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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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