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

Device Description

Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.

AI/ML Overview

The provided document is a 510(k) Summary for a medical device (ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads). It describes the device, its intended use, and claims substantial equivalence to predicate devices. Crucially, it states: "Clinical Testing: None provided as a basis for substantial equivalence."

Therefore, a study proving the device meets acceptance criteria as typically understood for AI/diagnostic devices (e.g., performance metrics, ground truth, expert adjudication, MRMC studies) was not conducted for this submission, as it is a medical device, not a diagnostic or AI product.

However, given the request's structure which assumes such a study, I can only extract information related to "Non-Clinical Testing" which serves a similar purpose of validating the device.

Here's a breakdown based on the provided text, primarily addressing the "Non-Clinical Testing" section since clinical trials were not performed.

Description of Acceptance Criteria and Device Performance

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Non-Clinical)	Reported Device Performance (Non-Clinical)
Meet or exceed current standards or guidelines for ArComXL™ liners.	ArComXL™ liners met or exceeded current standards or guidelines.

(Note: The document does not specify the exact "standards or guidelines" or quantitative performance metrics, only that they were met or exceeded.)

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

The document does not detail specific sample sizes for non-clinical testing. It simply states "Verification activities were performed on ArComXL™ liners." There is no mention of a "test set" in the context of clinical or diagnostic data, as this is a physical medical implant. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the way it would be for a diagnostic study.

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

This section is not applicable. Since no clinical or diagnostic study was performed, there was no "ground truth" to establish in the context of expert review of data/images. The "ground truth" for non-clinical testing of a physical implant would typically involve engineering specifications, material properties, and mechanical test results against established benchmarks or regulatory standards, which are not detailed here.

4. Adjudication method for the test set

This section is not applicable. No test set requiring adjudication by experts was utilized as no clinical or diagnostic study was conducted.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done

No, an MRMC comparative effectiveness study was not done. The document explicitly states: "Clinical Testing: None provided as a basis for substantial equivalence."

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

This section is not applicable. The device is a physical medical implant (hip replacement components), not an algorithm or AI product.

7. The type of ground truth used

For the non-clinical testing, the "ground truth" would be related to engineering specifications, material science properties, and established regulatory/industry standards for medical implants (e.g., ASTM F-648 for UHMWPE). The document confirms that the device characteristics were "identical to the predicate (K042051)" and met "current standards or guidelines."

8. The sample size for the training set

This section is not applicable. There is no "training set" in the context of an AI/algorithm for this device.

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

This section is not applicable. There is no "training set" or corresponding ground truth establishment in the context of an AI/algorithm for this device. The "ground truth" for the manufacturing materials and processes would be based on validated scientific and engineering principles and quality control measures.

Summary

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K062997 1/2

BIOMET

ORTHOPEDICS, INC.

510(k) Summar

Preparation Date:	September 28, 2006
Applicant/Sponsor:	Biomet Manufacturing Corp.56 East Bell DriveP.O. Box 587Warsaw, IN 46581-0587	DEC 08 2006
Contact Person:	Becky Earl
Proprietary Name:	ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads
Common Name:	UHMWPE; Femoral Heads
Classification Name:	- hip joint metal/polymer/metal semi-constrained porous coateduncemented prosthesis (888.3358)- hip joint metal/polymer semi-constrained cemented prosthesis(888.3350)- hip joint metal/ceramic/polymer semi-constrained cemented ornonporous uncemented prosthesis (888.3353)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: ArComXL™ Acetabular Liners— K042051 (Biomet, Inc.), ArCom® Acetabular Liners—K023357 (Biomet, Inc.), 36mm MaxRom™ Acetabular Liners—K032396 (Biomet, Inc.), M2a™ Acetabular System—K011110 (Biomet, Inc.), and M2a Magnum™ System-K042037 (Biomet, Inc.)

Device Description: Biomet Manufacturing Corp. is adding additional sizes and designs to the predicate ArComXL™ Acetabular Liners (K042051). The same manufacturing process used in the predicate results in a higher cross-linked polyethylene that Biomet will herein refer to as ArComXL™ . The femoral heads, sizes 38mm and 40mm, are a one-piece design with neck length variations ranging from -6mm to +9mm made from CoCrMo.

Intended 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 failed total hip arthroplasty.

Cemented and Uncemented Applications

Summary of Technologies: The intended use, indications, and design specifications of the acetabular liners remain similar or identical to their predicate component counterparts. The only exception is the addition of 32 and 36mm in two designs and 38 and 40mm size liners for all included designs. The raw material being utilized in the manufacture of the subject devices is an ultra-high

MAILING ADDRESS P.O. Box 587 Warsaw, IN 46581-0587

■

SHIPPING ADDRESS 56 E. Bell Drive Warsaw, IN 46582

OFFICE 574.267.6639

FAX
574.257.8137

E-MAIL biomet@biomet.com

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K062997 2/2

510(k) Summary - Page 2 of 2 STO(R) Summal y - Continuers and 38/40mm Femoral Heads (Continued)

molecular weight polyethylene (UHMWPE) per ASTM F-648, identical to the predicate (K042051). The morecallar welght polychylche (OHTTP: 2) per Rom P" (UHMWPE) Acetabular Liners were previously established in K042051.

The intended use, indications, contraindications, and design specifications of the femoral heads are The Interious use, Indications, contrainciedions, and acticulating surface which is changed from metal-onluentical to their predicates with the encopies in either cemented or uncemented applications.

Non-Clinical Testing: Verification activities were performed on ArComXL™ liners, which met or exceeded current standards or guidelines.

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

All trademarks are property of Biomet, Inc.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circle around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC - 8 2006

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

Re: K062997

Trade/Device Name: ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads 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 Dated: September 29, 2006 Received: October 02, 2006

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

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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 Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buchner

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

Enclosure

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062997 ''//

Indications for Use

510(k) Number (if known):

Device Name: ArComXL™ Polyethylene Liners and 38/40mm Femoral Heads

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 failed total hip arthroplasty.

Cemented and Uncemented Applications

Prescription Use X (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)

Barbara Buchholz

Restorative,

510(k) Number

Page 1 of 1

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.