Severely painful and/or disabled joint: as a result of osteoarthritis, posttraumatic 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, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

Device Description

The Mpact Extension components are designed to be used with the Medacta Total Hip Prosthesis System. The Mpact Extension acetabular components that are the subject of this 510(k) consist of a multi-hole or rim-hole shell (Ti-6Al-4V, ASTM F136 and Ti, ASTM F1580 porous coating), a fixed liner in sizes "J" and "K" that is made of ultra-high molecular weight polyethylene (UHMWPE ISO 5834-2 Type1) or HighCross® highly crosslinked ultra-high molecular weight polyethylene (HXUHMWPE), and a cortical bone screw, flat head (Ti-6AJ-4V, ISO 5832-3).

AI/ML Overview

The provided document describes the 510(k) submission for the Mpact Extension, a hip prosthesis system. It outlines the performance testing conducted to demonstrate substantial equivalence to predicate devices, but it does not include the detailed information requested regarding sample sizes, data provenance, expert qualifications, or comparative effectiveness studies in the context of an AI/algorithm-based device.

This document is for a traditional medical device (hip prosthesis), not an AI/ML-based medical device. Therefore, many of the requested categories (like "Number of experts used to establish ground truth," "Adjudication method," "MRMC comparative effectiveness study," "Training set sample size," etc.) are not applicable to this type of submission.

However, I can extract the available information related to acceptance criteria and device performance based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Type	Acceptance Criteria (Implied)	Reported Device Performance
Pull-out stability (modular connection of fixed liner to metal shell)	(Implied: Meet established standards/predicate device performance for pull-out strength/resistance)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Lever-out stability (modular connection of fixed liner to metal shell)	(Implied: Meet established standards/predicate device performance for lever-out resistance)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Torsional stability (modular connection of fixed liner to metal shell)	(Implied: Meet established standards/predicate device performance for torsional resistance)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Coating validation	(Implied: Meet established standards for coating adhesion, integrity, and biocompatibility)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Metal shell deformation resistance during impaction	(Implied: Resist deformation during surgical impaction within acceptable limits as per standards/predicate device performance)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Range of motion	(Implied: Demonstrate an acceptable range of motion, comparable to predicate devices or physiological norms)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Wear	(Implied: Exhibit wear rates within acceptable limits as per standards/predicate device performance)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)
Bone screw testing	(Implied: Meet established standards for bone screw performance, e.g., thread pull-out strength, torsional strength, fatigue)	Testing was conducted "as part of design verification to written protocols with pre-defined acceptance criteria." The testing "met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices." (Specific numerical values for acceptance criteria or performance are not provided in this summary.)

Study Proving Acceptance Criteria Met:

The study was described as "Performance testing of the Mpact Extension," conducted "in accordance with various international standards and FDA guidance documents." The testing was part of "design verification to written protocols with pre-defined acceptance criteria."

Details on the Study (as much as available in the text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: The document states that testing was "conducted on the worst case component size and option/design." However, it does not specify the exact number of samples or units tested for each type of test (e.g., number of shells, liners, or screws).
- Data Provenance: Not specified. This type of physical device testing typically wouldn't have "country of origin of the data" in the same sense as patient data.
- Retrospective or Prospective: Not applicable in the context of physical product testing. It's prospective testing.
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):
- Not applicable as this is performance testing of a physical medical device, not an AI/ML algorithm requiring expert interpretation for ground truth.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable.
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 not an AI/ML device.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI/ML device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- The "ground truth" or reference standard for this type of testing is established by the relevant "international standards and FDA guidance documents" specific to orthopedic implants. These standards define the benchmark performance requirements for pull-out strength, wear, deformation, etc.
The sample size for the training set:
- Not applicable. This is not an AI/ML device.
How the ground truth for the training set was established:
- Not applicable. This is not an AI/ML device.

Summary

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K122641 (pg 1/37

Image /page/0/Picture/1 description: The image shows the logo for Medacta International. The logo consists of two black triangles pointing upwards, followed by the word "edacta" in lowercase letters. Below the logo is the word "International" and a small cross symbol.

