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Mpact 3D Metal Implants
The Mpact 3D Metal Implants is designed to be used in total hip arthroplasty, for primary or revision surgery.
The patient should be skeletally mature.
Total hip arthroplasty is indicated in the following cases:
· Severely painful and/or disabled joint: as a result of osteoarthritis, post-traumatic arthritis or psoriactic arthritis, congenital hip dysplasia, ankylosing spondylitis.
· Avascular necrosis of the femoral head
· Acute traumatic fracture of the femoral head or neck
· Failure of previous hip surgery: joint reconstruction, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

Augments 3D Metal
The Augments 3D Metal are intended to be used in combination with the Mpact 3D Metal Multi-hole acetabular cup in hip replacement surgeries.
The Augments 3D Metal are indicated in cases of:
· Congenital dysplasia
· Acetabular fractures
· Revision of previous implants in presence of insufficient bone quality or seriously altered bone structures.

The Mpact® 3D Metal™ Implants and Augments 3D Metal™ are a line extension to the Mpact Acetabular System (K103721) which offers different acetabular shells, liner options, a screw plug, and cancellous bone screws for primary to complex hip revision solutions. The subject devices are manufactured using an Electron Beam Melting (EBM) process with titanium alloy powder. The devices subject to this 510(k) consist of two-hole shells, multi-hole shells, and augments.
The Mpact® 3D Metal™ Acetabular Two-Hole Shells are hemispherical porous shells with multiple liner options and two screw holes to be used with previously 510(k) cleared cancellous bone screws for additional fixation.
The Mpact® 3D Metal™ Acetabular Multi-Hole Shells are hemispherical porous shells with multiple liner options with up to 17 screw holes to be used with previously 510(k) cleared cancellous bone screws for additional fixation. The Mpact® 3D Metal™ Acetabular Shells can be coupled with standard Highcross Ultra-High Molecular Weight Polyethylene (UHMWPE) liners.
The Augments 3D Metal™ are porous metal augments designed to act as a defect filling implant in cases of severe bone loss in the acetabulum to help increase the stability of the acetabular component. The Augments 3D Metal™ are intended to be used in conjunction with the Mpact® Multi-Hole Acetabular Shells and Mpact® 3D Metal™ Multi-Hole Acetabular Shells to aid with bone defects in complex acetabular surgeries and provide surgeons with a prosthetic alternative to structural allograft in cases of segmental deficiencies.

This document is a 510(k) Premarket Notification from Medacta International SA for their Mpact® 3D Metal™ Implants and Augments 3D Metal™. It asserts substantial equivalence to predicate devices. It does not describe any studies involving AI or machine learning. Therefore, most of the requested information regarding acceptance criteria, device performance, sample sizes, ground truth, experts, adjudication methods, or MRMC studies for an AI/ML device is not applicable here.

However, it does describe the non-clinical performance and safety testing conducted for the medical device itself (hip implants and augments), to demonstrate substantial equivalence to predicate devices based on design, materials, manufacturing process, and performance.

Here's a breakdown of the available information based on your request, with an emphasis that this is for a physical medical device, not an AI/ML system:

1. A table of acceptance criteria and the reported device performance
The document states that "Testing was conducted according to written protocols with acceptance criteria that were based on standards." However, the specific acceptance criteria values and the reported device performance values are not provided in this summary document. It only lists the tests performed and the standards they reference.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This question is typically for AI/ML performance evaluation. For a physical device like hip implants, "test set" usually refers to the number of physical samples subjected to mechanical testing. This information (specific sample sizes for each test) is not provided in the summary. Data provenance is not applicable here as it refers to physical testing, not patient data.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as the "ground truth" for a physical implant's mechanical performance is defined by the established engineering standards (e.g., ASTM, ISO guidelines) against which its physical properties are tested. No human experts are used to "establish ground truth" in this context.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for physical device mechanical testing.

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 is for AI/ML systems and human reader performance.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is for AI/ML systems.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
For the mechanical performance of the device, the "ground truth" is defined by adherence to established international and national standards for medical devices and materials, specifically:

• ASTM F1854-15 (Stereological Evaluation of Porous Coatings)
• ASTM F1160-14 (Fatigue Shear Testing)
• ASTM F1044-05 (Static Shear Testing)
• ASTM F1147-05 (Tensile Strength Testing)
• ISO 7206-2:1996 (Deformation Testing)
• ASTM F1820-13 (Locking Mechanism Strength)
• EN ISO 21535:2009 (Range of Motion Testing)
• European Pharmacopoeia §2.6.14 and USP chapter (Bacterial Endotoxin Test)
• USP chapter (Pyrogen Test)

8. The sample size for the training set
Not applicable. This is for AI/ML systems.

9. How the ground truth for the training set was established
Not applicable. This is for AI/ML systems.

Summary of what is provided for the physical device:

The study proving the device meets acceptance criteria consists of non-clinical performance tests conducted according to written protocols and established standards.

Performed Non-Clinical Tests:

• Coating Characterization and Testing:
  • Stereological evaluation of porous coatings (ASTM F1854-15)
  • Fatigue shear testing (ASTM F1160-14)
  • Static shear testing (ASTM F1044-05)
  • Tensile strength testing (ASTM F1147-05)
• Deformation Testing: (ISO 7206-2:1996)
• Locking Mechanism Strength: (push-out, lever-out, and torque-out tests, ASTM F1820-13)
• Range of Motion Testing: (EN ISO 21535:2009)
• Dynamic Compression Testing of acetabular shell and augment assembly
• Fatigue Testing of the acetabular shell
• Pyrogenicity:
  • Bacterial Endotoxin Test (LAL test) according to European Pharmacopoeia §2.6.14 (equivalent to USP chapter )
  • Pyrogen test according to USP chapter

The document concludes that "Substantial equivalence has been demonstrated through a comparison of intended use, design and technological characteristics, as well as performance evaluations." This implies that the device met the acceptance criteria defined by these standards, but the specific results and numeric criteria are not detailed in this summary.

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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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