Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis.
Correction of functional deformity.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty.
Cemented and Uncemented Applications (as based on mating shell)

Device Description

Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.

AI/ML Overview

The provided text is a 510(k) summary for a medical device (Biomet's 100 kGy E-Poly™ Acetabular Liners- Additional Profiles), not a study demonstrating device performance against acceptance criteria. Therefore, most of the requested information regarding acceptance criteria, study details, and ground truth cannot be extracted directly from this document.

The document states:

"Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use."
"Clinical Testing: None provided as a basis for substantial equivalence."

This indicates that the device's substantial equivalence was based solely on non-clinical testing, comparing it to predicate devices (K070399). Clinical performance criteria and studies as typically described for software or diagnostic devices are not applicable here.

Here's a breakdown of what can be inferred or stated based on the provided text, and what cannot:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance (Implied)
Substantial Equivalence to predicate devices (K070399) based on non-clinical testing.	Non-clinical laboratory testing results indicated the device was functional within its intended use and met the criteria for substantial equivalence to the predicate.

Note: The specific, quantifiable acceptance criteria for "functional within its intended use" for the non-clinical testing are not detailed in this summary. These would typically involve mechanical, material, or biocompatibility testing data, but the summary only provides a general statement of compliance.

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

Not applicable / Not provided. No clinical "test set" in the context of human studies for AI performance, for example, was used or described. The non-clinical testing samples (e.g., number of liners tested for mechanical properties) are not specified.

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

Not applicable / Not provided. No human expert ground truth was established as this was a non-clinical submission.

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

Not applicable / Not provided.

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 a hardware medical device (hip implant component), not an AI or diagnostic imaging device. No MRMC study was conducted.

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

Not applicable. This is a hardware medical device.

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

Not applicable / Not provided in detail. For a non-clinical submission, "ground truth" would refer to established engineering standards, material specifications, or performance benchmarks related to mechanical properties, wear, biocompatibility, etc., when compared to the predicate device. The document only states "The components for cross-linked polyethylene in acetabular applications are adequately supported by biomechanical, materials data, and testing results provided within this Premarket Notification."

8. The sample size for the training set:

Not applicable / Not provided. There is no "training set" in the context of an algorithm or AI.

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

Not applicable / Not provided.

Summary of Device Performance Study (as per the document):

The device gained 510(k) clearance based on non-clinical laboratory testing that demonstrated substantial equivalence to existing predicate devices (specifically K070399). No clinical studies were conducted or provided as part of this submission for substantial equivalence. The non-clinical testing results "indicated that the device was functional within its intended use." The basis for substantial equivalence was also supported by the "intended use, indications and materials" being similar to the predicate, with the exception of added profiles (+3 MaxRom™ and +3 Hi-Wall).

Summary

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

K090103 (pg 1/2)

Image /page/0/Picture/1 description: The image shows a logo with the word "BIOMET" in a stylized font. The letters are outlined with a rough, textured edge, giving them a three-dimensional appearance. The overall design is simple and bold, with a focus on readability and visual impact. The logo appears to be for a company named "BIOMET".

FEB 11 2009

510(k) Summary

January 13, 2009 Preparation Date:

Biomet Manufacturing Corp. Applicant/Sponsor:

Contact Person: Becky Earl

MANUFA

Proprietary Name: 100 kGy E-Poly™Acetabular Liners- Additional Profiles: +3 MaxRom™ and +3 Hi-Wall

Common Name: UHMWPE Liners

Classification Name(s):

LPH- prosthesis, hip, semi-constrained, metal/polymer, porous uncemented (888.3358); �
JDI- prosthesis, hip, semi-constrained, metal/polymer, cemented (888.3350); �
LWJ- prosthesis, hip, semi-constrained, metal/polymer, uncemented (888.3360); g
MAY- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous 0 cemented, osteophilic finish (888.3353)
LZO- prosthesis, hip, semi-constrained, metal/ceramic/polymer, cemented or non-porous, o uncemented (888.3353)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: K070399, 100 kGy E-Poly™ Acetabular Liners-Additional Profiles

Device Description: Biomet Manufacturing Corp. is adding new +3 MaxRom™ and +3 Hi-Wall profiles to bevice Description Liomet Handracumy to allow the surgeon an option for achieving more range of motion and joint stability in smaller patients.

Intended Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
Rheumatoid arthritis. 2.
Correction of functional deformity. 3.
Treatment of non-union, femoral neck fracture, and trochanteric fractures of the র্থ proximal femur with head involvement, unmanageable using other techniques.
Revision of previously failed total hip arthroplasty. นว่

Cemented and Uncemented Applications

Summary of Technologies: The intended use, indications and materials of the subject Summary of Treennoniges o its predicate counterpart, with the exception of the additional profiles. The components forflain now act it is cross-linked polyethylene in acetabular applications are adequately supported sarely and chectiveness of the erass innou paterials data, and testing results provided within this Premarket Notification.

Mailing Address: P.O. Box 597 Warran, IN 46531-0587 Toll Free: 800,348,9500 stay bloadel com

Shipping Aidress: 56 East Dell Driva Wasser 11 20552

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

.K090103 (pg 2/2)

510(K) Notification Biomet Manufacturing Corp. Blomet Manafaccaring of artistics of articles: +3 MaxRom™ and +3 Hi-Wall Page 2 of 2

Non-Clinical Testing: Non-clinical laboratory testing was performed to determine substantial equivalence. The results indicated that the device was functional within its intended use.

Clinical Testing: None provided as a basis for substantial equivalence.

All trademarks are property of Biomet, Inc.

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

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three stripes on its wing, representing the department's commitment to health, human services, and well-being. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Biomet, Inc. % Ms. Becky Earl Regulatory Specialist 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581

Re: K090103

Trade/Device Name: 100kGy E-Poly Acetabular Liners - Additional Profiles; +3 MaxRom™ and +3 Hi-Wall

FEB 1 1 2009

Regulation Number: 21 CFR 888.3353

Regulation Name: Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prothesis

Regulatory Class: Class II

Product Code: MAY, LZO, LWJ, JDI, LPH

Dated: January 13, 2009

Received: January 15, 2009

Dear Ms. Earl:

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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set

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

Page 2 - Ms. Becky Earl

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at toll-free number (800) 638-2041 or (240) 276-3150 or the Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Mark N. Wilkerson

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

Enclosure

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

Indications for Use

510(k) Number (if known): K090103 (ps 1/1)

Device Name: 100kGy E-Poly™ Acetabular Liners-Additional Profiles: +3 MaxRom™ and +3 Hi-Wall

Indications for Use:

1. Non-inflammatory degenerative joint disease including osteoarthritis and avascular necrosis.
1. Rheumatoid arthritis.
1. Correction of functional deformity.
1. Treatment of non-union, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement, unmanageable using other techniques.
1. Revision of previously falled total hip arthroplasty.

Cemented and Uncemented Applications (as based on mating shell)

YES Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use NO (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mirle H. Milken

Page 1 of 1

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices

510(k) Number.

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.