SEP 28 2012

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: Mr. Adam Gross Director of Regulatory and Quality Medacta USA 4725 Calle Quetzal, Unit B Camarillo, CA, 93012 Phone: (805)437-7085 Fax: (805)437-7553 Email: AGross@medacta.us.com

Date Prepared: 08/31/2012

DEVICE INFORMATION

Trade/Proprietary Name: Mpact Extension Common Name: Total Hip Acetabular Components Class II

Classification Name: 21 CFR 888.3358 - Hip joint, femoral metal/polymer/metal semiconstrained porouscoated uncemented prosthesis Device Product Code: LPH

21 CFR 888.3353 - Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Device Product Code: LZO

Predicate Devices: K103721 Mpact Acetabular System, Medacta International K033338 Pinnacle Revision System, Depuy Orthopaedics

Mpact Extension 510(k)

Section 5 - Page 2004

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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, posttraumatic t arthritis, rheumatoid arthritis or psoriatic arthritis, congenital hip dysplasia. ankylosing spondvlitis.
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.

Comparison to Predicate Devices

The indications for use of the Mpact Extension are identical to the previously cleared predicate devices. The design features and materials of the subject devices are substantially equivalent to those of the predicate devices. The fundamental scientific technology of the modified devices has not changed relative to the predicate devices. The safety and effectiveness of the Mpact Extension are adequately supported by the substantial equivalence information, materials information, and analysis data provided within this Premarket Notification.

Performance Testing

No performance standards applicable to this device have been adopted under Section 514 of the Food, Drug and Cosmetic Act. Performance testing of the Mpact Extension was conducted in accordance with various international standards and FDA guidance documents. The Mpact Extension was tested as part of design verification to written protocols with pre-

Mpact Extension 510(k)

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defined acceptance criteria. The Mpact Extension testing was conducted on the worst case component size and option/design. The design verification testing included pull-out, lever-out and torsional stability of the modular connection of the fixed liner to the metal shell, coating validation, metal shell deformation resistance during impaction, range of motion, wear, and bone screw testing. The testing met all acceptance criteria and verifies that the performance of the Mpact Extension is substantially equivalent to the predicate devices.

K122641 (pg 313)

Conclusion:

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

Mpact Extension 510(k)

Section 5 - Page 4 A

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.

Public Health Service

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

SEP 28 2012

Medacta International % Medacta USA Mr. Adam Gross 4725 Calle Quetzal, Unit B Camarillo, CA 93012

Re: K122641

Trade/Device Name: Mpact Extension Regulation Number: 21 CFR 888.3353 Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Regulatory Class: Class II Product Code: LZO, LPH Dated: August 29, 2012 Received: August 29, 2012

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 I va may, alcreater, mains 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 If your device is eadditional 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 i lease be activities that i Drivistian that your device complies with other requirements of the Act that I DA has made a acterinalitions administered by other Federal agencies. You must

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Page 2 - Mr. Adam Gross

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 forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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 yours,
Mark McMullen

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

Enclosure

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Indications for Use

510(k) Number (if known): K(22641 (pa 1/1)

Device Name: Mpact Extension

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, posttraumatic . 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, internal fixation, arthrodesis, ● hemiarthroplasty: surface replacement arthroplasty, or total hip replacement where sufficient bone stock is present.

Prescription Use × (21 CFR 801 Subpart D)

AND/OR

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

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Oft) Division of Surgical, Orthopedic, and Restorative Devices

Mpact Extension 510(k) August 27, 2012

K122641 510(k) Number

Section 4 - Page 2 of 2

Regulation Number and Section

§ 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis.

(a)
Identification. A hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis is a device intended to be implanted to replace a hip joint. This device limits translation and rotation in one or more planes via the geometry of its articulating surfaces. It has no linkage across-the-joint. The two-part femoral component consists of a femoral stem made of alloys to be fixed in the intramedullary canal of the femur by impaction with or without use of bone cement. The proximal end of the femoral stem is tapered with a surface that ensures positive locking with the spherical ceramic (aluminium oxide, A12 03 ) head of the femoral component. The acetabular component is made of ultra-high molecular weight polyethylene or ultra-high molecular weight polyethylene reinforced with nonporous metal alloys, and used with or without bone cement.(b)
Classification. Class II.