Noninflammatory 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.
Dislocation risks.

The E1™ Avantage™ Head is a single-use implant, intended for uncemented applications.

Device Description

The E1 Active Articulation™ belongs to the family of dual mobility acetabular implants; the presence of two articulating surfaces in the same joint device. The E1 Active Articulation™ Head fits over a femoral modular head, which articulates within the E1™ Head. The resultant assembly then articulates within the acetabular metal shell. The E1™ Head is designed to be used with several styles of acetabular shells that have been cleared in previous submissions: Ma Magnum™ (K042037), Magnum™ Tri-Spike (K062995), and Mra 38™ Flared Cups and Non-Flared Cups (K01110). The E1 Active Articulation™ Heads are available in sizes 44-66mm and are manufactured from 100 kGy E1™, which is the same 100 kGy E-Poly™ material cleared in K070364, The claims based on small punch testing for the K070364 E-Poly™ (E1™) material were cleared previously in K100048 and are applicable to the identical E-Poly™ (E1™) subject material. The E1™ Active Articulation is designed for both primary and total revision surgeries, where all device components associated with the wear couple are removed and replaced. The system is intended for uncemented applications.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, the E1™ Avantage™ Head (a.k.a. E1™ Active Articulation), which is an artificial hip replacement component. The submission focuses on demonstrating substantial equivalence to predicate devices and detailing the characteristics of the E1™ Antioxidant Infused Technology material used in the device.

However, the document does not describe an acceptance criteria table for device performance against specific metrics in the way that would typically apply to software or AI-based devices. Instead, it details a series of claims for the material's performance based on non-clinical (bench) testing, comparing the E1™ material to control materials.

Therefore, the following information will be structured to address the spirit of the request based on the available data, acknowledging that it's a materials-based product and not a diagnostic AI device.

Acceptance Criteria and Study for the E1™ Avantage™ Head Device Material

The acceptance criteria are derived from the performance claims and test results for the E1™ Antioxidant Infused Technology material, which is a key component of the E1™ Avantage™ Head. The studies conducted are non-clinical (bench) tests comparing the E1™ material to various control or predicate materials.

1. Table of Acceptance Criteria and Reported Device Performance (Material Performance)

Acceptance Criteria Claim	Acceptance Metric / Comparison	Reported E1™ Material Performance
Claim 1: Prevent oxidative degradation of polyethylene.	No evidence of environmental stress cracking and no detectable oxidation (oxidation indices <0.1) after cyclic loading in an air atmosphere at 80°C for 5 weeks.	E1™ specimens showed no evidence of environmental stress cracking, and infrared spectroscopy showed no detectable oxidation in loaded or unloaded samples (oxidation indices <0.1).
Claim 2: Protect polyethylene from oxidation and cracking during environmental stress crack testing.	No evidence of environmental stress cracking or fracture and no detectable oxidation (oxidation indices <0.1) in loaded and unloaded samples, when compared head-to-head with gamma sterilized and sequentially crosslinked/annealed polyethylene, both of which showed evidence of increased oxidation and cracking/fracture.	E1™ material showed no evidence of environmental stress cracking or fracture and no detectable oxidation indices (<0.1) in loaded and unloaded samples using infrared spectroscopy. Both gamma sterilized and sequentially crosslinked and annealed polyethylene showed evidence of increased oxidation and cracking or fracture.
Claim 3: Maintain the mechanical strength of conventional UHMWPE under small punch testing.	E1™ material's ultimate load is greater than that of control materials (GUR1050 ICM and GUR1050 DCM) with statistical significance (p<0.001).	E1™ Hip Material: Ultimate load = 105.0 ± 5.5 N (vs. GUR1050 ICM control: 75.4 ± 5.3 N).E1™ Knee Material: Ultimate load = 97.2 ± 6.4 N (vs. GUR1050 DCM control: 86.6 ± 7.5 N).Both E1™ materials had ultimate loads greater than their respective controls, and these differences were statistically significant (p<0.001).
Claim 4: Maintain mechanical strength after accelerated aging.	No significant decrease (P>0.05) in ultimate load, ultimate tensile strength, or yield strength after accelerated aging (per ASTM F2003: 70°C and 5 atm of oxygen for 14 days).	E1™ Knee Material:- Ultimate load: 97.2 ± 6.4 N (before) vs. 100.0 ± 5.0 N (after aging, P>0.05).- Ultimate tensile strength: 45.8 ± 1.6 MPa (before) vs. 46.1 ± 2.9 MPa (after aging, P>0.05).- Yield strength: 22.6 ± 0.2 MPa (before) vs. 22.8 ± 0.3 MPa (after aging, P>0.05).E1™ Hip Material:- Ultimate load: 105.0 ± 5.5 N (before) vs. 115.0 ± 3.2 N (after aging, P>0.05).- Ultimate tensile strength: 43.1 ± 1.3 MPa (before) vs. 43.1 ± 1.2 MPa (after aging, P>0.05).- Yield strength: 24.2 ± 0.2 MPa (before) vs. 24.4 ± 0.2 MPa (after aging, P>0.05).No significant decrease in these mechanical properties after accelerated aging for both hip and knee E1™ materials (P>0.05).

