· Severely painful and/or disabled joint: as a result of osteoarthritis, rheumatod 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, internal fixation, arthrodesis, hemiarthroplasty,

surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

• Dislocation risks

Device Description

The Mpact Double Mobility System acetabular shells are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Double Mobility System consists of acetabular shells (size 42mm to 66mm in 2mm increments) that have a TiGrowth porous coating (Ti, ASTM F1580) and hemispherical shape that is identical to the K103721 and K132879 predicate devices. The material of the shells (High Nitrogen StSt - ISO 5832-9) and the double mobility design is the same as the K083116 predicate device.

The shells are used with the Versafitcup Double Mobility Liners that are registered with K083116, K092265, and K131458 predicate devices in addition to one new size (22.2/DMA) of the Medacta Double Mobility liner in both UHMWPE (ISO 5834-2 Type 1) and HighCross highly crosslinked UHMWPE which are included in this submission. These liners are identical to the liners in the K083116, K092265, and K131458 submissions but have a smaller external diameter than the predicates. These new liners can only be coupled with a 22.2mm femoral head and have a minimum thickness of 5 mm.

AI/ML Overview

The provided text is related to a 510(k) premarket notification for a medical device (Mpact Double Mobility System), which focuses on demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through clinical studies as would typically be described for AI/software devices. Therefore, much of the requested information regarding clinical study specifics (sample size, ground truth, expert qualifications, etc.) is not applicable or cannot be extracted from this document.

However, I can extract the information related to performance testing which serves as the "study" demonstrating the device's substantial equivalence based on pre-defined acceptance criteria.

Acceptance Criteria and Device Performance for Mpact Double Mobility System

The "study" for this device is primarily a demonstration of substantial equivalence through performance testing rather than a clinical trial with human subjects. The acceptance criteria were based on established standards, FDA guidance, and comparison to predicate devices. The document indicates that the Mpact Double Mobility System's performance was found to be "not worst case" compared to the worst-case predicate device and had "similar performance testing as the predicates."

1. Table of Acceptance Criteria and Reported Device Performance

Test/Characteristic	Acceptance Criteria (Based On)	Reported Device Performance
Acetabular Shell:
Coating Adhesion	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Chemical Characterization (Coating)	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Friction Test	ASTM G115-04 and ASTM D4518-94	Evaluated, similar performance as predicates.
Ion Release and Corrosion Test	ASTM F746-04	Evaluated, similar performance as predicates.
Acetabular Shell and Liner:
Excessive Wear During Motion	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Limited ROM	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Dislocation Risk	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.
Acetabular Liner:
Instability Risk of Modular Connection	Standards, FDA guidance, comparison to predicate devices	Evaluated, similar performance as predicates.

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

Sample Size: Not explicitly stated in terms of number of devices or components. The testing would involve specific numbers of components/assemblies required by the cited ASTM standards and internal protocols for mechanical and material tests.
Data Provenance: The tests are likely performed in a laboratory setting by Medacta International, the device manufacturer. This is not patient-specific data, but rather device performance data.

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

Not applicable in the context of this 510(k). This is pre-clinical engineering and materials testing, not a clinical study involving human judgment or expert consensus for "ground truth" derived from patient data. The "ground truth" here is the established performance characteristics and safety profiles of predicate devices and relevant industry standards.

4. Adjudication Method for the Test Set

Not applicable. There is no clinical "test set" requiring adjudication by human experts in this document. Test results are compared against pre-defined acceptance criteria based on standards and predicate device performance.

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 document describes a hip prosthesis, not an AI or software-based medical device. Therefore, no MRMC study or assessment of human reader improvement with AI assistance was performed or is relevant.

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

Not applicable. This is a hardware medical device (hip prosthesis), not an algorithm or AI.

7. The Type of Ground Truth Used

The "ground truth" for this submission are the performance characteristics and safety profiles of the legally marketed predicate devices, as well as relevant international and national standards (e.g., ASTM F1580, ISO 5834-2 Type 1, ASTM G115-04, ASTM D4518-94, ASTM F746-04). This document aims to demonstrate that the new device is substantially equivalent to these established benchmarks.

8. The Sample Size for the Training Set

Not applicable. There is no "training set" in the context of a 510(k) submission for a hip prosthesis. This term is specific to AI/machine learning models.

