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 by other techniques
Revision of previously failed total hip arthroplasty.

Device Description

The new device is composed of ArComXL ™ with inner diameters of 28, 32, and 36mm.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device, specifically ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners. This document focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive de novo clinical or performance studies with detailed acceptance criteria and performance metrics typically found for novel AI/software devices.

Therefore, for many of the requested categories, the information is not available in the provided text, as the regulatory pathway for this type of device (an acetabular liner) does not typically require the same level of detailed performance studies in the context of AI/software acceptance.

Here's an analysis based on the provided text, indicating where information is present or absent:

Acceptance Criteria and Study Details for ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance
Substantial Equivalence to Predicate Device:
Designs, Intended Use, Contraindications, and Design Specifications	"The designs, intended use, contraindications, and design specifications of the subject components remain identical to their predicate counterparts."
Non-Clinical Testing Standard/Guideline Compliance	"Testing met or exceeded current standards or guidelines." (Specific standards/guidelines not detailed in this summary.)
Composition	"The new device is composed of ArComXL™ with inner diameters of 28, 32, and 36mm." The submission allows the predicate system to be composed of ArComXL™ with an inner diameter of 36mm.
Intended Use (Identical to Predicate)	Indicated for single cemented or non-cemented use in cases of: 1) Non-inflammatory degenerative joint disease (osteoarthritis, avascular necrosis), 2) Rheumatoid arthritis, 3) Correction of functional deformity, 4) Treatment of specific femoral fractures, and 5) Revision of previously failed total hip arthroplasty.

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

Sample Size (Test Set): Not applicable. This submission relies on "non-clinical testing" of a predicate device and direct comparison of specifications. There is no specific "test set" of patient data in the context of an AI/software performance study.
Data Provenance: Not applicable in the context of AI/software data. The "non-clinical testing" likely refers to mechanical or material testing as per orthopedic implant standards, not patient data.

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

Not applicable. Ground truth, in the sense of expert annotation for AI/software, is not relevant to this device's 510(k) submission.

4. Adjudication method for the test set

Not applicable. There is no test set of subjective observations requiring adjudication.

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. An MRMC study is not relevant to this device (an acetabular liner). This is a physical orthopedic implant, not an AI-powered diagnostic or assistive tool.

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

No. This is not an algorithm or AI device.

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

Not applicable in the context of AI/software ground truth. The "ground truth" for this device's regulatory clearance would be compliance with material specifications, mechanical testing standards, and established clinical performance of the predicate device.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that requires a training set.

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

Not applicable.

Summary

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NOV 2 3 2005

510(k) Summary

Applicant/Sponsor:Biomet Manufacturing Corp. 56 East Bell Drive P.O. Box 587 Warsaw, IN 46581-0587

Contact Person: Allison K. Koskey Regulatory Specialist

Proprietary Name: ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners

Common Name: Acetabular liner

Classification Name(s):

1. Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis (21 CFR 888.3358)
1. Hip joint metal/polymer semi-constrained cemented prosthesis (21 CFR 88.3350)
1. Hip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis (21 CFR 888.3353)
1. Hip joint metal/polymer constrained cemented or uncemented prosthesis (21 CFR 888.3310)

Legally Marketed Devices To Which Substantial Equivalence Is Claimed: Rx90™ Low Profile Acetabular System (K042989)

Device Description: The new device is composed of ArComXL ™ with inner diameters of 28, 32, and 36mm.

Intended Use: The ArComXL™ Polyethylene Rx90™ Low Profile Acetabular

Liners are indicated for single cemented or non-cemented use in cases of:

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 by other techniques
1. Revision of previously failed total hip arthroplasty.

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K052255 Pre

510(k) Summary Biomet, Inc. ArComXL ™ Polyethylene Rx90™ Low Profile Acetabular Liners Page 2 of 2

Summary of Technologies: The designs, intended use, contraindications, and design specifications of the subject components remain identical to their predicate counterparts. This submission allows the Rx90™ Low Profile Acetabular System to be composed of ArComXL™ with an inner diameter of 36mm.

Non-Clinical Testing: Verification activities were previously performed on the ArComXL ™ polyethylene predicate devices. Testing 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 and Human Services. The logo consists of a stylized eagle with three curved lines representing its body and wings. The eagle is enclosed within a circular border. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is written around the upper portion of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 2 3 2005

Ms. Allison K. Koskey Regulatory Specialist Biomet Manufacturing Corp. 56 East Bell Drive P. O. Box 587 Warsaw, Indiana 46582

K052255 Re:

ArComXLIM Polyethylene Rx90™ Low Profile Acetabular Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Codes: LPH, LZO, JDI, KWZ, MEH Dated: October 28, 2005 Received: October 31, 2005

Dear Ms. Koskey:

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

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Page 2 - Ms. Allison K. Koskey

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 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

signature

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

Enclosure

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Indications for Use

KOS 22 5 5 510(k) Number (if known): ___

Device Name: ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners

Indications For Use: The ArComXL™ Polyethylene Rx90™ Low Profile Acetabular Liners are indicated for cemented or non-cemented use in cases of:

Non-inflammatory degenerative joint disease including osteoarthritis and 1) avascular necrosis
Rheumatoid arthritis 2)
Correction of functional deformity 3)
Treatment of non-union, femoral neck fracture, and trochanteric fractures of 4) the proximal femur with head involvement, unmanageable by other techniques.
Revision of previously failed total hip arthroplasty. 5)

Prescription use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

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

510(k) Number_KOS ZLLSS

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.