MSA HIP SYSTEM by GLOBAL MANUFACTURING TECHNOLOGY

The MSA Hip System is indicated for cementless use and is intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary surgery for total hip replacement patients suffering from severe hip pain and disability due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur. patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion patients with acute femoral neck fractures

Device Description

The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The proximal portion of the stem has a plasma spray coating and a hydroxyapatite coating. The MSA Hip System can be mated with a number of previously cleared femoral heads and acetabular components. The hip system is intended for cementless implantation. The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) and the modular necks are made of CoCr alloy (ASTM F1537).

AI/ML Overview

The provided text describes a 510(k) submission for the "MSA Hip System" and focuses on demonstrating substantial equivalence to predicate devices, rather than establishing acceptance criteria or reporting specific performance metrics against such criteria in the traditional sense of a clinical or standalone study.

Therefore, many of the requested sections about acceptance criteria, detailed study design, sample sizes, ground truth establishment, expert qualifications, and specific performance outcomes cannot be extracted from the provided text as it does not contain this type of information.

Here's what can be extracted and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria	Reported Device Performance
Not specified in document	Neck endurance testing results were satisfactory.
Not specified in document	Stem fatigue testing results were satisfactory.
Not specified in document	Interconnection strength of modular connections testing results were satisfactory.
Not specified in document	ROM (Range of Motion) testing results were satisfactory.
Not specified in document	Overall, non-clinical tests demonstrate substantial equivalence to legally marketed predicate devices.

Explanation: The document states that "The test results demonstrate that the MSA Hip System is substantially equivalent to legally marketed predicate devices." This implies that the tests performed (neck endurance, stem fatigue, interconnection strength, and ROM testing) met the necessary internal criteria to support substantial equivalence. However, the specific numerical acceptance criteria (e.g., minimum endurance cycles, maximum fatigue crack propagation) and quantifiable performance results for each test are not provided in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified. (The document mentions "non-clinical tests" but does not detail the number of units tested for each specific test like neck endurance or stem fatigue).
Data Provenance: Not specified. (As these are non-clinical tests, data provenance in terms of country of origin or retrospective/prospective status typically applies to clinical data, which is not discussed here.)

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not Applicable. This document describes non-clinical engineering tests (mechanical performance), not clinical studies where expert-established ground truth is typically assessed for diagnostic accuracy or similar endpoints.

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

Not Applicable. See explanation above.

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. This document does not mention any MRMC study or AI components. It pertains to a physical orthopedic implant.

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

Not Applicable. This document does not describe an algorithm or software device.

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

Not Applicable. For mechanical testing, the "ground truth" would be established by the physical testing methodology and predefined engineering standards for material properties and mechanical performance rather than clinical ground truth types.

8. The sample size for the training set:

Not Applicable. There is no mention of machine learning or an "algorithm" with a training set.

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

Not Applicable. There is no mention of machine learning or an "algorithm" with a training set.

Summary

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510(k) Summary

MAR - 1 2011 Manufacturer: Global Manufacturing Technology 8-10 Resolution Drive Unanderra NSW 2526 AUSTRALIA Phone: (011) 61 (2) 4272 4493 Device Trade Name: MSA Hip System Contact: Mr. Ricardo Lucchini Director Of Regulatory Affairs Prepared By: Musculoskeletal Clinical Regulatory Advisers, LLC 1331 H Street, NW. 12th Floor Washington, DC 20005 Phone: (202) 552-5800 Fax: (202) 552-5798 Date Prepared: February 10, 2011 Classification: 21 CFR 888.3353 Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis Class II MEH Product Codes: The MSA Hip System is indicated for cementless use and is Indications For Use: intended to replace a hip joint. The device is intended for: skeletally mature individuals undergoing primary � surgery for total hip replacement patients suffering from severe hip pain and disability . due to rheumatoid arthritis, osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur. patients with congenital hip dysplasia, protrusio . acetabuli, or slipped capital femoral epiphysis patients suffering from disability due to previous fusion . patients with acute femoral neck fractures ●

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Device Description: The MSA Hip System is a modular hip system consisting of a short stem which mates with a modular neck. The proximal portion of the stem has a plasma spray coating and a hydroxyapatite coating. The MSA Hip System can be mated with a number of previously cleared femoral heads and acetabular components. The hip system is intended for cementless implantation.

The hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) and the modular necks are made of CoCr alloy (ASTM F1537).

Comparative information presented in the 510(k) supports the substantial equivalence of the MSA Hip System with respect to its indications for use, design, materials, and This 510(k) demonstrates the method of fixation. substantial equivalence of the MSA Hip System to the following predicate devices: Aesculap Implant System's Metha Short Stem Hip System (K071916 and K080584); Zimmer's Mayo Conservative Hip Prosthesis (K030733 K943230): Wright Technology's and PROFEMUR Hip System (K081090 and K091423); and OMNI life science. Inc.'s Apex ARCTM Hip System (K090845).

The MSA Hip Stem shares the same indications for use for which the predicate systems were cleared. The geometry and design of the subject hip stem matches that of the predicate hips. The materials of the stem and neck are the same and the predicate stems and necks. Like the MSA Hip, the majority of the predicate stems are intended for cementless fixation.

The non-clinical tests performed by the company include Performance Data: neck endurance, stem fatigue, interconnection strength of modular connections, and ROM testing. The test results demonstrate that the MSA Hip System is substantially equivalent to legally marketed predicate devices.

Materials:

Predicate Devices:

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/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 stripes forming its body and wings. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" in a circular arrangement.

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

Global Manufacturing Technology % Musculoskeltal Clinincal Regulatory Advisers, LLC Hollace S. Rhodes Director, Orthopedic Regulatory Affairs 1331 H St NW, 12th Floor Washington DC, 20005

MAR - 1 2011

Re: K102172

Trade/Device Name: MSA Hip System 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: MEH Dated: February 24, 2011 Received: February 25, 2011

Dear Ms. Rhodes:

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 that I Drinas intact a and regulations administered by other Federal agencies. You must

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Page - 2 - Ms. Hollace S. Rhodes

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 (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 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Aliz. B. R k
for

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 4.

510(k) Number (if known): _KIO2172 (gg 1/1)

Device Name: MSA Hip System

The MSA Hip System is indicated for cementless use and is intended to replace a hip joint.

The device is intended for:

. skeletally mature individuals undergoing primary surgery for total hip replacement
patients suffering from severe hip pain and disability due to rheumatoid arthritis, . osteoarthritis, traumatic arthritis, polyarthritis, collagen disorders, avascular necrosis of the femoral head and nonunion of previous fracture of the femur.
patients with congenital hip dysplasia, protrusio acetabuli, or slipped capital femoral . epiphysis
patients suffering from disability due to previous fusion .
. patients with acute femoral neck fractures

Prescription Use (Part 29 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use no (29 CFR 801 Subpart C)

Concurrence of CDRH, Office of Device Evaluation (ODE)

for M. Melbern
(Division/Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K102172

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.