The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2™, or Apex K1™ Hip Stem in total hip replacement procedures. The acetabular cup liners are intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
e 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. .

Device Description

The Interface™ Acetabular Cup Liners are manufactured of compression molded ultrahigh molecular weight polyethylene, sterilized using ethylene oxide. The articular geometry of the liners are compatible with existing Apex Modular femoral heads, manufactured from cobalt chrome or alumina ceramic, 28 mm, 32 mm or 36 mm diameter. The subject device adds an option for a 20° elevated rim that was not previously offered.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the "Interface™ Acetabular Cup Liners." This submission focuses on establishing substantial equivalence to previously marketed predicate devices, rather than presenting a study of the device's clinical performance against specific acceptance criteria in the manner of a clinical trial for an AI/ML medical device.

Therefore, the specific information requested about acceptance criteria, device performance, sample sizes, expert involvement, ground truth, and training sets (relevant to AI/ML device studies) is not applicable to this 510(k) submission for a physical orthopedic implant.

Here's why and what information is available:

Nature of the Device: The Interface™ Acetabular Cup Liners are physical medical devices (orthopedic implants) used in total hip replacement procedures. They are not an AI/ML algorithm or software that performs diagnostic or prognostic functions.
Regulatory Pathway (510(k)): A 510(k) submission demonstrates "substantial equivalence" to a legally marketed predicate device. This typically involves comparing design, materials, manufacturing processes, intended use, and performance characteristics (often mechanical testing for implants) to established, safe, and effective devices. It does not generally require new clinical trials or performance studies against predefined clinical acceptance criteria in the same way an AI/ML device would.

What is provided in the document and how it relates to "acceptance criteria" for a physical device:

The "acceptance criteria" in this context are primarily the demonstration of substantial equivalence to predicate devices. The study proving this involves detailed comparisons rather than a clinical performance study.

1. Table of Acceptance Criteria and Reported Device Performance:

The "acceptance criteria" here are implicitly meeting the design, material, and functional equivalence to the predicates. The "reported device performance" is the comparison showing these equivalences.

Acceptance Criteria (Implicit for Substantial Equivalence)	Reported Device Performance (Comparison from document)
Intended Use: Similar to predicate device(s).	Similar: "Modular liner in metal shell, primary and revision THA" (Yes, cementless for both subject and predicates)
Design: Similar locking mechanism and articular geometry.	Liner engagement: Subject device has "19° taper and PE locking ring," which is identical to Interface™ (K031110) and ApeX-LNK Poly™ (K062489 and K073150).Liner options: Subject device offers "20° elevated rim," which is equivalent to the 20° elevated rim option in the Zimmer Trilogy® Acetabular System. Predicates offered Neutral, 10°, 15°, and 20° options.Head diameters: Subject device accommodates "28, 32 and 36 mm" heads, consistent with ApeX-LNK Poly™ and Zimmer Trilogy®. Interface™ (K031110) accommodated 28 and 32 mm.
Materials: Similar to predicate device(s).	Cross-linked UHMWPE: Subject device uses No (i.e., standard UHMWPE), similar to Interface™ and Zimmer Trilogy®. ApeX-LNK Poly™ uses Yes (cross-linked). This is a difference, but the submission claims it's not a barrier to equivalence.
Sterilization: Similar to predicate device(s).	Ethylene oxide: Subject device uses Ethylene oxide, identical to Interface™ and ApeX-LNK Poly™. Zimmer Trilogy® uses Gas plasma. This is a difference, but the submission claims it's not a barrier to equivalence, likely due to established sterilization methods.

2. Sample size used for the test set and the data provenance: Not applicable. This is not a clinical study involving a test set of patient data. The "test" is the comparison of device characteristics to predicates.

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 clinical sense, is not established for this type of submission. The "ground truth" is the established safety and effectiveness of the predicate devices.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.

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 an orthopedic implant, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not applicable in the context of AI/ML. For this 510(k) submission, the "ground truth" (or basis of comparison) is the known safety and effectiveness profiles of the predicate devices (Interface™ (K031110), ApeX-LNK Poly™ (K062489 and K073150), and Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners) as determined by their prior FDA clearances and long-standing use in the market.

8. The sample size for the training set: Not applicable. This is not an AI/ML device.

9. How the ground truth for the training set was established: Not applicable.

In summary: The provided document is a 510(k) premarket notification that demonstrates substantial equivalence for a physical medical device (acetabular cup liners). The "study" proving it meets "acceptance criteria" involves a detailed comparison of its design, materials, and intended use against already cleared predicate devices. The concepts of test sets, training sets, expert ground truth, and AI-assisted performance are not relevant to this type of regulatory submission.