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

The document does not explicitly state numerical sample sizes (e.g., number of specimens tested) for each specific test. However, it indicates multiple test specimens were used for each comparison (e.g., "E1™ specimens showed no evidence...", "GUR1050 E1™ specimens ran head to head...", "multiple samples for statistical analysis implicitly through the use of "±" notation for standard deviations).

Provenance: All data appears to be from bench testing conducted in a laboratory setting, not from human or animal studies. The studies reference a literature source (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684) and ASTM standards (F2183, D638, F2003). The location of the testing laboratories is not specified, but the applicant is based in Warsaw, Indiana, USA.

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

This request is not applicable to this submission. The device is a physical orthopaedic implant component, and the "ground truth" for its material properties is established through standardized laboratory testing methods and measurements, not through expert human interpretation or consensus of observational data.

4. Adjudication Method for the Test Set

This request is not applicable. As above, the "test set" consists of material specimens undergoing physical and chemical characterization, not subjective assessments requiring adjudication. The results are quantitative measurements against established standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

This request is not applicable. An MRMC study is relevant for diagnostic devices that involve multiple human readers interpreting medical images or data. The E1™ Avantage™ Head is a physical implant, and its performance is evaluated through bench testing of its material properties and mechanical characteristics, not through human interpretation of cases.

6. Standalone (Algorithm Only) Performance Study

This request is not applicable. This is not an algorithm or AI-based device. The "performance" described is the material performance of the polyethylene, not an algorithm's output.

7. Type of Ground Truth Used

The "ground truth" for the material performance claims is established through standardized physical and chemical measurements obtained from controlled bench tests. This includes:

Observations of environmental stress cracking (absence/presence).
Infrared spectroscopy for oxidation indices.
Small punch testing (ASTM F2183) for ultimate load.
Tensile testing (ASTM D638) for ultimate tensile strength and yield strength.
Accelerated aging protocols (ASTM F2003).

These methods provide objective, quantitative data about the material's properties.

8. Sample Size for the Training Set

This request is not applicable. There is no "training set" in the context of this device. The described studies are non-clinical performance evaluation tests of a manufactured material, not a machine learning model. The material itself is a result of a manufacturing process using specific raw materials and treatments (e.g., GUR1020/GUR1050 UHMWPE, 100 kGy gamma irradiation, vitamin E infusion, gamma sterilization).

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

This request is not applicable. As there is no training set, there is no ground truth established for it in this context.

Summary

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

K101336 (pg. 1 of 3)

Image /page/0/Picture/1 description: The image contains the text "BIOMET" in a stylized font at the top. Below that, the text "MANUFACTURING CORP." is printed in a simple, sans-serif font. The text is arranged in two lines, with "BIOMET" above and "MANUFACTURING CORP." below.