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

Not applicable. As there is no training set for an AI/ML model, this question is not relevant to the provided document.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three human profiles incorporated into its design. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 2, 2015

Medacta USA Mr. Adam Gross Director of Regulatory, Quality and Compliance 1556 West Carroll Avenue Chicago, Illinois 60607

Re: K143453 Trade/Device Name: Mpact Double Mobility System Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: Class II Product Code: LPH, LZO, MEH Dated: December 22, 2014 Received: December 30, 2014

Dear Mr. Gross:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Mr. Adam Gross

forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely vours.

Lori A. Wiggins -S

for Mark N. Melkerson Director Division of Orthopedic Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K143453

Device Name Mpact Double Mobility System

Indications for Use (Describe)

The hip prosthesis is 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, rheumatod 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, internal fixation, arthrodesis, hemiarthroplasty,

surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

• Dislocation risks

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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K143453 Page 1 of 3

Image /page/3/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two blue triangles, the word "Medacta" in blue, a yellow line underneath the word, and the word "International" in gray. There is also a Swiss flag to the right of the word "International".

510(k) Summary

Applicant/Sponsor: Medacta International SA Strada Regina 6874 Castel San Pietro (CH) Switzerland Phone (+41) 91 696 60 60 Fax (+41) 91 696 60 66

Contact Person: Adam Gross Director of Regulatory, Quality and Compliance Medacta USA 1556 W Carroll Ave Chicago, IL 60607 Phone: (805) 910-6511 Fax: (805) 437-7553 Email: AGross@medacta.us.com
Date Prepared: November 19, 2014

DEVICE INFORMATION

Trade/Proprietary Name: Mpact Double Mobility System Classification Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Class II 21 CFR 888.3358, Product Code LPH 21 CFR 888.3353, Product Code LZO, MEH

Predicate Device(s):

510(k)	Product	510(k) Holder	Clearance Date
K083116	Versafitcup Double Mobility	Medacta International	4/7/2009
K092265	Versafitcup DM Highly Crosslinked	Medacta International	3/12/2010
K103721	Mpact Acetabular System	Medacta International	3/21/2011
K132879	Mpact Extension	Medacta International	1/22/2014
K131458	Mpact DM Converter	Medacta International	10/1/2013

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Product Description

Indications for Use

The hip prosthesis is 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, post-traumatic arthritis, rheumatoid 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

• Dislocation risks

Comparison to Predicate Devices

The indications for use, design features and materials of the Mpact Double Mobility System are substantially equivalent to those of the predicate devices. The substantial equivalence of the Mpact Double Mobility System implants is supported by the performance testing, materials information, and data analysis provided within this Premarket Notification.

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Performance Testing

The Mpact Double Mobility System was evaluated by risk analysis to identify any new risks associated with the change. Based on the risk analysis, design verification was conducted to written protocols with pre-defined acceptance criteria. The protocols and pre-defined acceptance criteria were based on the standards, FDA guidance, and comparison to the predicate device system. The Mpact Double Mobility System was compared to the worst case predicate device and it was determined that the Mpact Double Mobility System is not worst case.

Mpact Double Mobility System has similar performance testing as the predicates in terms of:

Acetabular shell:

Coating adhesion and chemical characterization
Friction test ASTM G115-04 and ASTM D4518-94 ●
lon release and corrosion test ASTM F746-04 0

Acetabular shell and liner:

Excessive wear during motion
Limited ROM .
Dislocation Risk

Acetabular liner:

. Instability risk of the modular connection of the Mpact Double Mobility Liner and femoral head

Conclusion:

Based on the above information, the Mpact Double Mobility System can be considered as substantially equivalent to its predicate devices.

Regulation Number and Section

§ 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis.

(a)
Identification. A hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis is a device intended to be implanted to replace a hip joint. The device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across the joint. This generic type of device has a femoral component made of a cobalt-chromium-molybdenum (Co-Cr-Mo) alloy or a titanium-aluminum-vanadium (Ti-6Al-4V) alloy and an acetabular component composed of an ultra-high molecular weight polyethylene articulating bearing surface fixed in a metal shell made of Co-Cr-Mo or Ti-6Al-4V. The femoral stem and acetabular shell have a porous coating made of, in the case of Co-Cr-Mo substrates, beads of the same alloy, and in the case of Ti-6Al-4V substrates, fibers of commercially pure titanium or Ti-6Al-4V alloy. The porous coating has a volume porosity between 30 and 70 percent, an average pore size between 100 and 1,000 microns, interconnecting porosity, and a porous coating thickness between 500 and 1,500 microns. The generic type of device has a design to achieve biological fixation to bone without the use of bone cement.(b)
Classification. Class II.