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The Mpact® 3D Metal™ implants are designed for cementless use in total hip arthroplasty in primary or revision surgery. The patient should be skeletally mature.

The patient's condition should be due to one or more of:

· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatic arthritis, rheumatoid arthritis or psoriatic 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

The Mpact® 3D Metal Implants - DMLS Technology are sterile implantable devices intended to be used during Total Hip Arthroplasty. The devices subject of this submission are:

• Mpact® 3D Metal Acetabular Shells Two-Hole Ø 46-66 mm manufactured through DMLS ● Technology;
• . Mpact® 3D Metal Acetabular Shells Multi-Hole - Ø 46-72 mm - manufactured through DMLS Technology:
• . Mpact® 3D Metal Acetabular Shells Multi-Hole Thin - Ø 48-60 mm - manufactured through DMLS Technology; and
• . Compression Polyaxial Locking Screws - 11 sizes depending on screw length: from 20 to 70mm in 5mm steps.

The Mpact® 3D Metal Acetabular Shells manufactured through DMLS Technology are a line extension to the Mpact® 3D Metal Acetabular Shells and 3D Metal Augments (K171966) and to the Mpact® Acetabular Systems Shells (K103721, K122641 and K132879) and are designed to be used with the Medacta Total Hip Prosthesis System.

The subject Mpact® 3D Metal Acetabular Shells are manufactured using a Direct Metal Laser Sintering (DMLS) process with titanium alloy powder. DMLS is a metal additive layer manufacturing process that uses a precise and high-wattage laser to "sinter" powdered metals and alloys to form accurate, complex and fully-functional metal parts directly from CAD data.

Compression Polyaxial Locking Screws have been designed to provide fixation of implants to the cancellous bone and they can be considered a line extension to the predicate devices, Cancellous Bone Screws flat head, previously cleared within K103721 and K132879. The subject screws have a thread diameter of 6.5 mm and they can be coupled with implants that have dedicated fixation holes with a spherical seat shape of Ø8mm.

The outer screw of the Compression Polyaxial Locking Screws is made of titanium alloy (Ti6-Al4-V) according to ISO 5832-3:2016, Implants for Surgery - Metallic materials - Part 3: Wrought titanium 6aluminum 4-vanadium alloy, while, the inner part, not in contact with bone, is made of Co-Cr-Mo alloy according to ISO 5832-12:2019, Implants for Surgery - Metallic materials - Part 3: Wrought cobaltchromium-molybdenum alloy.

I am sorry, but the provided text describes a 510(k) premarket notification for a medical device (hip implants), which focuses on demonstrating substantial equivalence to predicate devices based on non-clinical performance data and design validation.

The information you are asking for, such as:

• Acceptance criteria and reported device performance (in a table)
• Sample size and data provenance for a "test set"
• Number of experts and their qualifications for ground truth establishment
• Adjudication method for a test set
• Multi-Reader Multi-Case (MRMC) comparative effectiveness study
• Standalone algorithm performance
• Type of ground truth used (expert consensus, pathology, outcomes data, etc.)
• Sample size for the training set
• How ground truth for the training set was established

These elements are typically requested for AI/Machine Learning-based medical devices that perform diagnostic or interpretative functions, where the device's "performance" is measured in terms of metrics like sensitivity, specificity, accuracy, or reader improvement, and involves substantial data sets with established ground truth.

The provided document explicitly states: "No clinical studies were conducted." This further confirms that the type of performance evaluation (and associated data provenance, ground truth establishment, expert involvement, etc.) relevant to AI/ML devices was not part of this specific 510(k) submission.

Therefore, I cannot extract the information you requested from the provided text for the following reasons:

1. Device Type: This is a physical implant, not an AI/ML diagnostic or interpretative device.
2. Regulatory Pathway: The 510(k) for this device focuses on demonstrating substantial equivalence through engineering and biomechanical testing, not through AI model performance metrics.
3. Absence of Clinical Studies: The document explicitly states no clinical studies were performed, which is where performance data related to human-in-the-loop or standalone AI would typically come from.
4. No AI Mentioned: There is no mention of AI, machine learning, algorithms for interpretation, or any kind of software performance criteria beyond mechanical and material properties.

The "Performance Data" section in the document (Section VII) lists non-clinical studies such as:

• Design Validation (cadaver workshops, evaluation forms, rationales)
• Performance Testing (stereological evaluation, static and fatigue shear tests, tension tests, ROM evaluation, fatigue and deformation tests, liner stability tests, mechanical tests for screws)
• Pyrogenicity testing
• Biocompatibility assessment

These are typical tests for a physical orthopedic implant seeking 510(k) clearance, not for an AI/ML software as a medical device (SaMD).

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