JAN 1 4 2011

Polymer, Cemented (21 CFR 888.3390) Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Restoration® ADM System-Howmedica Oseonics K072020 Restoration® ADM System X3® Acetabular Insert-Howmedica Osteonics K093644 Tri-Polar System-Biomet, Inc. Kadi 990 100 kGy E-Poly™ MaxRom™ Acetabular Liners-Biomet, Inc. K070364 K070399 100 kGv E-Poly Acetabular Liners, Additional Sizes-Biomet, Inc. RingLoc® 36mm Liners and Modular Femoral Heads-Biomet, Inc. K032396 Versafit Cup Double Mobility System-Medacta International K083116 E-Poly (Vitamin E) Acetabular Liners-Biomet, Inc. K050327 E1™ Antioxidant Infused Technology-Biomet, Inc. K100048

Mailing Address: P.O. Box 587 Warsaw, IN 46581-0587 Toll Free: 800.348.9500 Office: 574.267.6639 Main Fax: 574.267.8137 www.biomel.com

Shipping Address: 56 E. Bell Drive Warsaw, IN 46582

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

K101336 (pg. 2 of 3)

510(k) Summary E1™ Active Articulation Biomet Manufacturing Corp.

Device Description:

FDA CLEARED CLAIMS FOR E1™ ANTIOXIDANT INFUSED TECHNOLOGY2

Claim 1:

E1™ Antioxidant Infused Technology prevents oxidative degradation of polyethylene. Environmental stress crack testing was conducted by cyclically loading GUR1020 and GUR1050 E1 ™ test specimens in an air atmosphere maintained at 80°C for 5 weeks. Testing was completed per the literature (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684). E1™ specimens showed no evidence of environmental stress cracking and infrared spectroscopy showed no detectable oxidation in the loaded or unloaded samples (oxidation indices <0.1). E1 samples were machined from either GUR1020 (E1 knee) or GUR1050 (E1 hip) isostatically compression molded UHMWPE crosslinked with 100 kGy gamma irradiation under argon, doped with a-tocopherol, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Claim 2:

E1™ Antioxidant Infused Technology protects polyethylene from oxidation and cracking during environmental stress crack testing. Environmental stress crack testing was conducted by cyclically loading test specimens in an air atmosphere maintained at 80℃ for 5 weeks per the literature (Nabar, Sean, et al. Transactions of the 54th Annual Meeting of the ORS, Poster No. 1684). GUR1050 E1 ™ specimens ran head to head with GUR1050 gamma sterilized (25-40kGy in argon) polyethylene and sequentially crosslinked and annealed polyethylene (GUR 1050 barstock, 33kGy gamma irradiated in air, annealed at 130C in air and repeated for a total dose of 99kGy and machined into final part geometry). GUR1020 E1™ specimens ran head to head with GUR1050 direct compression molded polyethylene that was gamma sterilized (25-40kGy) in argon. The E1™ material tested that showed no evidence of environmental stress cracking or fracture and no detectable oxidation indices <0.1) in the loaded and unloaded samples using infrared spectroscopy. Both gamma sterilized and sequentially crosslinked and annealed polyethylene showed evidence of increased oxidation and cracking or fracture during environmental stress crack testing. E1 samples were machined from either GUR1020 or GUR1050 isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Claim 3:

E1™ Antioxidant Infused Technology maintains the mechanical strength of conventional UHMWPE under small punch testing. Small punch testing per ASTM F2183 was conducted for the E1 ™ hip material and the E1™ knee material. The E1™ hip material was compared to GUR1050 gamma sterilized in argon isostatic compression molded (ICM) UHMWPE and the E1™ knee material was compared to GUR1050 gamma sterilized (25-40kGy) in argon direct compression molded (DCM) UHMWPE. The ultimate load for the E1™ hip material and the GUR1050 ICM material are 105±5.5N and 75.4±5.3N respectively. The ultimate load for the E1 ™ knee material and the DCM control material are 97.2±6.4N and 86.6±7.5N respectively. The E1™ materials had ultimate loads greater than that of the ICM and DCM control. These differences were statistically significant (p<0.001 for all comparisons). E1 samples were machined

