OMNI Interface Acetabular System

• K Number: K142201
• Device Name: OMNI Interface Acetabular System
• Manufacturer: OMNLIFE SCIENCE
• Date Cleared: 2015-01-26 ( 168 days)
• Product Code: LPH , LZO , MEH
• Regulation Number: 888.3358
• Type: Traditional
• Panel: Orthopedic
• Reference & Predicate Devices: K112779 , K060635 , K123782
• Predicate For: N/A

Intended Use

The OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Congenital dislocation;
• Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur.

The OMNI Interface Acetabular System is intended for cementless and single use implantation only.

Device Description

The OMNI Interface Acetabular System consists of acetabular cups/shells that are made of titanium alloy, standard and crosslinked ultra high molecular weight polyethylene shell inserts and femoral heads that are used with compatible femoral hip stems for primary and revision total hip replacement. The shells are available in “no hole” and “3-hole” configuration and a size range from 46-76 mm and X size (48x-58xmm).

AI/ML Overview

The provided document is a 510(k) summary for the OMNI Interface™ Acetabular System, which is a medical device (hip implant). It is not an AI/ML device, and therefore the concepts of acceptance criteria for an algorithm, study design for AI models, ground truth, expert adjudication, or MRMC studies are not applicable.

The document discusses the substantial equivalence of the OMNI Interface™ Acetabular System to predicate devices. Substantial equivalence in this context means that the new device is as safe and effective as a legally marketed device that is not subject to premarket approval.

Here's an interpretation of the relevant information provided, framed as closely as possible to your request, but adapted for a non-AI medical device:

The "acceptance criteria" for a medical device like the OMNI Interface™ Acetabular System are typically related to its physical and mechanical performance, biocompatibility, and intended use as compared to existing, cleared devices. The "study that proves the device meets the acceptance criteria" refers to the testing and comparison performed to demonstrate substantial equivalence.

1. Table of Acceptance Criteria and Reported Device Performance:

Since this is not an AI device, there are no "performance metrics" in the sense of sensitivity, specificity, etc. The acceptance criteria relate to the device's characteristics and its ability to function as intended without raising new safety or effectiveness concerns compared to a predicate device.

Acceptance Criterion (Implicit)	Reported Device Performance (Demonstrated Substantial Equivalence)
Basic Design: Comparable to predicate devices.	"The OMNI Interface Acetabular System is substantially equivalent to the predicates as the basic design...are the same."
Interface: Compatible with other components.	"The OMNI Interface Acetabular System is substantially equivalent to the predicates as the...interface...are the same." Specifically, compatibility with the Paragon stem (K123782) was a key focus, and it was determined to be "as safe and effective as the predicate and does not raise any new safety or effectiveness concerns" when used with the Paragon stem. Comparisons between OMNI hip stems and Paragon stem, and OMNI and Global femoral heads, were included to support compatibility.
Fundamental Technology: Similar operational principles.	"The OMNI Interface Acetabular System is substantially equivalent to the predicates as the...fundamental technology...are the same."
Materials: Biocompatible and mechanically suitable.	"The OMNI Interface Acetabular System is substantially equivalent to the predicates as the...materials...are the same." "Based on the identical material..."
Intended Use: Consistent with predicate devices.	"The OMNI Interface Acetabular System is substantially equivalent to the predicates as the...intended use are the same." The indications for use listed are consistent with those for hip arthroplasty devices.
Mechanical Performance: Meets relevant standards for joint components (e.g., range of motion, fatigue).	"The results of testing for the proposed use of OMNI Interface Acetabular System with the Paragon Stem met the performance requirements for range of motion per ISO 21535." The submission also included "characterization data, compatibility and mechanical testing."
Safety and Effectiveness: No new concerns compared to predicates.	"The use of OMNI Interface Acetabular System with the Paragon stem is determined to be as safe and effective as the predicate and does not raise any new safety or effectiveness concerns."

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

This information isn't directly applicable as it's not an AI model. For mechanical medical devices, testing typically involves simulating physiological conditions using specific numbers of samples (e.g., a certain number of implants tested for fatigue or range of motion).

• Test Set (for mechanical testing): The document mentions "The results of testing for the proposed use of OMNI Interface Acetabular System with the Paragon Stem met the performance requirements for range of motion per ISO 21535." It also states "compatibility and mechanical testing." The specific sample sizes for these mechanical tests are not provided in this summary but would have been part of the full 510(k) submission.
• Data Provenance: Not applicable in the AI sense. The "data" here would be the results of laboratory mechanical and material tests conducted on the physical devices.

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

This concept is not applicable to this type of medical device submission. "Ground truth" in the context of AI refers to expert-labeled data for training and evaluating an algorithm. For a hip implant, the "truth" is established by manufacturing standards, preclinical mechanical testing, material specifications, and comparison to the performance of existing legally marketed predicate devices. No human experts are "labeling" data for an outcome here in the AI sense.

4. Adjudication Method:

Not applicable. Adjudication methods (like 2+1, 3+1) are used in AI studies to resolve disagreements among human labelers establishing ground truth. For a hip implant, material properties and mechanical performance tests have objective outcomes measured by equipment.

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

Not applicable. MRMC studies are used to evaluate how an AI algorithm affects the performance of human readers (e.g., radiologists interpreting images). This device is a physical implant, not an interpretive algorithm.

