in the context of this device.

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

• Not applicable, as there is no training set.

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