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 hip stems are made of Ti-6AI-4V (ASTM F136) with a commercially pure titanium plasma spray coating (ASTM F1580) on the proximal end. The stems are available with and without a hydroxyapatite coating. The modular necks are made of CoCr alloy (ASTM F1537). The MSA Hip System can be mated with metal or ceramic femoral heads and acetabular components.

AI/ML Overview

The provided text describes a Special 510(k) submission for the MSA Hip System, specifically to add ceramic femoral heads to the device. The submission focuses on demonstrating substantial equivalence to a previously cleared predicate device, rather than a clinical study evaluating human or AI performance.

Therefore, many of the requested elements (sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone AI performance, human-in-the-loop performance, etc.) are not applicable and not present in the provided document, as it is a regulatory submission for a physical medical device (hip implant) and not a software/AI-driven diagnostic or treatment device.

Here's a breakdown of the relevant information from the provided text based on your request:

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

Acceptance Criteria	Reported Device Performance
Pre-determined acceptance criteria identified in the Design Control Activities Summary for burst strength testing of ceramic femoral head	The test results demonstrate that the pre-determined acceptance criteria identified in the Design Control Activities Summary were met.

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

Test set sample size: Not specified. The document only mentions "burst strength testing of the ceramic femoral head" but does not provide details on the number of samples tested.
Data provenance: Not specified. The manufacturer, Global Manufacturing Technology, is located in Australia, so it is likely the testing was conducted there or at a supplier's facility. It is a technical test on the device itself, not human clinical 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)

Number of experts: Not applicable. The "ground truth" here is the physical performance of the device (burst strength) against engineering specifications, not a diagnostic assessment requiring expert interpretation of medical images or clinical outcomes. The determination of whether the acceptance criteria were met would be based on objective measurements and comparison to predefined thresholds, typically validated by engineers or quality control personnel.

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

Adjudication method: Not applicable. See point 3.

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

MRMC study: No. This is not applicable as the device is a physical hip implant, not an AI or diagnostic tool that involves human readers.

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

Standalone study: No. This is not applicable as the device is a physical hip implant.

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

Type of ground truth: Engineering specifications/pre-determined acceptance criteria for burst strength of the ceramic femoral head. This is a physical and mechanical performance metric.

8. The sample size for the training set

Training set sample size: Not applicable. This concept applies to machine learning models, not physical medical devices undergoing mechanical testing.

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

Ground truth for training set: Not applicable. See point 8.

Summary

{0}------------------------------------------------

DEC 1 5 2011

K113107 (pg 1/2)

5. 510(k) Summary

Contact:	Mr. Steve BanksDirector
Prepared By:	Musculoskeletal Clinical Regulatory Advisers, LLC1331 H Street, NW, 12th FloorWashington, DC 20005Phone: (202) 552-5800Fax: (202) 552-5798
Date Prepared:	October 19, 2011
Device Trade Name:	MSA Hip System
Manufacturer:	Global Manufacturing Technology8-10 Resolution DriveUnanderra NSW 2526AUSTRALIAPhone: (011) 61 (2) 8887 0100
Classification:	21 CFR 888.3353
	Hip joint metal/ceramic/polymer semi-constrainedcemented or nonporous uncemented prosthesis
	Class II
Product Code:	MEH, LZO

Reason for Special 510(k) Submission:

The purpose of this Special 510(k) is to add ceramic femoral heads to the MSA Hip System. There have been no changes to the intended use of the device or its fundamental scientific technology.

Indications For Use:

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.

{1}------------------------------------------------

· 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:

Predicate Devices:

The modified MSA Hip System is substantially equivalent to the predicate MSA Hip System (K102172) with respect to indications, design, and function.

Substantial Equivalence:

The company performed burst strength testing of the ceramic femoral head. The test results demonstrate that the pre-determined acceptance criteria identified in the Design Control Activities Summary were met.

Conclusion

The MSA Hip System when mated with a ceramic femoral head is substantially equivalent to previously cleared devices with respect to its indications for use, design, and function.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of a human figure.

DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Global Manufacturing Technology % Musculoskeletal Clinical Regulatory Advisers, LLC Ms. Hollace Rhodes Director, Orthopaedic Regulatory Affairs 1331 H St Northwest Washington, DC 20005

DEC 1 5 2011

Re: K113107

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

porous uncemented prosthesis

Regulatory Class: Class II Product Code: MEH, LZO Dated: November 16, 2011 Received: November 17, 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 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

{3}------------------------------------------------

Page 2 - Ms. Hollace Rhodes

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 yours,

incerely yours,

for Peter Vrooman
Mark N. Melkerson

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

Enclosure

{4}------------------------------------------------

Indications for Use 4.

510(k) Number (if known): 长川3107 (pg ١/١)

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

イ Prescription Use (Part 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)

for MxM
(Division Sign-Off)

Sign-Off) Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K113107

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.