6. Standalone Performance:

Not applicable. "Standalone performance" refers to the algorithm's performance without human intervention. This device is a component of a total hip replacement, which is entirely reliant on human surgeons for implantation and human patients for its function. The closest equivalent would be the mechanical performance of the device components themselves, which is implicitly what the "testing" section refers to.

7. Type of Ground Truth Used:

Not applicable in the AI sense. For this device, "truth" is established by:

• Engineering design specifications.
• Conformity to international standards (e.g., ISO 21535 mentioned for range of motion).
• Material science properties.
• Biocompatibility assessments.
• Demonstration of substantial equivalence to predicate devices which have a known history of safe and effective use.

8. Sample Size for the Training Set:

Not applicable. This device does not use a training set as it is not an AI/ML device.

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

Not applicable. No training set exists for this device.

Summary

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

January 26, 2015

OMNIlife Science, Inc. Ms. Vani Sindwani Regulatory Affairs Specialist 50 O'Connell Way, Suite 10 East Taunton, Massachusetts 02718

Re: K142201

Trade/Device Name: OMNI Interface™ Acetabular System 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, LZO, MEH Dated: November 25, 2014 Received: November 28, 2014

Dear Ms. Sindwani:

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

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Page 2 - Ms. Vani Sindwani

(21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Lori A. Wiggins -S

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

Enclosure

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510(k) Number (if known): K142201

Device Name: OMNI (previously Apex) Interface™ Acetabular System

Indications for Use:

The OMNI Interface™ Acetabular System is designed to be used in hip arthroplasty. The specific indications for use include -

• . Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
• Rheumatoid arthritis;
• Correction of functional deformity;
• Congenital dislocation;
• Revision procedures where other treatments or devices have failed;
• Femoral neck and trochanteric fractures of the proximal femur.

The OMNI Interface Acetabular System is intended for cementless and single use implantation only.

X AND/OR Over-The-Counter Use Prescription Use (Part 21 CFR 801 Subpart D) (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)

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510(k) Summary

TABLE 1: 510(k) SUMMARY
Date Summary Prepared	08/08/2014
Manufacturer/Distributor/Sponsor	OMNIlife Science, Inc.50 O'Connell WaySuite 10East Taunton, MA 02718
510(k) Contact	Vani SindwaniRegulatory Affairs SpecialistOMNIlife Science50 O' Connell WaySuite 10East Taunton, MA 02718Telephone: [phone]Fax: [phone]Email: [e-mail]
Trade Name	OMNI Interface™ Acetabular System
Common Name	Prosthesis, hip, semi-constrained, metal/polymer,porous uncemented
Classification	21 CFR 888.3358 Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis. LPH
Predicate Device	K112779 Apex Interface Acetabular SystemK060635 Consensus Acetabular Shell SystemK123782 Paragon Hip SystemReference Predicates:K031110 Apex Acetabular Shell
Purpose of Submission	This traditional 510(k) premarket notification is beingsubmitted to expand the indications for OMNI InterfaceAcetabular System. Through this premarket notificationOMNI intends to obtain clearance for the use of OMNIInterface Acetabular System with Global's Paragonstem cleared via K123782.
Device Description and Intended Use	The OMNI Interface Acetabular System consists ofacetabular cups/shells that are made of titanium alloy,standard and crosslinked ultra high molecular weightpolyethylene shell inserts and femoral heads that areused with compatible femoral hip stems for primary and
	revision total hip replacement. The shells are availablein “no hole” and “3-hole” configuration and a size rangefrom 46-76 mm and X size (48x-58xmm).
	The OMNI Interface™ Acetabular System is designedto be used in hip arthroplasty. The specific indicationsfor use include -Non-inflammatory degenerative joint disease,including osteoarthritis and avascular necrosis;Rheumatoid arthritis;Correction of functional deformity;Congenital dislocation;Revision procedures where other treatments ordevices have failed;Femoral neck and trochanteric fractures of theproximal femur.
	The OMNI Interface Acetabular System is intended forcementless and single use implantation only.
Substantial Equivalence Summary	The OMNI Interface Acetabular System is substantiallyequivalent to the predicates as the basic design,interface, fundamental technology, materials andintended use are the same.
	Paragon stem (K123782) is cleared to be used inconjunction with a compatible femoral head andacetabular component and is used with Consensus CS2Acetabular Shell System (K060635). OMNIlife sciencehas determined OMNI Interface Acetabular System tobe substantially equivalent to CS2 Acetabular ShellSystem thereby supporting its use with the Paragonstem.
	The use of OMNI Interface Acetabular System with theParagon stem is determined to be as safe and effectiveas the predicate and does not raise any new safety oreffectiveness concerns. The results of testing for theproposed use of OMNI Interface Acetabular Systemwith the Paragon Stem met the performancerequirements for range of motion per ISO 21535
The comparison between OMNI hip stems and theParagon stem, and OMNI and Global femoral headshave been included in this submission that furthersupports the compatibility of OMNI InterfaceAcetabular System and Paragon Stem.
Based on the identical material, the design andcharacterization data, compatibility and mechanicaltesting, and technological characteristics, OMNIlifescience believes the proposed OMNI InterfaceAcetabular System to be substantially equivalent tolegally marketed predicates and can be used withParagon stem for primary and revision hip arthroplasty.

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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.