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

K101336 (pg. 3 of

from either GUR1020 (E1 knee) or GUR1050 (E1 hip) ICM UHMWPE, crosslinked with 100 kGv gamma irradiation under argon, infused with vitamin E, and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

Claim 4 :

E1™ Antioxidant Infused Technology maintains mechanical strength after accelerated aging. There was no significant decrease (P>0.05) in ultimate load , ultimate tensile strength, or vield strength after accelerated aging for either the E1™ hip or the E1™ knee material. Ultimate load was measured by small punch testing per ASTM F2183; ultimate tensile strength and yield strength were measured by tensile testing per ASTM D638; Accelerated aging was performed per ASTM F2003 (70°C and 5 alm of oxygen for 14 days). The ultimate load for the E1 ™ knee material before and after accelerated aging was 97.2±6.4N and 100.0±5.0N respectively. The ultimate tensile strength for the E1™ knee material before and after accelerated aging was 45.8±1.6 and 46.1±2.9 MPa respectively. The vield strength for the E1 ™ knee material before and after accelerated aging was 22,640,2 and 22,840,3 MPa resolectively, The ultimate load for the E1 ™ hip material before and after accelerated aging was 105.0±5.5N and 115.0±3.2N respectively. The ultimate tensile strength for the E1™ hip material before and after accelerated aging was 43t3 and 43t2 MPa respectively. The yield strength for the E1™ hip material before and after accelerated aging was 24.2±0.2 and 24.4±0.2 MPa respectively. E1 samples were machined from either GUR1020 (knee material) or GUR1050 (hip material) isostatically compression molded UHMWPE, crosslinked with 100 kGy gamma irradiation under argon, infused with vitamin E. and subsequently gamma sterilized (25-40 kGy) in Argon. Bench testing is not necessarily indicative of clinical performance.

1. Cleared through 510(k) K100048
1. Note: E1™ Antioxidant Infused Technology may be used interchangeably with any of the following: E1™ Antioxidant Infused Bearings, E1™ Antioxidant Infused Material, E1™ material, E1™ technology, E1 ™ bearings, E1 ™ liners, E1 ™ acetabular liners and E1 ™ tibial bearings.

Indications for Use:

1. Noninflammatory 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 failed total hip arthroplasty.
1. Dislocation risks.

The E1™ Active Articulation is a single-use implant, intended for uncemented applications.

Summary of Technologies:

The E1™ Active Articulation Head has the same technological characteristics as the dual mobility predicates, with the exception that the UHMWPE material used is a 100kGy, Vitamin E infused polyethylene, which was previously cleared in K070364.

Non-Clinical Testing:

Wear, distraction testing of the bipolar portion (i.e., distraction of the UHMWPE from the femoral head), and Range of Motion testing were performed on the dual mobility subject device. The concentration and distribution of the Vitamin E in the E1™ Active Articulation Head material was determined. Results of the precinical testing performed are within the range of legally marketed predicates and indicate that the device is functional within its intended use.

Clinical Testing:

None provided as a basis for substantial equivalence.

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

Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. 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 bird-like figure with three lines extending from its head.

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

Biomet Manufacturing Corporation % Ms. Becky Earl Regulatory Specialist P.O. Box 587 Warsaw, Indiana 46581-0587

JAN 1 4 2011 Re: K101336 Trade/Device Name: El™ Avantage™ Head 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, OQG, LZO, KWY Dated: January 10, 2011 Received: January 11, 2011

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. 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 of medical

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

Page 2 - Ms. Becky Earl

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/ReportalProblem/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,

A.D. B. 2h.

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

Enclosure

{5}------------------------------------------------

Indications for Use

510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________

Device Name: E1™ Avantage™ Head_

Indications For Use:

1. Noninflammatory 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 failed total hip arthroplasty.
1. Dislocation risks.

The E1™ Avantage™ Head is a single-use implant, intended for uncemented applications.

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)

A. B. Rh f. nxn

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

510(k) Number K101336

Page 1 of 1

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.