Summary

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OCT 2 3 2009

Interface™ Acetabular Cup Liners

August 7. 2009

1. Submitter:	OMNI life scienceTM, Inc.175 Paramount DriveRaynham, MA 02767
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Contact: William McCallum (508) 824-2444 x423 (voice) (508) 822-6030 (fax)

2. Device Name

Proprietary Name:	Interface™ Acetabular Cup Liners
Common Name:	Acetabular cup, uncemented
Classification Names:	Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis; andHip joint metal/ceramic/polymer semi-constrained cemented or nonporous uncemented prosthesis
Regulatory Class:	Class II per 21 CFR §888.3358

3. Intended Use

. Non-inflammatory degenerative joint disease, including osteoarthritis and avascular necrosis;
e 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. .

4. Device Description

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5. Predicate Device Comparison

Substantial equivalence is claimed to the Interface™ (K031110), the ApeX-LNK Poly™ (K062489 and K073150), and the Zimmer Trilogy® Acetabular System (K934765, K953490, and K972774) UHMWPE cup liners. The following table summarizes the similarities and differences between the subject Apex Modular Interface™ Acetabular System cup liners and the predicate cup liners:

	SubjectUHMWPELiners	Interface™UHMWPE Liners(K031110)	ApeX-LNK Poly™(K062489 andK073150)	Zimmer Trilogy®AcetabularSystem
INTENDED USE
Modular liner inmetal shell, primaryand revision THA	Yes, cementless	Yes, cementless	Yes, cementless	Yes, cementless
DESIGN
Liner engagement	19° taper and PElocking ring	19° taper and PElocking ring	19° taper and PElocking ring	Locking ring andanti-rotation tabs
Liner options	20° elevated rim	Neutral and 15°elevated rim	Neutral and 10°elevated rim	Neutral, 10°, and20° elevated rim;also offset, oblique,and eccentricoptions
Head diameters	28, 32 and 36 mm	28 and 32 mm	28, 32, and 36 mm	28, 32, and 36 mm
MATERIALS
Cross-linkedUHMWPE	No	No	Yes	No
Sterilization	Ethylene oxide	Ethylene oxide	Ethylene oxide	Gas plasma

6. Basis of Substantial Equivalence

The Interface™ Acetabular Cup Liners described in this submission are substantially equivalent to the predicate devices based on similarities in design, intended use, material and manufacturing methods. The locking mechanism is identical to the locking mechanism in the predicate Interface™ Acetabular Cup Liners (K031110) and the ApeX-LNK Poly™ Acetabular Cup Liners (K062489 and K073150). The material, manufacturing, sterilization and packaging methods are identical to those of the predicate Interface™ Acetabular Cup Liners. The 20° elevated rim liner option is equivalent to the 20° elevated rim option in the Zimmer Trilogy® Acetabular System.

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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 an abstract design of three overlapping human profiles facing right, with stylized waves or lines below them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the design.

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

OMNI Life Science, Inc. % Mr. William McCallum 175 Paramount Drive Raynham, Massachusetts 02767

Re: K092443

OCT 2 3 2009

Trade/Device Name: Interface™ Acetabular Cup Liners Regulation Number: 21 CFR 888.3358 Regulation Name: Hip joint metal/polymer/metal semi-constrained porous-coated uncemented prosthesis Regulatory Class: II Product Code: LPH, LZO, MEH Dated: September 15, 2009 Received: September 18, 2009

Dear Mr. McCallum:

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 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 (reporting of medical 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.

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Page 2- Mr. William McCallum

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,
Mark A. Milkerson

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

Enclosure

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K092443

Indications for Use

510(k) Number (if known):

Device Name: Interface™ Acetabular Cup Liners

Indications For Use:

The Interface™ Acetabular Cup Liners are intended for use with the Interface™ Acetabular Cup, in combination with the Apex Modular™, Apex K2TM, or Apex K1™ Hip Stem in total hip replacement procedures. This acetabular cup is intended to articulate with a metal (cobalt chromium) or ceramic (alumina) femoral head. This prosthesis is intended for single use implantation, and may be used for the following conditions, as appropriate:

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. .

Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (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)

Sonita 2 for MXN

ision Sign Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K092443

Page 1 of

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.