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Mpact 3D Metal Augments are intended for cementless use to the bone interface and are affixed to a compatible Medacta Acetabular shell using bone cement in hip replacement surgeries.

Mpact 3D Metal Augments are indicated in cases of:

• Acetabular dysplasia;
• Acetabular fractures;
• Revision of previous implants in the presence of insufficient bone quality or seriously altered bone structures.

The Mpact 3D Metal Augment II is an acetabular implant intended to be used in Total Hip Arthroplasty cemented to its Medacta compatible Acetabular Shell. It is provided sterile and individually packaged to the end user.

The devices subject of this submission are:

• Mpact 3D Metal Augments II from size Ø46 to Ø80, made of Ti6Al4V according to ASTM F2924;
• Double Augment Technique Screw, made of Ti6Al4V according to ISO 5832-3.

The Mpact 3D Metal Augments II represent the second generation of the Mpact 3D Metal Augments cleared within K171966.

This FDA 510(k) clearance letter pertains to a medical device, specifically the Mpact 3D Metal Augments II, which are implants for hip replacement surgeries. The document focuses on establishing substantial equivalence to existing predicate devices based on design and performance testing. However, it does not describe a clinical study in the traditional sense, especially not one that involves human subjects or assesses AI performance.

The provided text details non-clinical performance data and validations to support the device's substantial equivalence to its predicate. It does not contain information about acceptance criteria for AI performance, sample sizes for test sets in an AI context, expert ground truth establishment, MRMC studies, or standalone algorithm performance.

Therefore, many of the requested sections (including specific tables for acceptance criteria and device performance based on AI metrics, details about test sets, ground truth establishment for AI, MRMC studies, and standalone performance) cannot be filled from the provided document.

Here's a breakdown of the information that is available:

1. A table of acceptance criteria and the reported device performance

The document describes performance testing as "Fatigue testing in single and double augment configurations" and "Rationale of comparison – EBM Additive Manufacturing Technology." It also mentions "Design Validation on Mpact 3D metal Augments II." However, it does not disclose specific acceptance criteria or quantitative performance results for these tests. It only states that "testing activities were conducted to written protocols" and these validations are "provided in support of the substantial equivalence determination." This is typical for a 510(k) summary, which generally summarizes the data rather than providing all raw or detailed results.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the document. The "tests" here refer to non-clinical laboratory and material tests, not clinical studies involving 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 to the type of device and study described. There's no "ground truth" to be established by experts in the context of material fatigue or design validation for an orthopedic implant as presented here.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable to the type of device and study described. Adjudication methods are typically used in clinical trials or studies involving expert review of medical images or outcomes.

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

There is no MRMC or comparative effectiveness study mentioned, as this is a physical medical device (hip augments), not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is an orthopedic implant, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

This is not applicable in the sense of medical diagnosis or AI performance. The "truth" for these non-clinical tests would be the physical properties and performance characteristics determined by established engineering and materials testing standards.

8. The sample size for the training set

This is not applicable, as there is no "training set" for an AI algorithm mentioned in this document.

9. How the ground truth for the training set was established

This is not applicable, as there is no "training set" or "ground truth" for it in the context of AI.

Summary of what the document does provide regarding the study/testing:

The document describes non-clinical testing and validations performed to demonstrate the substantial equivalence of the Mpact 3D Metal Augments II to its predicate devices. These tests include:

• Design Validation: Performed on Mpact 3D Metal Augments II (details not provided).
• Performance Testing:
  • Fatigue testing in single and double augment configurations.
  • Rationale of comparison – EBM Additive Manufacturing Technology.
• Pyrogenicity: Control validated using bacterial endotoxin test (LAL test) per ISO11737-3 and European Pharmacopoeia §2.6.14, and in-vivo evaluation in rabbits per USP .
• Biocompatibility assessment.
• Shelf-life evaluation.

The document states that Medacta International S.A., based in Switzerland, submitted this 510(k). The tests are non-clinical, so data provenance regarding country of origin or retrospective/prospective does not apply in the same way as for clinical data. The studies are laboratory-based and conducted according to written protocols to ensure materials and design meet safety and performance standards for orthopedic implants.

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The 3DMetal Femoral Cones are indicated for use with Revision and GMK Hinge knee systems, as well as the GMK femoral extension stems and offsets. Specific indications are as follows:

-Severely painful and/or disabled joint as a result of arthritis, traumatic arthritis,
rheumatoid 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 Diaphyseal Femoral Cones are sterile implantable devices intended to be used in the diaphyseal side of the femoral component in order to fill and reconstruct large bone deficiencies and cavitary defects in the diaphysis of the distal femur. The subject devices are available in four different sizes and they are to be cemented to the extension stem used in GMK Revision and GMK Hinge systems in Total Knee Arthroplasty procedures. Analogously to the reference devices, the 3DMetal Diaphyseal Femoral Cones are manufactured using Electron Beam Melting (EBM) process with titanium alloy powder.

The provided text describes a 510(k) premarket notification for a medical device called "3DMetal Diaphyseal Femoral Cones." This is a regulatory submission demonstrating substantial equivalence to a predicate device, not a study evaluating AI performance or a comparative effectiveness study. Therefore, most of the requested information regarding AI-specific criteria, human readers, ground truth establishment for AI, and training set details are not applicable to this document.

However, I can extract information related to the device's acceptance criteria (in terms of performance testing) and the studies conducted to show it meets those criteria.

1. Table of Acceptance Criteria and Reported Device Performance

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

• Sample Size for Test Set: Not explicitly stated for each test. The studies referenced (e.g., dynamic fatigue, stereological evaluation) would typically involve a specific number of device samples for testing, but the exact quantity is not detailed in this summary.
• Data Provenance: The studies are "Non-Clinical Studies" conducted to validate the device design and characterize its performance. This indicates laboratory testing of the device itself, not data derived from human subjects or clinical experience. The provenance is internal to the manufacturer (Medacta International SA), as these are design validation and characterization tests. These are prospective tests on newly manufactured samples of the device.

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

• Not Applicable. This is a submission for a physical medical implant, not an AI or diagnostic device that requires expert-established ground truth from images or other data. The "ground truth" here is established by engineering standards, material science, and biomechanical principles validated through laboratory testing.

4. Adjudication Method for the Test Set

• Not Applicable. As this is not a study involving human interpretation of data, there is no adjudication method in the sense of expert consensus. The results are determined by objective measurements from laboratory tests against predefined engineering specifications or recognized standards (e.g., ASTM, European Pharmacopoeia, USP).

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

• No. No MRMC comparative effectiveness study was done, as this is a physical medical implant, not an AI diagnostic or assistance device. The document explicitly states: "No clinical studies were conducted."

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 device.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)

• For the non-clinical tests, the "ground truth" is derived from established engineering standards, material specifications, and biomechanical principles. For example:
  • Dynamic Fatigue Test: Ground truth is the endurance limit or fatigue life expected for the material and design under specified loads, often benchmarked against predicate devices or industry standards.
  • Stereological Evaluation: Ground truth relates to the measured porosity and pore size distribution meeting predefined specifications for the 3DMetal structure, often against specific ASTM standards (e.g., F1854-15 mentioned).
  • Biocompatibility: Ground truth is that the material (Ti6Al4V) is known and accepted as biocompatible for implantable devices, and this is confirmed by testing for specific biological responses (e.g., pyrogenicity).

8. The Sample Size for the Training Set

• Not Applicable. This is not an AI or machine learning device; therefore, there is no "training set."

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

• Not Applicable. There is no training set for this device.

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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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